II 

113TH CONGRESS 

1ST SESSION S. 959 

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

compounding drugs. 

IN THE SENATE OF THE UNITED STATES 

MAY 15, 2013 

Mr. HARKIN (for himself, Mr. ALEXANDER, Mr. ROBERTS, Mr. FRANKEN, and 

Ms. MIKULSKI) introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

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

respect to compounding drugs. 

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; REFERENCES IN ACT. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Pharmaceutical Compounding Quality and Account6 ability Act’’. 

7 (b) REFERENCES IN ACT.—Except as otherwise spec8 ified, amendments made by this Act to a section or other 

9 provision of law are amendments to such section or other 


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1 provision of the Federal Food, Drug, and Cosmetic Act 

2 (21 U.S.C. 301 et seq.). 

3 SEC. 2. REGULATION OF HUMAN AND ANIMAL DRUG 

4 COMPOUNDING. 

5 (a) CLARIFICATION OF NEW DRUG AND NEW ANI6 MAL DRUG STATUS.—For purposes of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the 

8 terms ‘‘new drug’’ (as defined in section 201(p) of such 

9 Act) and ‘‘new animal drug’’ (as defined in section 201(v) 

10 of such Act) shall include a compounded human drug and 

11 a compounded animal drug, respectively. 

12 (b) REGULATION OF HUMAN AND ANIMAL DRUG

13 COMPOUNDING.—Section 503A (21 U.S.C. 353a) is 

14 amended to read as follows: 

15 ‘‘SEC. 503A. HUMAN AND ANIMAL DRUG COMPOUNDING. 

16 ‘‘(a) SCOPE.— 

17 ‘‘(1) COMPOUNDING.—In this section, the terms 

18 ‘compounding’ and ‘compound’— 

19 ‘‘(A) include— 

20 ‘‘(i) the combining, admixing, mixing, 

21 diluting, reconstituting, or otherwise alter22 ing of a marketed drug; 

23 ‘‘(ii) compounding a drug from a bulk 

24 drug substance; and 


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1 ‘‘(iii) repackaging, as defined in sub2 section (b)(5); and 

3 ‘‘(B) exclude mixing, reconstituting, or 

4 other such acts with respect to a marketed drug 

5 that are limited to and performed solely in ac6 cordance with specific directions for such acts 

7 contained in approved labeling provided by a 

8 drug’s manufacturer, when performed upon re9 ceipt of a prescription order for an identified in10 dividual patient. 

11 ‘‘(2) DISPENSING NOT A SALE.—In this section, 

12 the terms ‘sell’ or ‘resale’ do not include dispensing 

13 to patients, or, in the case of animal drugs, to the 

14 individual responsible for providing care for the ani15 mal for which the drug is intended, in accordance 

16 with State law, including any fee associated with 

17 such dispensing. 

18 ‘‘(3) EXEMPTIONS.—This section shall not 

19 apply to— 

20 ‘‘(A) medical gases; 

21 ‘‘(B) animal drugs that are subject to reg22 ulation as biological products by the Secretary 

23 of Agriculture under the Act commonly known 

24 as the Virus-Serum-Toxin Act; or 


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1 ‘‘(C) human blood and blood components 

2 for transfusion. 

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

4 ‘‘(1) COMPOUNDING MANUFACTURER.— 

5 ‘‘(A) IN GENERAL.—The term 

6 ‘compounding manufacturer’ means a facility at 

7 one geographic location or address— 

8 ‘‘(i) that compounds any sterile drug 

9 product without receiving a prescription 

10 order for such sterile drug product prior to 

11 beginning compounding, and distributes or 

12 offers to sell such compounded sterile drug 

13 product in interstate commerce; or 

14 ‘‘(ii) that repackages any preservative15 free sterile drug product or pools any ster16 ile drug products, except as provided in 

17 paragraph (7)(B). 

18 ‘‘(B) EXCLUDED ACTIVITIES.—Notwith19 standing subparagraph (A)(ii), a facility shall 

20 not be considered a compounding manufacturer 

21 if such facility— 

22 ‘‘(i) repackages drugs in accordance 

23 with section 506F or the final guidance de24 scribed in section 506F(d); and 


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1 ‘‘(ii) does not otherwise meet the defi2 nition of compounding manufacturer under 

3 subparagraph (A). 

4 ‘‘(2) POOLING; POOLS.—The terms ‘pooling’ 

5 and ‘pool’— 

6 ‘‘(A) mean taking a single drug approved 

7 under section 505 or 512, conditionally ap8 proved under section 571, included on the index 

9 established under section 572(a)(1), or licensed 

10 under section 351 of the Public Health Service 

11 Act from the container in which it is distributed 

12 by the original manufacturer and combining it 

13 with the same drug from one or more other 

14 containers without or before further manipu15 lating the product (such as by diluting it or 

16 mixing it with another, different drug or 

17 drugs); 

18 ‘‘(B) do not include combining the drug 

19 from two or more separate containers of the 

20 same drug when a single container of the drug 

21 is not sufficient to prepare a single dose for ad22 ministration to an individual patient; and 

23 ‘‘(C) do not include combining the drug 

24 from two or more separate containers of compo25 nent products of a total parenteral nutrition 


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1 product, if such pooling, and labeling and use 

2 of the finished total parenteral nutrition prod3 uct, comply with State pharmacy law. 

4 ‘‘(3) PRACTITIONER.—The term ‘practitioner’ 

5 includes a physician, veterinarian, or any other per6 son that is authorized to prescribe medication under 

7 State law. 

8 ‘‘(4) PRESCRIPTION; PRESCRIPTION ORDER.— 

9 The term ‘prescription’ or ‘prescription order’ means 

10 a prescription or prescription order, as defined 

11 under applicable State law, that complies with re12 quirements applicable under such State law. 

13 ‘‘(5) REPACKAGE OR REPACKAGING.—The term 

14 ‘repackage’ or ‘repackaging’ means taking a drug 

15 approved under section 505 or 512, conditionally ap16 proved under section 571, included on the index es17 tablished under section 572(a)(1), or licensed under 

18 section 351 of the Public Health Service Act from 

19 the container in which it is distributed by the origi20 nal manufacturer and placing it in a different con21 tainer of the same or smaller size without further 

22 manipulating the drug (such as by diluting it or 

23 mixing it with another, different drug or drugs), un24 less such repackaging is done pursuant to a pre25 scription for an identified individual patient. 


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1 ‘‘(6) STERILE DRUG PRODUCT.—The term 

2 ‘sterile drug product’ means a drug that is— 

3 ‘‘(A) intended for parenteral administra4 tion; 

5 ‘‘(B) an ophthalmic or inhalation drug; or 

6 ‘‘(C) required to be sterile under Federal 

7 or State law. 

