,,ii ,calendar ,no4 #hi #aacth ,,congress #ast ,session ,s4 #iei ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #ae1 #bjac ,mr4 ,harkin 7for himself1 ,mr4 ,alexander1 ,mr4 ,roberts1 ,mr4 ,franken1 ,ms4 ,mikulski1 and ,ms4 ,warren7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,june #ai1 #bjac ,reported by ,mr4 ,harkin1 with an amendment and an amendment to the title ,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to compounding drugs4 #a4 ,short title2 references in ,act 7a7 ,short title ,this ,act may be cited as the ,pharmaceutical ,compounding ,quality and ,accountability ,act4 7b7 ,references in ,act ,except as otherwise specified1 amendments made by this ,act to a section or other provision of law are amendments to such section or other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #b4 ,regulation of human and animal drug compounding 7a7 ,clarification of new drug and new animal drug status ,for purposes of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 the terms new drug 7as defined in section #bja7p7 of such ,act7 and new animal drug 7as defined in section #bja7v7 of such ,act7 shall include a compounded human drug and a compounded animal drug1 respectively4 7b7 ,regulation of human and animal drug compounding ,section #ejc;,a 7#ba ,u4,s4,c4 #cec;a7 is amended to read as follows3 #ejc;,a4 ,human and animal drug compounding 7a7 ,scope 7#a7 ,compounding ,in this section1 the terms compounding and compound-- 7,a7 include-- 7i7 the combining1 admixing1 mixing1 diluting1 reconstituting1 or otherwise altering of a marketed drug2 7ii7 compounding a drug from a bulk drug substance2 and 7iii7 repackaging1 as defined in subsection 7b77#e72 and 7,b7 exclude mixing1 reconstituting1 or other such acts with respect to a marketed drug that are limited to and performed solely in accordance with specific directions for such acts contained in approved labeling provided by a drug's manufacturer1 when performed upon receipt of a prescription order for an identified individual patient4 7#b7 ,dispensing not a sale ,in this section1 the terms sell or resale do not include dispensing to patients1 or1 in the case of animal drugs1 to the individual responsible for providing care for the animal for which the drug is intended1 in accordance with ,state law1 including any fee associated with such dispensing4 7#c7 ,exemptions ,this section shall not apply to-- 7,a7 medical gases2 7,b7 animal drugs that are subject to regulation as biological products by the ,secretary of ,agriculture under the ,act commonly known as the ,virus-,serum-,toxin ,act2 or 7,c7 human blood and blood components for transfusion4 7b7 ,definitions ,in this section3 7#a7 ,compounding manufacturer 7,a7 ,in general ,the term compounding manufacturer means a facility at one geographic location or address-- 7i7 that compounds any sterile drug product without receiving a prescription order for such sterile drug product prior to beginning compounding1 and distributes or offers to sell such compounded sterile drug product in interstate commerce2 or 7ii7 that repackages any preservative-free sterile drug product or pools any sterile drug products1 except as provided in paragraph 7#g77;,b74 7,b7 ,excluded activities ,notwithstanding subparagraph 7,a77ii71 a facility shall not be considered a compounding manufacturer if such facility-- 7i7 repackages drugs in accordance with section #ejf;,f or the final guidance described in section #ejf;,f7d72 and 7ii7 does not otherwise meet the definition of compounding manufacturer under subparagraph 7,a74 7#b7 ,pooling2 pools ,the terms pooling and pool-- 7,a7 mean taking a single drug approved under section #eje or #eab1 conditionally approved under section #ega1 included on the index established under section #egb7;a77#a71 or licensed under section #cea of the ,public ,health ,service ,act from the container in which it is distributed by the original manufacturer and combining it with the same drug from one or more other containers without or before further manipulating the product 7such as by diluting it or mixing it with another1 different drug or drugs72 7,b7 do not include combining the drug from two or more separate containers of the same drug when a single container of the drug is not sufficient to prepare a single dose for administration to an individual patient2 and 7,c7 do not include combining the drug from two or more separate containers of component products of a total parenteral nutrition product1 if such pooling1 and labeling and use of the finished total parenteral nutrition product1 comply with ,state pharmacy law4 7#c7 ,practitioner ,the term practitioner includes a physician1 veterinarian1 or any other person that is authorized to prescribe medication under ,state law4 7#d7 ,prescription2 prescription order ,the term prescription or prescription order means a prescription or prescription order1 as defined under applicable ,state law1 that complies with requirements applicable under such ,state law4 7#e7 ,repackage or repackaging ,the term repackage or repackaging means taking a drug approved under section #eje or #eab1 conditionally approved under section #ega1 included on the index established under section #egb7;a77#a71 or licensed under section #cea of the ,public ,health ,service ,act from the container in which it is distributed by the original manufacturer and placing it in a different container of the same or smaller size without further manipulating the drug 7such as by diluting it or mixing it with another1 different drug or drugs71 unless such repackaging is done pursuant to a prescription for an identified individual patient4 7#f7 ,sterile drug product ,the term sterile drug product means a drug that is-- 7,a7 intended for parenteral administration2 7,b7 an ophthalmic or inhalation drug2 or 7,c7 required to be sterile under ,federal or ,state law4 7#g7 ,traditional compounder 7,a7 ,in general ,the term traditional compounder means an entity-- 7i7 wherein a drug is compounded by-- 7,i7 a licensed pharmacist1 or other pharmacy personnel 7to the extent permitted under ,state law71 in a ,state-licensed pharmacy or a ,federal facility2 or 7,,ii7 a licensed physician or licensed veterinarian1 to the extent permitted under ,state law2 7ii7 that-- 7,i7 compounds a drug upon receipt of a prescription order for an identified individual patient2 or 7,,ii7 compounds a drug in limited quantities before receipt of a prescription order for an identified individual patient1 to the extent permitted under ,state law1 if such compounding is based on a history of the licensed pharmacist1 licensed physician1 or licensed veterinarian receiving prescription orders for the compounding of the drug1 which orders have been generated solely within an established relationship between the licensed pharmacist1 licensed physician1 or licensed veterinarian and-- 7aa7 such individual patient for whom the prescription order will be provided1 or1 in the case of an animal drug1 such individual responsible for providing care for the animal for which the drug is ordered2 or 7bb7 the licensed physician1 licensed veterinarian1 or other licensed practitioner who will write such prescription order2 and 7iii7 that does not meet the definition of a compounding manufacturer under paragraph 7#a74 7,b7 ,exceptions 7i7 ,hospitals and health systems 7,i7 ,in general ,a pharmacy within a hospital1 veterinary hospital1 or health system that compounds a drug and dispenses such drug 7which may include interstate shipment7 within such hospital or health system or ships such drug for dispensing to patients with an established relationship with the hospital or health system 7which may include interstate shipment71 or that repackages preservative-free sterile drug product or pools sterile drug products1 shall be considered a traditional compounder if such pharmacy otherwise meets the definition under subparagraph 7,a74 7,,ii7 ,health system defined ,for purposes of this subparagraph1 the term health system means two or more hospitals or veterinary hospitals that are owned and operated by the same entity and that share access to databases with drug order information for patients or animals1 as applicable4 ,a health system includes both the inpatient and outpatient facilities of hospitals within the health system4 7ii7 ,,pet and radiopharmaceuticals ,a pharmacy that compounds positron emission tomography drugs or radiopharmaceuticals shall be considered a traditional compounder if it does not compound other drugs that would cause it to be a compounding manufacturer described in paragraph 7#a77;,a74 7c7 ,exemptions from certain requirements 7#a7 ,drugs compounded by traditional compounders ,sections #eja7;a77#b77;,b71 #ejb7;f77#a71 #eje 7in the case of a human drug71 section #eab 7in the case of an animal drug71 and section #cea of the ,public ,health ,service ,act 7in the case of a biological product7 shall not apply to a compounded drug if such drug-- 7,a7 is compounded by a traditional compounder that is in compliance with this section2 and 7,b7 meets the requirements of this section applicable to drugs compounded by traditional compounders4 7#b7 ,drugs compounded by compounding manufacturers ,sections #ejb7;f77#a71 #eje 7in the case of a human drug71 section #eab 7in the case of an animal drug71 and section #cea of the ,public ,health ,service ,act 7in the case of a biological product7 shall not apply to a compounded prescription drug if such drug-- 7,a7 is compounded by a compounding manufacturer-- 7i7 that is not licensed as a pharmacy in any ,state2 and 7ii7 that is in compliance with this section2 and 7,b7 meets the requirements of this section applicable to drugs compounded by compounding manufacturers4 7d7 ,drugs that may not be compounded 7#a7 ,in general ,the following drugs may not be compounded1 except under conditions specified by the ,secretary3 7,a7 ,drugs that are demonstrably difficult to compound ,a drug or category of drugs that presents demonstrable difficulties for compounding1 which may include a complex dosage form or biological product1 as designated by the ,secretary pursuant to paragraph 7#b74 7,b7 ,marketed drugs ,a drug1 other than a biological product1 that is a copy of a marketed drug approved under #eje or #eab1 conditionally approved under section #ega1 or included on the index established under section #egb7;a77#a71 except as provided in paragraph 7#c74 7,c7 ,biological products ,a drug that is a biological product1 except as provided in paragraph 7#d74 7,d7 ,drugs removed for safety and efficacy ,a drug that appears on a list published by the ,secretary in the ,federal ,register of drugs that have been withdrawn or removed from the market because such drug or components of such drug have been found to be unsafe or not effective1 subject to paragraph 7#e74 7#b7 ,drugs that are demonstrably difficult to compound 7,a7 ,in general ,the ,secretary may promulgate a regulation that designates drugs or categories of drugs that are demonstrably difficult to compound that may not be compounded1 or that may be compounded only under conditions specified by the ,secretary4 ,such regulation-- 7i7 may include the designation of drugs or categories of drugs that are complex dosage forms or biological products1 such as extended release products1 metered dose inhalers1 transdermal patches1 and sterile liposomal products2 and 7ii7 shall specify1 for each drug included on the list1 whether the prohibition or condition applies to the use of the drug in humans1 animals1 or both4 7,b7 ,interim list 7i7 ,in general ,before the effective date of the regulation promulgated under subparagraph 7,a71 the ,secretary may designate drugs that are complex dosage forms or biological products that cannot be compounded by-- 7,i7 publishing a notice of such drugs proposed for designation1 including the rationale for such designation1 in the ,federal ,register2 7,,ii7 providing a period of not less than #fj days for comment on the notice2 and 7,,iii7 publishing a notice in the ,federal ,register designating the drugs that are complex dosage forms and biological products that cannot be compounded4 7ii7 ,sunset ,any notice provided under clause 7i7 shall cease to have force or effect on the date that is #e years after the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act or on the effective date of the final regulation under subparagraph 7,a71 whichever is earlier4 7#c7 ,exceptions regarding marketed drugs 7,a7 ,in general ,a drug 7other than a biological product7 that is a copy of a marketed drug approved under #eje or #eab1 conditionally approved under section #ega1 or included on the index established under section #egb7;a77#a71 including variations of such drug compounded from bulk substances1 may be compounded only if-- 7i7 7,i7 the compounded variation produces for the patient a clinical difference between the compounded drug and such marketed drug1 as determined by the prescribing practitioner1 and1 prior to beginning compounding a variation of such drug1 the facility compounding the variation receives a prescription order specifying that the variation may be compounded2 or 7,,ii7 7aa7 such marketed drug1 at the time of compounding a copy of such drug and at the time of distribution of the compounded drug1 is on the drug shortage list under section #ejf;,e 7in the case of a human drug71 on the ,current ,drug ,shortages list for veterinary products maintained on the ,internet ,web site of the ,food and ,drug ,administration 7in the case of an animal drug71 or in the ,secretary's sole discretion1 has otherwise been identified by the ,secretary as in shortage such as in a specific region or on a drug shortage list maintained by a private party2 and 7bb7 the traditional compounder or the compounding manufacturer notifies the ,secretary not later than #c calendar days after beginning the compounding1 unless the ,secretary waives the notice requirement2 and 7ii7 in the case of a marketed drug approved under section #eje that is subject to a risk evaluation and mitigation strategy approved with elements to assure safe use pursuant to section #eje-a1 the entity compounding the drug demonstrates to the ,secretary that the entity will utilize controls that are comparable to the controls applicable under the relevant risk evaluation and mitigation strategy4 7,b7 ,exclusion ,for purposes of this paragraph1 repackaging a marketed drug approved under section #eje1 #eab1 conditionally approved under section #ega1 or included on the index established under section #egb7;a77#a71 does not make the repackaged drug a copy of such marketed drug4 7#d7 ,exceptions regarding biological products ,a drug that is a biological product may be compounded only if-- 7,a7 such drug is compounded from a licensed biological product and the compounding does not involve combining or mixing the licensed biological product with-- 7i7 a bulk drug substance2 or 7ii7 another1 different drug or drugs approved under #eje or #eab1 conditionally approved under section #ega1 included on the index established under section #egb7;a77#a71 or licensed under section #cea of the ,public ,health ,service ,act1 unless the compounding is limited to the combining1 mixing1 or diluting of licensed allergenic products2 and 7,b7 7i7 with respect to a traditional compounder1 the compounded biological product produces for the patient a clinical difference between the compounded drug and the licensed biological product1 as determined by the prescribing practitioner1 and1 prior to beginning compounding such drug1 the facility compounding the variation receives a prescription order specifying that the biological product may be compounded2 7ii7 with respect to a compounding manufacturer1 the compounded variation biological product produces for the patient a clinical difference between the compounded drug and the licensed biological product1 as determined by a licensed practitioner responsible for the patient's care in a health care entity that provides medical services through licensed prescribers directly to patients1 and1 prior to beginning compounding such drug1 the compounding manufacturer receives a duly authorized medical order from a hospital or health system specifying that the biological product may be compounded2 or 7iii7 the compounded biological product is an allergenic product4 7#e7 ,requirement regarding drugs removed for safety or efficacy ,the list published by the ,secretary in the ,federal ,register of drugs that have been withdrawn or removed from the market1 as described in paragraph 7#a77;,d71 shall specify whether a human drug on such list may1 notwithstanding the inclusion on such list1 be compounded for use in animals4 ,the ,secretary shall update the lists described in subparagraphs 7,d7 and 7,e7 of subsection 7e77#b71 as appropriate1 to conform with the list described in paragraph 7#a77;,d74 7e7 ,quality of drug ingredients 7#a7 ,human drugs ,a traditional compounder or a compounding manufacturer shall-- 7,a7 compound a human drug using only bulk drug substances 7as defined in regulations of the ,secretary published at section #bjg4c7;a77#d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77-- 7i7 that-- 7,i7 comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph1 if a monograph exists and has not been identified under paragraph 7#f71 and the ,united ,states ,pharmacopoeia chapters on pharmacy compounding2 7,,ii7 if such a monograph does not exist1 are drug substances that are components of drugs approved by the ,secretary2 or 7,,iii7 if such a monograph does not exist and the drug substance is not a component of a drug approved by the ,secretary1 that appear on a list developed by the ,secretary through regulations issued by the ,secretary2 7ii7 that are manufactured by an establishment that is registered under section #eaj 7including a foreign establishment that is registered under section #eaj7;i772 and 7iii7 that are accompanied by valid certificates of analysis for each specific lot of bulk drug substance2 and 7,b7 use ingredients 7other than bulk drug substances7 that comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph1 if a monograph exists and has not been identified under paragraph 7#f71 and with the ,united ,states ,pharmacopoeia chapter on pharmacy compounding4 7#b7 ,animal drugs ,a traditional compounder or a compounding manufacturer shall-- 7,a7 compound an animal drug using only bulk drug substances 7as defined in regulations of the ,secretary published at section #bjg4c7;a77#d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations77 that-- 7i7 are manufactured by an establishment that is registered under section #eaj 7including a foreign establishment that is registered under section #eaj7;i772 and 7ii7 are accompanied by valid certificates of analysis for each specific lot of bulk drug substance2 7,b7 use ingredients 7other than bulk drug substances7 that comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph1 if a monograph exists and has not been identified under paragraph 7#f71 and with the ,united ,states ,pharmacopoeia chapters on pharmacy compounding2 7,c7 in the case of a compounded animal drug for use in non-food-producing minor species1 use bulk substances that-- 7i7 comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph1 if a monograph exists and has not been identified under paragraph 7#f71 and with the ,united ,states ,pharmacopoeia chapters on pharmacy compounding2 7ii7 if such a monograph does not exist1 are drug substances that are components of drugs approved by the ,secretary2 or 7iii7 if such a monograph does not exist and the drug substance is not a component of a drug approved by the ,secretary1 that appear on a list developed by the ,secretary through regulations issued by the ,secretary2 7,d7 in the case of a compounded animal drug for use in non-food-producing major species1 beginning on the date of publication of the list established in accordance with paragraph 7#c77;,a71 shall use bulk substances that are included on such list1 subject to paragraph 7#c77;,c72 and 7,e7 in the case of a compounded animal drug for use in food-producing major and minor species1 shall use bulk substances that are included on a list established by the ,secretary of bulk substances acceptable for use in compounding a drug for one or more such species1 in accordance with paragraph 7#d74 7#c7 ,non-food-producing major species listing procedure 7,a7 ,in general ,not later than #cj days after the effective date of the ,pharmaceutical ,compounding ,quality and ,accountability ,act1 the ,secretary shall establish a list of bulk substances acceptable for compounding a drug for use in non-food-producing major species1 and any conditions applicable to such use1 and may also identify bulk substances that the ,secretary has determined not acceptable for compounding with respect to a drug for use in such species4 7,b7 ,procedure ,in developing and updating the list under subparagraph 7,a71 the ,secretary shall-- 7i7 publish a notice in the ,federal ,register identifying bulk substances proposed as acceptable and any bulk substance determine to be unacceptable1 and the rationale for such proposed designations2 7ii7 provide a period of not less than #cj days for comment on the notice2 and 7iii7 publish a notice in the ,federal ,register designating the bulk substances acceptable1 and any bulk substances determined to be unacceptable1 and the rationale for such designations and determinations4 7,c7 ,notification ,upon initial publication of the list under subparagraph 7,b77iii71 any traditional compounder or compounding manufacturer that has received and filled a prescription in the #fj days prior to such publication for a compounded drug for a non-food-producing major species from a bulk substance not addressed in the notice 7either as acceptable or unacceptable71 and that reasonably expect to receive and fill another prescription for such a drug for such species within #fj days after such publication1 may notify the ,secretary of such bulk substance within #cj days of such publication1 in a manner to be determined by the ,secretary and published in the ,federal ,register on or before publication of the list under subparagraph 7,b77iii74 ,a traditional compounder or compounding manufacturer that provides such notice shall not be subject to the restriction in paragraph 7#b77;,d7 until such time as the ,secretary designates such bulk substance as acceptable or determines it to be unacceptable pursuant to the process described in subparagraph 7,b77iii74 7,d7 ,modification of list ,the ,secretary may amend the list at any time1 in accordance with process described in subparagraph 7,b74 7,e7 ,criteria ,in evaluating bulk substances for purposes of subparagraph 7,b71 the ,secretary shall consider1 among other factors-- 7i7 the safety of the bulk substance2 7ii7 historical use of the substance in pharmacy compounding2 7iii7 evidence of the effectiveness of the bulk substance or lack of effectiveness2 7iv7 whether any drug approved under section #eje or #eab1 conditionally approved under section #ega1 or included on the index established under section #egb7;a77#a71 can be used on label1 or any drug approved under section #eje or #eab can be used in an extralabel manner in accordance with section paragraphs 7#d7 and 7#e7 of section #eab7;a71 to treat the applicable condition in the identified species2 and 7v7 whether a compounded drug appropriate to treat the applicable condition in the identified species could be obtained by manipulating a drug approved under #eje or #eab1 conditionally approved under section #ega1 or included on the index established under section #egb7;a77#a74 7#d7 ,food-producing animals listing procedure ,in establishing a list of designated bulk substances acceptable for use in compounding a drug for use in food-producing major and minor species under paragraph 7#b71 and any conditions applicable to such use1 the ,secretary shall-- 7,a7 publish a notice in the ,federal ,register identifying bulk substances proposed as acceptable and any bulk substance determine to be unacceptable1 and the rationale for such designations2 7,b7 provide a period of not less than #cj days for comment on the notice2 and 7,c7 publish a notice in the ,federal ,register designating the bulk substances acceptable for use in compounding a drug for use in food-producing major and minor species1 and the rationale for such designations4 7#e7 ,withdrawal periods ,the requirements for establishing substantially extended withdrawal periods in accordance with section #ecj4bj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 shall apply to compounded animal drugs for use in food-producing animals that are compounded using bulk substances4 7#f7 ,identification by ,secretary 7,a7 ,in general ,notwithstanding the existence of an applicable monograph under subparagraph 7,a77i77,i7 or 7,b7 of paragraph 7#a7 or subparagraph 7,b7 or 7,c77i7 of paragraph 7#b71 the ,secretary may identify bulk substances that the ,secretary determines1 based on public health concerns1 may not be used in compounding a drug4 7,b7 ,procedure ,in identifying the bulk substances that may not be used in compounding1 the ,secretary shall-- 7i7 publish a notice of such bulk substances proposed for identification in the ,federal ,register2 7ii7 provide a period of not less than #fj days for comment on the notice2 7iii7 publish a notice in the ,federal ,register identifying the bulk substances that may not be used in compounding a drug2 and 7iv7 state whether the bulk is not suitable for compounding of human drugs1 animal drugs1 or both4 7f7 ,requirements regarding wholesaling and labeling applicable to traditional compounders and compounding manufacturers 7#a7 ,in general ,a compounded drug-- 7,a7 may not be sold by an entity other than the compounding manufacturer or traditional compounder that compounded the drug2 7,b7 compounded by a compounding manufacturer may not be sold to an entity other than a health care entity that provides medical services through licensed prescribers directly to patients or animals1 or a network of such providers1 except that a compounding manufacturer may transfer without profit a compounded sterile drug to a licensed pharmacy if-- 7i7 the licensed pharmacy falls under the same corporate ownership as the compounding manufacturer2 7ii7 the transfer of such compounded sterile drug is solely for the purpose of dispensing the compounded sterile drug to the end user1 who has been instructed by the prescribing physician to self-administer such compounded sterile drug2 7iii7 as of the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act1 the compounding manufacturer is an entity that provides pharmacy benefits management services on behalf of a health benefits plan2 7iv7 the compounding manufacturer identifies itself to the ,secretary upon registering under subsection 7g77#b7 as an entity that qualifies for the exemption under this subparagraph1 and provides documentation of the compounding of such drugs as of the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act1 in a manner described by the ,secretary2 and 7v7 the compounding manufacturer receives confirmation from the ,secretary that the compounding manufacturer qualifies for the exemption under this subparagraph and the sterile drug or drugs for which the exemption applies2 and 7,c7 in the case of a compounded drug sold to a health care entity described in subparagraph 7,b71 shall be labeled not for resale4 7#b7 ,advertising and promotion ,the advertising and promotion of compounded drugs shall not be false or misleading in any particular4 7g7 ,other requirements applicable to compounding manufacturers 7#a7 ,licensed pharmacist oversight ,a compounding manufacturer shall ensure that a pharmacist licensed in the ,state where the compounding manufacturer is located exercises direct supervision over the operations of the compounding manufacturer4 7#b7 ,registration of compounding manufacturers and reporting of drugs 7,a7 ,registration of compounding manufacturers 7i7 ,annual registration ,during the period beginning on ,october #a and ending on ,december #ca each year1 each compounding manufacturer shall register with the ,secretary its name1 place of business1 and unique facility identifier 7which shall conform to the requirements for the unique facility identifier established under section #eaj71 and a point of contact e-mail address4 7ii7 ,new compounding manufacturers ,each compounding manufacturer1 upon first engaging in the operations described in subsection 7b77#a71 shall immediately register with the ,secretary and provide the information described under clause 7i74 ,the ,secretary shall establish a timeline for registration for the first year following the effective date of the ,pharmaceutical ,compounding ,quality and ,accountability ,act4 ,in no case may registration be required until at least #fj days following publication of the timeline in the ,federal ,register4 7iii7 ,additional facilities ,each compounding manufacturer duly registered in accordance with clauses 7i7 and 7ii7 shall immediately identify to the ,secretary any additional facility that engages in the activities described in subsection 7b77#a7 and that is owned or operated in any ,state by the person that owns or operates the compounding manufacturer4 7iv7 ,availability of registration for inspection ,the ,secretary shall make available for inspection1 to any person so requesting1 any registration filed pursuant to this subparagraph1 except that any drug reporting information submitted pursuant to this subparagraph and the information accompanying such reporting shall be exempt from such inspection1 unless the ,secretary finds that such an exemption would be inconsistent with the protection of the public health4 7,b7 ,drug reporting by compounding manufacturers 7i7 ,in general ,each compounding manufacturer who registers with the ,secretary under subparagraph 7,a7 shall submit to the ,secretary1 once during the month of ,june of each year and once during the month of ,december of each year1 a report-- 7,i7 identifying the drugs compounded by such compounding manufacturer during the previous #f-month period2 and 7,,ii7 with respect to each drug identified under subclause 7,i71 providing the active ingredient1 the source of such active ingredient1 the ,national ,drug ,code number of the source drug or bulk active ingredient1 the strength of the active ingredient per unit1 the dosage form and route of administration1 the package description1 the number of individual units produced1 the ,national ,drug ,code number of the final product1 and which conforms to other applicable requirements identified by the ,secretary in accordance with clause 7ii74 7ii7 ,form ,each report under clause 7i7 shall be prepared in such form and manner as the ,secretary may prescribe by regulation or guidance4 7,c7 ,electronic registration and reporting ,registrations and drug reporting under this paragraph 7including the submission of updated information7 shall be submitted to the ,secretary by electronic means unless the ,secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting waiver4 7,d7 ,risk-based inspection frequency 7i7 ,in general ,compounding manufacturers shall be subject to inspection pursuant to section #gjd4 7ii7 ,risk-based schedule ,the ,secretary1 acting through one or more officers or employees duly designated by the ,secretary1 shall inspect compounding manufacturers described in clause 7i7 in accordance with a risk-based schedule established by the ,secretary4 7iii7 ,risk factors ,in establishing the risk-based schedule under clause 7ii71 the ,secretary shall inspect compounding manufacturers according to the known safety risks of such compounding manufacturers1 which shall be based on the following factors3 7,i7 ,the compliance history of the compounding manufacturer4 7,,ii7 ,the record1 history1 and nature of recalls linked to the compounding manufacturer4 7,,iii7 ,the inherent risk of the drug compounded at the compounding manufacturer4 7,,iv7 ,the inspection frequency and history of the compounding manufacturer1 including whether the compounding manufacturer has been inspected pursuant to section #gjd within the last #d years4 7,v7 ,any other criteria deemed necessary and appropriate by the ,secretary for purposes of allocating inspection resources4 7#c7 ,adverse event reporting 7,a7 ,definitions ,in this paragraph3 7i7 ,adverse event ,the term adverse event means any health-related event associated with the use of a compounded drug that is adverse1 including-- 7,i7 an event occurring in the course of the use of the drug in professional practice2 7,,ii7 an event occurring from an overdose of the drug1 whether accidental or intentional2 7,,iii7 an event occurring from abuse of the drug2 7,,iv7 an event occurring from withdrawal of the drug2 and 7,v7 any failure of expected pharmacological action of the drug4 7ii7 ,serious adverse event ,the term serious adverse event means an adverse event that-- 7,i7 results in-- 7aa7 death2 7bb7 an adverse drug event that places the patient at immediate risk of death from the adverse drug event as it occurred 7not including an adverse drug event that might have caused death had it occurred in a more severe form72 7cc7 inpatient hospitalization or prolongation of existing hospitalization2 7dd7 a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions2 or 7ee7 a congenital anomaly or birth defect2 or 7,,ii7 based on appropriate medical judgment1 may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described in subclause 7,i74 7,b7 ,reports 7i7 ,adverse event reporting requirement 7,i7 #ae-;day report ,if a compounding manufacturer becomes aware of any serious adverse event1 such manufacturer shall submit reports of each instance to the ,secretary as soon as practicable1 but in no case later than #ae calendar days after the initial receipt of the applicable information4 ,such manufacturer shall investigate and submit to the ,secretary followup reports for each such instance not later than #ae calendar days after receipt of new information or as requested by the ,secretary4 ,unless and until the ,secretary establishes the content and format of adverse event reports by guidance or regulation1 reports shall be submitted in accordance with the content and format requirements under section #caj4cje of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 7in the case of human drugs71 section #fjj4hj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 7in the case of biological products71 or section #ead4hj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 7in the case of animal drugs74 7,,ii7 ,annual report ,compounding manufacturers that report serious adverse events shall submit in ,december of each year a narrative summary of any analysis of each report submitted under subclause 7,i71 including a history of actions taken during the year because of each report1 using the content1 format1 and manner established by the ,secretary by guidance or regulation4 ,until such time as the ,secretary publishes such guidance or regulation1 each compounding manufacturer shall retain such summaries as part of the records to be maintained in accordance with subparagraph 7,c74 7ii7 ,product quality reporting requirement ,not later than #c calendar days after the compounding manufacturer becomes aware of information pertaining to sterility1 stability1 or other product quality concerns that could result in serious adverse events1 the compounding manufacturer shall submit to the ,secretary a product quality report1 in a form and manner established by the ,secretary by guidance or regulation4 7,c7 ,maintenance of records ,a compounding manufacturer shall maintain for a period of #aj years records of all serious adverse drug events known to the compound manufacturer in accordance with section #cad4hj7;i7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation71 or as otherwise directed by the ,secretary in regulations4 7#d7 ,labeling of drugs 7,a7 ,label ,the label of a drug compounded by a compounding manufacturer shall include-- 7i7 the statement ,this is a compounded drug4 or a reasonable comparable alternative statement 7as specified by the ,secretary7 that identifies the drug as a compounded drug2 7ii7 the name1 address1 and phone number of the applicable compounding manufacturer2 and 7iii7 with respect to the compounded drug-- 7,i7 the lot or batch number2 7,,ii7 the established name of the medication2 7,,iii7 the dosage form and strength2 7,,iv7 the statement of quantity or volume1 as appropriate2 7,v7 in the case of a drug intended for use in a food-producing animal1 the withdrawal period established pursuant to subsection 7e77#e7 to ensure that no residues from the compounded drug can be detected in edible tissues of the treated animal2 7,,vi7 the date that the drug was compounded2 7,,vii7 the expiration date2 7,,viii7 storage and handling instructions2 7,,ix7 the ,national ,drug ,code number1 if available2 7,x7 the not for resale statement required as required by subsection 7f77#a77;,c72 and 7,,xi7 subject to subparagraph 7,b77i71 a list of active and inactive ingredients1 identified by established name and the quantity or proportion of each ingredient4 7,b7 ,container ,the container from which the individual units of a drug compounded by a compounding manufacturer are removed for dispensing or for administration 7such as a plastic bag containing individual product syringes7 shall include-- 7i7 the information described under subparagraph 7,a77iii77,,xi71 if there is not space on the label for such information2 7ii7 the following information to facilitate adverse event reporting3 www4fda4gov_/medwatch and #a-hjj-;,,fda-#ajhh2 and 7iii7 the directions for use1 including dosage and administration1 as appropriate4 7,c7 ,additional information ,the label and labeling of a drug compounded by a compounding manufacturer shall include any other information as determined necessary and specified in regulations promulgated by the ,secretary4 7h7 ,compounding manufacturer establishment and reinspection fees 7#a7 ,definitions ,in this subsection-- 7,a7 the term affiliate has the meaning given such term in section #gce7aa72 7,b7 the term gross annual sales means the total worldwide gross annual sales1 in ,united ,states dollars1 for a compounding manufacturer1 including the sales of all the affiliates of the compounding manufacturer2 and 7,c7 the term reinspection means1 with respect to a compounding manufacturer1 one or more inspections conducted under section #gjd subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this ,act1 specifically to determine whether compliance has been achieved to the ,secretary's satisfaction4 7#b7 ,establishment and reinspection fees ,for fiscal year #bjae and each subsequent fiscal year1 the ,secretary shall1 in accordance with this subsection1 assess and collect-- 7,a7 an annual establishment fee from each compounding manufacturer to cover inspection-related costs relating to inspections of drug compounders for such year2 and 7,b7 a reinspection fee from each compounding manufacturer subject to a reinspection in such fiscal year4 7#c7 ,establishment and reinspection fee setting ,the ,secretary shall establish the establishment and reinspection fee to be collected under this subsection for each fiscal year1 based on the methodology described in paragraph 7#d7 and shall publish such fee in a ,federal ,register notice not later than #fj days before the start of each such year4 7#d7 ,amount of establishment and reinspection fee 7,a7 ,in general ,except as provided in subparagraph 7,d71 the amount of the annual establishment fee and the reinspection fee 7if applicable7 under paragraph 7#b7 for each compounding manufacturer in a fiscal year shall be equal to the sum of-- 7i7 7,i7 #ae1jjj per compounding manufacturer1 multiplied by 7,,ii7 the inflation adjustment factor described in subparagraph 7,b72 plus 7ii7 the small business adjustment factor described in subparagraph 7,c74 7,b7 ,inflation adjustment factor 7i7 ,in general ,for fiscal year #bjae and subsequent fiscal years1 the revenues established in subparagraph 7,a7 shall be adjusted by the ,secretary by notice1 published in the ,federal ,register1 for a fiscal year by the amount equal to the sum of-- 7,i7 one2 7,,ii7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the ,food and ,drug ,administration for the first #c years of the preceding #d fiscal years1 and 7,,iii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,u4,s4 ,city ,average2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the ,food and ,drug ,administration for the first #c years of the preceding #d fiscal years4 7ii7 ,compounded basis ,the adjustment made each fiscal year under clause 7i7 shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year #bjad under clause 7i74 7,c7 ,small business adjustment factor ,the small business adjustment factor described in subparagraph 7,a77ii7 shall be an amount established by the ,secretary for each fiscal year based on the ,secretary's estimate of-- 7i7 the number of small businesses that will pay a reduced establishment fee for such fiscal year2 and 7ii7 the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the ,secretary would have collected if no entity qualified for the small business exception in subparagraph 7,d74 7,d7 ,exception for small businesses 7i7 ,in general ,in the case of a compounding manufacturer with gross annual sales of #a1jjj1jjj or less in the #ab months ending ,june #a of the fiscal year immediately preceding the fiscal year in which the fees under this subsection are assessed1 the amount of the establishment fee and reinspection fee under paragraph 7#b7 for a fiscal year shall be equal to #a_/c of the amount calculated under subparagraph 7,a77i7 in such fiscal year4 7ii7 ,application ,the ,secretary may require a small business to apply for the exception under this subparagraph by certifying its gross annual sales for the #ab months ending ,june #a of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed4 ,any such application must be submitted to the ,secretary prior to ,august #a for the following fiscal year4 ,any statement or representation made to the ,secretary shall be subject to section #ajja of title #ah1 ,united ,states ,code4 7,e7 ,crediting of fees ,in establishing the small business adjustment factor under subparagraph 7,c7 for a fiscal year1 the ,secretary shall provide for the crediting of fees from the previous year to the next year if the ,secretary overestimated the amount of the small business adjustment factor for such previous fiscal year1 and consider the need to account for any adjustment of fees and such other factors as the ,secretary determines appropriate4 7#e7 ,use of fees ,the ,secretary shall make all of the fees collected pursuant to subparagraph 7,a7 and 7,b7 of paragraph 7#b7 available solely to pay for the inspection-related costs 7including re-inspection7 for the oversight of drug compounding4 7#f7 ,supplement not supplant ,funds received by the ,secretary pursuant to this subsection shall be used to supplement and not supplant any other ,federal funds available to carry out the activities described in this subsection4 7#g7 ,crediting and availability of fees ,fees authorized under this subsection shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for the purpose of paying the inspection-related costs 7including reinspection7 for the oversight of drug compounding4 7#h7 ,collection of fees 7,a7 ,establishment fee ,a compounding manufacturer shall remit the establishment fee due under this subsection in a fiscal year when submitting a registration pursuant to subsection 7g7 for such fiscal year4 7,b7 ,reinspection fee ,the ,secretary shall specify in the ,federal ,register notice described in paragraph 7#c7 the manner in which reinspection fees assessed under this subsection shall be collected and the timeline for payment of such fees4 ,such a fee shall be collected after the ,secretary has conducted a reinspection of the compounding manufacturer involved4 7,c7 ,effect of failure to pay fees 7i7 ,registration ,a compounding manufacturer shall not be considered registered under subsection 7g7 in a fiscal year until the date that the compounding manufacturer remits the establishment fee under this subsection for such fiscal year4 7ii7 ,misbranding ,all drugs compounded by a compounding manufacturer for which any establishment fee or reinspection fee has not been paid as required by this subsection shall be deemed misbranded under section #ejb7;cc7 until the fees owed for such compounding manufacturer under this subsection have been paid4 7,d7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under this subsection within #cj days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to provisions of subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7#i7 ,annual report to congress ,not later than #abj days after each fiscal year in which fees are assessed and collected under this subsection1 the ,secretary shall submit a report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to include a description of fees assessed and collected for each year1 a summary description of entities paying the fees1 and the number of inspections and reinspections of such entities performed each year4 7#aj7 ,authorization of appropriations ,for fiscal year #bjae and each subsequent fiscal year1 there is authorized to be appropriated for fees under this subsection an amount equivalent to the total amount of fees assessed for such fiscal year under this subsection4 7i7 ,action by ,secretary regarding complaints from ,state boards of pharmacy 7#a7 ,designation ,the ,secretary shall designate a point of contact and establish a format and procedure for a ,state ,board of ,pharmacy to notify the ,secretary if it appears to a ,state ,board of ,pharmacy that an entity licensed by a ,state as a pharmacy is required to be registered with the ,secretary as a compounding manufacturer4 7#b7 ,determination ,if the ,secretary determines that such an entity described in paragraph 7#a7 is required to be registered with the ,secretary as a compounding manufacturer1 the ,secretary shall transmit such determination to the ,state ,board of ,pharmacy in the ,state in which the entity is located1 and to the ,state ,board of ,pharmacy in the notifying ,state1 if different1 within #ae days of such determination4 7#c7 ,effect ,the ,secretary shall encourage direct communications between ,states regarding traditional compounders4 ,nothing in this subsection shall expand the ,secretary's authority over or responsibility for traditional compounding4 7j7 ,prescription order reference ,for purposes of this section1 reference to a prescription order for an identified individual patient includes1 in the case of animal drugs1 a prescription order for a specific herd or flock 7or other identified group7 of animals4 4 7c7 ,prohibited act ,section #cja 7#ba ,u4,s4,c4 #cca7 is amended-- 7#a7 in subsection 7e71 by striking #dag1 #daf1 #ejd and inserting #dag1 #daf1 #ejc;,a7g71 #ejd2 and 7#b7 by adding at the end the following3 7ccc7 ,the resale of a compounded drug that is labeled not for resale as required by section #ejc;,a4 4 7d7 ,report by ,,gao ,not later than ,november #a1 #bjaf1 the ,comptroller ,general of the ,united ,states shall conduct study and submit to ,congress a report regarding the impact of this ,act 7and the amendments made by this ,act7 on the safety of animal drug compounding and the availability of safe and effective drugs for animals4 #c4 ,other requirements relating to compounding manufacturers 7a7 ,labeling ,section #ejb 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7bb7 ,if it is a compounded drug and the labeling does not include the information as required by subsections 7f77#a77;,c7 and 7g77#d7 of section #ejc;,a1 as applicable4 7cc7 ,if it is a drug1 and it was compounded by a compounding manufacturer for which fees have not been paid as required by section #ejc;,a7g74 4 7b7 ,application of inspection requirements to compounding manufacturers ,section #gjd7;a77#b7 7#ba ,u4,s4,c4 #cgd7;a77#b77 is amended by adding at the end the following flush text3 ,the exemption in subparagraph 7,a7 does not apply with respect to compounding manufacturers 7as such term is defined in section #ejc;,a74 4 7c7 ,adulteration of compounded animal drugs containing drug residues ,section #djb7;a77#b77;,c7 is amended by striking #eab2 and inserting #eab2 or 7iii7 any residue from a compounded animal drug24 #d4 ,implementation ,in promulgating any regulations to implement this ,act 7and the amendments made by this ,act71 the ,secretary of ,health and ,human ,services shall-- 7#a7 issue a notice of proposed rulemaking that includes the proposed regulation2 7#b7 provide a period of not less than #fj days for comments on the proposed regulation2 and 7#c7 publish the final regulation not more than #ah months following publication of the proposed rule and not less than #cj days before the effective date of such final regulation4 #e4 ,effective date ,this ,act 7and the amendments made by this ,act7 shall take effect on the date that is #a year after the date of enactment of this ,act4 #a4 ,short title ,this ,act may be cited as the ,pharmaceutical ,quality1 ,security1 and ,accountability ,act4 #b4 ,references in ,act2 table of contents 7a7 ,references in ,act ,except as otherwise specified1 amendments made by this ,act to a section or other provision of law are amendments to such section or other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4 ,sec4 #b4 ,references in ,act2 table of contents4 ,,title ,i--,human drug compounding ,sec4 #aja4 ,short title4 ,sec4 #ajb4 ,regulation of human drug compounding4 ,sec4 #ajc4 ,other requirements4 ,sec4 #ajd4 ,implementation4 ,sec4 #aje4 ,effective date4 ,,title ,,ii--,drug ,supply ,chain ,security ,sec4 #bja4 ,short title4 ,sec4 #bjb4 ,pharmaceutical distribution supply chain4 ,sec4 #bjc4 ,enhanced drug distribution security4 ,sec4 #bjd4 ,national licensure standards for prescription drug wholesale distributors4 ,sec4 #bje4 ,national licensure standards for third-party logistics providers2 uniform national policy4 ,sec4 #bjf4 ,penalties4 ,sec4 #bjg4 ,conforming amendment4 ,sec4 #bjh4 ,savings clause4 ,i ,human drug compounding #aja4 ,short title ,this title may be cited as the ,pharmaceutical ,compounding ,quality and ,accountability ,act4 #ajb4 ,regulation of human drug compounding 7a7 ,clarification of new drug status ,for purposes of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 the term new drug 7as defined in section #bja7p7 of such ,act7 shall include a compounded human drug4 7b7 ,regulation of human drug compounding ,section #ejc;,a 7#ba ,u4,s4,c4 #cec;a7 is amended to read as