,i #aacth ,,congress #ast ,session ,h4 ,r4 #bahf ,,in ,,the ,,house ,,of ,,representatives ,may #bc1 #bjac ,mr4 ,markey 7for himself1 ,ms4 ,slaughter1 ,mr4 ,clay1 and ,mr4 ,rangel7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to provide for the compounding of drug products4 #a4 ,short title ,this ,act may be cited as the ,verifying ,authority and ,legality ,in ,drug ,compounding ,act of #bjac or the ,,valid ,compounding ,act4 #b4 ,application of ,federal law to practice of pharmacy compounding 7a7 ,amendment ,section #ejc;,a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec;a7 is amended to read as follows3 #ejc;,a4 ,pharmacy compounding 7a7 ,in general ,sections #eja7;a77#b77;,b71 #ejb7;f77#a71 and #eje shall not apply with respect to a drug product if each of the following applies3 7#a7 ,except as provided in subsection 7d71 the drug product is compounded for an identified individual patient based on the receipt of a prescription order4 7#b7 ,the drug product is compounded by a licensed pharmacist in a ,state-licensed pharmacy or a ,federal facility1 or by a licensed physician1 pursuant to such prescription order or notation4 7#c7 ,in the case of a drug product that is compounded using bulk substances 7as defined in section #bjg4c7;a77#d7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations7-- 7,a7 such bulk substances-- 7i7 are components of one or more drugs for which an approval of an application filed under subsection 7b7 or 7j7 of section #eje is in effect2 7ii7 are components of drugs that may be lawfully marketed in the ,united ,states without such an approval pursuant to the definition of a new drug in section #bja2 or 7iii7 appear on the list in effect under subsection 7b72 and 7,b7 such bulk substances comply with the standards of an applicable ,united ,states ,pharmacopeia or ,national ,formulary monograph1 if a monograph exists4 7#d7 ,any bulk substance used for purposes of compounding the drug product-- 7,a7 is manufactured by an establishment that is registered under section #eaj 7including a foreign establishment that is registered under section #eaj7;i772 and 7,b7 is accompanied by valid certificates of analysis4 7#e7 ,the pharmacist or physician compounding the drug product complies with the standards of any applicable ,united ,states ,pharmacopeia chapters on pharmacy compounding4 7#f7 ,the drug product1 including the dosage form and any ingredient thereof-- 7,a7 is not included in the list under subsection 7c72 and 7,b7 is not withdrawn or removed from the market because such drug product or any ingredient thereof has been found to be unsafe or not effective4 7#g7 ,subject to subsection 7e71 the drug product is not a copy of a commercially available drug4 7#h7 ,if the drug product is produced using high-risk sterile compounding1 the drug product is compounded in accordance with the standards1 processes1 and procedures established under subsection 7f74 7b7 ,list of bulk substances from which drug products may be compounded 7#a7 ,in general ,for purposes of subsection 7a77#c77;,a77iii71 the ,secretary shall1 by guidance-- 7,a7 develop and maintain a list of bulk substances from which drug products may be compounded2 and 7,b7 include in the list only bulk substances that are not described in clause 7i7 or 7ii7 of subsection 7a77#c77;,a7 and may be compounded to meet a medical need that cannot be filled by using a bulk substance that is described in such clause 7i7 or 7ii72 7,c7 specify for each bulk substance on the list under this subsection any limitation on compounding the bulk substance2 and 7,d7 specify for each bulk substance on the list under this subsection the particular medical need that is met by placing such substance on the list4 7#b7 ,initial publication2 updates ,the ,secretary shall-- 7,a7 not later than #a year after the date of the enactment of the ,verifying ,authority and ,legality ,in ,drug ,compounding ,act of #bjac1 publish an initial list under paragraph 7#a72 and 7,b7 not less frequently than every year thereafter1 review and1 as appropriate1 update the list under paragraph 7#a74 7#c7 ,availability ,the ,secretary shall make the list under paragraph 7#a7 available on the public ,web site of the ,food and ,drug ,administration4 7#d7 ,transmission to ,state regulatory agencies ,upon publication of the initial list under paragraph 7#a71 and upon each update to the list1 the ,secretary shall transmit an up-to-date copy of the list to the agency in each ,state with primary responsibility for regulating pharmacies4 7#e7 ,petitions 7,a7 ,in general ,in carrying out this subsection1 the ,secretary shall receive and consider petitions from any person identifying a substance that should be added to1 or removed from1 the list under this subsection4 7,b7 ,requirement for petitions seeking to add a bulk substance ,any petition seeking to add a bulk substance to the list under this subsection shall specify the reasons-- 7i7 why the bulk substance is needed for a procedure or population2 and 7ii7 why such need is not met by bulk substances that are described in clause 7i7 or 7ii7 of subsection 7a77#c77;,a74 7,c7 ,approval or denial ,the ,secretary shall approve or deny any petition received under this paragraph1 and update the list under paragraph 7#a7 accordingly1 not later than #ij days after receipt of