8 ‘‘(7) TRADITIONAL COMPOUNDER.— 

9 ‘‘(A) IN GENERAL.—The term ‘traditional 

10 compounder’ means an entity— 

11 ‘‘(i) wherein a drug is compounded 

12 by— 

13 ‘‘(I) a licensed pharmacist, or 

14 other pharmacy personnel (to the ex15 tent permitted under State law), in a 

16 State-licensed pharmacy or a Federal 

17 facility; or 

18 ‘‘(II) a licensed physician or li19 censed veterinarian, to the extent per20 mitted under State law; 

21 ‘‘(ii) that— 

22 ‘‘(I) compounds a drug upon re23 ceipt of a prescription order for an 

24 identified individual patient; or 


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1 ‘‘(II) compounds a drug in lim2 ited quantities before receipt of a pre3 scription order for an identified indi4 vidual patient, to the extent permitted 

5 under State law, if such compounding 

6 is based on a history of the licensed 

7 pharmacist, licensed physician, or li8 censed veterinarian receiving prescrip9 tion orders for the compounding of 

10 the drug, which orders have been gen11 erated solely within an established re12 lationship between the licensed phar13 macist, licensed physician, or licensed 

14 veterinarian and— 

15 ‘‘(aa) such individual patient 

16 for whom the prescription order 

17 will be provided, or, in the case 

18 of an animal drug, such indi19 vidual responsible for providing 

20 care for the animal for which the 

21 drug is ordered; or 

22 ‘‘(bb) the licensed physician, 

23 licensed veterinarian, or other li24 censed practitioner who will write 

25 such prescription order; and 


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1 ‘‘(iii) that does not meet the definition 

2 of a compounding manufacturer under 

3 paragraph (1). 

4 ‘‘(B) EXCEPTIONS.— 

5 ‘‘(i) HOSPITALS AND HEALTH SYS6 TEMS.— 

7 ‘‘(I) IN GENERAL.—A pharmacy 

8 within a hospital, veterinary hospital, 

9 or health system that compounds a 

10 drug and dispenses such drug (which 

11 may include interstate shipment) 

12 within such hospital or health system 

13 or ships such drug for dispensing to 

14 patients with an established relation15 ship with the hospital or health sys16 tem (which may include interstate 

17 shipment), or that repackages preserv18 ative-free sterile drug product or pools 

19 sterile drug products, shall be consid20 ered a traditional compounder if such 

21 pharmacy otherwise meets the defini22 tion under subparagraph (A). 

23 ‘‘(II) HEALTH SYSTEM DE24 FINED.—For purposes of this sub25 paragraph, the term ‘health system’ 


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1 means two or more hospitals or veteri2 nary hospitals that are owned and op3 erated by the same entity and that 

4 share access to databases with drug 

5 order information for patients or ani6 mals, as applicable. A health system 

7 includes both the inpatient and out8 patient facilities of hospitals within 

9 the health system. 

10 ‘‘(ii) PET AND RADIOPHARMA11 CEUTICALS.—A pharmacy that compounds 

12 positron emission tomography drugs or 

13 radiopharmaceuticals shall be considered a 

14 traditional compounder if it does not com15 pound other drugs that would cause it to 

16 be a compounding manufacturer described 

17 in paragraph (1)(A). 

18 ‘‘(c) EXEMPTIONS FROM CERTAIN REQUIRE19 MENTS.— 

20 ‘‘(1) DRUGS COMPOUNDED BY TRADITIONAL

21 COMPOUNDERS.—Sections 501(a)(2)(B), 502(f)(1), 

22 505 (in the case of a human drug), section 512 (in 

23 the case of an animal drug), and section 351 of the 

24 Public Health Service Act (in the case of a biological 


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1 product) shall not apply to a compounded drug if 

2 such drug— 

3 ‘‘(A) is compounded by a traditional 

4 compounder that is in compliance with this sec5 tion; and 

6 ‘‘(B) meets the requirements of this sec7 tion applicable to drugs compounded by tradi8 tional compounders. 

9 ‘‘(2) DRUGS COMPOUNDED BY COMPOUNDING

10 MANUFACTURERS.—Sections 502(f)(1), 505 (in the 

11 case of a human drug), section 512 (in the case of 

12 an animal drug), and section 351 of the Public 

13 Health Service Act (in the case of a biological prod14 uct) shall not apply to a compounded prescription 

15 drug if such drug— 

16 ‘‘(A) is compounded by a compounding 

17 manufacturer— 

18 ‘‘(i) that is not licensed as a phar19 macy in any State; and 

20 ‘‘(ii) that is in compliance with this 

21 section; and 

22 ‘‘(B) meets the requirements of this sec23 tion applicable to drugs compounded by 

24 compounding manufacturers. 

25 ‘‘(d) DRUGS THAT MAY NOT BE COMPOUNDED.— 


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1 ‘‘(1) IN GENERAL.—The following drugs may 

2 not be compounded, except under conditions speci3 fied by the Secretary: 

4 ‘‘(A) DRUGS THAT ARE DEMONSTRABLY

5 DIFFICULT TO COMPOUND.—A drug or category 

6 of drugs that presents demonstrable difficulties 

7 for compounding, which may include a complex 

8 dosage form or biological product, as designated 

9 by the Secretary pursuant to paragraph (2). 

10 ‘‘(B) MARKETED DRUGS.—A drug, other 

11 than a biological product, that is a copy of a 

12 marketed drug approved under 505 or 512, 

13 conditionally approved under section 571, or in14 cluded on the index established under section 

15 572(a)(1), except as provided in paragraph (3). 

16 ‘‘(C) BIOLOGICAL PRODUCTS.—A drug 

17 that is a biological product, except as provided 

18 in paragraph (4). 

19 ‘‘(D) DRUGS REMOVED FOR SAFETY AND

20 EFFICACY.—A drug that appears on a list pub21 lished by the Secretary in the Federal Register 

22 of drugs that have been withdrawn or removed 

23 from the market because such drug or compo24 nents of such drug have been found to be un25 safe or not effective, subject to paragraph (5). 


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1 ‘‘(2) DRUGS THAT ARE DEMONSTRABLY DIF2 FICULT TO COMPOUND.— 

3 ‘‘(A) IN GENERAL.—The Secretary may 

4 promulgate a regulation that designates drugs 

5 or categories of drugs that are demonstrably 

6 difficult to compound that may not be com7 pounded, or that may be compounded only 

8 under conditions specified by the Secretary. 

9 Such regulation— 

10 ‘‘(i) may include the designation of 

11 drugs or categories of drugs that are com12 plex dosage forms or biological products, 

13 such as extended release products, metered 

14 dose inhalers, transdermal patches, and 

15 sterile liposomal products; and 

16 ‘‘(ii) shall specify, for each drug in17 cluded on the list, whether the prohibition 

18 or condition applies to the use of the drug 

19 in humans, animals, or both. 

20 ‘‘(B) INTERIM LIST.— 

21 ‘‘(i) IN GENERAL.—Before the effec22 tive date of the regulation promulgated 

23 under subparagraph (A), the Secretary 

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1 age forms or biological products that can2 not be compounded by— 

3 ‘‘(I) publishing a notice of such 

4 drugs proposed for designation, in5 cluding the rationale for such designa6 tion, in the Federal Register; 

7 ‘‘(II) providing a period of not 

8 less than 60 days for comment on the 

9 notice; and 

10 ‘‘(III) publishing a notice in the 

11 Federal Register designating the 

12 drugs that are complex dosage forms 

13 and biological products that cannot be 

14 compounded. 

15 ‘‘(ii) SUNSET.—Any notice provided 

16 under clause (i) shall cease to have force or 

17 effect on the date that is 5 years after the 

18 date of enactment of the Pharmaceutical 

19 Compounding Quality and Accountability 

20 Act or on the effective date of the final 

21 regulation under subparagraph (A), which22 ever is earlier. 

