,,ii #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 and ,ms4 ,mikulski7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,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