the petition1 unless an extension of time is mutually agreed upon by the ,secretary and the petitioner4 7,d7 ,final agency action ,a decision of the ,secretary to approve or deny a petition received under this paragraph shall constitute final agency action subject to judicial review4 7,e7 ,public posting ,the ,secretary shall publically post-- 7i7 all petitions received under this paragraph within #ba days of receipt2 and 7ii7 each approval1 denial1 and extension under subparagraph 7,c7 promptly4 7c7 ,list of drug products that should not be compounded 7#a7 ,in general ,for purposes of subsection 7a77#f71 the ,secretary shall1 by guidance-- 7,a7 develop and maintain a list of drug products that should not be compounded1 including any categories1 dosage forms1 or ingredients of such drug products2 and 7,b7 include on such list1 at a minimum-- 7i7 drug products 7or categories1 dosage forms1 or ingredients thereof7 whose compounding is reasonably likely to cause an adverse effect on safety or effectiveness of such drug product1 including extended release products1 metered dose inhalers1 transdermal patches1 and liposomal products2 and 7ii7 drug products 7or categories1 dosage forms1 or ingredients thereof7 that have been withdrawn or removed from the market because they have been found to be unsafe or not effective4 7#b7 ,applicability of certain provisions ,the provisions of paragraphs 7#b71 7#c71 and 7#d7 of subsection 7b7 shall apply with respect to the list under this subsection to the same extent and in the same manner as such provisions apply with respect to the list under subsection 7b74 7#c7 ,petitions ,in carrying out this subsection1 the ,secretary shall receive and consider petitions from any person identifying a drug product that should be added to1 or removed from1 the list under this subsection4 ,subparagraphs 7,c7 through 7,e7 of subsection 7b77#b7 shall apply with respect to petitions under this paragraph to the same extent and in the same manner as such subparagraphs apply with respect to petitions under subsection 7b77#e74 7d7 ,exception to requirement of identified individual patient 7#a7 ,in ,general ,a pharmacy or pharmacist that is not required to be registered under section #eaj may compound a drug product without regard to subsection 7a77#a7 if the pharmacy or pharmacist-- 7,a7 registers with the ,secretary as specified pursuant to paragraph 7#b72 and 7,b7 agrees to comply with any condition of operation or limitation of activity specified by the ,secretary1 including the conditions and limitations specified pursuant to paragraph 7#b74 7#b7 ,registration and requirements ,the ,secretary shall specify by regulation for each type of pharmacy or pharmacist compounding drug products pursuant to the exception under this subsection-- 7,a7 the registration requirements for such pharmacy or pharmacist and the information that must be submitted with the registration1 which information shall include-- 7i7 the name and location of the pharmacy2 7ii7 the types of drugs that are compounded2 7iii7 the active ingredients in each such drug2 7iv7 the source and strength of the active ingredient in each drug2 7v7 the dosage form and route of administration of each drug2 7vi7 the number of individual units produced of each drug2 7vii7 the ,states to which drugs were shipped2 7viii7 the number of individual units of each drug that are shipped to each ,state2 and 7ix7 affirmation that the pharmacy or pharmacist is in compliance with ,state pharmacy licensing regulations2 7,b7 the frequency in which information described in subparagraph 7,a7 must be submitted2 7,c7 the conditions of operation1 including good manufacturing practices and requirements for third-party testing1 applicable to the compounding of drugs2 and 7,d7 any limitations on the activities of such pharmacy or pharmacist4 7#c7 ,types of pharmacies eligible ,the ,secretary shall specify separate requirements for each type of pharmacy and pharmacist authorized to compound drug products pursuant to the exception under this subsection4 ,the ,secretary shall include separate requirements for-- 7,a7 any pharmacy or pharmacist within a hospital system that is compounding drug products exclusively for dispensing to patients within that hospital system2 and 7,b7 any pharmacy or pharmacist that compounds sterile drug products4 7#d7 ,memorandum of understanding 7,a7 ,in general ,subject to subparagraph 7,c71 the ,secretary may enter into appropriate memoranda of understanding with ,states to address ,state implementation of the exception under this subsection-- 7i7 ensuring1 to the ,secretary's satisfaction1 that the ,state will implement the exception under this subsection in accordance with the requirements of this section2 and 7ii7 including such other information and assurances as the ,secretary may require4 7,b7 ,process2 criteria ,the ,secretary shall-- 7i7 establish a process and criteria for entering into a memorandum of understanding under this paragraph1 including the sharing of information between ,state and ,federal authorities2 and 7ii7 reevaluate each such memorandum of understanding not less than every #e years to ensure1 to the ,secretary's satisfaction1 that the ,state's implementation of the memorandum of understanding continues to conform to the requirements of this section4 7,c7 ,exclusive ,federal authority ,the ,secretary shall retain exclusive ,federal authority to implement the exception under this subsection with respect to pharmacies and pharmacists that-- 7i7 perform high-risk sterile compounding2 or 7ii7 compound drug products for shipment across ,state lines4 7#e7 ,maintenance of list ,the ,secretary shall maintain a publically available list-- 7,a7 identifying all pharmacies and pharmacists registered under this subsection2 and 7,b7 indicating1 for each such pharmacy and pharmacist1 whether the pharmacy or pharmacist is subject to regulation by a ,state pursuant to a memorandum of understanding in effect under paragraph 7#d74 7e7 ,exceptions regarding copies of commercially available drugs ,a drug that is a copy of a commercially available drug may be compounded pursuant to this section without regard to subsection 7a77#g7 if-- 7#a7 7,a7 the commercially available drug that is being compounded is at the time of distribution on the drug shortage list under section #ejf;,e1 and the pharmacy has provided notice to the ,secretary that such drug is being compounded not later than #e days after distributing such drug2 or 7,b7 the ,secretary determines that compounding the drug product is necessary to protect public health or wellbeing2 and 7#b7 in the case of a commercially available drug marketed pursuant to a risk evaluation and mitigation strategy approved under section #eje-a and including one or more elements to assure safe use1 the pharmacy or pharmacist compounding the drug that is a copy of such commercially available drug demonstrates to the ,secretary that controls will be used that are comparable to such elements to assure safe use4 7f7 ,high-,risk sterile compounding ,for purposes of subsection 7a77#h71 the ,secretary shall establish standards1 processes1 and procedures for high-risk sterile compounding4 7g7 ,inspections ,notwithstanding section #gjd7;a77#b77;,a71 the facilities of any pharmacy or pharmacist compounding drug products under this section-- 7#a7 shall be subject to inspection under section #gjd2 and 7#b7 shall1 upon request of an officer or employee designated by the ,secretary1 permit such officer or employee at all reasonable times to have access to1 and to copy and verify1 records for purposes of determining compliance with the provisions of this ,act applicable to such compounding4 7h7 ,sharing of information ,if during an inspection of the facilities of a pharmacy or pharmacist under this section the ,secretary discovers a violation of this ,act1 the ,secretary shall give notice of the violation-- 7#a7 to the ,state in which the facilities are located2 and 7#b7 to any ,state to which the pharmacy or pharmacist has shipped a drug product during the preceding #cj days4 7i7 ,labeling ,the labeling of any drug product compounded pursuant to this section shall include-- 7#a7 the name of each drug and ingredient included2 7#b7 the name1 address1 and phone number of the licensed compounding pharmacy1 pharmacist1 or physician2 7#c7 the date on which the drug was compounded2 7#d7 instructions for storage and use2 7#e7 the following statement3 ,this drug has not been tested for safety and effectiveness and is not approved by the ,,fda4 ,this drug was made specifically for you because your health care provider determined that no ,,fda-approved product would suit your needs4 ,serious adverse reactions to this drug should be reported to the ,,fda at 1 to the pharmacy where the drug was received1 and to your health care provider4 7,the blank shall specify a phone number and a ,web site1 to be provided by the ,secretary for purposes of this subsection472 and 7#f7 such other information as the ,secretary may require4 7j7 ,reporting by pharmacists and physicians 7#a7 ,adverse event ,if a pharmacist or physician compounding a drug product pursuant to this section becomes aware of any adverse event associated with the use of such product1 not later than #aj calendar days after becoming so aware1 the pharmacist or physician shall report such adverse event to the ,secretary4 7#b7 ,information related to risk of injury or death ,if a pharmacist or physician compounding a drug product pursuant to this section becomes aware of information concerning any bacteriological1 fungal1 or other contamination2 any significant chemical1 physical1 or other change2 or any deterioration of a compounded drug product that has already been distributed by the pharmacist or physician1 that could cause serious injury or death1 not later than #b calendar days after becoming so aware1 the pharmacist or physician shall report such information to the ,secretary4 7k7 ,compounding 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 covered compounding pharmacy means a pharmacy that1 pursuant to subsection 7d7 7the exception to the requirement of an identified individual patient7-- 7i7 performs high-risk sterile compounding2 7ii7 compounds drug products for shipment across ,state lines2 or 7iii7 otherwise performs compounding pursuant to subsection 7d7 that is not regulated by a ,state pursuant to a memorandum of understanding under subsection 7d77#d72 7,c7 the term gross annual sales means the total worldwide gross annual sales1 in ,united ,states dollars1 for a covered compounding pharmacy1 including the sales of all the affiliates of the