I 

113TH CONGRESS 

1ST SESSION H. R. 2186 

To amend the Federal Food, Drug, and Cosmetic Act to provide for the 

compounding of drug products. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 23, 2013 

Mr. MARKEY (for himself, Ms. SLAUGHTER, Mr. CLAY, and Mr. RANGEL) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

provide for the compounding of drug products. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Verifying Authority 

5 and Legality In Drug Compounding Act of 2013’’ or the 

6 ‘‘VALID Compounding Act’’. 


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1 SEC. 2. APPLICATION OF FEDERAL LAW TO PRACTICE OF 

2 PHARMACY COMPOUNDING. 

3 (a) AMENDMENT.—Section 503A of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is 

5 amended to read as follows: 

6 ‘‘SEC. 503A. PHARMACY COMPOUNDING. 

7 ‘‘(a) IN GENERAL.—Sections 501(a)(2)(B), 

8 502(f)(1), and 505 shall not apply with respect to a drug 

9 product if each of the following applies: 

10 ‘‘(1) Except as provided in subsection (d), the 

11 drug product is compounded for an identified indi12 vidual patient based on the receipt of a prescription 

13 order. 

14 ‘‘(2) The drug product is compounded by a li15 censed pharmacist in a State-licensed pharmacy or a 

16 Federal facility, or by a licensed physician, pursuant 

17 to such prescription order or notation. 

18 ‘‘(3) In the case of a drug product that is com19 pounded using bulk substances (as defined in section 

20 207.3(a)(4) of title 21, Code of Federal Regulations 

21 (or any successor regulations)— 

22 ‘‘(A) such bulk substances— 

23 ‘‘(i) are components of one or more 

24 drugs for which an approval of an applica25 tion filed under subsection (b) or (j) of sec26 tion 505 is in effect; 


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1 ‘‘(ii) are components of drugs that 

2 may be lawfully marketed in the United 

3 States without such an approval pursuant 

4 to the definition of a new drug in section 

5 201; or 

6 ‘‘(iii) appear on the list in effect 

7 under subsection (b); and 

8 ‘‘(B) such bulk substances comply with the 

9 standards of an applicable United States Phar10 macopeia or National Formulary monograph, if 

11 a monograph exists. 

12 ‘‘(4) Any bulk substance used for purposes of 

13 compounding the drug product— 

14 ‘‘(A) is manufactured by an establishment 

15 that is registered under section 510 (including 

16 a foreign establishment that is registered under 

17 section 510(i)); and 

18 ‘‘(B) is accompanied by valid certificates of 

19 analysis. 

20 ‘‘(5) The pharmacist or physician compounding 

21 the drug product complies with the standards of any 

22 applicable United States Pharmacopeia chapters on 

23 pharmacy compounding. 

24 ‘‘(6) The drug product, including the dosage 

25 form and any ingredient thereof— 


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1 ‘‘(A) is not included in the list under sub2 section (c); and 

3 ‘‘(B) is not withdrawn or removed from 

4 the market because such drug product or any 

5 ingredient thereof has been found to be unsafe 

6 or not effective. 

7 ‘‘(7) Subject to subsection (e), the drug product 

8 is not a copy of a commercially available drug. 

9 ‘‘(8) If the drug product is produced using 

10 high-risk sterile compounding, the drug product is 

11 compounded in accordance with the standards, proc12 esses, and procedures established under subsection 

13 (f). 

14 ‘‘(b) LIST OF BULK SUBSTANCES FROM WHICH

15 DRUG PRODUCTS MAY BE COMPOUNDED.— 

16 ‘‘(1) IN GENERAL.—For purposes of subsection 

17 (a)(3)(A)(iii), the Secretary shall, by guidance— 

18 ‘‘(A) develop and maintain a list of bulk 

19 substances from which drug products may be 

20 compounded; and 

21 ‘‘(B) include in the list only bulk sub22 stances that are not described in clause (i) or 

23 (ii) of subsection (a)(3)(A) and may be com24 pounded to meet a medical need that cannot be 


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1 filled by using a bulk substance that is de2 scribed in such clause (i) or (ii); 

3 ‘‘(C) specify for each bulk substance on the 

4 list under this subsection any limitation on 

5 compounding the bulk substance; and 

6 ‘‘(D) specify for each bulk substance on 

7 the list under this subsection the particular 

8 medical need that is met by placing such sub9 stance on the list. 