23 ‘‘(3) EXCEPTIONS REGARDING MARKETED

24 DRUGS.— 


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1 ‘‘(A) IN GENERAL.—A drug (other than a 

2 biological product) that is a copy of a marketed 

3 drug approved under 505 or 512, conditionally 

4 approved under section 571, or included on the 

5 index established under section 572(a)(1), in6 cluding variations of such drug compounded 

7 from bulk substances, may be compounded only 

8 if— 

9 ‘‘(i)(I) the compounded variation pro10 duces for the patient a clinical difference 

11 between the compounded drug and such 

12 marketed drug, as determined by the pre13 scribing practitioner, and, prior to begin14 ning compounding a variation of such 

15 drug, the facility compounding the vari16 ation receives a prescription order speci17 fying that the variation may be com18 pounded; or 

19 ‘‘(II)(aa) such marketed drug, at the 

20 time of compounding a copy of such drug 

21 and at the time of distribution of the com22 pounded drug, is on the drug shortage list 

23 under section 506E (in the case of a 

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1 tained on the Internet Web site of the 

2 Food and Drug Administration (in the 

3 case of an animal drug), or in the Sec4 retary’s sole discretion, has otherwise been 

5 identified by the Secretary as in shortage 

6 such as in a specific region or on a drug 

7 shortage list maintained by a private 

8 party; and 

9 ‘‘(bb) the traditional compounder or 

10 the compounding manufacturer notifies the 

11 Secretary not later than 3 calendar days 

12 after beginning the compounding, unless 

13 the Secretary waives the notice require14 ment; and 

15 ‘‘(ii) in the case of a marketed drug 

16 approved under section 505 that is subject 

17 to a risk evaluation and mitigation strat18 egy approved with elements to assure safe 

19 use pursuant to section 505–1, the entity 

20 compounding the drug demonstrates to the 

21 Secretary that the entity will utilize con22 trols that are comparable to the controls 

23 applicable under the relevant risk evalua24 tion and mitigation strategy. 


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1 ‘‘(B) EXCLUSION.—For purposes of this 

2 paragraph, repackaging a marketed drug ap3 proved under section 505, 512, conditionally ap4 proved under section 571, or included on the 

5 index established under section 572(a)(1), does 

6 not make the repackaged drug a copy of such 

7 marketed drug. 

8 ‘‘(4) EXCEPTIONS REGARDING BIOLOGICAL

9 PRODUCTS.—A drug that is a biological product may 

10 be compounded only if— 

11 ‘‘(A) such drug is compounded from a li12 censed biological product and the compounding 

13 does not involve combining or mixing the li14 censed biological product with— 

15 ‘‘(i) a bulk drug substance; or 

16 ‘‘(ii) another, different drug or drugs 

17 approved under 505 or 512, conditionally 

18 approved under section 571, included on 

19 the index established under section 

20 572(a)(1), or licensed under section 351 of 

21 the Public Health Service Act, unless the 

22 compounding is limited to the combining, 

23 mixing, or diluting of licensed allergenic 

24 products; and 


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1 ‘‘(B)(i) with respect to a traditional 

2 compounder, the compounded biological product 

3 produces for the patient a clinical difference be4 tween the compounded drug and the licensed bi5 ological product, as determined by the pre6 scribing practitioner, and, prior to beginning 

7 compounding such drug, the facility 

8 compounding the variation receives a prescrip9 tion order specifying that the biological product 

10 may be compounded; 

11 ‘‘(ii) with respect to a compounding manu12 facturer, the compounded variation biological 

13 product produces for the patient a clinical dif14 ference between the compounded drug and the 

15 licensed biological product, as determined by a 

16 licensed practitioner responsible for the pa17 tient’s care in a health care entity that provides 

18 medical services through licensed prescribers di19 rectly to patients, and, prior to beginning 

20 compounding such drug, the compounding man21 ufacturer receives a duly authorized medical 

22 order from a hospital or health system speci23 fying that the biological product may be com24 pounded; or 


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1 ‘‘(iii) the compounded biological product is 

2 an allergenic product. 

3 ‘‘(5) REQUIREMENT REGARDING DRUGS RE4 MOVED FOR SAFETY OR EFFICACY.—The list pub5 lished by the Secretary in the Federal Register of 

6 drugs that have been withdrawn or removed from 

7 the market, as described in paragraph (1)(D), shall 

8 specify whether a human drug on such list may, not9 withstanding the inclusion on such list, be com10 pounded for use in animals. The Secretary shall up11 date the lists described in subparagraphs (D) and 

12 (E) of subsection (e)(2), as appropriate, to conform 

13 with the list described in paragraph (1)(D). 

14 ‘‘(e) QUALITY OF DRUG INGREDIENTS.— 

15 ‘‘(1) HUMAN DRUGS.—A traditional 

16 compounder or a compounding manufacturer shall— 

17 ‘‘(A) compound a human drug using only 

18 bulk drug substances (as defined in regulations 

19 of the Secretary published at section 

20 207.3(a)(4) of title 21, Code of Federal Regula21 tions (or any successor regulations))— 

22 ‘‘(i) that— 

23 ‘‘(I) comply with the standards of 

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1 graph, if a monograph exists and has 

2 not been identified under paragraph 

3 (6), and the United States Pharma4 copoeia chapters on pharmacy 

5 compounding; 

6 ‘‘(II) if such a monograph does 

7 not exist, are drug substances that 

8 are components of drugs approved by 

9 the Secretary; or 

10 ‘‘(III) if such a monograph does 

11 not exist and the drug substance is 

12 not a component of a drug approved 

13 by the Secretary, that appear on a list 

14 developed by the Secretary through 

15 regulations issued by the Secretary; 

16 ‘‘(ii) that are manufactured by an es17 tablishment that is registered under sec18 tion 510 (including a foreign establishment 

19 that is registered under section 510(i)); 

20 and 

21 ‘‘(iii) that are accompanied by valid 

22 certificates of analysis for each specific lot 

23 of bulk drug substance; and 

24 ‘‘(B) use ingredients (other than bulk drug 

25 substances) that comply with the standards of 


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1 an applicable United States Pharmacopoeia or 

2 National Formulary monograph, if a mono3 graph exists and has not been identified under 

4 paragraph (6), and with the United States 

5 Pharmacopoeia chapter on pharmacy 

6 compounding. 