follows3 #ejc;,a4 ,human drug compounding 7a7 ,scope 7#a7 ,compounding ,in this section1 the terms compounding and compound-- 7,a7 include-- 7i7 the combining1 admixing1 mixing1 diluting1 reconstituting1 or otherwise altering of a marketed drug2 7ii7 compounding a drug from a bulk drug substance2 and 7iii7 repackaging2 and 7,b7 exclude mixing1 reconstituting1 or other such acts with respect to a marketed drug that are limited to and performed in accordance with specific directions for such acts contained in approved labeling provided by a drug's manufacturer1 when performed based upon a prescription order for an identified individual patient4 7#b7 ,administration and dispensing not a sale ,in this section1 the terms sell or resale do not include-- 7,a7 circumstances in which drug is administered to a patient or provided to a patient who has been instructed to self-administer the drug2 7,b7 the dispensing of a drug pursuant to a prescription executed in accordance with section #ejc7;b77#a72 or 7,c7 any fee associated with such administration1 provision1 or dispensing of the drug4 7#c7 ,inapplicability to certain drugs 7,a7 ,in general ,for purposes of this section1 the activities described in paragraph 7#a7 shall not be considered compounding if such activities are conducted in whole or in part with respect to a drug described in subparagraph 7,b74 7,b7 ,excluded drugs ,the drugs described in this subparagraph are the following3 7i7 ,blood and blood components for transfusion4 7ii7 ,medical gases1 as defined in section #ege4 7#d7 ,animal drugs for human use ,nothing in this section shall be construed to permit the use of animal drugs in compounding a drug for human use4 7b7 ,definitions ,in this section3 7#a7 ,compounding manufacturer 7,a7 ,in general ,the term compounding manufacturer means a facility at one geographic location or address-- 7i7 that compounds any sterile drug without receiving a prescription order for an identified individual patient for such sterile drug prior to beginning compounding1 and distributes or offers to sell such compounded sterile drug in interstate commerce2 or 7ii7 that repackages any preservative-free sterile drug or engages in sterile pooling4 7,b7 ,exclusions 7i7 ,excluded activities ,notwithstanding subparagraph 7,a77ii71 a facility shall not be considered a compounding manufacturer if such facility-- 7,i7 repackages drugs in accordance with section #ejf;,f or the final guidance described in section #ejf;,f7d7 once the final guidance is published2 and 7,,ii7 does not otherwise meet the definition of compounding manufacturer under subparagraph 7,a74 7ii7 ,compounding nuclear pharmacy ,the term compounding manufacturer shall not include a compounding nuclear pharmacy4 7#b7 ,compounding nuclear pharmacy ,the term compounding nuclear pharmacy means an entity that-- 7,a7 is a ,state-licensed pharmacy or a ,federal facility2 7,b7 holds a license currently in effect from the ,nuclear ,regulatory ,commission or from a ,state pursuant to an agreement with such commission under section #bgd of the ,atomic ,energy ,act of #aied2 and 7,c7 does not compound non-radioactive drugs that would cause the entity to be a compounding manufacturer described in paragraph 7#a77;,a74 7#c7 ,copy ,the term copy means an identical or nearly identical version of a drug4 7#d7 ,practitioner ,the term practitioner includes a physician or any other person that is authorized to prescribe medication under ,state law4 7#e7 ,radioactive drug ,the term radioactive drug-- 7,a7 means any substance defined as a drug in section #bja7;g77#a7 that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide regenerator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides2 and 7,b7 includes a radioactive biological product1 which means a biological product which is labeled with a radionuclide or intended solely to be labeled with a radionuclide4 7#f7 ,repackage or repackaging ,the term repackage or repackaging-- 7,a7 means taking a drug approved under section #eje or licensed under section #cea of the ,public ,health ,service ,act from the container in which it is distributed by the original manufacturer and placing it in a different container of the same or smaller size without further manipulating the drug 7such as by diluting it or mixing it with another1 different drug or drugs72 and 7,b7 does not include removing the drug from its original container for immediate administration to an identified individual patient1 such as withdrawing a drug into a syringe for immediate injection or filling a cassette for immediate use within a drug delivery device4 7#g7 ,sterile drug ,the term sterile drug means a drug that is-- 7,a7 intended for parenteral administration2 7,b7 an ophthalmic or oral inhalation drug in aqueous format2 or 7,c7 required to be sterile under ,federal or ,state law4 7#h7 ,sterile pooling ,the term sterile pooling-- 7,a7 means taking a single sterile drug approved under section #eje from the container in which it is distributed by the original manufacturer and combining it with the same sterile drug from one or more other containers without or before further manipulating the product 7such as by diluting it or mixing it with another1 different drug or drugs72 7,b7 does not include combining the drug from two or more separate containers of the same drug when a single container of the drug is not sufficient to prepare a single dose for administration to an individual patient2 and 7,c7 does not include combining a single drug from two or more separate containers of component products of a parenteral nutrition product1 if such pooling1 labeling1 and use of the finished parenteral nutrition product1 comply with ,state pharmacy law4 7#i7 ,traditional compounder 7,a7 ,in general ,the term traditional compounder means a facility operating pursuant to ,state law-- 7i7 wherein a drug is compounded by-- 7,i7 a licensed pharmacist in a ,state-licensed pharmacy or a licensed ,federal facility2 or 7,,ii7 a licensed physician2 7ii7 that-- 7,i7 compounds a drug upon receipt of a prescription order for an identified individual patient2 or 7,,ii7 compounds a drug in limited quantities before receipt of a prescription order for an identified individual patient1 if such compounding is based on a history of the licensed pharmacist or licensed physician receiving prescription orders for the compounding of the drug1 which orders have been generated solely within an established relationship between the licensed pharmacist or licensed physician and-- 7aa7 such individual patient for whom the prescription order will be provided2 or 7bb7 the licensed physician or other licensed practitioner who will write such prescription order2 and 7iii7 that does not meet the definition of a compounding manufacturer under paragraph 7#a74 7,b7 ,exceptions 7i7 ,hospitals and health systems ,a pharmacy within a hospital or health system shall be considered a traditional compounder if such pharmacy otherwise meets the definition under subparagraph 7,a7 and if1 with respect to a drug compounded by such pharmacy1 the only activity conducted by the pharmacy is to dispense or administer such drug 7which may include interstate shipment7 solely to a patient of such hospital or health system4 7ii7 ,health system defined ,the term health system-- 7,i7 means an entity that owns and operates-- 7aa7 one hospital2 or 7bb7 two or more hospitals that have common access to databases with drug order information for patients2 and 7,,ii7 includes only the inpatient1 outpatient1 and ambulatory facilities wholly owned and operated by such entity1 and accredited by a national accreditation body recognized by the ,secretary4 7c7 ,exemptions from certain requirements 7#a7 ,in general ,except as otherwise provided in paragraphs 7#b71 7#c71 and 7#d71 a compounded drug shall be subject to all the requirements of this ,act applicable to new drugs4 7#b7 ,drugs compounded by traditional compounders ,sections #eja7;a77#b77;,b71 #ejb7;f77#a71 and #eje of this ,act and section #cea of the ,public ,health ,service ,act shall not apply to a compounded drug if such drug-- 7,a7 is compounded by a traditional compounder that is in compliance with this section2 and 7,b7 meets the requirements of this section applicable to drugs compounded by traditional compounders4 7#c7 ,drugs compounded by compounding manufacturers ,sections #ejb7;f77#a7 and #eje of this ,act and section #cea of the ,public ,health ,service ,act shall not apply to a compounded prescription drug1 if such prescription drug-- 7,a7 is compounded by a compounding manufacturer-- 7i7 that is not licensed as a pharmacy in any ,state2 and 7ii7 that is in compliance with this section2 and 7,b7 meets the requirements of this section applicable to drugs compounded by compounding manufacturers4 7#d7 ,drugs compounded by compounding nuclear pharmacies ,sections #eja7;a77#b77;,b71 #ejb7;f77#a71 and #eje of this ,act and section #cea of the ,public ,health ,service ,act shall not apply to a compounded radioactive drug if such drug is compounded-- 7,a7 by a licensed pharmacist in a compounding nuclear pharmacy2 7,b7 solely using a radioactive drug approved under section #eje or licensed under section #cea of the ,public ,health ,service ,act1 and one or more ingredients in compliance with subsection 7e77#a77;,b72 and 7,c7 in compliance with the ,united ,states ,pharmacopoeia chapters on pharmacy compounding4 7d7 ,drugs that may not be compounded 7#a7 ,in general ,the following drugs may not be compounded3 7,a7 ,drugs that are demonstrably difficult to compound ,a drug or category of drugs that presents demonstrable difficulties for compounding1 which may include a complex dosage form or biological product1 as designated by the ,secretary pursuant to paragraph 7#b74 7,b7 ,marketed drugs ,a drug 7other than a biological product7 that is a copy of a marketed drug approved under #eje or a variation of such drug compounded from bulk drug substances1 except as provided in paragraph 7#c74 7,c7 ,biological products ,a drug that is a biological product1 except as provided in paragraph 7#d74 7,d7 ,drugs subject to risk evaluation and mitigation strategy ,a copy or variation of a drug approved under section #eje or licensed under section #cea of the ,public ,health ,service ,act that is the subject of a risk evaluation and mitigation strategy approved with elements to assure safe use pursuant to section #eje-a1 except provided in paragraph 7#e74 7,e7 ,drugs removed for safety and efficacy ,a drug that appears on a list published by the ,secretary in the ,federal ,register of drugs that have been withdrawn or removed from the market because such drug or components of such drug have been found to be unsafe or not effective4 7#b7 ,drugs that are demonstrably difficult to compound 7,a7 ,in general ,the ,secretary may promulgate a regulation that designates drugs or categories of drugs that are demonstrably difficult to compound that may not be compounded1 or that may be compounded only under conditions specified by the ,secretary4 ,such regulation may include the designation of drugs or categories of drugs that are complex dosage forms or biological products1 such as extended release products1 metered dose inhalers1 transdermal patches1 and sterile liposomal products4 7,b7 ,interim list 7i7 ,in general ,before the effective date of the regulation promulgated under subparagraph 7,a71 the ,secretary may designate drugs or categories of drugs that present demonstrable difficulties for compounding1 which may include complex dosage forms or biological products that cannot be compounded1 except under conditions specified by the ,secretary1 by-- 7,i7 publishing a notice of such drugs or categories of drugs proposed for designation1 including the rationale for such designation1 in the ,federal ,register2 7,,ii7 providing a period of not less than #fj calendar days for comment on the notice2 and 7,,iii7 publishing a notice in the ,federal ,register designating such drugs or categories of drugs that cannot be compounded1 including the rationale for such designation4 7ii7 ,sunset ,any notice provided under clause 7i7 shall cease to have force or effect on the date that is #e years after the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act or on the effective date of the final regulation under subparagraph 7,a71 whichever is earlier4 7,c7 ,consultation with stakeholders ,prior to establishing the lists described in this paragraph1 the ,secretary shall consult with relevant stakeholders including pharmacists1 professional associations1 patient and public health advocacy groups1 manufacturers and physicians about the need for the compounded drugs to be included or excluded from the lists4 7,d7 ,updates to difficult to compound list ,five years after the effective date of the regulation described in subparagraph 7,a71 and every #e years thereafter1 the ,secretary shall publish a ,federal ,register notice seeking public input about the need for the compounded drugs to be included or excluded from the list described in subparagraph 7,a74 ,nothing in the previous sentence prohibits notifications or submissions before or during any #e-year period described under such sentence regarding the need for the compounded drugs to be included or excluded from the list4 7#c7 ,exceptions regarding marketed drugs 7,a7 ,in general ,a drug 7other than a biological product7 that is a copy of a marketed drug approved under #eje1 including variations of such drug compounded from bulk drug substances1 may be compounded only if-- 7i7 the compounded variation produces for the individually identified patient a clinical difference between the compounded drug and such marketed drug1 as determined by the prescribing practitioner1 and1 prior to beginning compounding such variation1 the traditional compounder compounding the variation receives a prescription order for an identified individual patient specifying that the variation may be compounded2 or 7ii7 7,i7 such marketed drug1 at the time of compounding a copy of such drug and at the time of distribution of the compounded drug1 is on the drug shortage list under section #ejf;,e1 or has otherwise been identified by the ,secretary1 in the ,secretary's sole discretion1 as in shortage1 such as in a specific region or on a drug shortage list maintained by a private party2 7,,ii7 the facility compounding the drug notifies the ,secretary not later than #c calendar days after beginning the compounding2 and 7,,iii7 in the case of a compounding manufacturer1 the compounding manufacturer has registered under subsection 7g77#b7 as an entity that intends to compound pursuant to this paragraph and notifies the ,secretary at least #ad calendar days prior to beginning the compounding4 7,b7 ,notice waiver ,the ,secretary may waive a notice required under subparagraph 7,a77ii74 7,c7 ,exclusion ,for purposes of this paragraph1 repackaging a marketed drug approved under section #eje does not make the repackaged drug a copy of such marketed drug1 unless the repackaged drug is also a marketed drug approved under section #eje4 7#d7 ,exceptions regarding biological products 7,a7 ,in general ,a drug that is a variation of a licensed biological product may be compounded only if-- 7i7 7,i7 such compounded variation is compounded solely using a licensed biological product1 or solely using a licensed biological product and one or more ingredients in compliance with subsection 7e77#a77;,b72 or 7,,ii7 in the case of a licensed allergenic product1 such variation is compounded solely using one or more licensed allergenic products1 or solely using one or more licensed allergenic products and one or more ingredients in compliance with subsection 7e77#a77;,b72 7ii7 such compounded variation produces for the patient a clinical difference between such compounded variation and the licensed biological product1 as determined by-- 7,i7 the prescribing practitioner 7in the case of a variation compounded by a traditional compounder72 or 7,,ii7 a licensed practitioner responsible for the patient's care in a health care entity that provides medical services through licensed practitioners directly to patients 7in the case of a variation compounded by a compounding manufacturer72 7iii7 prior to beginning compounding-- 7,i7 except as provided in subparagraph 7,b71 the traditional compounder receives a prescription order for an identified individual patient specifying that the biological product may be compounded for an identified individual patient2 or 7,,ii7 the compounding manufacturer receives a duly authorized medical order from a health care entity that provides medical services through licensed practitioners directly to patients1 specifying that the biological product may be compounded based on such order for an identified patient or patients2 and 7iv7 in the case of a radioactive biological product1 the compounded variation is compounded by a compounding nuclear pharmacy in accordance with subsection 7b77#b74 7,b7 ,special rule for pediatric uses ,a traditional compounder that is a hospital or health system may begin compounding a drug that is a variation of a licensed biological product prior to receiving a prescription order as required under subparagraph 7,a77iii7 if-- 7i7 such compounded variation is a diluted or repackaged variation of the licensed biological product for emergent use in pediatric patients2 and 7ii7 such compounded variation produces for the patient a clinical difference between such compounded variation and the licensed biological product1 as determined by a licensed practitioner responsible for the patient's care in the hospital or health system4 7,c7 ,inapplicability ,clauses 7ii7 and 7iii7 of subparagraph 7,a7 shall not apply to a compounded allergenic product4 7,d7 ,pooling ,notwithstanding any other provision of this section1 sterile pooling of a biological product is not permitted4 7#e7 ,requirement for drugs that have risk evaluation and mitigation strategies 7,a7 ,in general ,a copy or variation of a drug approved under section #eje or biological product licensed under section #cea of the ,public ,health ,service ,act that is the subject of a risk evaluation and mitigation strategy approved with elements to assure safe use pursuant to section #eje-a1 may be compounded only if-- 7i7 the entity compounding the copy or variation receives a prescription order for an identified individual patient specifying that the drug or biological product may be compounded2 and 7ii7 the entity compounding the copy or variation demonstrates to the ,secretary1 prior to beginning compounding1 that the entity will utilize controls that are comparable to the controls applicable under the relevant risk evaluation and mitigation strategy for the approved drug or licensed biological product4 7,b7 ,effect ,nothing in this paragraph shall be construed to permit compounding a copy or variation of a drug other than as permitted in paragraphs 7#c7 and 7#d74 7e7 ,quality of drug ingredients 7#a7 ,human drugs ,a traditional compounder or a compounding manufacturer shall-- 7,a7 if compounding a drug from bulk drug substances 7as defined in regulations of the ,secretary published at section #bjg4c7;a77#d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations771 use only bulk substances-- 7i7 that-- 7,i7 comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph1 if a monograph exists and has not been identified under paragraph 7#b72 7,,ii7 if such a monograph does not exist1 are drug substances that are components of drugs approved by the ,secretary2 or 7,,iii7 if such a monograph does not exist and the drug substance is not a component of a drug approved by the ,secretary1 that appear on a list developed by the ,secretary through regulations issued by the ,secretary2 7ii7 that are manufactured by an establishment that is registered under section #eaj 7including a foreign establishment that is registered under section #eaj7;i772 and 7iii7 that are accompanied by valid certificates of analysis for each specific lot of bulk drug substance2 7,b7 use ingredients 7other than bulk drug substances7 that comply with the standards of an applicable ,united ,states ,pharmacopoeia or ,national ,formulary monograph1 if a monograph exists and has not been identified under paragraph 7#b72 and 7,c7 in the case of a traditional compounder1 comply with the standards of the ,united ,states ,pharmacopoeia chapters on pharmacy compounding4 7#b7 ,identification by secretary 7,a7 ,in general ,notwithstanding the existence of an applicable monograph under subparagraph 7,a77i77,i7 or 7,b7 of paragraph 7#a71 the ,secretary may identify bulk substances that the ,secretary determines1 based on public health concerns1 may not be used in compounding a drug4 7,b7 ,procedure ,in identifying the bulk substances that may not be used in compounding1 the ,secretary shall-- 7i7 publish a notice of such bulk substances proposed for identification in the ,federal ,register1 including the rationale for such proposal2 7ii7 provide a period of not less than #fj calendar days for comment on the notice2 and 7iii7 publish a notice in the ,federal ,register identifying the bulk substances that may not be used in compounding a drug4 7f7 ,requirements regarding wholesaling and labeling applicable to traditional compounders and compounding manufacturers ,a compounded drug-- 7#a7 may not be sold by an entity other than the compounding manufacturer or traditional compounder that compounded the drug2 7#b7 compounded by a compounding manufacturer may not be sold or transferred to an entity other than a health care entity that provides medical services through licensed practitioners directly to patients1 or a network of such providers1 except that a compounding manufacturer may transfer without profit a compounded sterile drug to a licensed pharmacy if-- 7,a7 as of the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act1 and at the time of such transfer1 the licensed pharmacy falls under the same corporate ownership as the compounding manufacturer2 7,b7 the transfer of such compounded sterile drug is solely for the purpose of dispensing the compounded sterile drug to the end user1 who has been instructed by the prescribing physician to self-administer such compounded sterile drug2 7,c7 as of the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act1 and at the time of such transfer1 the compounding manufacturer is an entity wholly owned by an entity that provides pharmacy benefits management services on behalf of a health benefits plan2 7,d7 the compounding manufacturer identifies itself to the ,secretary upon registering under subsection 7g77#b7 as an entity that qualifies for the exception under this paragraph1 and provides documentation of the compounding of such drugs as of the date of enactment of the ,pharmaceutical ,compounding ,quality and ,accountability ,act1 in a manner described by the ,secretary2 and 7,e7 the compounding manufacturer receives confirmation from the ,secretary that the compounding manufacturer qualifies for the exception under this paragraph and the sterile drug or drugs for which the exemption applies2 and 7#c7 in the case of a compounded drug offered for sale1 shall be labeled not for resale4 7g7 ,other requirements applicable to compounding manufacturers 7#a7 ,licensed pharmacist oversight ,a compounding manufacturer shall ensure that a pharmacist licensed in the ,state where the compounding manufacturer is located exercises direct supervision over the operations of the compounding manufacturer4 7#b7 ,registration of compounding manufacturers and reporting of drugs 7,a7 ,registration of compounding manufacturers 7i7 ,annual registration ,during the period beginning on ,october #a and ending on ,december #ca each year1 each compounding manufacturer shall register with the ,secretary its name1 place of business1 and unique facility identifier 7which shall conform to the requirements for the unique facility identifier established under section #eaj71 and a point of contact e-mail address1 and shall indicate whether the compounding manufacturer intends to compound drug in shortage pursuant to subsection 7d77#c77;,a77ii74 7ii7 ,new compounding manufacturers ,each compounding manufacturer1 upon first engaging in the operations described in subsection 7b77#a71 shall immediately register with the ,secretary and provide the information described under clause 7i74 ,the ,secretary shall establish a timeline for registration for the first year following the effective date of the ,pharmaceutical ,compounding ,quality and ,accountability ,act4 ,in no case may registration be required until at least #fj calendar days following publication of the timeline in the ,federal ,register4 7iii7 ,availability of registration for inspection ,the ,secretary shall make available for inspection1 to any person so requesting1 any registration filed pursuant to this subparagraph4 7,b7 ,drug reporting by compounding manufacturers 7i7 ,in general ,each compounding manufacturer who registers with the ,secretary under subparagraph 7,a7 shall submit to the ,secretary1 once during the month of ,june of each year and once during the month of ,december of each year1 a report-- 7,i7 identifying the drugs compounded by such compounding manufacturer during the previous #f-month period2 and 7,,ii7 with respect to each drug identified under subclause 7,i71 providing the active ingredient1 the source of such