10 ‘‘(2) INITIAL PUBLICATION; UPDATES.—The 

11 Secretary shall— 

12 ‘‘(A) not later than 1 year after the date 

13 of the enactment of the Verifying Authority and 

14 Legality In Drug Compounding Act of 2013, 

15 publish an initial list under paragraph (1); and 

16 ‘‘(B) not less frequently than every year 

17 thereafter, review and, as appropriate, update 

18 the list under paragraph (1). 

19 ‘‘(3) AVAILABILITY.—The Secretary shall make 

20 the list under paragraph (1) available on the public 

21 Web site of the Food and Drug Administration. 

22 ‘‘(4) TRANSMISSION TO STATE REGULATORY

23 AGENCIES.—Upon publication of the initial list 

24 under paragraph (1), and upon each update to the 

25 list, the Secretary shall transmit an up-to-date copy 


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1 of the list to the agency in each State with primary 

2 responsibility for regulating pharmacies. 

3 ‘‘(5) PETITIONS.— 

4 ‘‘(A) IN GENERAL.—In carrying out this 

5 subsection, the Secretary shall receive and con6 sider petitions from any person identifying a 

7 substance that should be added to, or removed 

8 from, the list under this subsection. 

9 ‘‘(B) REQUIREMENT FOR PETITIONS SEEK10 ING TO ADD A BULK SUBSTANCE.—Any petition 

11 seeking to add a bulk substance to the list 

12 under this subsection shall specify the rea13 sons— 

14 ‘‘(i) why the bulk substance is needed 

15 for a procedure or population; and 

16 ‘‘(ii) why such need is not met by bulk 

17 substances that are described in clause (i) 

18 or (ii) of subsection (a)(3)(A). 

19 ‘‘(C) APPROVAL OR DENIAL.—The Sec20 retary shall approve or deny any petition re21 ceived under this paragraph, and update the list 

22 under paragraph (1) accordingly, not later than 

23 90 days after receipt of the petition, unless an 

24 extension of time is mutually agreed upon by 

25 the Secretary and the petitioner. 


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1 ‘‘(D) FINAL AGENCY ACTION.—A decision 

2 of the Secretary to approve or deny a petition 

3 received under this paragraph shall constitute 

4 final agency action subject to judicial review. 

5 ‘‘(E) PUBLIC POSTING.—The Secretary 

6 shall publically post— 

7 ‘‘(i) all petitions received under this 

8 paragraph within 21 days of receipt; and 

9 ‘‘(ii) each approval, denial, and exten10 sion under subparagraph (C) promptly. 

11 ‘‘(c) LIST OF DRUG PRODUCTS THAT SHOULD NOT

12 BE COMPOUNDED.— 

13 ‘‘(1) IN GENERAL.—For purposes of subsection 

14 (a)(6), the Secretary shall, by guidance— 

15 ‘‘(A) develop and maintain a list of drug 

16 products that should not be compounded, in17 cluding any categories, dosage forms, or ingre18 dients of such drug products; and 

19 ‘‘(B) include on such list, at a minimum— 

20 ‘‘(i) drug products (or categories, dos21 age forms, or ingredients thereof) whose 

22 compounding is reasonably likely to cause 

23 an adverse effect on safety or effectiveness 

24 of such drug product, including extended 

25 release products, metered dose inhalers, 


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1 transdermal patches, and liposomal prod2 ucts; and 

3 ‘‘(ii) drug products (or categories, 

4 dosage forms, or ingredients thereof) that 

5 have been withdrawn or removed from the 

6 market because they have been found to be 

7 unsafe or not effective. 

8 ‘‘(2) APPLICABILITY OF CERTAIN PROVI9 SIONS.—The provisions of paragraphs (2), (3), and 

10 (4) of subsection (b) shall apply with respect to the 

11 list under this subsection to the same extent and in 

12 the same manner as such provisions apply with re13 spect to the list under subsection (b). 