7 ‘‘(2) ANIMAL DRUGS.—A traditional 

8 compounder or a compounding manufacturer shall— 

9 ‘‘(A) compound an animal drug using only 

10 bulk drug substances (as defined in regulations 

11 of the Secretary published at section 

12 207.3(a)(4) of title 21, Code of Federal Regula13 tions (or any successor regulations)) that— 

14 ‘‘(i) are manufactured by an establish15 ment that is registered under section 510 

16 (including a foreign establishment that is 

17 registered under section 510(i)); and 

18 ‘‘(ii) are accompanied by valid certifi19 cates of analysis for each specific lot of 

20 bulk drug substance; 

21 ‘‘(B) use ingredients (other than bulk drug 

22 substances) that comply with the standards of 

23 an applicable United States Pharmacopoeia or 

24 National Formulary monograph, if a mono25 graph exists and has not been identified under 


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1 paragraph (6), and with the United States 

2 Pharmacopoeia chapters on pharmacy 

3 compounding; 

4 ‘‘(C) in the case of a compounded animal 

5 drug for use in non-food-producing minor spe6 cies, use bulk substances that— 

7 ‘‘(i) comply with the standards of an 

8 applicable United States Pharmacopoeia or 

9 National Formulary monograph, if a 

10 monograph exists and has not been identi11 fied under paragraph (6), and with the 

12 United States Pharmacopoeia chapters on 

13 pharmacy compounding; 

14 ‘‘(ii) if such a monograph does not 

15 exist, are drug substances that are compo16 nents of drugs approved by the Secretary; 

17 or 

18 ‘‘(iii) if such a monograph does not 

19 exist and the drug substance is not a com20 ponent of a drug approved by the Sec21 retary, that appear on a list developed by 

22 the Secretary through regulations issued 

23 by the Secretary; 

24 ‘‘(D) in the case of a compounded animal 

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1 cies, beginning on the date of publication of the 

2 list established in accordance with paragraph 

3 (3)(A), shall use bulk substances that are in4 cluded on such list, subject to paragraph 

5 (3)(C); and 

6 ‘‘(E) in the case of a compounded animal 

7 drug for use in food-producing major and minor 

8 species, shall use bulk substances that are in9 cluded on a list established by the Secretary of 

10 bulk substances acceptable for use in 

11 compounding a drug for one or more such spe12 cies, in accordance with paragraph (4). 

13 ‘‘(3) NON-FOOD-PRODUCING MAJOR SPECIES

14 LISTING PROCEDURE.— 

15 ‘‘(A) IN GENERAL.—Not later than 30 

16 days after the effective date of the Pharma17 ceutical Compounding Quality and Account18 ability Act, the Secretary shall establish a list 

19 of bulk substances acceptable for compounding 

20 a drug for use in non-food-producing major spe21 cies, and any conditions applicable to such use, 

22 and may also identify bulk substances that the 

23 Secretary has determined not acceptable for 

24 compounding with respect to a drug for use in 

25 such species. 


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1 ‘‘(B) PROCEDURE.—In developing and up2 dating the list under subparagraph (A), the 

3 Secretary shall— 

4 ‘‘(i) publish a notice in the Federal 

5 Register identifying bulk substances pro6 posed as acceptable and any bulk sub7 stance determine to be unacceptable, and 

8 the rationale for such proposed designa9 tions; 

10 ‘‘(ii) provide a period of not less than 

11 30 days for comment on the notice; and 

12 ‘‘(iii) publish a notice in the Federal 

13 Register designating the bulk substances 

14 acceptable, and any bulk substances deter15 mined to be unacceptable, and the ration16 ale for such designations and determina17 tions. 

18 ‘‘(C) NOTIFICATION.—Upon initial publica19 tion of the list under subparagraph (B)(iii), any 

20 traditional compounder or compounding manu21 facturer that has received and filled a prescrip22 tion in the 60 days prior to such publication for 

23 a compounded drug for a non-food-producing 

24 major species from a bulk substance not ad25 dressed in the notice (either as acceptable or 


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1 unacceptable), and that reasonably expect to re2 ceive and fill another prescription for such a 

3 drug for such species within 60 days after such 

4 publication, may notify the Secretary of such 

5 bulk substance within 30 days of such publica6 tion, in a manner to be determined by the Sec7 retary and published in the Federal Register on 

8 or before publication of the list under subpara9 graph (B)(iii). A traditional compounder or 

10 compounding manufacturer that provides such 

11 notice shall not be subject to the restriction in 

12 paragraph (2)(D) until such time as the Sec13 retary designates such bulk substance as ac14 ceptable or determines it to be unacceptable 

15 pursuant to the process described in subpara16 graph (B)(iii). 

17 ‘‘(D) MODIFICATION OF LIST.—The Sec18 retary may amend the list at any time, in ac19 cordance with process described in subpara20 graph (B). 

21 ‘‘(E) CRITERIA.—In evaluating bulk sub22 stances for purposes of subparagraph (B), the 

23 Secretary shall consider, among other factors— 

24 ‘‘(i) the safety of the bulk substance; 


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1 ‘‘(ii) historical use of the substance in 

2 pharmacy compounding; 

3 ‘‘(iii) evidence of the effectiveness of 

4 the bulk substance or lack of effectiveness; 

5 ‘‘(iv) whether any drug approved 

6 under section 505 or 512, conditionally ap7 proved under section 571, or included on 

8 the index established under section 

9 572(a)(1), can be used on label, or any 

10 drug approved under section 505 or 512 

11 can be used in an extralabel manner in ac12 cordance with section paragraphs (4) and 

13 (5) of section 512(a), to treat the applica14 ble condition in the identified species; and 

15 ‘‘(v) whether a compounded drug ap16 propriate to treat the applicable condition 

17 in the identified species could be obtained 

18 by manipulating a drug approved under 

19 505 or 512, conditionally approved under 

20 section 571, or included on the index es21 tablished under section 572(a)(1). 

22 ‘‘(4) FOOD-PRODUCING ANIMALS LISTING PRO23 CEDURE.—In establishing a list of designated bulk 

24 substances acceptable for use in compounding a 

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1 cies under paragraph (2), and any conditions appli2 cable to such use, the Secretary shall— 

3 ‘‘(A) publish a notice in the Federal Reg4 ister identifying bulk substances proposed as 

5 acceptable and any bulk substance determine to 

6 be unacceptable, and the rationale for such des7 ignations; 

8 ‘‘(B) provide a period of not less than 30 

9 days for comment on the notice; and 

10 ‘‘(C) publish a notice in the Federal Reg11 ister designating the bulk substances acceptable 

12 for use in compounding a drug for use in food13 producing major and minor species, and the ra14 tionale for such designations. 

15 ‘‘(5) WITHDRAWAL PERIODS.—The require16 ments for establishing substantially extended with17 drawal periods in accordance with section 530.20 of 

18 title 21, Code of Federal Regulations (or any suc19 cessor regulations) shall apply to compounded ani20 mal drugs for use in food-producing animals that 

21 are compounded using bulk substances. 

22 ‘‘(6) IDENTIFICATION BY SECRETARY.— 

23 ‘‘(A) IN GENERAL.—Notwithstanding the 

24 existence of an applicable monograph under 

25 subparagraph (A)(i)(I) or (B) of paragraph (1) 


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1 or subparagraph (B) or (C)(i) of paragraph (2), 

2 the Secretary may identify bulk substances that 

3 the Secretary determines, based on public 

4 health concerns, may not be used in 

5 compounding a drug. 

6 ‘‘(B) PROCEDURE.—In identifying the bulk 

7 substances that may not be used in 

8 compounding, the Secretary shall— 

9 ‘‘(i) publish a notice of such bulk sub10 stances proposed for identification in the 

11 Federal Register; 

12 ‘‘(ii) provide a period of not less than 

13 60 days for comment on the notice; 

14 ‘‘(iii) publish a notice in the Federal 

15 Register identifying the bulk substances 

16 that may not be used in compounding a 

17 drug; and 

18 ‘‘(iv) state whether the bulk is not 

19 suitable for compounding of human drugs, 

20 animal drugs, or both. 