active ingredient1 the ,national ,drug ,code number1 if available1 of the source drug or bulk active ingredient1 the strength of the active ingredient per unit1 the dosage form and route of administration1 the package description1 the number of individual units produced1 the ,national ,drug ,code number of the final product1 if assigned4 7ii7 ,form ,each report under clause 7i7 shall be prepared in such form and manner as the ,secretary may prescribe by regulation or guidance4 7iii7 ,confidentiality ,reports submitted pursuant to this subparagraph shall be exempt from inspection under subparagraph 7,a77iii71 unless the ,secretary finds that such an exemption would be inconsistent with the protection of the public health4 7,c7 ,electronic registration and reporting ,registrations and drug reporting under this paragraph 7including the submission of updated information7 shall be submitted to the ,secretary by electronic means unless the ,secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting waiver4 7,d7 ,risk-based inspection frequency 7i7 ,in general ,compounding manufacturers shall be subject to inspection pursuant to section #gjd4 7ii7 ,risk-based schedule ,the ,secretary1 acting through one or more officers or employees duly designated by the ,secretary1 shall inspect compounding manufacturers described in clause 7i7 in accordance with a risk-based schedule established by the ,secretary4 7iii7 ,risk factors ,in establishing the risk-based schedule under clause 7ii71 the ,secretary shall inspect compounding manufacturers according to the known safety risks of such compounding manufacturers1 which shall be based on the following factors3 7,i7 ,the compliance history of the compounding manufacturer4 7,,ii7 ,the record1 history1 and nature of recalls linked to the compounding manufacturer4 7,,iii7 ,the inherent risk of the drug compounded at the compounding manufacturer4 7,,iv7 ,the inspection frequency and history of the compounding manufacturer1 including whether the compounding manufacturer has been inspected pursuant to section #gjd within the last #d years4 7,v7 ,whether the compounding manufacturer has registered under subsection 7g77#b7 as an entity that intends to compound pursuant to subsection 7d77#c77;,a77ii74 7,,vi7 ,any other criteria deemed necessary and appropriate by the ,secretary for purposes of allocating inspection resources4 7#c7 ,adverse event reporting 7,a7 ,definitions ,in this paragraph3 7i7 ,adverse event ,the term adverse event means any health-related event associated with the use of a compounded drug that is adverse1 including-- 7,i7 an event occurring in the course of the use of the drug in professional practice2 7,,ii7 an event occurring from an overdose of the drug1 whether accidental or intentional2 7,,iii7 an event occurring from abuse of the drug2 7,,iv7 an event occurring from withdrawal of the drug2 and 7,v7 any failure of expected pharmacological action of the drug4 7ii7 ,serious adverse event ,the term serious adverse event means an adverse event that-- 7,i7 results in-- 7aa7 death2 7bb7 an adverse drug event that places the patient at immediate risk of death from the adverse drug event as it occurred 7not including an adverse drug event that might have caused death had it occurred in a more severe form72 7cc7 inpatient hospitalization or prolongation of existing hospitalization2 7dd7 a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions2 or 7ee7 a congenital anomaly or birth defect2 or 7,,ii7 based on appropriate medical judgment1 may jeopardize the patient and may require a medical or surgical intervention to prevent an outcome described in subclause 7,i74 7,b7 ,reports 7i7 ,adverse event reporting requirement 7,i7 #ae-;day report ,if a compounding manufacturer becomes aware of any serious adverse event1 such manufacturer shall submit reports of each instance to the ,secretary as soon as practicable1 but in no case later than #ae calendar days after the initial receipt of the applicable information4 ,such manufacturer shall investigate and submit to the ,secretary followup reports for each such instance not later than #ae calendar days after receipt of new information or as requested by the ,secretary4 ,unless and until the ,secretary establishes the content and format of adverse event reports by guidance or regulation1 reports shall be submitted in accordance with the content and format requirements under section #caj4cje of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7 or section #fjj4hj of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,,ii7 ,annual report ,compounding manufacturers that report serious adverse events shall submit in ,december of each year a narrative summary of any analysis of each report submitted under subclause 7,i71 including a history of actions taken during the year because of each report1 using the content1 format1 and manner established by the ,secretary by guidance or regulation4 ,until such time as the ,secretary publishes such guidance or regulation1 each compounding manufacturer shall retain such summaries as part of the records to be maintained in accordance with subparagraph 7,c74 7ii7 ,product quality reporting requirement ,not later than #c calendar days after the compounding manufacturer becomes aware of information pertaining to sterility1 stability1 or other product quality concerns that could result in serious adverse events1 the compounding manufacturer shall submit to the ,secretary a product quality report1 in a form and manner established by the ,secretary by guidance or regulation4 7,c7 ,maintenance of records ,a compounding manufacturer shall maintain for a period of #aj years records of all serious adverse drug events known to the compound manufacturer in accordance with section #cad4hj7;i7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulation71 or as otherwise directed by the ,secretary in regulations4 7#d7 ,labeling of drugs 7,a7 ,label ,the label of a drug compounded by a compounding manufacturer shall include-- 7i7 the statement ,this is a compounded drug4 or a reasonable comparable alternative statement 7as specified by the ,secretary7 that prominently identifies the drug as a compounded drug2 7ii7 the name1 address1 and phone number of the applicable compounding manufacturer2 and 7iii7 with respect to the compounded drug-- 7,i7 the lot or batch number2 7,,ii7 the established name of the medication2 7,,iii7 the dosage form and strength2 7,,iv7 the statement of quantity or volume1 as appropriate2 7,v7 the date that the drug was compounded2 7,,vi7 the expiration date2 7,,vii7 storage and handling instructions2 7,,viii7 the ,national ,drug ,code number1 if available2 7,,ix7 the not for resale statement as required by subsection 7f77#c72 and 7,x7 subject to subparagraph 7,b77i71 a list of active and inactive ingredients1 identified by established name and the quantity or proportion of each ingredient4 7,b7 ,container ,the container from which the individual units of a drug compounded by a compounding manufacturer are removed for dispensing or for administration 7such as a plastic bag containing individual product syringes7 shall include-- 7i7 the information described under subparagraph 7,a77iii77,x71 if there is not space on the label for such information2 7ii7 the following information to facilitate adverse event reporting3 www4fda4gov_/medwatch and #a-hjj-;,,fda-#ajhh2 and 7iii7 the directions for use1 including1 as appropriate1 dosage and administration4 7,c7 ,additional information ,the label and labeling of a drug compounded by a compounding manufacturer shall include any other information as determined necessary and specified in regulations promulgated by the ,secretary4 7h7 ,compounding manufacturer establishment and reinspection fees 7#a7 ,definitions ,in this subsection-- 7,a7 the term affiliate has the meaning given such term in section #gce7aa72 7,b7 the term gross annual sales means the total worldwide gross annual sales1 in ,united ,states dollars1 for a compounding manufacturer1 including the sales of all the affiliates of the compounding manufacturer2 and 7,c7 the term reinspection means1 with respect to a compounding manufacturer1 #a or more inspections conducted under section #gjd subsequent to an inspection conducted under such provision which identified noncompliance materially related to an applicable requirement of this ,act1 specifically to determine whether compliance has been achieved to the ,secretary's satisfaction4 7#b7 ,establishment and reinspection fees 7,a7 ,in general ,for fiscal year #bjae and each subsequent fiscal year1 the ,secretary shall1 in accordance with this subsection1 assess and collect-- 7i7 an annual establishment fee from each compounding manufacturer2 and 7ii7 a reinspection fee from each compounding manufacturer subject to a reinspection in such fiscal year4 7,b7 ,multiple reinspections ,a compounding manufacturer subject to multiple reinspections in a fiscal year shall be subject to a reinspection fee for each reinspection4 7#c7 ,establishment and reinspection fee setting ,the ,secretary shall establish the establishment and reinspection fee to be collected under this subsection for each fiscal year1 based on the methodology described in paragraph 7#d7 and shall publish such fee in a ,federal ,register notice not later than #fj calendar days before the start of each such year4 7#d7 ,amount of establishment fee and reinspection fee 7,a7 ,in general ,for each compounding manufacturer in a fiscal year-- 7i7 except as provided in subparagraph 7,d71 the amount of the annual establishment fee under paragraph 7#b7 shall be equal to the sum of-- 7,i7 #ae1jjj1 multiplied by the inflation adjustment factor described in subparagraph 7,b72 plus 7,,ii7 the small business adjustment factor described in subparagraph 7,c72 and 7ii7 the amount of any reinspection fee 7if applicable7 under paragraph 7#b7 shall be equal to #ae1jjj1 multiplied by the inflation adjustment factor described in subparagraph 7,b74 7,b7 ,inflation adjustment factor 7i7 ,in general ,for fiscal year #bjae and subsequent fiscal years1 the fee amounts established in subparagraph 7,a7 shall be adjusted by the ,secretary by notice1 published in the ,federal ,register1 for a fiscal year by the amount equal to the sum of-- 7,i7 one2 7,,ii7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of an average full-time equivalent position of the ,food and ,drug ,administration for the first #c years of the preceding #d fiscal years2 and 7,,iii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,u4,s4 ,city ,average2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of an average full-time equivalent position of the ,food and ,drug ,administration for the first #c years of the preceding #d fiscal years4 7ii7 ,compounded basis ,the adjustment made each fiscal year under clause 7i7 shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year #bjad under clause 7i74 7,c7 ,small business adjustment factor ,the small business adjustment factor referred to subparagraph 7,a77i77,,ii7 shall be an amount established by the ,secretary for each fiscal year based on the ,secretary's estimate of-- 7i7 the number of small businesses that will pay a reduced establishment fee for such fiscal year2 and 7ii7 the adjustment to the establishment fee necessary to achieve total fees equaling the total fees that the ,secretary would have collected if no entity qualified for the small business exception in subparagraph 7,d74 7,d7 ,exception for small businesses 7i7 ,in general ,in the case of a compounding manufacturer with gross annual sales of #a1jjj1jjj or less in the #ab months ending ,april #a of the fiscal year immediately preceding the fiscal year in which the fees under this subsection are assessed1 the amount of the establishment fee under paragraph 7#b7 for a fiscal year shall be equal to #a_/c of the amount calculated under subparagraph 7,a77i77,i7 in such fiscal year4 7ii7 ,application ,to qualify for the exception under this subparagraph1 a small business shall submit to the ,secretary a written request for such exception1 in a format specified by the ,secretary in guidance1 certifying its gross annual sales for the #ab months ending ,april #a of the fiscal year immediately preceding the fiscal year in which fees under this subsection are assessed4 ,any such application must be submitted to the ,secretary not later than ,april #cj for the following fiscal year4 ,any statement or representation made to the ,secretary shall be subject to section #ajja of title #ah1 ,united ,states ,code4 7,e7 ,crediting of fees ,in establishing the small business adjustment factor under subparagraph 7,c7 for a fiscal year1 the ,secretary shall provide for the crediting of fees from the previous year to the next year if the ,secretary overestimated the amount of the small business adjustment factor for such previous fiscal year1 and consider the need to account for any adjustment of fees and such other factors as the ,secretary determines appropriate4 7#e7 ,use of fees ,the ,secretary shall make all of the fees collected pursuant to clauses 7i7 and 7ii7 of paragraph 7#b77;,a7 available solely to pay for the costs of oversight of compounding manufacturers4 7#f7 ,supplement not supplant ,funds received by the ,secretary pursuant to this subsection shall be used to supplement and not supplant any other ,federal funds available to carry out the activities described in this section4 7#g7 ,crediting and availability of fees ,fees authorized under this subsection shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for the purpose of paying the costs of oversight of compounding manufacturers4 7#h7 ,collection of fees 7,a7 ,establishment fee ,a compounding manufacturer shall remit the establishment fee due under this subsection in a fiscal year when submitting a registration pursuant to subsection 7g7 for such fiscal year4 7,b7 ,reinspection fee ,the ,secretary shall specify in the ,federal ,register notice described in paragraph 7#c7 the manner in which reinspection fees assessed under this subsection shall be collected and the timeline for payment of such fees4 ,such a fee shall be collected after the ,secretary has conducted a reinspection of the compounding manufacturer involved4 7,c7 ,effect of failure to pay fees 7i7 ,registration ,a compounding manufacturer shall not be considered registered under subsection 7g7 in a fiscal year until the date that the compounding manufacturer remits the establishment fee under this subsection for such fiscal year4 7ii7 ,misbranding ,all drugs manufactured1 prepared1 propagated1 compounded1 or processed by a compounding manufacturer for which any establishment fee or reinspection fee has not been paid as required by this subsection shall be deemed misbranded under section #ejb7;cc7 until the fees owed for such compounding manufacturer under this subsection have been paid4 7,d7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under this subsection within #cj calendar days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to provisions of subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7#i7 ,annual report to congress ,not later than #abj calendar days after each fiscal year in which fees are assessed and collected under this subsection1 the ,secretary shall submit a report to the ,committee on ,health ,education ,labor and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 to include a description of fees assessed and collected for each year1 a summary description of entities paying the fees1 and the number of inspections and reinspections of such entities performed each year4 7#aj7 ,authorization of appropriations ,for fiscal year #bjae and each subsequent fiscal year1 there is authorized to be appropriated for fees under this subsection an amount equivalent to the total amount of fees assessed for such fiscal year under this subsection4 7i7 ,action by secretary regarding complaints from state boards of pharmacy 7#a7 ,identification of compounding manufacturers ,the ,secretary shall encourage ,states to identify to the ,secretary facilities that are licensed by a ,state as a pharmacy that appear to be entities that are required to be registered with the ,secretary as a compounding manufacturer4 7#b7 ,designation ,the ,secretary shall designate a point of contact and establish a format and procedure for a ,state ,board of ,pharmacy to notify the ,secretary if it appears to a ,state ,board of ,pharmacy that an entity licensed by a ,state as a pharmacy is required to be registered with the ,secretary as a compounding manufacturer4 7#c7 ,determination ,if the ,secretary determines that such an entity described in paragraph 7#b7 is required to be registered with the ,secretary as a compounding manufacturer1 the ,secretary shall transmit such determination to the ,state ,board of ,pharmacy in the ,state in which the entity is located1 and to the ,state ,board of ,pharmacy in the notifying ,state1 if different1 within #ae calendar days of such determination and shall make such determination publicly available on the ,internet ,web site of the ,food and ,drug ,administration4 7#d7 ,effect ,the ,secretary shall encourage direct communications between ,states regarding traditional compounders4 ,nothing in this subsection shall expand the ,secretary's authority over or responsibility for traditional compounders4 4 7c7 ,prohibited act ,section #cja 7#ba ,u4,s4,c4 #cca7 is amended-- 7#a7 in subsection 7e71 by striking #dag1 #daf1 #ejd and inserting #dag1 #daf1 #ejc;,a7g71 #ejd2 and 7#b7 by adding at the end the following3 7ccc7 7#a7 ,the resale of a compounded drug that is labeled not for resale as required by section #ejc;,a4 7#b7 ,the failure to register in accordance with subsection 7g7 of section #ejc;,a or the failure to submit a report as required by subsection 7g77#b77;,b7 or 7g77#c7 of such section4 4 7d7 ,report by ,,gao ,not later than ,november #a1 #bjaf1 the ,comptroller ,general of the ,united ,states shall conduct a study and submit to ,congress a report on the safety of animal drug compounding and the availability of safe and effective drugs for animals4 #ajc4 ,other requirements 7a7 ,labeling ,section #ejb 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7bb7 ,if it is a compounded drug and the labeling does not include the information as required by subsections 7f77#c7 and 7g77#d7 of section #ejc;,a1 as applicable4 7cc7 ,if the advertising or promotion of a compounded drug is false or misleading in any particular4 7dd7 ,if it is a drug1 and it was manufactured1 prepared1 propagated1 compounded1 or processed by a compounding manufacturer for which fees have not been paid as required by section #ejc;,a7g74 4 7b7 ,application of inspection requirements to compounding manufacturers ,section #gjd7;a77#b7 7#ba ,u4,s4,c4 #cgd7;a77#b77 is amended by adding at the end the following flush text3 ,the exemption in subparagraph 7,a7 does not apply with respect to compounding manufacturers 7as such term is defined in section #ejc;,a74 4 #ajd4 ,implementation 7a7 ,consultation with stakeholders ,in implementing this title 7and the amendments made by this title71 the ,secretary of ,health and ,human ,services shall consult with relevant stakeholders including pharmacists1 professional associations1 patient and public health advocacy groups1 manufacturers and physicians4 7b7 ,regulations ,in promulgating any regulations to implement this title 7and the amendments made by this title71 the ,secretary of ,health and ,human ,services shall-- 7#a7 issue a notice of proposed rulemaking that includes the proposed regulation2 7#b7 provide a period of not less than #fj calendar days for comments on the proposed regulation2 and 7#c7 publish the final regulation not more than #ah months following publication of the proposed rule and not less than #cj calendar days before the effective date of such final regulation4 #aje4 ,effective date ,this title 7and the amendments made by this title7 shall take effect on the date that is #a year after the date of enactment of this ,act4 ,,ii ,drug ,supply ,chain ,security #bja4 ,short title ,this title may be cited as the ,drug ,supply ,chain ,security ,act4 #bjb4 ,pharmaceutical distribution supply chain ,chapter ,v 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 ,h ,pharmaceutical distribution supply chain #eha4 ,definitions ,in this subchapter3 7#a7 ,authorized ,the term authorized means-- 7,a7 in the case of a manufacturer or repackager1 having a valid registration in accordance with section #eaj2 7,b7 in the case of a wholesale distributor1 having a valid license under ,state law or section #ehc1 in accordance with section #ehb7;a77#f7 and complying with the licensure reporting requirements under section #ejc7;e71 as amended by the ,drug ,supply ,chain ,security ,act2 7,c7 in the case of a third-party logistics provider1 having a valid license under ,state law or section #ehd7;a77#a71 in accordance with section #ehb7;a77#g7 and complying with the licensure reporting requirements under section #ehd7;b72 and 7,d7 in the case of a dispenser1 having a valid license under ,state law4 7#b7 ,dispenser ,the term dispenser-- 7,a7 means a retail pharmacy1 hospital pharmacy1 a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor1 or any other person authorized by law to dispense or administer prescription drugs1 and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor2 and 7,b7 does not include a person who dispenses only products to be used in animals in accordance with section #eab7;a77#e74 7#c7 ,disposition ,the term disposition1 with respect to a product within the possession or control of an entity1 means the removal of such product from the pharmaceutical distribution supply chain1 which may include disposal or return of the product for disposal or other appropriate handling and other actions1 such as retaining a sample of the product for further additional physical examination or laboratory analysis of the product by a manufacturer or regulatory or law enforcement agency4 7#d7 ,distribute or distribution ,the term distribute or distribution means the sale1 purchase1 trade1 delivery1 handling1 storage1 or receipt of a product1 and does not include the dispensing of a product pursuant to a prescription executed in accordance with section #ejc7;b77#a7 or the dispensing of a product approved under section #eab7;b74 7#e7 ,exclusive distributor ,the term exclusive distributor means the wholesale distributor that directly purchased the product from the manufacturer and is the sole distributor of that manufacturer's product to a subsequent repackager1 wholesale distributor1 or dispenser4 7#f7 ,homogeneous case ,the term homogeneous case means a sealed case containing only product that has a single ,national ,drug ,code number belonging to a single lot4 7#g7 ,illegitimate product ,the term illegitimate product means a product for which credible evidence shows that the product-- 7,a7 is counterfeit1 diverted1 or stolen2 7,b7 is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans2 7,c7 is the subject of a fraudulent transaction2 or 7,d7 appears otherwise unfit for distribution such that the product could result in serious adverse health consequence or death to humans4 7#h7 ,licensed ,the term licensed means-- 7,a7 in the case of a wholesale distributor1 having a valid license in accordance with section #ejc7;e7 or section #ehb7;a77#f71 as applicable2 7,b7 in the case of a third-party logistics provider1 having a valid license in accordance with section #ehd7;a7 or section #ehb7;a77#g71 as applicable2 and 7,c7 in the case of a dispenser1 having a valid license under ,state law4 7#i7 ,manufacturer 7,a7 ,in general ,the term manufacturer means1 with respect to a product-- 7i7 a person that holds an application approved under section #eje or a license issued under section #cea of the ,public ,health ,service ,act for such product1 or if such product is not the subject of an approved application or license1 the person who manufactured the product2 7ii7 a co-licensed partner of the person described in clause 7i7 that obtains the product directly from a person described in this clause or clause 7i7 or 7iii72 or 7iii7 an affiliate of a person described in clause 7i7 or 7ii7 that receives the product directly from a person described in this clause or clause 7i7 or 7ii74 7,b7 ,affiliate ,for purposes of this paragraph1 the term affiliate means a member of an affiliated group1 as that term is defined in section #aejd7;a7 of the ,internal ,revenue ,code1 or a member of a group of corporations that would constitute an affiliated group1 as so defined1 but for the fact that one or more members of the group is a corporation described in section #aejd7;b77#c7 of the ,internal ,revenue ,code4 7#aj7 ,package 7,a7 ,in general ,the term package means the smallest individual saleable unit of product for distribution by a manufacturer or repackager that is intended by the manufacturer for ultimate sale to the dispenser of such product4 7,b7 ,individual saleable unit ,for purposes of this paragraph1 an individual saleable unit is the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser4 7#aa7 ,prescription drug ,the term prescription drug means a drug for human use subject to section #ejc7;b77#a74 7#ab7 ,product ,the term product means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing 7such as capsules1 tablets1 and lyophilized products before