14 ‘‘(3) PETITIONS.—In carrying out this sub15 section, the Secretary shall receive and consider peti16 tions from any person identifying a drug product 

17 that should be added to, or removed from, the list 

18 under this subsection. Subparagraphs (C) through 

19 (E) of subsection (b)(2) shall apply with respect to 

20 petitions under this paragraph to the same extent 

21 and in the same manner as such subparagraphs 

22 apply with respect to petitions under subsection 

23 (b)(5). 

24 ‘‘(d) EXCEPTION TO REQUIREMENT OF IDENTIFIED

25 INDIVIDUAL PATIENT.— 


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1 ‘‘(1) IN GENERAL.—A pharmacy or pharmacist 

2 that is not required to be registered under section 

3 510 may compound a drug product without regard 

4 to subsection (a)(1) if the pharmacy or phar5 macist— 

6 ‘‘(A) registers with the Secretary as speci7 fied pursuant to paragraph (2); and 

8 ‘‘(B) agrees to comply with any condition 

9 of operation or limitation of activity specified by 

10 the Secretary, including the conditions and limi11 tations specified pursuant to paragraph (2). 

12 ‘‘(2) REGISTRATION AND REQUIREMENTS.—The 

13 Secretary shall specify by regulation for each type of 

14 pharmacy or pharmacist compounding drug products 

15 pursuant to the exception under this subsection— 

16 ‘‘(A) the registration requirements for such 

17 pharmacy or pharmacist and the information 

18 that must be submitted with the registration, 

19 which information shall include— 

20 ‘‘(i) the name and location of the 

21 pharmacy; 

22 ‘‘(ii) the types of drugs that are com23 pounded; 

24 ‘‘(iii) the active ingredients in each 

25 such drug; 


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1 ‘‘(iv) the source and strength of the 

2 active ingredient in each drug; 

3 ‘‘(v) the dosage form and route of ad4 ministration of each drug; 

5 ‘‘(vi) the number of individual units 

6 produced of each drug; 

7 ‘‘(vii) the States to which drugs were 

8 shipped; 

9 ‘‘(viii) the number of individual units 

10 of each drug that are shipped to each 

11 State; and 

12 ‘‘(ix) affirmation that the pharmacy 

13 or pharmacist is in compliance with State 

14 pharmacy licensing regulations; 

15 ‘‘(B) the frequency in which information 

16 described in subparagraph (A) must be sub17 mitted; 

18 ‘‘(C) the conditions of operation, including 

19 good manufacturing practices and requirements 

20 for third-party testing, applicable to the 

21 compounding of drugs; and 

22 ‘‘(D) any limitations on the activities of 

23 such pharmacy or pharmacist. 

24 ‘‘(3) TYPES OF PHARMACIES ELIGIBLE.—The 

25 Secretary shall specify separate requirements for 


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1 each type of pharmacy and pharmacist authorized to 

2 compound drug products pursuant to the exception 

3 under this subsection. The Secretary shall include 

4 separate requirements for— 

5 ‘‘(A) any pharmacy or pharmacist within a 

6 hospital system that is compounding drug prod7 ucts exclusively for dispensing to patients with8 in that hospital system; and 

9 ‘‘(B) any pharmacy or pharmacist that 

10 compounds sterile drug products. 

11 ‘‘(4) MEMORANDUM OF UNDERSTANDING.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (C), the Secretary may enter into appro14 priate memoranda of understanding with States 

15 to address State implementation of the excep16 tion under this subsection— 

17 ‘‘(i) ensuring, to the Secretary’s satis18 faction, that the State will implement the 

19 exception under this subsection in accord20 ance with the requirements of this section; 

21 and 

22 ‘‘(ii) including such other information 

23 and assurances as the Secretary may re24 quire. 


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1 ‘‘(B) PROCESS; CRITERIA.—The Secretary 

2 shall— 

3 ‘‘(i) establish a process and criteria 

4 for entering into a memorandum of under5 standing under this paragraph, including 

6 the sharing of information between State 

7 and Federal authorities; and 

8 ‘‘(ii) reevaluate each such memo9 randum of understanding not less than 

10 every 5 years to ensure, to the Secretary’s 

11 satisfaction, that the State’s implementa12 tion of the memorandum of understanding 

13 continues to conform to the requirements 

14 of this section. 