21 ‘‘(f) REQUIREMENTS REGARDING WHOLESALING

22 AND LABELING APPLICABLE TO TRADITIONAL

23 COMPOUNDERS AND COMPOUNDING MANUFACTURERS.— 

24 ‘‘(1) IN GENERAL.—A compounded drug— 


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1 ‘‘(A) may not be sold by an entity other 

2 than the compounding manufacturer or tradi3 tional compounder that compounded the drug; 

4 ‘‘(B) compounded by a compounding man5 ufacturer may not be sold to an entity other 

6 than a health care entity that provides medical 

7 services through licensed prescribers directly to 

8 patients or animals, or a network of such pro9 viders, except that a compounding manufac10 turer may transfer without profit a compounded 

11 sterile drug to a licensed pharmacy if— 

12 ‘‘(i) the licensed pharmacy falls under 

13 the same corporate ownership as the 

14 compounding manufacturer; 

15 ‘‘(ii) the transfer of such compounded 

16 sterile drug is solely for the purpose of dis17 pensing the compounded sterile drug to the 

18 end user, who has been instructed by the 

19 prescribing physician to self-administer 

20 such compounded sterile drug; 

21 ‘‘(iii) as of the date of enactment of 

22 the Pharmaceutical Compounding Quality 

23 and Accountability Act, the compounding 

24 manufacturer is an entity that provides 


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1 pharmacy benefits management services on 

2 behalf of a health benefits plan; 

3 ‘‘(iv) the compounding manufacturer 

4 identifies itself to the Secretary upon reg5 istering under subsection (g)(2) as an enti6 ty that qualifies for the exemption under 

7 this subparagraph, and provides docu8 mentation of the compounding of such 

9 drugs as of the date of enactment of the 

10 Pharmaceutical Compounding Quality and 

11 Accountability Act, in a manner described 

12 by the Secretary; and 

13 ‘‘(v) the compounding manufacturer 

14 receives confirmation from the Secretary 

15 that the compounding manufacturer quali16 fies for the exemption under this subpara17 graph and the sterile drug or drugs for 

18 which the exemption applies; and 

19 ‘‘(C) in the case of a compounded drug 

20 sold to a health care entity described in sub21 paragraph (B), shall be labeled ‘not for resale’. 

22 ‘‘(2) ADVERTISING AND PROMOTION.—The ad23 vertising and promotion of compounded drugs shall 

24 not be false or misleading in any particular. 


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1 ‘‘(g) OTHER REQUIREMENTS APPLICABLE TO

2 COMPOUNDING MANUFACTURERS.— 

3 ‘‘(1) LICENSED PHARMACIST OVERSIGHT.—A 

4 compounding manufacturer shall ensure that a phar5 macist licensed in the State where the compounding 

6 manufacturer is located exercises direct supervision 

7 over the operations of the compounding manufac8 turer. 

9 ‘‘(2) REGISTRATION OF COMPOUNDING MANU10 FACTURERS AND REPORTING OF DRUGS.— 

11 ‘‘(A) REGISTRATION OF COMPOUNDING

12 MANUFACTURERS.— 

13 ‘‘(i) ANNUAL REGISTRATION.—During 

14 the period beginning on October 1 and 

15 ending on December 31 each year, each 

16 compounding manufacturer shall register 

17 with the Secretary its name, place of busi18 ness, and unique facility identifier (which 

19 shall conform to the requirements for the 

20 unique facility identifier established under 

21 section 510), and a point of contact e-mail 

22 address. 

23 ‘‘(ii) NEW COMPOUNDING MANUFAC24 TURERS.—Each compounding manufac25 turer, upon first engaging in the operVerDate Mar 15 2010 23:12 May 21, 2013 Jkt 029200 PO 00000 Frm 00031 Fmt 6652 Sfmt 6201 E:\BILLS\S959.IS S959

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1 ations described in subsection (b)(1), shall 

2 immediately register with the Secretary 

3 and provide the information described 

4 under clause (i). The Secretary shall estab5 lish a timeline for registration for the first 

6 year following the effective date of the 

7 Pharmaceutical Compounding Quality and 

8 Accountability Act. In no case may reg9 istration be required until at least 60 days 

10 following publication of the timeline in the 

11 Federal Register. 

12 ‘‘(iii) ADDITIONAL FACILITIES.—Each 

13 compounding manufacturer duly registered 

14 in accordance with clauses (i) and (ii) shall 

15 immediately identify to the Secretary any 

16 additional facility that engages in the ac17 tivities described in subsection (b)(1) and 

18 that is owned or operated in any State by 

19 the person that owns or operates the 

20 compounding manufacturer. 

21 ‘‘(iv) AVAILABILITY OF REGISTRATION

22 FOR INSPECTION.—The Secretary shall 

23 make available for inspection, to any per24 son so requesting, any registration filed 

25 pursuant to this subparagraph, except that 


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1 any drug reporting information submitted 

2 pursuant to this subparagraph and the in3 formation accompanying such reporting 

4 shall be exempt from such inspection, un5 less the Secretary finds that such an ex6 emption would be inconsistent with the 

7 protection of the public health. 

8 ‘‘(B) DRUG REPORTING BY COMPOUNDING

9 MANUFACTURERS.— 

10 ‘‘(i) IN GENERAL.—Each compound11 ing manufacturer who registers with the 

12 Secretary under subparagraph (A) shall 

13 submit to the Secretary, once during the 

14 month of June of each year and once dur15 ing the month of December of each year, 

16 a report— 

17 ‘‘(I) identifying the drugs com18 pounded by such compounding manu19 facturer during the previous 6-month 

20 period; and 

21 ‘‘(II) with respect to each drug 

22 identified under subclause (I), pro23 viding the active ingredient, the 

24 source of such active ingredient, the 

25 National Drug Code number of the 


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1 source drug or bulk active ingredient, 

2 the strength of the active ingredient 

3 per unit, the dosage form and route of 

4 administration, the package descrip5 tion, the number of individual units 

6 produced, the National Drug Code 

7 number of the final product, and 

8 which conforms to other applicable re9 quirements identified by the Secretary 

10 in accordance with clause (ii). 

11 ‘‘(ii) FORM.—Each report under 

12 clause (i) shall be prepared in such form 

13 and manner as the Secretary may pre14 scribe by regulation or guidance. 

15 ‘‘(C) ELECTRONIC REGISTRATION AND RE16 PORTING.—Registrations and drug reporting 

17 under this paragraph (including the submission 

18 of updated information) shall be submitted to 

19 the Secretary by electronic means unless the 

20 Secretary grants a request for waiver of such 

21 requirement because use of electronic means is 

22 not reasonable for the person requesting waiver. 

23 ‘‘(D) RISK-BASED INSPECTION FRE24 QUENCY.— 


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1 ‘‘(i) IN GENERAL.—Compounding 

2 manufacturers shall be subject to inspec3 tion pursuant to section 704. 

4 ‘‘(ii) RISK-BASED SCHEDULE.—The 

5 Secretary, acting through one or more offi6 cers or employees duly designated by the 

7 Secretary, shall inspect compounding man8 ufacturers described in clause (i) in accord9 ance with a risk-based schedule established 

10 by the Secretary. 