covered compounding pharmacy2 and 7,d7 the term reinspection means1 with respect to a covered compounding pharmacy1 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 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 covered compounding pharmacy2 and 7ii7 a reinspection fee from each covered compounding pharmacy subject to a reinspection in such fiscal year4 7,b7 ,multiple reinspections ,a covered compounding pharmacy 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 days before the start of each such year4 7#d7 ,amount of establishment fee and reinspection fee 7,a7 ,in general ,for each covered compounding pharmacy 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 covered compounding pharmacy 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 covered compounding pharmacies4 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 covered compounding pharmacies4 7#h7 ,collection of fees 7,a7 ,establishment fee ,a covered compounding pharmacy shall remit the establishment fee due under this subsection in a fiscal year when submitting a registration pursuant to subsection 7d7 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 covered compounding pharmacy involved4 7,c7 ,effect of failure to pay fees 7i7 ,registration ,a covered compounding pharmacy shall not be considered registered under subsection 7d7 in a fiscal year until the date that the covered compounding pharmacy remits the establishment fee under this subsection for such fiscal year4 7ii7 ,misbranding ,all drugs manufactured1 prepared1 propagated1 compounded1 or processed by a covered compounding pharmacy 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 covered compounding pharmacy 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 ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 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 7l7 ,definitions ,in this section3 7#a7 ,the terms compound and compounding-- 7,a7 do not include mixing1 reconstituting1 or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling2 and 7,b7 in the case of a radioactive drug 7as defined in section #caj4c7n7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations771 also do not include a minor deviation from such directions with regard to radioactivity1 volume1 or stability1 that is made by or under the direct supervision of an authorized nuclear pharmacist or a physician who is an authorized user 7as such terms are defined in section #ce4b of title #aj1 ,code of ,federal ,regulations1 7or any successor regulations774 7#b7 ,the term copy of a commercially available drug product does not include a drug product in which there is a change1 made for an identified individual patient1 which produces for that patient a significant difference1 as determined by the prescribing practitioner1 between the compounded drug and the comparable commercially available drug product1 provided that in the case of a radioactive drug 7as defined in section #caj4c7n7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations771 the reasons for the determination by the prescribing practitioner have been documented and such documentation is maintained by the pharmacy4 7#c7 ,the term high-risk sterile compounding means compounding sterile drug products using nonsterile ingredients1 nonsterile devices1 or nonsterile components4 4 7b7 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7bb7 ,if it is a drug product compounded pursuant to section #ejc;,a and its labeling does not include the information required by section #ejc;,a7i74 7cc7 ,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;,a7k74 4 7c7 ,conforming amendment ,section #gjd7;a77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgd7;a77#b77;,a77 is amended by inserting subject to section #ejc;,a1 before pharmacies which maintain establishments4 7d7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall promulgate final regulations for carrying out the amendments made by subsections 7a71 7b71 and 7c74 7e7 ,effective date ,the amendments made by subsections 7a71 7b71 and 7c7 shall take effect on the date that is #a year after the date of the enactment of this ,act4 #c4 ,registration of manufacturers compounding drug products 7a7 ,registration ,section #eaj7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7;g77 is amended by adding at the end the following3 ,with respect to compounding drugs1 the exemption in paragraph 7#a7 does not apply with respect to any pharmacy to the extent to which the pharmacy is1 in effect1 manufacturing such drugs1 as determined by the ,secretary1 taking into consideration the extent to which such pharmacy sells the drugs across ,state lines1 the quantity of the drugs sold1 and any other factors determined appropriate by the ,secretary44 7b7 ,regulations ,not later than #a year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall promulgate regulations for carrying out the amendment made by subsection 7a74 7c7 ,effective date ,the amendment made by subsection 7a7 shall take effect on the date that is #a year after the date of the enactment of this ,act4 #d4 ,no preemption of additional non-,federal requirements ,the requirements of this ,act 7including the requirements of the amendments made by this ,act7 do not preempt any non-,federal requirement that is in addition to1 and compatible with1 such requirements4