15 ‘‘(C) EXCLUSIVE FEDERAL AUTHORITY.— 

16 The Secretary shall retain exclusive Federal au17 thority to implement the exception under this 

18 subsection with respect to pharmacies and 

19 pharmacists that— 

20 ‘‘(i) perform high-risk sterile 

21 compounding; or 

22 ‘‘(ii) compound drug products for 

23 shipment across State lines. 

24 ‘‘(5) MAINTENANCE OF LIST.—The Secretary 

25 shall maintain a publically available list— 


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1 ‘‘(A) identifying all pharmacies and phar2 macists registered under this subsection; and 

3 ‘‘(B) indicating, for each such pharmacy 

4 and pharmacist, whether the pharmacy or phar5 macist is subject to regulation by a State pur6 suant to a memorandum of understanding in ef7 fect under paragraph (4). 

8 ‘‘(e) EXCEPTIONS REGARDING COPIES OF COMMER9 CIALLY AVAILABLE DRUGS.—A drug that is a copy of a 

10 commercially available drug may be compounded pursuant 

11 to this section without regard to subsection (a)(7) if— 

12 ‘‘(1)(A) the commercially available drug that is 

13 being compounded is at the time of distribution on 

14 the drug shortage list under section 506E, and the 

15 pharmacy has provided notice to the Secretary that 

16 such drug is being compounded not later than 5 

17 days after distributing such drug; or 

18 ‘‘(B) the Secretary determines that compound19 ing the drug product is necessary to protect public 

20 health or wellbeing; and 

21 ‘‘(2) in the case of a commercially available 

22 drug marketed pursuant to a risk evaluation and 

23 mitigation strategy approved under section 505–1 

24 and including one or more elements to assure safe 

25 use, the pharmacy or pharmacist compounding the 


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1 drug that is a copy of such commercially available 

2 drug demonstrates to the Secretary that controls will 

3 be used that are comparable to such elements to as4 sure safe use. 

5 ‘‘(f) HIGH-RISK STERILE COMPOUNDING.—For pur6 poses of subsection (a)(8), the Secretary shall establish 

7 standards, processes, and procedures for high-risk sterile 

8 compounding. 

9 ‘‘(g) INSPECTIONS.—Notwithstanding section 

10 704(a)(2)(A), the facilities of any pharmacy or pharmacist 

11 compounding drug products under this section— 

12 ‘‘(1) shall be subject to inspection under section 

13 704; and 

14 ‘‘(2) shall, upon request of an officer or em15 ployee designated by the Secretary, permit such offi16 cer or employee at all reasonable times to have ac17 cess to, and to copy and verify, records for purposes 

18 of determining compliance with the provisions of this 

19 Act applicable to such compounding. 

20 ‘‘(h) SHARING OF INFORMATION.—If during an in21 spection of the facilities of a pharmacy or pharmacist 

22 under this section the Secretary discovers a violation of 

23 this Act, the Secretary shall give notice of the violation— 

24 ‘‘(1) to the State in which the facilities are lo25 cated; and 


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1 ‘‘(2) to any State to which the pharmacy or 

2 pharmacist has shipped a drug product during the 

3 preceding 30 days. 

4 ‘‘(i) LABELING.—The labeling of any drug product 

5 compounded pursuant to this section shall include— 

6 ‘‘(1) the name of each drug and ingredient in7 cluded; 

8 ‘‘(2) the name, address, and phone number of 

9 the licensed compounding pharmacy, pharmacist, or 

10 physician; 

11 ‘‘(3) the date on which the drug was com12 pounded; 

13 ‘‘(4) instructions for storage and use; 

14 ‘‘(5) the following statement: ‘This drug has 

15 not been tested for safety and effectiveness and is 

16 not approved by the FDA. This drug was made spe17 cifically for you because your health care provider 

18 determined that no FDA-approved product would 

19 suit your needs. Serious adverse reactions to this 

20 drug should be reported to the FDA at 

21 llllllllllllllll, to the phar22 macy where the drug was received, and to your 

23 health care provider.’ (The blank shall specify a 

24 phone number and a Web site, to be provided by the 

25 Secretary for purposes of this subsection.); and 


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1 ‘‘(6) such other information as the Secretary 

2 may require. 