reconstitution71 but for purposes of section #ehb1 does not include blood or blood components intended for transfusion1 radioactive drugs or radioactive biological products 7as defined in section #fjj4c7;ee7 of title #ba1 ,code of ,federal ,regulations7 that are regulated by the ,nuclear ,regulatory ,commission or by a ,state pursuant to an agreement with such ,commission under section #bgd of the ,atomic ,energy ,act of #aied 7#db ,u4,s4,c4 #bjba71 an intravenous product described in clause xiv1 xv1 or xvi of paragraph 7#bc71 any medical gas 7as defined in section #ege71 or a drug compounded in compliance with section #ejc;,a4 7#ac7 ,product identifier ,the term product identifier means a standardized graphic that includes1 in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely-recognized international standards development organization1 the standardized numerical identifier1 lot number1 and expiration date of the product4 7#ad7 ,quarantine ,the term quarantine means the storage or identification of a product1 to prevent distribution or transfer of the product1 in a physically separate area clearly identified for such use or through other procedures4 7#ae7 ,repackager ,the term repackager means a person who owns or operates an establishment that repacks and relabels a product or package for further sale4 7#af7 ,return ,the term return means providing product to the authorized immediate trading partner from which such product was purchased1 or to a returns processor or reverse logistics provider for handling of such product4 7#ag7 ,returns processor or reverse logistics provider ,the term returns processor or reverse logistics provider means a person who owns or operates an establishment that dispositions or otherwise processes saleable or nonsaleable product received from an authorized trading partner such that the product may be processed for credit to the purchaser1 manufacturer1 or seller or disposed of for no further distribution4 7#ah7 ,specific patient need ,the term specific patient need refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient4 ,such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need4 7#ai7 ,standardized numerical identifier ,the term standardized numerical identifier means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the ,national ,drug ,code that corresponds to the specific product 7including the particular package configuration7 combined with a unique alphanumeric serial number of up to #bj characters4 7#bj7 ,suspect product ,the term suspect product means a product for which there is reason to believe that such product-- 7,a7 is potentially counterfeit1 diverted1 or stolen2 7,b7 is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans2 7,c7 is potentially the subject of a fraudulent transaction2 or 7,d7 appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans4 7#ba7 ,third-party logistics provider ,the term third-party logistics provider means an entity that provides or coordinates warehousing1 or other logistics services of a product in interstate commerce on behalf of a manufacturer1 wholesale distributor1 or dispenser of a product1 but does not take ownership of the product1 nor have responsibility to direct the sale or disposition of the product4 7#bb7 ,trading partner ,the term trading partner means-- 7,a7 a manufacturer1 repackager1 wholesale distributor1 or dispenser from whom a manufacturer1 repackager1 wholesale distributor1 or dispenser accepts direct ownership of a product or to whom a manufacturer1 repackager1 wholesale distributor1 or dispenser transfers direct ownership of a product2 or 7,b7 a third-party logistics provider from whom a manufacturer1 repackager1 wholesale distributor1 or dispenser accepts direct possession of a product or to whom a manufacturer1 repackager1 wholesale distributor1 or dispenser transfers direct possession of a product4 7#bc7 ,transaction 7,a7 ,in general ,the term transaction means the transfer of product between persons in which a change of ownership occurs4 7,b7 ,exemptions ,the term transaction does not include-- 7i7 intracompany distribution of any product between members of an affiliated group 7as defined in section #aejd7;a7 of the ,internal ,revenue ,code of #aihf7 or within a manufacturer2 7ii7 the distribution of a product among hospitals or other health care entities that are under common control2 7iii7 the distribution of a product for emergency medical reasons including a public health emergency declaration pursuant to section #cai of the ,public ,health ,service ,act1 except that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason2 7iv7 the dispensing of a product pursuant to a valid prescription executed in accordance with section #ejc7;b77#a72 7v7 the distribution of product samples by a manufacturer or a licensed wholesale distributor in accordance with section #ejc7;d72 7vi7 the distribution of blood or blood components intended for transfusion2 7vii7 the distribution of minimal quantities of product by a licensed retail pharmacy to a licensed practitioner for office use2 7viii7 the sale1 purchase1 or trade of a drug or an offer to sell1 purchase1 or trade a drug by a charitable organization described in section #eja7;c77#c7 of the ,internal ,revenue ,code of #aied to a nonprofit affiliate of the organization to the extent otherwise permitted by law2 7ix7 the distribution of a product pursuant to the sale or merger of a pharmacy or pharmacies or a wholesale distributor or wholesale distributors1 except that any records required to be maintained for the product shall be transferred to the new owner of the pharmacy or pharmacies or wholesale distributor or wholesale distributors2 7x7 the dispensing of a product approved under section #eab7;b72 7xi7 products transferred to or from any facility that is licensed by the ,nuclear ,regulatory ,commission or by a ,state pursuant to an agreement with such ,commission under section #bgd of the ,atomic ,energy ,act of #aied 7#db ,u4,s4,c4 #bjba72 7xii7 a combination product that is-- 7,i7 a product comprised of a device and #a or more other regulated components 7such as a drug_/device1 biologic_/device1 or drug_/device_/biologic7 that are physically1 chemically1 or otherwise combined or mixed and produced as a single entity2 7,,ii7 #b or more separate products packaged together in a single package or as a unit and comprised of a drug and device or device and biological product2 or 7,,iii7 #b or more finished medical devices plus one or more drug or biological products which are packaged together in what is referred to as a medical convenience kit as described in clause 7xiii72 7xiii7 the distribution of a collection of finished medical devices or a collection of finished drug or biological products assembled in kit form strictly for the convenience of the purchaser or user 7to be known as a medical convenience kit7 if-- 7,i7 the medical convenience kit is assembled in an establishment that is registered with the ,food and ,drug ,administration as a device manufacturer in accordance with section #eaj7;b77#b72 7,,ii7 the person who manufacturers a medical convenience kit purchased the product contained in the medical convenience kit directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer2 7,,iii7 the person who manufacturers a medical convenience kit does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor2 7,,iv7 the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the ,comprehensive ,drug ,abuse ,prevention and ,control ,act of #aigj2 and 7,v7 the products contained in the medical convenience kit are-- 7aa7 intravenous solutions intended for the replenishment of fluids and electrolytes2 7bb7 products intended to maintain the equilibrium of water and minerals in the body2 7cc7 products intended for irrigation or reconstitution2 7dd7 anesthetics2 7ee7 anticoagulants2 7ff7 vasopressors2 or 7gg7 sympathicomimetics2 7xiv7 the distribution of an intravenous product that1 by its formulation1 is intended for the replenishment of fluids and electrolytes 7such as sodium1 chloride1 and potassium7 or calories 7such as dextrose and amino acids72 7xv7 the distribution of an intravenous product used to maintain the equilibrium of water and minerals in the body1 such as dialysis solutions2 7xvi7 the distribution of a product that is intended for irrigation or reconstitution1 or sterile water1 whether intended for such purposes or for injection2 7xvii7 the distribution of a medical gas 7as defined in section #ege72 or 7xviii7 the distribution or sale of any licensed product under section #cea of the ,public ,health ,service ,act that meets the definition of a device under section #bja7;h74 7#bd7 ,transaction history ,the term transaction history means a statement in paper or electronic form1 including the transaction information for each prior transaction going back to the manufacturer of the product4 7#be7 ,transaction information ,the term transaction information means-- 7,a7 the proprietary or established name or names of the product2 7,b7 the strength and dosage form of the product2 7,c7 the ,national ,drug ,code number of the product2 7,d7 the container size2 7,e7 the number of containers2 7,f7 the lot number of the product2 7,g7 the date of the transaction2 7,h7 the date of the shipment1 if different from the date of the transaction2 7,i7 the business name and address of the person from whom ownership is being transferred2 and 7,j7 the business name and address of the person to whom ownership is being transferred4 7#bf7 ,transaction statement ,the transaction statement is a statement1 in paper or electronic form1 that the entity transferring ownership in a transaction-- 7,a7 is authorized as required under the ,drug ,supply ,chain ,security ,act2 7,b7 received the product from a person that is authorized as required under the ,drug ,supply ,chain ,security ,act2 7,c7 received transaction information and a transaction statement from the prior owner of the product1 as required under section #ehb2 7,d7 did not knowingly ship a suspect or illegitimate product2 7,e7 had systems and processes in place to comply with verification requirements under section #ehb2 7,f7 did not knowingly provide false transaction information2 and 7,g7 did not knowingly alter the transaction history4 7#bg7 ,verification or verify ,the term verification or verify means determining whether the product identifier affixed to1 or imprinted upon1 a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager1 as applicable in accordance with section #ehb4 7#bh7 ,wholesale distributor ,the term wholesale distributor means a person 7other than a manufacturer1 a manufacturer's co-licensed partner1 a third-party logistics provider1 or repackager7 engaged in wholesale distribution 7as defined in section #ejc7;e77#d71 as amended by the ,drug ,supply ,chain ,security ,act74 #ehb4 ,requirements 7a7 ,in general 7#a7 ,other activities ,each manufacturer1 repackager1 wholesale distributor1 third-party logistics provider1 and dispenser shall comply with the requirements set forth in this section with respect to the role of such manufacturer1 repackager1 wholesale distributor1 third-party logistics provider1 or dispenser in a transaction involving product4 ,if an entity meets the definition of more than one of the entities listed in the preceding sentence1 such entity shall comply with all applicable requirements in this section1 but shall not be required to duplicate requirements4 7#b7 ,initial standards 7,a7 ,in general ,the ,secretary shall1 in consultation with other appropriate ,federal officials1 manufacturers1 repackagers1 wholesale distributors1 third-party logistics providers1 dispensers1 and other pharmaceutical distribution supply chain stakeholders1 issue a draft guidance document that establishes standards for the interoperable exchange of transaction information1 transaction history1 and transaction statements1 in paper or electronic format1 for compliance with subsections 7a71 7b71 7c71 7d71 7e71 and 7f74 ,in establishing such standards1 the ,secretary shall consider the feasibility of establishing standardized documentation to be used by members of the pharmaceutical distribution supply chain to convey the transaction information1 transaction history1 and transaction statement to the subsequent purchaser of a product and to facilitate the exchange of lot level data4 ,the standards established under this paragraph shall take into consideration the standards established under section #eje;,d and shall comply with a form and format developed by a widely recognized international standards development organization4 7,b7 ,public input ,prior to issuing the draft guidance under subparagraph 7,a71 the ,secretary shall gather comments and information from stakeholders and maintain such comments and information in a public docket for at least #fj days prior to issuing such guidance4 7,c7 ,publication ,the ,secretary shall publish the standards established under subparagraph 7,a7 not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act4 7#c7 ,waivers1 exceptions1 and exemptions 7,a7 ,in general ,not later than #b years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the ,secretary shall1 by guidance-- 7i7 establish a process by which an authorized manufacturer1 repackager1 wholesale distributor1 or dispenser may request a waiver from any of the requirements set forth in this section if the ,secretary determines that such requirements would result in an undue economic hardship or for emergency medical reasons1 including a public health emergency declaration pursuant to section #cai of the ,public ,health ,service ,act2 7ii7 establish a process by which the ,secretary determines exceptions1 and a process through which a manufacturer or repackager may request such an exception1 to the requirements relating to product identifiers if a product is packaged in a container too small or otherwise unable to accommodate a label with sufficient space to bear the information required for compliance with this section2 and 7iii7 establish a process by which the ,secretary may determine other products or transactions that shall be exempt from the requirements of this section4 7,b7 ,content ,the guidance issued under subparagraph 7,a7 shall include a process for the biennial review and renewal of such waivers1 exceptions1 and exemptions1 as applicable4 7,c7 ,process ,in issuing the guidance under this paragraph1 the ,secretary shall provide an effective date that is not later than #ahj days prior to the date on which manufacturers are required to affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction into commerce consistent with this section4 7#d7 ,self-executing requirements ,except where otherwise specified1 the requirements of this section may be enforced without further regulations or guidance from the ,secretary4 7#e7 ,grandfathering product 7,a7 ,product identifier ,not later than #b years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the ,secretary shall finalize guidance specifying whether and under what circumstances product that is not labeled with a product identifier and that is in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of this section shall be exempted from the requirements of this section4 7,b7 ,tracing ,for a product that entered the pharmaceutical distribution supply chain prior to the date that is #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act-- 7i7 authorized trading partners shall be exempt from providing transaction information as required under subsections 7b77#a77;,a77i71 7c77#a77;,a77ii71 7d77#a77;,a77ii71 and 7e77#a77;,a77ii72 7ii7 transaction history required under this section shall begin with the owner of such product on such date2 and 7iii7 the owners of such product on such date shall be exempt from asserting receipt of transaction information and transaction statement from the prior owner as required under this section4 7#f7 ,wholesale distributor licenses ,notwithstanding section #eha7h77;,a71 until the effective date of the wholesale distributor licensing regulations under section #ehc1 the term licensed or authorized1 as it relates to a wholesale distributor with respect to prescription drugs1 shall mean a wholesale distributor with a valid license under ,state law4 7#g7 ,third-party logistics provider licenses ,until the effective date of the third-party logistics provider licensing regulations under section #ehd1 a third-party logistics provider shall be considered licensed under section #eha7h77;,b7 unless the ,secretary has made a finding that the third-party logistics provider does not utilize good handling and distribution practices and publishes notice thereof4 7#h7 ,label changes ,changes made to package labels solely to incorporate the product identifier may be submitted to the ,secretary in the annual report of an establishment1 in accordance with section #cad4gj7;d7 of chapter #ba1 ,code of ,federal ,regulations 7or any successor regulation74 7#i7 ,product identifiers ,with respect to any requirement relating to product identifiers under this subchapter-- 7,a7 unless the ,secretary allows1 through guidance1 the use of other technologies for data instead of or in addition to the technologies described in clauses 7i7 and 7ii71 the applicable data-- 7i7 shall be included in a #b-;dimensional data matrix barcode when affixed to1 or imprinted upon1 a package2 and 7ii7 shall be included in a linear or #b-;dimensional data matrix barcode when affixed to1 or imprinted upon1 a homogeneous case2 and 7,b7 verification of the product identifier may occur by using human-readable or machine-readable methods4 7b7 ,manufacturer requirements 7#a7 ,product tracing 7,a7 ,in general ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a manufacturer shall-- 7i7 prior to1 or at the time of1 each transaction in which such manufacturer transfers-- 7,i7 ownership of a product1 provide the subsequent recipient with transaction history1 transaction information1 and a transaction statement1 in a single document in an electronic or paper format2 or 7,,ii7 possession of a product to a third-party logistics provider for the purpose of transferring ownership as part of a transaction to a subsequent recipient1 provide to the third-party logistics provider the transaction history1 transaction information1 and a transaction statement for such transaction to a subsequent recipient2 and 7ii7 maintain the transaction information1 transaction history1 and transaction statement for each transaction for not less than #f years after the date of the transaction4 7,b7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product1 a manufacturer shall1 not later than #bd hours after receiving the request or in other such reasonable time as determined by the ,secretary1 based on the circumstances of the request1 provide the applicable transaction information1 transaction history1 and transaction statement for the product4 7#b7 ,product identifier ,beginning not later than #d years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce4 ,such manufacturer shall maintain the product identifier information for such product for not less than #f years after the date of the transaction4 7#c7 ,authorized trading partners ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the trading partners of a manufacturer may be only authorized trading partners4 7#d7 ,verification ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a manufacturer shall have systems in place to enable the manufacturer to comply with the following requirements3 7,a7 ,suspect product 7i7 ,in general ,upon making a determination that a product in the possession or control of the manufacturer is a suspect product1 or upon receiving a request for verification from the ,secretary that has made a determination that a product within the possession or control of a manufacturer is a suspect product1 a manufacturer shall-- 7,i7 quarantine such product within the possession or control of the manufacturer from product intended for distribution until such product is cleared or dispositioned2 and 7,,ii7 promptly conduct an investigation in coordination with trading partners1 as applicable1 to determine whether the product is an illegitimate product1 which shall include validating any applicable transaction history and transaction information in the possession of the manufacturer and otherwise investigating to determine whether the product is an illegitimate product1 and1 beginning #d years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 verifying the product at the package level1 including the standardized numerical identifier4 7ii7 ,cleared product ,if the manufacturer makes the determination that a suspect product is not an illegitimate product1 the manufacturer shall promptly notify the ,secretary1 if applicable1 of such determination and such product may be further distributed4 7iii7 ,records ,a manufacturer shall keep records of the investigation of a suspect product for not less than #f years after the conclusion of the investigation4 7,b7 ,illegitimate product 7i7 ,in general ,upon determining that a product in the possession or control of a manufacturer is an illegitimate product1 the manufacturer shall1 in a manner consistent with the systems and processes of such manufacturer-- 7,i7 quarantine such product within the possession or control of the manufacturer from product intended for distribution until such product is dispositioned2 7,,ii7 disposition the illegitimate product within the possession or control of the manufacturer2 7,,iii7 take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the manufacturer2 and 7,,iv7 retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official7 upon request by the ,secretary 7or other appropriate ,federal or ,state official71 as necessary and appropriate4 7ii7 ,making a notification 7,i7 ,illegitimate product ,upon determining that a product in the possession or control of the manufacturer is an illegitimate product1 the manufacturer shall notify the ,secretary and all immediate trading partners that the manufacturer has reason to believe may have received such illegitimate product of such determination not later than #bd hours after making such determination4 7,,ii7 ,high risk of illegitimacy ,a manufacturer shall notify the ,secretary and immediate trading partners that the manufacturer has reason to believe may have in the trading partner's possession a product manufactured by1 or purported to be a product manufactured by1 the manufacturer not later than #bd hours after determining or being notified by the ,secretary or a trading partner that there is a high risk that such product is an illegitimate product4 ,for purposes of this subclause1 a high risk may include a specific high-risk that could increase the likelihood that illegitimate product will enter the pharmaceutical distribution supply chain and other high risks as determined by the ,secretary in guidance pursuant to subsection 7i74 7iii7 ,responding to a notification ,upon the receipt of a notification from the ,secretary or a trading partner that a determination has been made that a product is an illegitimate product1 a manufacturer shall identify all illegitimate product subject to such notification that is in the possession or control of the manufacturer1 including any product that is subsequently received1 and shall perform the activities described in subparagraph 7,a74 7iv7 ,terminating a notification ,upon making a determination1 in consultation with the ,secretary1 that a notification is no longer necessary1 a manufacturer shall promptly notify immediate trading partners that the manufacturer notified pursuant to clause 7ii7 that such notification has been terminated4 7v7 ,records ,a manufacturer shall keep records of the disposition of an illegitimate product for not less than #f years after the conclusion of the disposition4 7,c7 ,requests for verification ,beginning #d years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 upon receiving a request for verification from an authorized repackager1 wholesale distributor1 or dispenser that is in possession or control of a product such person believes to be manufactured by such manufacturer1 a manufacturer shall1 not later than #bd hours after receiving the verification request or in other such reasonable time as determined by the ,secretary1 based on the circumstances of the request1 notify the person making the request whether the product identifier1 including the standardized numerical identifier1 that is the subject of the request corresponds to the product identifier affixed or imprinted by the manufacturer4 ,if a manufacturer responding to a verification request identifies a product identifier that does not correspond to that affixed or imprinted by the manufacturer1 the manufacturer shall treat such product as suspect product and conduct an investigation as described in subparagraph 7,a74 ,if the manufacturer has reason to believe the product is an illegitimate product1 the manufacturer shall advise the person making the request of such belief at the time such manufacturer responds to the verification request4 7,d7 ,electronic database ,a manufacturer may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity4 ,the owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain1 as appropriate4 ,the development and operation of such a database shall not relieve a manufacturer of the requirement under this