11 ‘‘(iii) RISK FACTORS.—In establishing 

12 the risk-based schedule under clause (ii), 

13 the Secretary shall inspect compounding 

14 manufacturers according to the known 

15 safety risks of such compounding manufac16 turers, which shall be based on the fol17 lowing factors: 

18 ‘‘(I) The compliance history of 

19 the compounding manufacturer. 

20 ‘‘(II) The record, history, and na21 ture of recalls linked to the 

22 compounding manufacturer. 

23 ‘‘(III) The inherent risk of the 

24 drug compounded at the compounding 

25 manufacturer. 


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1 ‘‘(IV) The inspection frequency 

2 and history of the compounding man3 ufacturer, including whether the 

4 compounding manufacturer has been 

5 inspected pursuant to section 704 

6 within the last 4 years. 

7 ‘‘(V) Any other criteria deemed 

8 necessary and appropriate by the Sec9 retary for purposes of allocating in10 spection resources. 

11 ‘‘(3) ADVERSE EVENT REPORTING.— 

12 ‘‘(A) DEFINITIONS.—In this paragraph: 

13 ‘‘(i) ADVERSE EVENT.—The term ‘ad14 verse event’ means any health-related event 

15 associated with the use of a compounded 

16 drug that is adverse, including— 

17 ‘‘(I) an event occurring in the 

18 course of the use of the drug in pro19 fessional practice; 

20 ‘‘(II) an event occurring from an 

21 overdose of the drug, whether acci22 dental or intentional; 

23 ‘‘(III) an event occurring from 

24 abuse of the drug; 


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1 ‘‘(IV) an event occurring from 

2 withdrawal of the drug; and 

3 ‘‘(V) any failure of expected 

4 pharmacological action of the drug. 

5 ‘‘(ii) SERIOUS ADVERSE EVENT.—The 

6 term ‘serious adverse event’ means an ad7 verse event that— 

8 ‘‘(I) results in— 

9 ‘‘(aa) death; 

10 ‘‘(bb) an adverse drug event 

11 that places the patient at imme12 diate risk of death from the ad13 verse drug event as it occurred 

14 (not including an adverse drug 

15 event that might have caused 

16 death had it occurred in a more 

17 severe form); 

18 ‘‘(cc) inpatient hospitaliza19 tion or prolongation of existing 

20 hospitalization; 

21 ‘‘(dd) a persistent or signifi22 cant incapacity or substantial 

23 disruption of the ability to con24 duct normal life functions; or 


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1 ‘‘(ee) a congenital anomaly 

2 or birth defect; or 

3 ‘‘(II) based on appropriate med4 ical judgment, may jeopardize the pa5 tient and may require a medical or 

6 surgical intervention to prevent an 

7 outcome described in subclause (I). 

8 ‘‘(B) REPORTS.— 

9 ‘‘(i) ADVERSE EVENT REPORTING RE10 QUIREMENT.— 

11 ‘‘(I) 15-DAY REPORT.—If a 

12 compounding manufacturer becomes 

13 aware of any serious adverse event, 

14 such manufacturer shall submit re15 ports of each instance to the Sec16 retary as soon as practicable, but in 

17 no case later than 15 calendar days 

18 after the initial receipt of the applica19 ble information. Such manufacturer 

20 shall investigate and submit to the 

21 Secretary followup reports for each 

22 such instance not later than 15 cal23 endar days after receipt of new infor24 mation or as requested by the Sec25 retary. Unless and until the Secretary 


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1 establishes the content and format of 

2 adverse event reports by guidance or 

3 regulation, reports shall be submitted 

4 in accordance with the content and 

5 format requirements under section 

6 310.305 of title 21, Code of Federal 

7 Regulations (or any successor regula8 tions) (in the case of human drugs), 

9 section 600.80 of title 21, Code of 

10 Federal Regulations (or any successor 

11 regulations) (in the case of biological 

12 products), or section 514.80 of title 

13 21, Code of Federal Regulations (or 

14 any successor regulations) (in the case 

15 of animal drugs). 

16 ‘‘(II) ANNUAL REPORT.— 

17 Compounding manufacturers that re18 port serious adverse events shall sub19 mit in December of each year a nar20 rative summary of any analysis of 

21 each report submitted under subclause 

22 (I), including a history of actions 

23 taken during the year because of each 

24 report, using the content, format, and 

25 manner established by the Secretary 


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1 by guidance or regulation. Until such 

2 time as the Secretary publishes such 

3 guidance or regulation, each 

4 compounding manufacturer shall re5 tain such summaries as part of the 

6 records to be maintained in accord7 ance with subparagraph (C). 

8 ‘‘(ii) PRODUCT QUALITY REPORTING

9 REQUIREMENT.—Not later than 3 calendar 

10 days after the compounding manufacturer 

11 becomes aware of information pertaining 

12 to sterility, stability, or other product qual13 ity concerns that could result in serious 

14 adverse events, the compounding manufac15 turer shall submit to the Secretary a prod16 uct quality report, in a form and manner 

17 established by the Secretary by guidance or 

18 regulation. 

19 ‘‘(C) MAINTENANCE OF RECORDS.—A 

20 compounding manufacturer shall maintain for a 

21 period of 10 years records of all serious adverse 

22 drug events known to the compound manufac23 turer in accordance with section 314.80(i) of 

24 title 21, Code of Federal Regulations (or any 


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1 successor regulation), or as otherwise directed 

2 by the Secretary in regulations. 

3 ‘‘(4) LABELING OF DRUGS.— 

4 ‘‘(A) LABEL.—The label of a drug com5 pounded by a compounding manufacturer shall 

6 include— 

7 ‘‘(i) the statement ‘This is a com8 pounded drug.’ or a reasonable comparable 

9 alternative statement (as specified by the 

10 Secretary) that identifies the drug as a 

11 compounded drug; 

12 ‘‘(ii) the name, address, and phone 

13 number of the applicable compounding 

14 manufacturer; and 

15 ‘‘(iii) with respect to the compounded 

16 drug— 

17 ‘‘(I) the lot or batch number; 

18 ‘‘(II) the established name of the 

19 medication; 

20 ‘‘(III) the dosage form and 

21 strength; 

22 ‘‘(IV) the statement of quantity 

23 or volume, as appropriate; 

24 ‘‘(V) in the case of a drug in25 tended for use in a food-producing 


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1 animal, the withdrawal period estab2 lished pursuant to subsection (e)(5) to 

3 ensure that no residues from the com4 pounded drug can be detected in edi5 ble tissues of the treated animal; 

6 ‘‘(VI) the date that the drug was 

7 compounded; 

8 ‘‘(VII) the expiration date; 

9 ‘‘(VIII) storage and handling in10 structions; 

11 ‘‘(IX) the National Drug Code 

12 number, if available; 

13 ‘‘(X) the ‘not for resale’ state14 ment required as required by sub15 section (f)(1)(C); and 

16 ‘‘(XI) subject to subparagraph 

17 (B)(i), a list of active and inactive in18 gredients, identified by established 

19 name and the quantity or proportion 

20 of each ingredient. 