3 ‘‘(j) REPORTING BY PHARMACISTS AND PHYSI4 CIANS.— 

5 ‘‘(1) ADVERSE EVENT.—If a pharmacist or 

6 physician compounding a drug product pursuant to 

7 this section becomes aware of any adverse event as8 sociated with the use of such product, not later than 

9 10 calendar days after becoming so aware, the phar10 macist or physician shall report such adverse event 

11 to the Secretary. 

12 ‘‘(2) INFORMATION RELATED TO RISK OF IN13 JURY OR DEATH.—If a pharmacist or physician 

14 compounding a drug product pursuant to this sec15 tion becomes aware of information concerning any 

16 bacteriological, fungal, or other contamination; any 

17 significant chemical, physical, or other change; or 

18 any deterioration of a compounded drug product 

19 that has already been distributed by the pharmacist 

20 or physician, that could cause serious injury or 

21 death, not later than 2 calendar days after becoming 

22 so aware, the pharmacist or physician shall report 

23 such information to the Secretary. 

24 ‘‘(k) COMPOUNDING ESTABLISHMENT AND REIN25 SPECTION FEES.— 


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1 ‘‘(1) DEFINITIONS.—In this subsection— 

2 ‘‘(A) the term ‘affiliate’ has the meaning 

3 given such term in section 735(11); 

4 ‘‘(B) the term ‘covered compounding phar5 macy’ means a pharmacy that, pursuant to sub6 section (d) (the exception to the requirement of 

7 an identified individual patient)— 

8 ‘‘(i) performs high-risk sterile 

9 compounding; 

10 ‘‘(ii) compounds drug products for 

11 shipment across State lines; or 

12 ‘‘(iii) otherwise performs compounding 

13 pursuant to subsection (d) that is not reg14 ulated by a State pursuant to a memo15 randum of understanding under subsection 

16 (d)(4); 

17 ‘‘(C) the term ‘gross annual sales’ means 

18 the total worldwide gross annual sales, in 

19 United States dollars, for a covered compound20 ing pharmacy, including the sales of all the af21 filiates of the covered compounding pharmacy; 

22 and 

23 ‘‘(D) the term ‘reinspection’ means, with 

24 respect to a covered compounding pharmacy, 

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1 tion 704 subsequent to an inspection conducted 

2 under such provision which identified non3 compliance materially related to an applicable 

4 requirement of this Act, specifically to deter5 mine whether compliance has been achieved to 

6 the Secretary’s satisfaction. 

7 ‘‘(2) ESTABLISHMENT AND REINSPECTION

8 FEES.— 

9 ‘‘(A) IN GENERAL.—For fiscal year 2015 

10 and each subsequent fiscal year, the Secretary 

11 shall, in accordance with this subsection, assess 

12 and collect— 

13 ‘‘(i) an annual establishment fee from 

14 each covered compounding pharmacy; and 

15 ‘‘(ii) a reinspection fee from each cov16 ered compounding pharmacy subject to a 

17 reinspection in such fiscal year. 

18 ‘‘(B) MULTIPLE REINSPECTIONS.—A cov19 ered compounding pharmacy subject to multiple 

20 reinspections in a fiscal year shall be subject to 

21 a reinspection fee for each reinspection. 

22 ‘‘(3) ESTABLISHMENT AND REINSPECTION FEE

23 SETTING.—The Secretary shall establish the estab24 lishment and reinspection fee to be collected under 

25 this subsection for each fiscal year, based on the 


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1 methodology described in paragraph (4) and shall 

2 publish such fee in a Federal Register notice not 

3 later than 60 days before the start of each such 

4 year. 

5 ‘‘(4) AMOUNT OF ESTABLISHMENT FEE AND

6 REINSPECTION FEE.— 

7 ‘‘(A) IN GENERAL.—For each covered 

8 compounding pharmacy in a fiscal year— 

9 ‘‘(i) except as provided in subpara10 graph (D), the amount of the annual es11 tablishment fee under paragraph (2) shall 

12 be equal to the sum of— 

13 ‘‘(I) $15,000, multiplied by the 

14 inflation adjustment factor described 

15 in subparagraph (B); plus 

16 ‘‘(II) the small business adjust17 ment factor described in subpara18 graph (C); and 

19 ‘‘(ii) the amount of any reinspection 

20 fee (if applicable) under paragraph (2) 

21 shall be equal to $15,000, multiplied by 

22 the inflation adjustment factor described in 

23 subparagraph (B). 