paragraph to respond to a verification request submitted by means other than a secure electronic database4 7,e7 ,saleable returned product ,beginning #d years after the date of enactment of the ,drug ,supply ,chain ,security ,act 7except as provided pursuant to subsection 7a77#e771 upon receipt of a returned product that the manufacturer intends to further distribute1 before further distributing such product1 the manufacturer shall verify the product identifier1 including the standardized numerical identifier1 for each sealed homogeneous case of such product or1 if such product is not in a sealed homogeneous case1 verify the product identifier1 including the standardized numerical identifier1 on each package4 7,f7 ,nonsaleable returned product ,a manufacturer may return a nonsaleable product to the manufacturer or repackager1 to the wholesale distributor from whom such product was purchased1 or to a person acting on behalf of such a person1 including a returns processor1 without providing the information described in paragraph 7#a77;,a77i74 7c7 ,wholesale distributor requirements 7#a7 ,product tracing 7,a7 ,in general ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the following requirements shall apply to wholesale distributors3 7i7 ,a wholesale distributor shall not accept ownership of a product unless the previous owner prior to1 or at the time of1 the transaction provides the transaction history1 transaction information1 and a transaction statement for the product1 as applicable under this subparagraph4 7ii7 7,i7 7aa7 ,if the wholesale distributor purchased a product directly from the manufacturer1 the exclusive distributor of the manufacturer1 or a repackager that purchased directly from the manufacturer1 then prior to1 or at the time of1 each transaction in which the wholesale distributor transfers ownership of a product1 the wholesale distributor shall provide to the subsequent purchaser-- 7,,aa7 a transaction statement1 which shall state that such wholesale distributor1 or a member of the affiliated group of such wholesale distributor1 purchased the product directly from the manufacturer1 exclusive distributor of the manufacturer1 or repackager that purchased directly from the manufacturer2 and 7,,bb7 subject to subclause 7,,ii71 the transaction history and transaction information4 7bb7 ,the wholesale distributor shall provide the transaction history1 transaction information1 and transaction statement under item 7aa7-- 7,,aa7 if provided to a dispenser1 on a single document in an electronic or paper format2 and 7,,bb7 if provided to a wholesale distributor1 through any combination of self-generated paper1 electronic data1 or manufacturer-provided information on the product package4 7,,ii7 ,for purposes of transactions described in subclause 7,i71 transaction history and transaction information shall not be required to include the lot number of the product1 the initial transaction date1 or the initial shipment date from the manufacturer 7as defined in subparagraphs 7,f71 7,g71 and 7,h7 of section #eha7be774 7iii7 ,if the wholesale distributor did not purchase a product directly from the manufacturer1 the exclusive distributor of the manufacturer1 or a repackager that purchased directly from the manufacturer1 as described in clause 7ii71 then prior to1 or at the time of1 each transaction or subsequent transaction1 the wholesale distributor shall provide to the subsequent purchaser a transaction statement1 transaction history1 and transaction information1 in a paper or electronic format that complies with the guidance document issued under subsection 7a77#b74 7iv7 ,for the purposes of clause 7iii71 the transaction history supplied shall begin only with the wholesale distributor described in clause 7ii77,i71 but the wholesale distributor described in clause 7iii7 shall inform the subsequent purchaser that such wholesale distributor received a direct purchase statement from a wholesale distributor described in clause 7ii77,i74 7v7 ,a wholesale distributor shall maintain the transaction information1 transaction history1 and transaction statement for each transaction described in clauses 7i71 7ii71 and 7iii7 for not less than #f years after the date of the transaction4 7,b7 ,returns 7i7 ,saleable returns ,notwithstanding subparagraph 7,a77i71 the following shall apply3 7,i7 ,requirements ,until the date that is #f years after the date of enactment of the ,drug ,supply ,chain ,security ,act 7except as provided pursuant to subsection 7a77#e771 a wholesale distributor may accept returned product from a dispenser pursuant to the terms and conditions of any agreement between the parties1 and1 notwithstanding subparagraph 7,a77ii71 may distribute such returned product without providing the transaction history4 ,for transactions subsequent to the return1 the transaction history of such product shall begin with the wholesale distributor that accepted the returned product1 consistent with the requirements of this subsection4 7,,ii7 ,enhanced requirements ,beginning #f years after the date of enactment of the ,drug ,supply ,chain ,security ,act 7except as provided pursuant to subsection 7a77#e771 a wholesale distributor may accept returned product from a dispenser only if the wholesale distributor can associate returned product with the transaction information and transaction statement associated with that product4 ,for all transactions after such date1 the transaction history1 as applicable1 of such product shall begin with the wholesale distributor that accepted and verified the returned product4 ,for purposes of this subparagraph1 the transaction information and transaction history1 as applicable1 need not include transaction dates if it is not reasonably practicable to obtain such dates4 7ii7 ,nonsaleable returns ,a wholesale distributor may return a nonsaleable prescription drug to the manufacturer or repackager1 to the wholesale distributor from whom such prescription drug was purchased1 or to a person acting on behalf of such a person1 including a returns processor1 without providing the information required under subparagraph 7,a77i74 7,c7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product a wholesale distributor shall1 not later than #bd hours after receiving the request or in other such reasonable time as determined by the ,secretary1 based on the circumstances of the request1 provide the applicable transaction information1 transaction history1 and transaction statement for the product4 7#b7 ,product identifier ,beginning #f years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a wholesale distributor may engage in transactions involving a product only if such product is encoded with a product identifier 7except as provided pursuant to subsection 7a77#e774 7#c7 ,authorized trading partners ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the trading partners of a wholesale distributor may be only authorized trading partners4 7#d7 ,verification ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a wholesale distributor shall have systems in place to enable the wholesale distributor to comply with the following requirements3 7,a7 ,suspect product 7i7 ,in general ,upon making a determination that a product in the possession or control of the wholesale distributor is a suspect product1 or upon receiving a request for verification from the ,secretary that has made a determination that a product within the possession or control of a wholesale distributor is a suspect product1 a wholesale distributor shall-- 7,i7 quarantine such product within the possession or control of the wholesale distributor from product intended for distribution until such product is cleared or dispositioned2 and 7,,ii7 promptly conduct an investigation in coordination with trading partners1 as applicable1 to determine whether the product is an illegitimate product1 which shall include validating any applicable transaction history and transaction information in the possession of the wholesale distributor and otherwise investigating to determine whether the product is an illegitimate product1 and1 beginning #f years after the date of enactment of the ,drug ,supply ,chain ,security ,act 7except as provided pursuant to subsection 7a77#e771 verifying the product at the package level1 including the standardized numerical identifier4 7ii7 ,cleared product ,if the wholesale distributor determines that a suspect product is not an illegitimate product1 the wholesale distributor shall promptly notify the ,secretary1 if applicable1 of such determination and such product may be further distributed4 7iii7 ,records ,a wholesale distributor shall keep records of the investigation of a suspect product for not less than #f years after the conclusion of the investigation4 7,b7 ,illegitimate product 7i7 ,in general ,upon determining1 in coordination with the manufacturer1 that a product in the possession or control of a wholesale distributor is an illegitimate product1 the wholesale distributor shall1 in a manner that is consistent with the systems and processes of such wholesale distributor-- 7,i7 quarantine such product within the possession or control of the wholesale distributor from product intended for distribution until such product is dispositioned2 7,,ii7 disposition the illegitimate product within the possession or control of the wholesale distributor2 7,,iii7 take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the wholesale distributor2 and 7,,iv7 retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official7 upon request by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official71 as necessary and appropriate4 7ii7 ,making a notification ,upon determining that a product in the possession or control of the wholesale distributor is an illegitimate product1 the wholesale distributor shall notify the ,secretary and all immediate trading partners that the wholesale distributor has reason to believe may have received such illegitimate product of such determination not later than #bd hours after making such determination4 7iii7 ,responding to a notification ,upon the receipt of a notification from the ,secretary or a trading partner that a determination has been made that a product is an illegitimate product1 a wholesale distributor shall identify all illegitimate product subject to such notification that is in the possession or control of the wholesale distributor1 including any product that is subsequently received1 and shall perform the activities described in subparagraph 7,a74 7iv7 ,terminating a notification ,upon a determination1 in consultation with the ,secretary1 that a notification is no longer necessary1 a wholesale distributor shall promptly notify immediate trading partners that the wholesale distributor notified pursuant to clause 7ii7 that such notification has been terminated4 7v7 ,records ,a wholesale distributor shall keep records of the disposition of an illegitimate product for not less than #f years after the conclusion of the disposition4 7,c7 ,electronic database ,a wholesale distributor may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity4 ,the owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain1 as appropriate4 ,the development and operation of such a database shall not relieve a wholesale distributor of the requirement under this paragraph to respond to a verification request submitted by means other than a secure electronic database4 7,d7 ,verification of saleable returned product ,beginning #f years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 upon receipt of a returned product that the wholesale distributor intends to further distribute1 before further distributing such product1 the wholesale distributor shall verify the product identifier1 including the standardized numerical identifier1 for each sealed homogeneous case of such product or1 if such product is not in a sealed homogeneous case1 verify the product identifier1 including the standardized numerical identifier1 on each package4 7d7 ,dispenser requirements 7#a7 ,product tracing 7,a7 ,in general ,beginning #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a dispenser-- 7i7 shall not accept ownership of a product1 unless the previous owner prior to1 or at the time of1 the transaction1 provides transaction history1 transaction information1 and a transaction statement2 7ii7 prior to1 or at the time of1 each transaction in which the dispenser transfers ownership of a product 7but not including dispensing to a patient or returns7 shall provide the subsequent owner with transaction history1 transaction information1 and a transaction statement for the product1 except that the requirements of this clause shall not apply to sales by a dispenser to another dispenser to fulfill a specific patient need2 and 7iii7 shall maintain transaction information1 transaction history1 and transaction statements1 as necessary to investigate a suspect product1 for not less than #f years after the transaction4 7,b7 ,agreements with third parties ,a dispenser may enter into a written agreement with a third party1 including an authorized wholesale distributor1 under which the third party confidentially maintains the transaction information1 transaction history1 and transaction statements required to be maintained under this subsection on behalf of the dispenser4 ,if a dispenser enters into such an agreement1 the dispenser shall maintain a copy of the written agreement and shall not be relieved of the obligations of the dispenser under this subsection4 7,c7 ,returns 7i7 ,saleable returns ,a dispenser may return product to the trading partner from which the dispenser obtained the product without providing the information required under subparagraph 7,a74 7ii7 ,nonsaleable returns ,a dispenser may return a nonsaleable product to the manufacturer or repackager1 to the wholesale distributor from whom such product was purchased1 to a returns processor1 or to a person acting on behalf of such a person without providing the information required under subparagraph 7,a77i74 7,d7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect or an illegitimate product1 a dispenser shall1 not later than #b business days after receiving the request or in another such reasonable time as determined by the ,secretary1 based on the circumstances of the request1 provide the applicable transaction information1 transaction statement1 and transaction history which the dispenser received from the previous owner1 which shall not include the lot number of the product1 the initial transaction date1 or the initial shipment date from the manufacturer unless such information was included in the transaction information1 transaction statement1 and transaction history provided by the manufacturer or wholesale distributor to the dispenser4 ,the dispenser may respond to the request by providing the applicable information in either paper or electronic format4 7#b7 ,product identifier ,beginning not later than #g years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a dispenser may engage in transactions involving a product only if such product is encoded with a product identifier 7except as provided pursuant to subsection 7a77#e774 7#c7 ,authorized trading partners ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the trading partners of a dispenser may be only authorized trading partners4 7#d7 ,verification ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a dispenser shall have systems in place to enable the dispenser to comply with the following requirements3 7,a7 ,suspect product 7i7 ,in general ,upon making a determination that a product in the possession or control of the dispenser is a suspect product1 or upon receiving a request for verification from the ,secretary that has made a determination that a product within the possession or control of a dispenser is a suspect product1 a dispenser shall-- 7,i7 quarantine such product within the possession or control of the dispenser from product intended for distribution until such product is cleared or dispositioned2 and 7,,ii7 promptly conduct an investigation in coordination with trading partners1 as applicable1 to determine whether the product is an illegitimate product4 7ii7 ,investigation ,an investigation conducted under clause 7i77,,ii7 shall include-- 7,i7 beginning #g years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 verifying whether the lot number of a suspect product corresponds with the lot number for such product2 7,,ii7 beginning #g years after the date of enactment of such ,act1 verifying that the product identifier1 including the standardized numerical identifier1 of at least #c packages or #aj percent of such suspect product1 whichever is greater1 or all packages1 if there are fewer than #c1 corresponds with the product identifier for such product2 7,,iii7 validating any applicable transaction history and transaction information in the possession of the dispenser2 and 7,,iv7 otherwise investigating to determine whether the product is an illegitimate product4 7iii7 ,cleared product ,if the dispenser makes the determination that a suspect product is not an illegitimate product1 the dispenser shall promptly notify the ,secretary1 if applicable1 of such determination and such product may be further distributed or dispensed4 7iv7 ,records ,a dispenser shall keep records of the investigation of a suspect product for not less than #f years after the conclusion of the investigation4 7,b7 ,illegitimate product 7i7 ,in general ,upon determining1 in coordination with the manufacturer1 that a product in the possession or control of a dispenser is an illegitimate product1 the dispenser shall-- 7,i7 disposition the illegitimate product within the possession or control of the dispenser2 7,,ii7 take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the dispenser2 and 7,,iii7 retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official7 upon request by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official71 as necessary and appropriate4 7ii7 ,making a notification ,upon determining that a product in the possession or control of the dispenser is an illegitimate product1 the dispenser shall notify the ,secretary and all immediate trading partners that the dispenser has reason to believe may have received such illegitimate product of such determination not later than #bd hours after making such determination4 7iii7 ,responding to a notification ,upon the receipt of a notification from the ,secretary or a trading partner that a determination has been made that a product is an illegitimate product1 a dispenser shall identify all illegitimate product subject to such notification that is in the possession or control of the dispenser1 including any product that is subsequently received1 and shall perform the activities described in subparagraph 7,a74 7iv7 ,terminating a notification ,upon making a determination1 in consultation with the ,secretary1 that a notification is no longer necessary1 a dispenser shall promptly notify immediate trading partners that the dispenser notified pursuant to clause 7ii7 that such notification has been terminated4 7v7 ,records ,a dispenser shall keep records of the disposition of an illegitimate product for not less than #f years after the conclusion of the disposition4 7,c7 ,electronic database ,a dispenser may satisfy the requirements of this paragraph by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity4 7e7 ,repackager requirements 7#a7 ,product tracing 7,a7 ,in general ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a repackager shall-- 7i7 not accept ownership of a product unless the previous owner1 prior to1 or at the time of1 the transaction1 provides transaction history1 transaction information1 and a transaction statement for the product2 7ii7 prior to1 or at the time of1 each transaction in which the repackager transfers ownership of a product1 or transfers possession of a product to a third-party logistics provider1 provide the subsequent owner with transaction history1 transaction information1 and a transaction statement2 and 7iii7 maintain the transaction information1 transaction history1 and transaction statement for each transaction described in clauses 7i7 and 7ii7 for not less than #f years after the transaction4 7,b7 ,nonsaleable returns ,a repackager may return a nonsaleable product to the manufacturer or repackager1 or to the wholesale distributor from whom such product was purchased1 or to a person acting on behalf of such a person1 including a returns processor1 without providing the information required under subparagraph 7,a77ii74 7,c7 ,requests for information ,upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product1 a repackager shall1 not later than #bd hours after receiving the request or in other such reasonable time as determined by the ,secretary1 based on the circumstances of the request1 provide the applicable transaction information1 transaction history and transaction statement for the product4 7#b7 ,product identifier ,beginning not later than #e years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a repackager-- 7,a7 shall affix or imprint a product identifier to each package and homogenous case of product intended to be introduced in a transaction in commerce2 7,b7 shall maintain the product identifier information for such product for not less than #f years after the date of the transaction2 7,c7 may engage in transactions involving a product only if such product is encoded with a product identifier 7except as provided pursuant to subsection 7a77#e772 and 7,d7 maintain records for not less than #f years to allow the repackager to associate the product identifier the repackager affixes or imprints with the product identifier assigned by the original manufacturer of the product4 7#c7 ,authorized trading partners ,beginning #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the trading partners of a repackager may be only authorized trading partners4 7#d7 ,verification ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a repackager shall have systems in place to enable the repackager to comply with the following requirements3 7,a7 ,suspect product 7i7 ,in general ,upon making a determination that a product in the possession or control of the repackager is a suspect product1 or upon receiving a request for verification from the ,secretary that has made a determination that a product within the possession or control of a repackager is a suspect product1 a repackager shall-- 7,i7 quarantine such product within the possession or control of the repackager from product intended for distribution until such product is cleared or dispositioned2 and 7,,ii7 promptly conduct an investigation in coordination with trading partners1 as applicable1 to determine whether the product is an illegitimate product1 which shall include validating any applicable transaction history and transaction information in the possession of the repackager and otherwise investigating to determine whether the product is an illegitimate product1 and1 beginning #e years after the date of enactment of the ,drug ,supply ,chain ,security ,act 7except as provided pursuant to subsection 7a77#e771 verifying the product at the package level1 including the standardized numerical identifier4 7ii7 ,cleared product ,if the repackager makes the determination that a suspect product is not an illegitimate product1 the repackager shall promptly notify the ,secretary1 if applicable1 of such determination and such product may be further distributed4 7iii7 ,records ,a repackager shall keep records of the investigation of a suspect product for not less than #f years after the conclusion of the investigation4 7,b7 ,illegitimate product 7i7 ,in general ,upon determining1 in coordination with the manufacturer1 that a product in the possession or control of a repackager is an illegitimate product1 the repackager shall1 in a manner that is consistent with the systems and processes of such repackager-- 7,i7 quarantine such product within the possession or control of the repackager from product intended for distribution until such product is dispositioned2 7,,ii7 disposition the illegitimate product within the possession or control of the repackager2 7,,iii7 take reasonable and appropriate steps to assist a trading partner to disposition an illegitimate product not in the possession or control of the repackager2 and 7,,iv7 retain a sample of the product for further physical examination or laboratory analysis of the product by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official7 upon request by the manufacturer or ,secretary 7or other appropriate ,federal or ,state official71 as necessary and appropriate4 7ii7 ,making a notification ,upon determining that a product in the possession or control of the repackager is an illegitimate product1 the repackager shall notify the ,secretary and all immediate trading partners that the repackager has reason to believe may have received the illegitimate product of such determination not later than #bd hours after making such determination4 7iii7 ,responding to a notification ,upon the receipt of a notification from the ,secretary or a trading partner1 a repackager shall identify all illegitimate product subject to such notification that is in the possession or control of the repackager1 including any product that is subsequently received1 and shall perform the activities described in subparagraph 