21 ‘‘(B) CONTAINER.—The container from 

22 which the individual units of a drug com23 pounded by a compounding manufacturer are 

24 removed for dispensing or for administration 


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1 (such as a plastic bag containing individual 

2 product syringes) shall include— 

3 ‘‘(i) the information described under 

4 subparagraph (A)(iii)(XI), if there is not 

5 space on the label for such information; 

6 ‘‘(ii) the following information to fa7 cilitate adverse event reporting: 

8 www.fda.gov/medwatch and 1–800–FDA– 

9 1088; and 

10 ‘‘(iii) the directions for use, including 

11 dosage and administration, as appropriate. 

12 ‘‘(C) ADDITIONAL INFORMATION.—The 

13 label and labeling of a drug compounded by a 

14 compounding manufacturer shall include any 

15 other information as determined necessary and 

16 specified in regulations promulgated by the Sec17 retary. 

18 ‘‘(h) COMPOUNDING MANUFACTURER ESTABLISH19 MENT AND REINSPECTION FEES.— 

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

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

22 given such term in section 735(11); 

23 ‘‘(B) the term ‘gross annual sales’ means 

24 the total worldwide gross annual sales, in 

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1 ufacturer, including the sales of all the affiliates 

2 of the compounding manufacturer; and 

3 ‘‘(C) the term ‘reinspection’ means, with 

4 respect to a compounding manufacturer, one or 

5 more inspections conducted under section 704 

6 subsequent to an inspection conducted under 

7 such provision which identified noncompliance 

8 materially related to an applicable requirement 

9 of this Act, specifically to determine whether 

10 compliance has been achieved to the Secretary’s 

11 satisfaction. 

12 ‘‘(2) ESTABLISHMENT AND REINSPECTION

13 FEES.—For fiscal year 2015 and each subsequent 

14 fiscal year, the Secretary shall, in accordance with 

15 this subsection, assess and collect— 

16 ‘‘(A) an annual establishment fee from 

17 each compounding manufacturer to cover in18 spection-related costs relating to inspections of 

19 drug compounders for such year; and 

20 ‘‘(B) a reinspection fee from each 

21 compounding manufacturer subject to a rein22 spection in such fiscal year. 

23 ‘‘(3) ESTABLISHMENT AND REINSPECTION FEE

24 SETTING.—The Secretary shall establish the estab25 lishment and reinspection fee to be collected under 


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1 this subsection for each fiscal year, based on the 

2 methodology described in paragraph (4) and shall 

3 publish such fee in a Federal Register notice not 

4 later than 60 days before the start of each such 

5 year. 

6 ‘‘(4) AMOUNT OF ESTABLISHMENT AND REIN7 SPECTION FEE.— 

8 ‘‘(A) IN GENERAL.—Except as provided in 

9 subparagraph (D), the amount of the annual 

10 establishment fee and the reinspection fee (if 

11 applicable) under paragraph (2) for each 

12 compounding manufacturer in a fiscal year 

13 shall be equal to the sum of— 

14 ‘‘(i)(I) $15,000 per compounding 

15 manufacturer, multiplied by 

16 ‘‘(II) the inflation adjustment factor 

17 described in subparagraph (B); plus 

18 ‘‘(ii) the small business adjustment 

19 factor described in subparagraph (C). 

20 ‘‘(B) INFLATION ADJUSTMENT FACTOR.— 

21 ‘‘(i) IN GENERAL.—For fiscal year 

22 2015 and subsequent fiscal years, the reve23 nues established in subparagraph (A) shall 

24 be adjusted by the Secretary by notice, 

25 published in the Federal Register, for a 


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1 fiscal year by the amount equal to the sum 

2 of— 

3 ‘‘(I) one; 

4 ‘‘(II) the average annual percent 

5 change in the cost, per full-time equiv6 alent position of the Food and Drug 

7 Administration, of all personnel com8 pensation and benefits paid with re9 spect to such positions for the first 3 

10 years of the preceding 4 fiscal years, 

11 multiplied by the proportion of per12 sonnel compensation and benefits 

13 costs to total costs of an average full14 time equivalent position of the Food 

15 and Drug Administration for the first 

16 3 years of the preceding 4 fiscal 

17 years, and 

18 ‘‘(III) the average annual percent 

19 change that occurred in the Consumer 

20 Price Index for urban consumers 

21 (U.S. City Average; Not Seasonally 

22 Adjusted; All items; Annual Index) for 

23 the first 3 years of the preceding 4 

24 years of available data multiplied by 

25 the proportion of all costs other than 


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1 personnel compensation and benefits 

2 costs to total costs of an average full3 time equivalent position of the Food 

4 and Drug Administration for the first 

5 3 years of the preceding 4 fiscal 

6 years. 

7 ‘‘(ii) COMPOUNDED BASIS.—The ad8 justment made each fiscal year under 

9 clause (i) shall be added on a compounded 

10 basis to the sum of all adjustments made 

11 each fiscal year after fiscal year 2014 

12 under clause (i). 

13 ‘‘(C) SMALL BUSINESS ADJUSTMENT FAC14 TOR.—The small business adjustment factor de15 scribed in subparagraph (A)(ii) shall be an 

16 amount established by the Secretary for each 

17 fiscal year based on the Secretary’s estimate 

18 of— 

19 ‘‘(i) the number of small businesses 

20 that will pay a reduced establishment fee 

21 for such fiscal year; and 

22 ‘‘(ii) the adjustment to the establish23 ment fee necessary to achieve total fees 

24 equaling the total fees that the Secretary 

25 would have collected if no entity qualified 


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1 for the small business exception in sub2 paragraph (D). 

3 ‘‘(D) EXCEPTION FOR SMALL BUSI4 NESSES.— 

5 ‘‘(i) IN GENERAL.—In the case of a 

6 compounding manufacturer with gross an7 nual sales of $1,000,000 or less in the 12 

8 months ending June 1 of the fiscal year 

9 immediately preceding the fiscal year in 

10 which the fees under this subsection are 

11 assessed, the amount of the establishment 

12 fee and reinspection fee under paragraph 

(2) for a fiscal year shall be equal to 1 13 ⁄3 of 

14 the amount calculated under subparagraph 

15 (A)(i) in such fiscal year. 

16 ‘‘(ii) APPLICATION.—The Secretary 

17 may require a small business to apply for 

18 the exception under this subparagraph by 

19 certifying its gross annual sales for the 12 

20 months ending June 1 of the fiscal year 

21 immediately preceding the fiscal year in 

22 which fees under this subsection are as23 sessed. Any such application must be sub24 mitted to the Secretary prior to August 1 

25 for the following fiscal year. Any statement 


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1 or representation made to the Secretary 

2 shall be subject to section 1001 of title 18, 

3 United States Code. 

4 ‘‘(E) CREDITING OF FEES.—In estab5 lishing the small business adjustment factor 

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

7 Secretary shall provide for the crediting of fees 

8 from the previous year to the next year if the 

9 Secretary overestimated the amount of the 

10 small business adjustment factor for such pre11 vious fiscal year, and consider the need to ac12 count for any adjustment of fees and such other 

13 factors as the Secretary determines appropriate. 

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

15 all of the fees collected pursuant to subparagraph 

16 (A) and (B) of paragraph (2) available solely to pay 

17 for the inspection-related costs (including re-inspec18 tion) for the oversight of drug compounding. 