24 ‘‘(B) INFLATION ADJUSTMENT FACTOR.— 


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1 ‘‘(i) IN GENERAL.—For fiscal year 

2 2015 and subsequent fiscal years, the fee 

3 amounts established in subparagraph (A) 

4 shall be adjusted by the Secretary by no5 tice, published in the Federal Register, for 

6 a fiscal year by the amount equal to the 

7 sum of— 

8 ‘‘(I) one; 

9 ‘‘(II) the average annual percent 

10 change in the cost, per full-time equiv11 alent position of the Food and Drug 

12 Administration, of all personnel com13 pensation and benefits paid with re14 spect to such positions for the first 3 

15 years of the preceding 4 fiscal years, 

16 multiplied by the proportion of per17 sonnel compensation and benefits 

18 costs to total costs of an average full19 time equivalent position of the Food 

20 and Drug Administration for the first 

21 3 years of the preceding 4 fiscal 

22 years; and 

23 ‘‘(III) the average annual percent 

24 change that occurred in the Consumer 

25 Price Index for urban consumers 


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1 (U.S. City Average; Not Seasonally 

2 Adjusted; All items; Annual Index) for 

3 the first 3 years of the preceding 4 

4 years of available data multiplied by 

5 the proportion of all costs other than 

6 personnel compensation and benefits 

7 costs to total costs of an average full8 time equivalent position of the Food 

9 and Drug Administration for the first 

10 3 years of the preceding 4 fiscal 

11 years. 

12 ‘‘(ii) COMPOUNDED BASIS.—The ad13 justment made each fiscal year under 

14 clause (i) shall be added on a compounded 

15 basis to the sum of all adjustments made 

16 each fiscal year after fiscal year 2014 

17 under clause (i). 

18 ‘‘(C) SMALL BUSINESS ADJUSTMENT FAC19 TOR.—The small business adjustment factor re20 ferred to subparagraph (A)(i)(II) shall be an 

21 amount established by the Secretary for each 

22 fiscal year based on the Secretary’s estimate 

23 of— 


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1 ‘‘(i) the number of small businesses 

2 that will pay a reduced establishment fee 

3 for such fiscal year; and 

4 ‘‘(ii) the adjustment to the establish5 ment fee necessary to achieve total fees 

6 equaling the total fees that the Secretary 

7 would have collected if no entity qualified 

8 for the small business exception in sub9 paragraph (D). 

10 ‘‘(D) EXCEPTION FOR SMALL BUSI11 NESSES.— 

12 ‘‘(i) IN GENERAL.—In the case of a 

13 covered compounding pharmacy with gross 

14 annual sales of $1,000,000 or less in the 

15 12 months ending April 1 of the fiscal year 

16 immediately preceding the fiscal year in 

17 which the fees under this subsection are 

18 assessed, the amount of the establishment 

19 fee under paragraph (2) for a fiscal year 

shall be equal to 1 20 ⁄3 of the amount cal21 culated under subparagraph (A)(i)(I) in 

22 such fiscal year. 

23 ‘‘(ii) APPLICATION.—To qualify for 

24 the exception under this subparagraph, a 

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1 retary a written request for such exception, 

2 in a format specified by the Secretary in 

3 guidance, certifying its gross annual sales 

4 for the 12 months ending April 1 of the 

5 fiscal year immediately preceding the fiscal 

6 year in which fees under this subsection 

7 are assessed. Any such application must be 

8 submitted to the Secretary not later than 

9 April 30 for the following fiscal year. Any 

10 statement or representation made to the 

11 Secretary shall be subject to section 1001 

12 of title 18, United States Code. 

13 ‘‘(E) CREDITING OF FEES.—In estab14 lishing the small business adjustment factor 

15 under subparagraph (C) for a fiscal year, the 

16 Secretary shall provide for the crediting of fees 

17 from the previous year to the next year if the 

18 Secretary overestimated the amount of the 

19 small business adjustment factor for such pre20 vious fiscal year, and consider the need to ac21 count for any adjustment of fees and such other 

22 factors as the Secretary determines appropriate. 