7,a74 7iv7 ,terminating a notification ,upon a determination1 in consultation with the ,secretary1 that a notification is no longer necessary1 a repackager shall promptly notify immediate trading partners that the repackager notified pursuant to clause 7ii7 that such notification has been terminated4 7v7 ,records ,a repackager shall keep records of the disposition of an illegitimate product for not less than #f years after the conclusion of the disposition4 7,c7 ,requests for verification ,beginning #e years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 upon receiving a request for verification from an authorized manufacturer1 wholesale distributor1 or dispenser that is in possession or control of a product they believe to be repackaged by such repackager1 a repackager shall1 not later than #bd hours after receiving the verification request or in other such reasonable time as determined by the ,secretary1 based on the circumstances of the request1 notify the person making the request whether the product identifier1 including the standardized numerical identifier1 that is the subject of the request corresponds to the product identifier affixed or imprinted by the repackager4 ,if a repackager responding to a verification request identifies a product identifier that does not correspond to that affixed or imprinted by the repackager1 the repackager shall treat such product as suspect product and conduct an investigation as described in subparagraph 7,a74 ,if the repackager has reason to believe the product is an illegitimate product1 the repackager shall advise the person making the request of such belief at the time such manufacturer responds to the verification request4 7,d7 ,electronic database ,a repackager may satisfy the requirements of paragraph 7#d7 by developing a secure electronic database or utilizing a secure electronic database developed or operated by another entity4 ,the owner of such database shall establish the requirements and processes to respond to requests and may provide for data access to other members of the pharmaceutical distribution supply chain1 as appropriate4 ,the development and operation of such a database shall not relieve a repackager of the requirement under subparagraph 7,c7 to respond to a verification request submitted by means other than a secure electronic database4 7,e7 ,verification of saleable returned product ,beginning #e years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 upon receipt of a returned product that the repackager intends to further distribute1 before further distributing such product1 the repackager shall verify the product identifier for each sealed homogeneous case of such product or1 if such product is not in a sealed homogeneous case1 verify the product identifier on each package4 7f7 ,third-party logistics provider requirements 7#a7 ,in general ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a third-party logistics provider shall-- 7,a7 not accept possession of a product unless the owner of the product provides the transaction history1 transaction information1 and a transaction statement for the product2 7,b7 maintain a copy of the information described in subparagraph 7,a7 for not less than #f years after the transfer of possession2 and 7,c7 upon a request by the ,secretary or other appropriate ,federal or ,state official1 in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product1 not later than #bd hours after receiving the request or in other such reasonable time as determined by the ,secretary based on the circumstances of the request1 provide the applicable transaction information1 transaction history1 and transaction statement for the product4 7#b7 ,product tracing ,beginning not later than #f years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a third-party logistics provider may accept possession of product only if such product is encoded with a product identifier 7except as provided pursuant to subsection 7a77#e774 7#c7 ,authorized trading partners ,beginning #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the trading partners of a third-party logistics provider may be only authorized trading partners4 7#d7 ,verification ,beginning not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a third-party logistics provider shall have systems in place to enable the third-party logistics provider to comply with the following requirements3 7,a7 ,suspect product 7i7 ,in general ,upon making a determination that a product in the possession or control of a third-party logistics provider is a suspect product1 a third-party logistics provider shall-- 7,i7 quarantine such product within the possession or control of the third-party logistics provider from product intended for distribution until such product is cleared or transferred to the owner of such product for disposition of the product2 and 7,,ii7 promptly notify the owner of such product of the need to conduct an investigation to determine whether the product is an illegitimate product4 7ii7 ,cleared product ,if the owner of the product notifies the third-party logistics provider of the determination that a suspect product is not an illegitimate product1 such product may be further distributed4 7iii7 ,records ,a third-party logistics provider shall keep records of the activities described in subclauses 7,i7 and 7,,ii7 of clause 7i71 as such subclauses relate to a suspect product1 for not less than #f years after the conclusion of the investigation4 7,b7 ,illegitimate product 7i7 ,in general ,upon determining1 in coordination with the manufacturer1 that a product in the possession or control of a third-party logistics provider is an illegitimate product1 the third-party logistics provider shall-- 7,i7 promptly notify the owner of such product of the need to disposition such product2 and 7,,ii7 promptly transfer possession of the product to the owner of such product to disposition the product4 7ii7 ,making a notification ,upon determining that a product in the possession or control of the third-party logistics provider is an illegitimate product1 the third-party logistics provider shall notify the ,secretary not later than #bd hours after making such determination4 7iii7 ,responding to a notification ,upon the receipt of a notification from the ,secretary1 a third-party logistics provider shall identify all illegitimate product subject to such notification that is in the possession or control of the third-party logistics provider1 including any product that is subsequently received1 and shall perform the activities described in subparagraph 7,a74 7iv7 ,terminating a notification ,upon making a determination1 in consultation with the ,secretary and the owner of such product1 that a notification is no longer necessary1 a third-party logistics provider shall promptly terminate such notification4 7v7 ,records ,a third-party logistics provider shall keep records of the activities described in subclauses 7,i7 and 7,,ii7 of clause 7i7 as such subclauses relate to an illegitimate product for not less than #f years after the conclusion of the disposition4 7g7 ,drop shipments 7#a7 ,in general ,a wholesale distributor that does not physically handle or store product shall be exempt from the provisions of this section1 except the notification requirements under clauses 7ii71 7iii71 and 7iv7 of subsection 7c77#d77;,b71 provided that the manufacturer1 repackager1 or other wholesale distributor that distributes the product to the dispenser by means of drop shipment for such wholesale distributor includes on the transaction information and transaction history to the dispenser the contact information of such wholesale distributor and provides the transaction information1 transaction history1 and transaction statement directly to the dispenser4 7#b7 ,clarification ,for purposes of this subsection1 providing administrative services1 including processing of orders and payments1 shall not by itself1 be construed as being involved in the handling1 distribution1 or storage of a product4 4 #bjc4 ,enhanced drug distribution security ,section #ehb1 as added by section #bjb1 is amended by adding at the end the following3 7h7 ,enhanced drug distribution security 7#a7 ,in general ,on the date that is #aj years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the following interoperable1 electronic tracing of product at the package level requirements shall go into effect3 7,a7 ,the transaction information and the transaction statements as required under this section shall be exchanged in a secure1 interoperable1 electronic manner in accordance with the standards established under the guidance issued pursuant to paragraphs 7#c7 and 7#d7 of subsection 7i71 including any revision of such guidance issued in accordance with paragraph 7#e7 of such subsection4 7,b7 ,the transaction information required under this section shall include the product identifier at the package level for each package included in the transaction4 7,c7 ,systems and processes for verification of product at the package level1 including the standardized numerical identifier1 shall be required in accordance with the standards established under the guidance issued pursuant to subsection 7a77#b7 and the guidances issued pursuant to paragraphs 7#b71 7#c71 and 7#d7 of subsection 7i71 including any revision of such guidances issued in accordance with paragraph 7#e7 of such subsection1 which may include the use of aggregation and inference as necessary4 7,d7 ,the systems and processes necessary to promptly respond with the transaction information and transaction statement for a product upon a request by the ,secretary 7or other appropriate ,federal or ,state official7 in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product shall be required4 7,e7 ,the systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer1 as applicable1 shall be required-- 7i7 in the event of a request by the ,secretary 7or other appropriate ,federal or ,state official71 on account of a recall or for the purposes of investigating a suspect product or an illegitimate product2 or 7ii7 in the event of a request by an authorized trading partner1 in a secure manner that ensures the protection of confidential commercial information and trade secrets1 for purposes of investigating a suspect product or assisting the ,secretary 7or other appropriate ,federal or ,state official7 with a request described in clause 7i74 7,f7 ,each person accepting a saleable return shall have systems and processes in place to allow acceptance of such product and may accept saleable returns only if such person can associate the saleable return product with the transaction information and transaction statement associated with that product4 7#b7 ,compliance 7,a7 ,information maintenance agreement ,a dispenser may enter into a written agreement with a third party1 including an authorized wholesale distributor1 under which the third party shall confidentially maintain any information and statements required to be maintained under this section4 ,if a dispenser enters into such an agreement1 the dispenser shall maintain a copy of the written agreement and shall not be relieved of the obligations of the dispenser under this subsection4 7,b7 ,alternative methods ,the ,secretary1 taking into consideration the assessment conducted under paragraph 7#c71 shall provide for alternative methods of compliance with any of the requirements set forth in paragraph 7#a71 including-- 7i7 establishing timelines for compliance by small businesses 7including small business dispensers with #be or fewer full time employees7 with such requirements1 in order to ensure that such requirements do not impose undue economic hardship for small businesses1 including small business dispensers for whom the criteria set forth in the assessment under paragraph 7#c7 is not met1 if the ,secretary determines that such requirements under paragraph 7#a7 would result in undue economic hardship2 and 7ii7 establishing a process by which a dispenser may request a waiver from any of the requirements set forth in paragraph 7#a7 if the ,secretary determines that such requirements would result in an undue economic hardship1 which shall include a process for the biennial review and renewal of any such waiver4 7#c7 ,assessment 7,a7 ,in general ,not later than the date that is #ah months after the ,secretary issues the final guidance required under subsection 7i71 the ,secretary shall enter into contract with a private1 independent consulting firm with expertise to conduct a technology and software assessment that looks at the feasibility of dispensers with #be or fewer full-time employees conducting interoperable1 electronic tracing of products at the package level4 ,in no case may such assessment commence later than #g years after the date of enactment of the ,drug ,supply ,chain ,security ,act4 7,b7 ,condition ,as a condition of the award of the contract under subparagraph 7,a71 the private1 independent consulting firm shall agree to consult with dispensers with #be or fewer full-time employees when conducting the assessment under such subparagraph4 7,c7 ,content ,the assessment conducted under subparagraph 7,a7 shall assess whether-- 7i7 the necessary software and hardware is readily accessible to such dispensers2 7ii7 the necessary software and hardware is prohibitively expensive to obtain1 install1 and maintain for such dispensers2 and 7iii7 the necessary hardware and software can be integrated into business practices1 such as interoperability with wholesale distributors1 for such dispensers4 7,d7 ,publication ,the ,secretary shall-- 7i7 publish the statement of work for the assessment conducted under subparagraph 7,a7 for public comment prior to beginning the assessment2 7ii7 publish the final assessment for public comment not later than #cj calendar days after receiving such assessment2 and 7iii7 hold a public meeting not later than #ahj calendar days after receiving the final assessment at which public stakeholders may present their views on the assessment4 7#d7 ,procedure ,notwithstanding section #eec of title #e1 ,united ,states ,code1 the ,secretary1 in promulgating any regulation pursuant to this section1 shall-- 7,a7 provide appropriate flexibility by-- 7i7 not requiring the adoption of specific business systems for the maintenance and transmission of data2 7ii7 prescribing alternative methods of compliance for any of the requirements set forth in paragraph 7#a7 or set forth in regulations implementing such requirements1 including timelines-- 7,i7 for small businesses to comply with the requirements set forth in the regulations in order to ensure that such requirements do not impose undue economic hardship for small businesses 7including small business dispensers for whom the criteria set forth in the assessment under paragraph 7#c7 is not met71 if the ,secretary determines that such requirements would result in undue economic hardship2 and 7,,ii7 which shall include establishing a process by which a dispenser may request a waiver from any of the requirements set forth in such regulations if the ,secretary determines that such requirements would result in an undue economic hardship2 and 7iii7 taking into consideration-- 7,i7 the results of pilot projects1 including pilot projects pursuant to this section2 7,,ii7 the public meetings held and related guidance documents issued under this section2 7,,iii7 the public health benefits of any additional regulations in comparison to the cost of compliance with such requirements1 including on entities of varying sizes and capabilities2 7,,iv7 the diversity of the pharmaceutical distribution supply chain by providing appropriate flexibility for each sector1 including both large and small businesses2 and 7,v7 the assessment pursuant to paragraph 7#c7 with respect to small business dispensers1 including related public comment and the public meeting1 and requirements under this section2 7,b7 issue a notice of proposed rulemaking that includes a copy of the proposed regulation2 7,c7 provide a period of not less than #fj days for comments on the proposed regulation2 and 7,d7 publish the final regulation not less than #b years prior to the effective date of the regulation4 7i7 ,guidance documents 7#a7 ,in general ,for the purposes of facilitating the successful and efficient adoption of secure1 interoperable product tracing at the package level in order to enhance drug distribution security and further protect the public health1 the ,secretary shall issue the guidance documents as provided for in this subsection4 7#b7 ,suspect and illegitimate product 7,a7 ,in general ,not later than #ahj days after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the ,secretary shall issue a guidance document to aid trading partners in the identification of a suspect product and notification termination4 ,such guidance document shall-- 7i7 identify specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain2 7ii7 provide recommendation on how trading partners may identify such product and make a determination if the product is a suspect product as soon as practicable2 and 7iii7 set forth the process by which manufacturers1 repackagers1 wholesale distributors1 dispensers1 and third-party logistics providers shall terminate notifications in consultation with the ,secretary regarding illegitimate product pursuant to subsections 7b77#d77;,b71 7c77#d77;,b71 7d77#d77;,b71 7e77#d77;,b71 and 7f77#d77;,b74 7,b7 ,revised guidance ,if the ,secretary revises the guidance issued under subparagraph 7,a71 the ,secretary shall follow the procedure set forth in paragraph 7#e74 7#c7 ,unit level tracing 7,a7 ,in general ,in order to enhance drug distribution security at the package level1 not later than #ah months after conducting a public meeting on the system attributes necessary to enable secure tracing of product at the package level1 including allowing for the use of verification1 inference1 and aggregation1 as necessary1 the ,secretary shall issue a final guidance document that outlines and makes recommendations with respect to the system attributes necessary to enable secure tracing at the package level as required under the requirements established under subsection 7h74 ,such guidance document shall-- 7i7 define the circumstances under which the sectors within the pharmaceutical distribution supply chain may1 in the most efficient manner practicable1 infer the contents of a case1 pallet1 tote1 or other aggregate of individual packages or containers of product1 from a product identifier associated with the case1 pallet1 tote1 or other aggregate1 without opening each case1 pallet1 tote1 or other aggregate or otherwise individually scanning each package2 7ii7 identify methods and processes to enhance secure tracing of product at the package level1 such as secure processes to facilitate the use of inference1 enhanced verification activities1 the use of aggregation and inference1 processes that utilize the product identifiers to enhance tracing of product at the package level1 including the standardized numerical identifier1 or package security features2 and 7iii7 ensure the protection of confidential commercial information and trade secrets4 7,b7 ,procedure ,in issuing the guidance under subparagraph 7,a71 and in revising such guidance1 if applicable1 the ,secretary shall follow the procedure set forth in paragraph 7#e74 7#d7 ,standards for interoperable data exchange 7,a7 ,in general ,in order to enhance secure tracing of a product at the package level1 the ,secretary1 not later than #ah months after conducting a public meeting on the interoperable standards necessary to enhance the security of the pharmaceutical distribution supply chain1 shall update the guidance issued pursuant to subsection 7a77#b71 as necessary and appropriate1 and finalize such guidance document so that the guidance document-- 7i7 identifies and makes recommendations with respect to the standards necessary for adoption in order to support the secure1 interoperable electronic data exchange among the pharmaceutical distribution supply chain that comply with a form and format developed by a widely recognized international standards development organization2 7ii7 takes into consideration standards established pursuant to subsection 7a77#b7 and section #eje;,d2 7iii7 facilitates the creation of a uniform process or methodology for product tracing2 and 7iv7 ensures the protection of confidential commercial information and trade secrets4 7,b7 ,procedure ,in issuing the guidance under subparagraph 7,a71 and in revising such guidance1 if applicable1 the ,secretary shall follow the procedure set forth in paragraph 7#e74 7#e7 ,procedure ,in issuing or revising any guidance issued pursuant to this subsection or subsection 7h71 except the initial guidance issued under paragraph 7#b77;,a71 the ,secretary shall-- 7,a7 publish a notice in the ,federal ,register for a period not less than #cj days announcing that the draft or revised draft guidance is available2 7,b7 post the draft guidance document on the ,internet ,web site of the ,food and ,drug ,administration and make such draft guidance document available in hard copy2 7,c7 provide an opportunity for comment and review and take into consideration any comments received2 7,d7 revise the draft guidance1 as appropriate2 7,e7 publish a notice in the ,federal ,register for a period not less than #cj days announcing that the final guidance or final revised guidance is available2 7,f7 post the final guidance document on the ,internet ,website of the ,food and ,drug ,administration and make such final guidance document available in hard copy2 and 7,g7 provide for an effective date of not earlier than #a year after such guidance becomes final4 7j7 ,public meetings 7#a7 ,in general ,the ,secretary shall hold not less than #c public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide for comment4 ,the ,secretary may hold the first such public meeting not earlier than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act4 ,in carrying out the public meetings described in this paragraph1 the ,secretary shall-- 7,a7 prioritize topics necessary to inform the issuance of the guidance described in paragraphs 7#c7 and 7#d7 of subsection 7i72 and 7,b7 take all measures reasonable and practicable to ensure the protection of confidential commercial information and trade secrets4 7#b7 ,content ,each of the following topics shall be addressed in at least one of the public meetings described in paragraph 7#a73 7,a7 ,an assessment of the steps taken under subsections 7b7 through 7f7 to build capacity for a unit-level system1 including the impact of the requirements of such subsections on-- 7i7 the ability of the health care system collectively to maintain patient access to medicines2 7ii7 the scalability of such requirements1 including as it relates to product lines2 and 7iii7 the capability of different sectors and subsectors1 including both large and small businesses1 to affix and utilize the product identifier4 7,b7 ,the system attributes necessary to support the requirements set forth under subsection 7h71 including the standards necessary for adoption in order to support the secure1 interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain4 7,c7 ,best practices in each of the different sectors within the pharmaceutical distribution supply chain to implement the requirements of this section4 7,d7 ,the costs and benefits of the implementation of this section1 including the impact on each pharmaceutical distribution supply chain sector and on public health4 7,e7 ,whether electronic tracing requirements1 including tracing of product at the package level1 are feasible1 cost-effective1 and needed to protect the public health4 7,f7 ,the systems and processes needed to utilize the product identifiers to enhance tracing of product at the package level1 including allowing for verification1 aggregation1 and inference1 as necessary4 7,g7 ,the technical capabilities and legal authorities1 if any1 needed to establish an interoperable1 electronic system that provides for tracing of product at the package level4 7,h7 ,the impact that such additional requirements would have on patient safety1 the drug supply1 cost and regulatory burden1 and timely patient access to prescription drugs4 7,i7 ,other topics1 as determined appropriate by the ,secretary4 7k7 ,pilot projects 7#a7 ,in general ,the ,secretary shall establish #a or more pilot projects1 in coordination with authorized manufacturers1 repackagers1 wholesale distributors1 third-party logistics providers1 and dispensers1 to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain4 ,such projects shall build upon efforts1 in existence as of the date of enactment of the ,drug ,supply ,chain ,security ,act1 to enhance the safety and security of the pharmaceutical distribution supply chain1 take into consideration any pilot projects conducted prior to such date of enactment1 and inform the draft and final guidance under paragraphs 7#c7 and 7#d7 of subsection 7i74 7#b7 ,content 7,a7 ,in general ,the ,secretary shall ensure that the pilot projects under paragraph 7#a7 reflect the diversity of the pharmaceutical distribution supply chain and that the pilot projects1 when taken as a whole1 include participants representative of every sector1 including both large and small businesses4 7,b7 ,project design ,the pilot projects under paragraph 7#a7 shall be