19 ‘‘(6) SUPPLEMENT NOT SUPPLANT.—Funds re20 ceived by the Secretary pursuant to this subsection 

21 shall be used to supplement and not supplant any 

22 other Federal funds available to carry out the activi23 ties described in this subsection. 

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

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1 lected and available for obligation only to the extent 

2 and in the amount provided in advance in appropria3 tions Acts. Such fees are authorized to remain avail4 able until expended. Such sums as may be necessary 

5 may be transferred from the Food and Drug Admin6 istration salaries and expenses appropriation account 

7 without fiscal year limitation to such appropriation 

8 account for salaries and expenses with such fiscal 

9 year limitation. The sums transferred shall be avail10 able solely for the purpose of paying the inspection11 related costs (including reinspection) for the over12 sight of drug compounding. 

13 ‘‘(8) COLLECTION OF FEES.— 

14 ‘‘(A) ESTABLISHMENT FEE.—A 

15 compounding manufacturer shall remit the es16 tablishment fee due under this subsection in a 

17 fiscal year when submitting a registration pur18 suant to subsection (g) for such fiscal year. 

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

20 shall specify in the Federal Register notice de21 scribed in paragraph (3) the manner in which 

22 reinspection fees assessed under this subsection 

23 shall be collected and the timeline for payment 

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


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1 the Secretary has conducted a reinspection of 

2 the compounding manufacturer involved. 

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

4 ‘‘(i) REGISTRATION.—A compounding 

5 manufacturer shall not be considered reg6 istered under subsection (g) in a fiscal year 

7 until the date that the compounding manu8 facturer remits the establishment fee under 

9 this subsection for such fiscal year. 

10 ‘‘(ii) MISBRANDING.—All drugs com11 pounded by a compounding manufacturer 

12 for which any establishment fee or rein13 spection fee has not been paid as required 

14 by this subsection shall be deemed mis15 branded under section 502(cc) until the 

16 fees owed for such compounding manufac17 turer under this subsection have been paid. 

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

19 any case where the Secretary does not receive 

20 payment of a fee assessed under this subsection 

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

22 treated as a claim of the United States Govern23 ment subject to provisions of subchapter II of 

24 chapter 37 of title 31, United States Code. 


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

2 later than 120 days after each fiscal year in which 

3 fees are assessed and collected under this subsection, 

4 the Secretary shall submit a report to the Com5 mittee on Health, Education, Labor, and Pensions 

6 of the Senate and the Committee on Energy and 

7 Commerce of the House of Representatives, to in8 clude a description of fees assessed and collected for 

9 each year, a summary description of entities paying 

10 the fees, and the number of inspections and re11 inspections of such entities performed each year. 

12 ‘‘(10) AUTHORIZATION OF APPROPRIATIONS.— 

13 For fiscal year 2015 and each subsequent fiscal 

14 year, there is authorized to be appropriated for fees 

15 under this subsection an amount equivalent to the 

16 total amount of fees assessed for such fiscal year 

17 under this subsection. 

18 ‘‘(i) ACTION BY SECRETARY REGARDING COM19 PLAINTS FROM STATE BOARDS OF PHARMACY.— 

20 ‘‘(1) DESIGNATION.—The Secretary shall des21 ignate a point of contact and establish a format and 

22 procedure for a State Board of Pharmacy to notify 

23 the Secretary if it appears to a State Board of Phar24 macy that an entity licensed by a State as a pharVerDate Mar 15 2010 23:12 May 21, 2013 Jkt 029200 PO 00000 Frm 00052 Fmt 6652 Sfmt 6201 E:\BILLS\S959.IS S959

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1 macy is required to be registered with the Secretary 

2 as a compounding manufacturer. 

3 ‘‘(2) DETERMINATION.—If the Secretary deter4 mines that such an entity described in paragraph (1) 

5 is required to be registered with the Secretary as a 

6 compounding manufacturer, the Secretary shall 

7 transmit such determination to the State Board of 

8 Pharmacy in the State in which the entity is located, 

9 and to the State Board of Pharmacy in the notifying 

10 State, if different, within 15 days of such determina11 tion. 

12 ‘‘(3) EFFECT.—The Secretary shall encourage 

13 direct communications between States regarding tra14 ditional compounders. Nothing in this subsection 

15 shall expand the Secretary’s authority over or re16 sponsibility for traditional compounding. 

17 ‘‘(j) PRESCRIPTION ORDER REFERENCE.—For pur18 poses of this section, reference to a prescription order for 

19 an identified individual patient includes, in the case of ani20 mal drugs, a prescription order for a specific herd or flock 

21 (or other identified group) of animals.’’. 

22 (c) PROHIBITED ACT.—Section 301 (21 U.S.C. 331) 

23 is amended— 

24 (1) in subsection (e), by striking ‘‘417, 416, 

25 504’’ and inserting ‘‘417, 416, 503A(g), 504’’; and 


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1 (2) by adding at the end the following: 

2 ‘‘(ccc) The resale of a compounded drug that is la3 beled ‘not for resale’ as required by section 503A.’’. 

4 (d) REPORT BY GAO.—Not later than November 1, 

5 2016, the Comptroller General of the United States shall 

6 conduct study and submit to Congress a report regarding 

7 the impact of this Act (and the amendments made by this 

8 Act) on the safety of animal drug compounding and the 

9 availability of safe and effective drugs for animals. 

10 SEC. 3. OTHER REQUIREMENTS RELATING TO 

11 COMPOUNDING MANUFACTURERS. 

12 (a) LABELING.—Section 502 (21 U.S.C. 352) is 

13 amended by adding at the end the following: 

14 ‘‘(bb) If it is a compounded drug and the labeling 

15 does not include the information as required by sub16 sections (f)(1)(C) and (g)(4) of section 503A, as applica17 ble. 

18 ‘‘(cc) If it is a drug, and it was compounded by a 

19 compounding manufacturer for which fees have not been 

20 paid as required by section 503A(g).’’. 

21 (b) APPLICATION OF INSPECTION REQUIREMENTS TO

22 COMPOUNDING MANUFACTURERS.—Section 704(a)(2) 

23 (21 U.S.C. 374(a)(2)) is amended by adding at the end 

24 the following flush text: 


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1 ‘‘The exemption in subparagraph (A) does not apply with 

2 respect to compounding manufacturers (as such term is 

3 defined in section 503A).’’. 

4 (c) ADULTERATION OF COMPOUNDED ANIMAL

5 DRUGS CONTAINING DRUG RESIDUES.—Section 

6 402(a)(2)(C) is amended by striking ‘‘512;’’ and inserting 

7 ‘‘512; or (iii) any residue from a compounded animal 

8 drug;’’. 

9 SEC. 4. IMPLEMENTATION. 

10 In promulgating any regulations to implement this 

11 Act (and the amendments made by this Act), the Sec12 retary of Health and Human Services shall— 

13 (1) issue a notice of proposed rulemaking that 

14 includes the proposed regulation; 

15 (2) provide a period of not less than 60 days 

16 for comments on the proposed regulation; and 

17 (3) publish the final regulation not more than 

18 18 months following publication of the proposed rule 

19 and not less than 30 days before the effective date 

20 of such final regulation. 

21 SEC. 5. EFFECTIVE DATE. 

22 This Act (and the amendments made by this Act) 

23 shall take effect on the date that is 1 year after the date 

24 of enactment of this Act. 

Æ 


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