23 ‘‘(5) USE OF FEES.—The Secretary shall make 

24 all of the fees collected pursuant to clauses (i) and 

25 (ii) of paragraph (2)(A) available solely to pay for 


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1 the costs of oversight of covered compounding phar2 macies. 

3 ‘‘(6) SUPPLEMENT NOT SUPPLANT.—Funds re4 ceived by the Secretary pursuant to this subsection 

5 shall be used to supplement and not supplant any 

6 other Federal funds available to carry out the activi7 ties described in this section. 

8 ‘‘(7) CREDITING AND AVAILABILITY OF FEES.— 

9 Fees authorized under this subsection shall be col10 lected and available for obligation only to the extent 

11 and in the amount provided in advance in appropria12 tions Acts. Such fees are authorized to remain avail13 able until expended. Such sums as may be necessary 

14 may be transferred from the Food and Drug Admin15 istration salaries and expenses appropriation account 

16 without fiscal year limitation to such appropriation 

17 account for salaries and expenses with such fiscal 

18 year limitation. The sums transferred shall be avail19 able solely for the purpose of paying the costs of 

20 oversight of covered compounding pharmacies. 

21 ‘‘(8) COLLECTION OF FEES.— 

22 ‘‘(A) ESTABLISHMENT FEE.—A covered 

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1 cal year when submitting a registration pursu2 ant to subsection (d) for such fiscal year. 

3 ‘‘(B) REINSPECTION FEE.—The Secretary 

4 shall specify in the Federal Register notice de5 scribed in paragraph (3) the manner in which 

6 reinspection fees assessed under this subsection 

7 shall be collected and the timeline for payment 

8 of such fees. Such a fee shall be collected after 

9 the Secretary has conducted a reinspection of 

10 the covered compounding pharmacy involved. 

11 ‘‘(C) EFFECT OF FAILURE TO PAY FEES.— 

12 ‘‘(i) REGISTRATION.—A covered 

13 compounding pharmacy shall not be con14 sidered registered under subsection (d) in 

15 a fiscal year until the date that the covered 

16 compounding pharmacy remits the estab17 lishment fee under this subsection for such 

18 fiscal year. 

19 ‘‘(ii) MISBRANDING.—All drugs manu20 factured, prepared, propagated, com21 pounded, or processed by a covered 

22 compounding pharmacy for which any es23 tablishment fee or reinspection fee has not 

24 been paid as required by this subsection 

25 shall be deemed misbranded under section 


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1 502(cc) until the fees owed for such cov2 ered compounding pharmacy under this 

3 subsection have been paid. 

4 ‘‘(D) COLLECTION OF UNPAID FEES.—In 

5 any case where the Secretary does not receive 

6 payment of a fee assessed under this subsection 

7 within 30 days after it is due, such fee shall be 

8 treated as a claim of the United States Govern9 ment subject to provisions of subchapter II of 

10 chapter 37 of title 31, United States Code. 

11 ‘‘(9) ANNUAL REPORT TO CONGRESS.—Not 

12 later than 120 days after each fiscal year in which 

13 fees are assessed and collected under this subsection, 

14 the Secretary shall submit a report to the Com15 mittee on Energy and Commerce of the House of 

16 Representatives and the Committee on Health, Edu17 cation, Labor, and Pensions of the Senate, to in18 clude a description of fees assessed and collected for 

19 each year, a summary description of entities paying 

20 the fees, and the number of inspections and re21 inspections of such entities performed each year. 

22 ‘‘(10) AUTHORIZATION OF APPROPRIATIONS.— 

23 For fiscal year 2015 and each subsequent fiscal 

24 year, there is authorized to be appropriated for fees 

25 under this subsection an amount equivalent to the 


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1 total amount of fees assessed for such fiscal year 

2 under this subsection. 