designed to-- 7i7 utilize the product identifier for tracing of a product1 which may include verification of the product identifier of a product1 including the use of aggregation and inference2 7ii7 improve the technical capabilities of each sector and subsector to comply with systems and processes needed to utilize the product identifiers to enhance tracing of a product2 7iii7 identify system attributes that are necessary to implement the requirements established under this section2 and 7iv7 complete other activities as determined by the ,secretary4 7l7 ,sunset ,the following requirements shall have no force or effect beginning on the date that is #aj years after the date of enactment of the ,drug ,supply ,chain ,security ,act3 7#a7 ,the provision and receipt of transaction history under this section4 7#b7 ,the requirements set forth for returns under subsections 7b77#d77;,e71 7c77#a77;,b77i71 7d77#a77;,c77i71 and 7e77#d77;,e74 7m7 ,rule of construction ,the requirements set forth in subsections 7h77#d71 7j71 and 7k7 shall not be construed as a condition1 prohibition1 or precedent for precluding or delaying the provisions becoming effective pursuant to subsection 7h74 4 #bjd4 ,national licensure standards for prescription drug wholesale distributors 7a7 ,amendments 7#a7 ,license requirement ,section #ejc7;e7 7#ba ,u4,s4,c4 #cec7;e77 is amended by striking paragraphs 7#a71 7#b71 and 7#c7 and inserting the following3 7#a7 ,license requirement ,subject to section #ehc3 7,a7 ,in general ,no person may engage in wholesale distribution of a drug subject to subsection 7b77#a7 in any ,state unless such person-- 7i7 7,i7 is licensed by the ,state from which the drug is distributed2 or 7,,ii7 if the ,state from which the drug distributed has not established a licensure requirement1 is licensed by the ,secretary2 and 7ii7 if the drug is distributed interstate1 is licensed by the ,state into which the drug is distributed if the ,state into which the drug is distributed requires the licensure of a person that distributes drugs into the ,state4 7,b7 ,license standards ,each ,federal and ,state license described in subparagraph 7,a7 shall meet the standards1 terms1 and conditions established by the ,secretary under section #ehc4 7#b7 ,licensure reporting and database 7,a7 ,licensure reporting ,beginning #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 any person who owns or operates an establishment that engages in wholesale distribution shall report to the ,secretary1 on an annual basis pursuant to a schedule determined by the ,secretary-- 7i7 each ,state by which the person is licensed and the appropriate identification number of each such license2 and 7ii7 the name1 address1 and contact information of each facility at which1 and all trade names under which1 the person conducts business4 7,b7 ,database ,not later than #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the ,secretary shall establish a database of licensed wholesale distributors4 ,such database shall-- 7i7 identify each wholesale distributor by name1 contact information1 and each ,state where such wholesale distributor is appropriately licensed to engage in wholesale distribution2 7ii7 be available to the public on the ,internet ,web site of the ,food and ,drug ,administration2 and 7iii7 be regularly updated on a schedule determined by the ,secretary4 7#c7 ,costs 7,a7 ,authorized licensure fees of secretary ,if a ,state does not establish a licensing program for persons engaged in the wholesale distribution of a drug subject to subsection 7b71 the ,secretary shall license a person engaged in wholesale distribution located in such ,state and may collect a reasonable fee in such amount necessary to reimburse the ,secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section4 ,the ,secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service4 ,fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 7,b7 ,state licensing fees ,nothing in this ,act shall prohibit ,states from collecting fees from wholesale distributors in connection with ,state licensing of such distributors4 4 7#b7 ,wholesale distribution ,section #ejc7;e7 7#ba ,u4,s4,c4 #cec7;e771 as amended by paragraph 7#a71 is further amended by adding at the end the following3 7#d7 ,for the purposes of this subsection and subsection 7d71 the term wholesale distribution means the distribution of a drug subject to subsection 7b7 to a person other than a consumer or patient1 or receipt of a drug subject to subsection 7b7 by a person other than the consumer or patient1 but does not include-- 7,a7 intracompany distribution of any drug between members of an affiliated group 7as defined in section #aejd7;a7 of the ,internal ,revenue ,code of #aihf7 or within a manufacturer2 7,b7 the distribution of a drug1 or an offer to distribute a drug among hospitals or other health care entities which are under common control2 7,c7 the distribution of a drug or an offer to distribute a drug for emergency medical reasons1 including a public health emergency declaration pursuant to section #cai of the ,public ,health ,service ,act1 except that1 for purposes of this paragraph1 a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason2 7,d7 the dispensing of a drug pursuant to a valid prescription executed in accordance with section #ejc7;b77#a72 7,e7 the distribution of minimal quantities of drug by a licensed retail pharmacy to a licensed practitioner for office use2 7,f7 the distribution of a drug or an offer to distribute a drug by a charitable organization to a nonprofit affiliate of the organization to the extent otherwise permitted by law2 7,g7 the purchase or other acquisition by a dispenser1 hospital1 or other health care entity of a drug for use by such dispenser1 hospital1 or other health care entity2 7,h7 the distribution of a drug by the manufacturer of such drug2 7,i7 the receipt or transfer of a drug by an authorized third-party logistics provider provided that such third-party logistics provider does not take ownership of the drug2 7,j7 a common carrier that transports a drug1 provided that the common carrier does not take ownership of the drug2 7,k7 the distribution of a drug1 or an offer to distribute a drug by an authorized repackager that has taken ownership or possession of the drug and repacks it in accordance with section #ehb7;e72 7,l7 salable drug returns when conducted by a dispenser2 7,m7 the distribution of a medical convenience kit which is a collection of finished medical devices or a collection of drug or biologic products assembled in kit form strictly for the convenience of the purchaser or user if-- 7i7 the medical convenience kit is assembled in an establishment that is registered with the ,food and ,drug ,administration as a device manufacturer in accordance with section #eaj7;b77#b72 7ii7 the person who manufacturers the medical convenience kit purchased the finished drug or biologic product contained in the medical convenience kit directly from the pharmaceutical manufacturer or from a wholesale distributor that purchased the product directly from the pharmaceutical manufacturer2 7iii7 the person who manufacturers a medical convenience kit does not alter the primary container or label of the product as purchased from the manufacturer or wholesale distributor2 7iv7 the medical convenience kit does not contain a controlled substance that appears in a schedule contained in the ,comprehensive ,drug ,abuse ,prevention and ,control ,act of #aigj 7#ba ,u4,s4,c4 #hja1 et seq72 and 7v7 the products contained in the medical convenience kit are-- 7,i7 intravenous solutions intended for the replenishment of fluids and electrolytes2 7,,ii7 drugs intended to maintain the equilibrium of water and minerals in the body2 7,,iii7 drugs intended for irrigation or reconstitution2 7,,iv7 anesthetics2 7,v7 anticoagulants2 7,,vi7 vasopressors2 or 7,,vii7 sympathicomimetics2 7,n7 the distribution of an intravenous drug that1 by its formulation1 is intended for the replenishment of fluids and electrolytes 7such as sodium1 chloride1 and potassium7 or calories 7such as dextrose and amino acids72 7,o7 the distribution of an intravenous drug used to maintain the equilibrium of water and minerals in the body1 such as dialysis solutions2 7,p7 the distribution of a drug that is intended for irrigation or reconstitution1 or sterile water1 whether intended for such purposes or for injection2 7,q7 the distribution of medical gas1 as defined in section #ege2 7,r7 facilitating the distribution of a product by providing solely administrative services1 including processing of orders and payments2 or 7,s7 the transfer of a product by a hospital or other health care entity to a repackager registered under section #eaj for the purpose of repackaging the drug for use by that hospital1 or other health care entity and other health care entities that are under common control1 if ownership of the drug remains with the hospital or other health care entity at all times4 4 7#c7 ,third-party logistics providers ,section #ejc7;e77#ba ,u4,s4,c4 #cec7;e771 as amended by paragraph 7#b71 is further amended by adding at the end the following3 7#e7 ,third-party logistics providers ,notwithstanding paragraphs 7#a7 through 7#d71 each entity that meets the definition of a third-party logistics provider under section #eha7ba7 shall obtain a license as a third-party logistics provider as described in section #ehd7;a7 and is not required to obtain a license as a wholesale distributor if the entity never assumes an ownership interest in the product it handles4 4 7#d7 ,licensure standards ,subchapter ,h of chapter ,v1 as added by section #bjb1 is amended by adding at the end the following3 #ehc4 ,national licensure standards for prescription drug wholesale distributors 7a7 ,in general ,the ,secretary shall1 not later than #b years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 establish by regulation minimum standards1 terms1 and conditions for the licensing of persons under section #ejc7;e77#a7 7as amended by the ,drug ,supply ,chain ,security ,act71 including the revocation1 reissuance1 and renewal of such license4 7b7 ,content ,the standards established under subsection 7a7 shall apply to all ,state and ,federal licenses described under section #ejc7;e77#a7 7as amended by the ,drug ,supply ,chain ,security ,act7 and shall prescribe minimum requirements for the following3 7#a7 ,the storage and handling of such drugs1 including facility requirements4 7#b7 ,the establishment and maintenance of records of the distributions of such drugs4 7#c7 ,the furnishing of a bond or other equivalent means of security1 as follows3 7,a7 7i7 ,for the issuance or renewal of a wholesale distributor license1 an applicant that is not a government owned and operated wholesale distributor shall submit a surety bond of #ajj1jjj or other equivalent means of security acceptable to the ,state4 7ii7 ,for purposes of clause 7i71 the ,state or other applicable authority may accept a surety bond in the amount of #be1jjj if the annual gross receipts of the previous tax year for the wholesaler is #aj1jjj1jjj or less4 7,b7 ,if a wholesale distributor can provide evidence that it possesses the required bond in a ,state1 the requirement for a bond in another ,state shall be waived4 7#d7 ,mandatory background checks and fingerprinting of facility managers or designated representatives4 7#e7 ,the establishment and implementation of qualifications for key personnel4 7#f7 ,the mandatory physical inspection of any facility to be used in wholesale distribution within a reasonable time frame from the initial application of the facility and to be conducted by the licensing authority or by the ,state1 consistent with subsection 7c74 7#g7 ,in accordance with subsection 7d71 the prohibition of certain persons from receiving or maintaining licensure for wholesale distribution4 7c7 ,inspections ,to satisfy the inspection requirement under subsection 7b77#f71 the ,federal or ,state licensing authority may conduct the inspection or may accept an inspection by the ,state in which the facility is located1 or by a third-party accreditation or inspection service approved by the ,secretary or the ,state licensing such wholesale distributor4 7d7 ,prohibited persons ,the standards established under subsection 7a7 shall include requirements to prohibit a person from receiving or maintaining licensure for wholesale distribution if the person-- 7#a7 has been convicted of any felony for conduct relating to wholesale distribution1 any felony violation of subsection 7i7 or 7k7 of section #cja1 or any felony violation of section #acfe of title #ah1 ,united ,states ,code1 relating to product tampering2 or 7#b7 has engaged in a pattern of violating the requirements of this section1 or ,state requirements for licensure1 that presents a threat of serious adverse health consequences or death to humans4 7e7 ,requirements ,the ,secretary1 in promulgating any regulation pursuant to this section1 shall1 notwithstanding section #eec of title #e1 ,united ,states ,code-- 7#a7 issue a notice of proposed rulemaking that includes a copy of the proposed regulation2 7#b7 provide a period of not less than #fj days for comments on the proposed regulation2 and 7#c7 provide that the final regulation take effect on the date that is #b years after the date such final regulation is published4 4 7b7 ,authorized distributors of record ,section #ejc7;d7 7#ba ,u4,s4,c4 #cec7;d77 is amended by adding at the end the following3 7#d7 ,in this subsection1 the term authorized distributors of record means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer's products4 4 7c7 ,effective date ,the amendments made by subsections 7a7 and 7b7 shall take effect on the day that is #a year after the date of enactment of this ,act4 #bje4 ,national licensure standards for third-party logistics providers2 uniform national policy ,subchapter ,h of chapter ,v1 as amended by section #bjd1 is further amended by adding at the end the following3 #ehd4 ,national licensure standards for third-party logistics providers 7a7 ,license requirements ,no third-party logistics provider in any ,state may conduct activities in any ,state unless each facility of such third-party logistics provider-- 7#a7 7,a7 is licensed by the ,state from which the drug is distributed by the third-party logistics provider1 in accordance with the regulations promulgated under subsection 7d72 or 7,b7 if the ,state from which the drug distributed by the third-party logistics provider has not established a licensure requirement1 is licensed by the ,secretary1 in accordance with the regulations promulgated under subsection 7d72 and 7#b7 if the drug is distributed interstate1 is licensed by the ,state into which the drug is distributed by the third-party logistics provider if such ,state licenses third-party logistics providers that distribute drugs into the ,state and the third-party logistics provider is not licensed by the ,secretary as described in paragraph 7#a77;,b74 7b7 ,licensure reporting ,beginning #a year after the date of enactment of the ,drug ,supply ,chain ,security ,act1 a facility of a third-party logistics provider shall report to the ,secretary1 on an annual basis pursuant to a schedule determined by the ,secretary-- 7#a7 the ,state by which the facility is licensed and the appropriate identification number of such license2 and 7#b7 the name and address of the facility1 and all trade names under which1 such facility conducts business4 7c7 ,costs 7#a7 ,authorized licensure fees of secretary ,if a ,state does not establish a licensing program for a third-party logistics provider1 the ,secretary shall license the third-party logistics provider located in such ,state and may collect a reasonable fee in such amount necessary to reimburse the ,secretary for costs associated with establishing and administering the licensure program and conducting periodic inspections under this section4 ,the ,secretary shall adjust fee rates as needed on an annual basis to generate only the amount of revenue needed to perform this service4 ,fees authorized under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 7#b7 ,state licensing fees 7,a7 ,state established program ,nothing in this ,act shall prohibit a ,state that has established a program to license a third-party logistics provider from collecting fees from a third-party logistics provider for such a license4 7,b7 ,no ,state established program ,a ,state that does not establish a program to license a third-party logistics provider in accordance with this section shall be prohibited from collecting a ,state licensing fee from a third-party logistics provider4 7d7 ,license regulations 7#a7 ,in general ,not later than #b years after the date of enactment of the ,drug ,supply ,chain ,security ,act1 the ,secretary shall issue regulations regarding the minimum issuance and eligibility requirements for licensing under subsection 7a71 including the revocation and reissuance of such license1 to third-party logistics providers under this section4 7#b7 ,content ,such regulations shall-- 7,a7 establish a process by which a third-party accreditation program approved by the ,secretary shall1 upon request by a third-party logistics provider1 issue a license to each third-party logistics provider that meets the minimum requirements set forth in this section2 7,b7 establish a process by which the ,secretary shall issue a license to each third-party logistics provider that meets the minimum requirements set forth in this section if the ,secretary is not able to approve a third-party accreditation program because no such program meets the ,secretary's requirements necessary for approval of such a third-party accreditation program2 7,c7 require that the entity complies with storage practices1 as determined by the ,secretary for such facility1 including-- 7i7 maintaining access to warehouse space of suitable size to facilitate safe operations1 including a suitable area to quarantine suspect product2 7ii7 maintaining adequate security2 and 7iii7 having written policies and procedures to-- 7,i7 address receipt1 security1 storage1 inventory1 shipment1 and distribution of a product2 7,,ii7 identify1 record1 and report confirmed losses or thefts in the ,united ,states2 7,,iii7 correct errors and inaccuracies in inventories2 7,,iv7 provide support for manufacturer recalls2 7,v7 prepare for1 protect against1 and address any reasonably foreseeable crisis that affects security or operation at the facility1 such as a strike1 fire1 or flood2 7,,vi7 ensure that any expired product is segregated from other products and returned to the manufacturer or re-packager or destroyed2 7,,vii7 maintain the capability to trace the receipt and outbound distribution of a product1 and supplies and records of inventory2 and 7,,viii7 quarantine or destroy a suspect product if directed to do so by the respective manufacturer1 wholesale distributor1 dispenser or an authorized government agency2 7,d7 provide for periodic inspection by the licensing authority1 as determined by the ,secretary1 of such facility warehouse space to ensure compliance with this section2 7,e7 prohibit a facility from having as a manager or designated representative anyone convicted of any felony violation of subsection 7i7 or 7k7 of section #cja or any violation of section #acfe of title #ah1 ,united ,states ,code relating to product tampering2 7,f7 provide for mandatory background checks of a facility manager or a designated representative of such manager2 and 7,g7 require a third-party logistics provider to provide the ,secretary1 upon a request by the ,secretary1 a list of all product manufacturers1 wholesale distributors1 and dispensers for whom the third-party logistics provider provides services at such facility4 7#c7 ,procedure ,in promulgating the regulations under this subsection1 the ,secretary shall1 notwithstanding section #eec of title #e1 ,united ,states ,code-- 7,a7 issue a notice of proposed rulemaking that includes a copy of the proposed regulation2 7,b7 provide a period of not less than #fj days for comments on the proposed regulation2 and 7,c7 provide that the final regulation takes effect upon the expiration of #a year after the date that such final regulation is issued4 7e7 ,renewal of licenses ,the ,secretary shall develop procedures for license renewal4 ,licenses issued under this section shall expire on the date that is #c years after issuance of the license4 ,such an expired license may be renewed for additional #c-year periods according to procedures developed by the ,secretary4 #ehe4 ,uniform national policy 7a7 ,product tracing and other requirements ,beginning on the date of enactment of the ,drug ,supply ,chain ,security ,act1 no ,state or political subdivision of a ,state may establish or continue in effect any requirements for tracing products through the distribution system 7including any requirements with respect to statements of distribution history1 transaction history1 transaction information1 or transaction statement of a product as such product changes ownership in the supply chain1 or verification1 investigation1 disposition1 notification1 or record-keeping relating to such systems1 including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system7 which are inconsistent with1 more stringent than1 or in addition to1 any requirements applicable under section #ejc7;e7 7as amended by such ,act7 or this subchapter 7or regulations issued thereunder71 or which are inconsistent with-- 7#a7 any waiver1 exception1 or exemption pursuant to section #eha or #ehb2 or 7#b7 any restrictions specified in section #ehb4 7b7 ,distribution and licensing standards 7#a7 ,in general ,beginning on the date of enactment of the ,drug ,supply ,chain ,security ,act1 no ,state or political subdivision of a ,state may establish or continue any standards1 requirements1 or regulations with respect to wholesale prescription drug distributor or third-party logistics provider licensure that are less stringent than the standards and requirements applicable under section #ejc7;e7 7as amended by such ,act71 in the case of a wholesale distributor1 or section #ehd1 in the case of a third-party logistics provider4 7#b7 ,state regulation of third-party logistics providers ,no ,state shall regulate third-party logistics providers as wholesale distributors4 7#c7 ,administration fees ,notwithstanding paragraph 7#a71 a ,state may administer fee collections for effectuating the wholesale drug distributor and third-party logistics provider licensure requirements under sections #ejc7;e7 7as amended by the ,drug ,supply ,chain ,security ,act71 #ehc1 and #ehd4 7#d7 ,enforcement1 suspension1 and revocation of licenses ,notwithstanding paragraph 7#a71 a ,state-- 7,a7 may take administrative action1 including fines1 to enforce a licensure requirement promulgated by the ,state in accordance with section #ejc7;e7 7as amended by the ,drug ,supply ,chain ,security ,act7 or this subchapter2 7,b7 may provide for the suspension or revocation of licenses issued by the ,state for violations of the laws of such ,state2 7,c7 upon conviction of violations of ,federal1 ,state1 or local drug laws or regulations1 may provide for fines1 imprisonment1 or civil penalties2 and 7,d7 may regulate activities of licensed entities in a manner that is consistent with product tracing requirements under section #ehb4 7c7 ,exception ,nothing in subsection 7a7 or 7b7 shall be construed to preempt ,state requirements related to the distribution of prescription drugs if such requirements are not related to product tracing as described in subsection 7a71 including any requirements applicable under section #ejc7;e7 7as amended by the ,drug ,supply ,chain ,security ,act7 or this subchapter 7or regulations issued thereunder74 4 #bjf4 ,penalties 7a7 ,prohibited act ,section #cja7t77#ba ,u4,s4,c4 #cca7t771 is amended-- 7#a7 by striking or after the requirements of section #ejc7;d712 and 7#b7 by inserting 1 failure to comply with the requirements under section #ehb1 the failure to comply with the requirements under section #ehd1 as applicable1 after in violation of section #ejc7;e74 7b7 ,misbranding ,section #ejb 7#ba ,u4,s4,c4 #ceb71 as amended by section #ajc1 is further amended by adding at the end the following3 7ee7 ,if it is a drug and it fails to bear the product identifier as required by section #ehb4 4 #bjg4 ,conforming amendment 7a7 ,in general ,section #cjc7;b77#a77;,d77#ba ,u4,s4,c4 #ccc7;b77#a77;,d77 is amended by striking #ejc7;e77#b77;,a7 and inserting #ejc7;e77#a74 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect on the day that is #a year after the date of enactment of this ,act4 #bjh4 ,savings clause ,except as provided in the amendments made by paragraphs 7#a71 7#b71 and 7#c7 of section #bjd7;a7 and by section #bjf7;a71 nothing in this title 7including the amendments made by this title7 shall be construed as altering any authority of the ,secretary of ,health and ,human ,services with respect to a drug subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a77 under any other provision of such ,act or the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq474 ,amend the title so as to read3 ,a bill to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to compounding drugs and the pharmaceutical distribution supply chain44 ,june #ai1 #bjac ,reported with an amendment and an amendment to the title