3 ‘‘(l) DEFINITIONS.—In this section: 

4 ‘‘(1) The terms ‘compound’ and ‘compound5 ing’— 

6 ‘‘(A) do not include mixing, reconstituting, 

7 or other such acts that are performed in ac8 cordance with directions contained in approved 

9 labeling provided by the product’s manufacturer 

10 and other manufacturer directions consistent 

11 with that labeling; and 

12 ‘‘(B) in the case of a radioactive drug (as 

13 defined in section 310.3(n) of title 21, Code of 

14 Federal Regulations (or any successor regula15 tions)), also do not include a minor deviation 

16 from such directions with regard to radioac17 tivity, volume, or stability, that is made by or 

18 under the direct supervision of an ‘authorized 

19 nuclear pharmacist’ or a physician who is an 

20 ‘authorized user’ (as such terms are defined in 

21 section 35.2 of title 10, Code of Federal Regu22 lations, (or any successor regulations)). 

23 ‘‘(2) The term ‘copy of a commercially available 

24 drug product’ does not include a drug product in 

25 which there is a change, made for an identified indiVerDate Mar 15 2010 22:51 May 31, 2013 Jkt 029200 PO 00000 Frm 00027 Fmt 6652 Sfmt 6201 E:\BILLS\H2186.IH H2186

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1 vidual patient, which produces for that patient a sig2 nificant difference, as determined by the prescribing 

3 practitioner, between the compounded drug and the 

4 comparable commercially available drug product, 

5 provided that in the case of a radioactive drug (as 

6 defined in section 310.3(n) of title 21, Code of Fed7 eral Regulations (or any successor regulations)), the 

8 reasons for the determination by the prescribing 

9 practitioner have been documented and such docu10 mentation is maintained by the pharmacy. 

11 ‘‘(3) The term ‘high-risk sterile compounding’ 

12 means compounding sterile drug products using non13 sterile ingredients, nonsterile devices, or nonsterile 

14 components.’’. 

15 (b) MISBRANDING.—Section 502 of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend17 ed by adding at the end the following: 

18 ‘‘(bb) If it is a drug product compounded pursuant 

19 to section 503A and its labeling does not include the infor20 mation required by section 503A(i). 

21 ‘‘(cc) If it is a drug, and it was manufactured, pre22 pared, propagated, compounded, or processed by a 

23 compounding manufacturer for which fees have not been 

24 paid as required by section 503A(k).’’. 


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1 (c) CONFORMING AMENDMENT.—Section 

2 704(a)(2)(A) of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 374(a)(2)(A)) is amended by inserting 

4 ‘‘subject to section 503A,’’ before ‘‘pharmacies which 

5 maintain establishments’’. 

6 (d) REGULATIONS.—Not later than 1 year after the 

7 date of the enactment of this Act, the Secretary shall pro8 mulgate final regulations for carrying out the amendments 

9 made by subsections (a), (b), and (c). 

10 (e) EFFECTIVE DATE.—The amendments made by 

11 subsections (a), (b), and (c) shall take effect on the date 

12 that is 1 year after the date of the enactment of this Act. 

13 SEC. 3. REGISTRATION OF MANUFACTURERS COMPOUND14 ING DRUG PRODUCTS. 

15 (a) REGISTRATION.—Section 510(g) of the Federal 

16 Food, Drug, and Cosmetic Act (21 U.S.C. 360(g)) is 

17 amended by adding at the end the following: ‘‘With respect 

18 to compounding drugs, the exemption in paragraph (1) 

19 does not apply with respect to any pharmacy to the extent 

20 to which the pharmacy is, in effect, manufacturing such 

21 drugs, as determined by the Secretary, taking into consid22 eration the extent to which such pharmacy sells the drugs 

23 across State lines, the quantity of the drugs sold, and any 

24 other factors determined appropriate by the Secretary.’’. 


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1 (b) REGULATIONS.—Not later than 1 year after the 

2 date of the enactment of this Act, the Secretary of Health 

3 and Human Services shall promulgate regulations for car4 rying out the amendment made by subsection (a). 

5 (c) EFFECTIVE DATE.—The amendment made by 

6 subsection (a) shall take effect on the date that is 1 year 

7 after the date of the enactment of this Act. 

8 SEC. 4. NO PREEMPTION OF ADDITIONAL NON-FEDERAL 

9 REQUIREMENTS. 

10 The requirements of this Act (including the require11 ments of the amendments made by this Act) do not pre12 empt any non-Federal requirement that is in addition to, 

13 and compatible with, such requirements. 

Æ 


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