I 

113TH CONGRESS 

1ST SESSION H. R. 3019 

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to 

enhance the requirements for pharmacies that compound drug products. 

IN THE HOUSE OF REPRESENTATIVES 

AUGUST 2, 2013 

Ms. DELAURO (for herself, Mrs. LOWEY, Mr. CONYERS, Mr. HONDA, and Mr. 

ELLISON) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend chapter V of the Federal Food, Drug, and Cosmetic Act to enhance the requirements for pharmacies 

that compound 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 ‘‘Supporting Access to 

5 Formulated and Effective Compounded Drugs Act of 

6 2013’’ or the ‘‘S.A.F.E. Compounded Drugs Act of 2013’’. 


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1 SEC. 2. ENHANCED REQUIREMENTS FOR COMPOUNDED 

2 DRUGS. 

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

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

5 amended— 

6 (1) in subsection (a)(1)(A), by inserting ‘‘that 

7 is registered with the Secretary under subsection 

8 (b)(6) (or is subject to the exception under sub9 section (b)(6)(C))’’ after ‘‘State licensed pharmacy’’; 

10 (2) in subsection (b)— 

11 (A) in paragraph (1)(A), by inserting 

12 ‘‘(meaning not more than 5 percent of the total 

13 quantity of drugs products compounded by the 

14 pharmacist or physician in any 30 day period)’’ 

15 after ‘‘limited quantities’’; 

16 (B) in paragraph (1)(C), by striking ‘‘and’’ 

17 at the end; 

18 (C) in paragraph (1)(D), by striking ‘‘reg19 ularly or in inordinate amounts (as defined by 

20 the Secretary)’’; 

21 (D) by adding at the end of paragraph (1) 

22 the following: 

23 ‘‘(E) does not compound a drug product 

24 that appears on the list promulgated by the 

25 Secretary under subsection (h); and 


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1 ‘‘(F) does not compound a drug product in 

2 violation of the minimum standards promul3 gated under subsection (i).’’; and 

4 (E) by adding at the end of the subsection 

5 the following: 

6 ‘‘(4) NOTIFICATION.— 

7 ‘‘(A) PRESCRIBER NOTIFICATION.—Before 

8 providing a prescription order for a drug to be 

9 compounded under subsection (a), the physician 

10 or other licensed practitioner who will write 

11 such order shall— 

12 ‘‘(i) inform the individual patient for 

13 whom such order is being written that a 

14 compounded drug is being prescribed; and 

15 ‘‘(ii) provide such patient with a writ16 ten document containing information con17 cerning the availability, safety, and produc18 tion of compounded drugs. 

19 ‘‘(B) CONFIRMATION BY PHARMACIST.— 

20 Except in the case of a compounded drug prod21 uct used in a procedure described in subpara22 graph (C), a licensed pharmacist or licensed 

23 physician who dispenses a compounded drug 

24 under subsection (a) shall, at the time such 

25 drug is dispensed— 


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1 ‘‘(i) confirm that the patient (or the 

2 individual to whom the drug is delivered on 

3 behalf of the patient) understands that the 

4 drug is a compounded drug; and 

5 ‘‘(ii) provide a written document con6 taining the information described in sub7 paragraph (A)(ii). 

8 ‘‘(C) PROVIDER NOTIFICATION.—Prior to 

9 providing a health care service that will be con10 ducted by a health care provider in a health 

11 care setting (such as a hospital or a physician’s 

12 office) and during which service a drug com13 pounded under subsection (a) will be adminis14 tered to a patient for purposes of treating such 

15 patient, the health care provider shall— 

16 ‘‘(i) inform the patient that a com17 pounded drug will be used during the pro18 cedure; and 

19 ‘‘(ii) provide such patient with a writ20 ten document containing the information 

21 described in subparagraph (A)(ii). 

22 ‘‘(5) LABELING.— 

23 ‘‘(A) IN GENERAL.—A drug product com24 pounded under subsection (a) shall be clearly 


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1 labeled as a ‘non-FDA approved compounded 

2 drug product’. 

3 ‘‘(B) DEVELOPMENT OF REQUIRE4 MENTS.—In determining the requirements for 

5 the label under subparagraph (A), the Sec6 retary— 

7 ‘‘(i) shall establish, and consult with, 

8 a temporary advisory committee on com9 pounded drug product labeling require10 ments; and 

11 ‘‘(ii) may establish different labeling 

12 requirements for— 

13 ‘‘(I) a compounded drug product 

14 intended for use by a health care pro15 vider in an office or treatment setting; 

16 and 

17 ‘‘(II) a compounded drug product 

18 intended for any use not described in 

19 subclause (I). 

20 ‘‘(6) REGISTRATION.— 

21 ‘‘(A) ESTABLISHMENT OF PROCESS.—The 

22 Secretary, in consultation with experts and rep23 resentatives of stakeholders including phar24 macies, compounding pharmacies, State regu25 lators, and health care providers, shall establish 


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1 a process for pharmacies described in sub2 section (a)(1)(A) to register as a compounding 

3 pharmacy. Such registration shall be conducted 

4 through an electronic method. 

5 ‘‘(B) REGISTRATION REQUIREMENT.—Ex6 cept as provided in subparagraph (C), in order 

7 to be registered with the Secretary for purposes 

8 of subsection (a)(1)(A), every person who owns 

9 or operates a pharmacy shall submit to the Sec10 retary, in such time and manner as the Sec11 retary may require— 

12 ‘‘(i) contact information for the phar13 macy; 

14 ‘‘(ii) the State or States that the 

15 pharmacy is licensed in; 

16 ‘‘(iii) the methods used by the facility 

17 in compounding; and 

18 ‘‘(iv) any additional information re19 quired by the Secretary, which may include 

20 the quantity of product compounded at 

21 such pharmacy for the purpose of deter22 mining if a drug manufacturing facility is 

23 inappropriately registering as a 

24 compounding pharmacy. 


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1 ‘‘(C) PROHIBITION ON DUAL REGISTRA2 TION.—An entity registered under this sub3 section shall not be required to submit a reg4 istration under section 510. 

5 ‘‘(D) EXCEPTION.—A pharmacy shall be 

6 exempt from the requirement to register under 

7 subsection (a)(1)(A) if the pharmacy— 

8 ‘‘(i) employs fewer than 20 full-time 

9 employees (or 20 full-time equivalents); 

10 and 

11 ‘‘(ii) performs traditional 

12 compounding of drug products for use in a 

13 single State.’’; and 

14 (3) by adding at the end of section 503A the 

15 following: 

16 ‘‘(g) DATABASE.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall estab18 lish and maintain a database of information on 

19 pharmacies compounding drug products under sub20 section (a) that are licensed in more than one State, 

21 including— 

22 ‘‘(A) the minimum standards for a 

23 compounding pharmacy license in each State; 


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1 ‘‘(B) relevant information provided to the 

2 Secretary by State agencies that regulate phar3 macies; 

4 ‘‘(C) reliable, timely, and comprehensive 

5 data related to inspections of such pharmacies, 

6 including the classification of actions indicated 

7 as a result of such inspections; and 

8 ‘‘(D) other information determined rel9 evant by the Secretary. 

10 ‘‘(2) DESIGN.—The database under paragraph 

11 (1)— 

12 ‘‘(A) shall be accessible, as determined ap13 propriate by the Secretary, to State agencies 

14 that regulate pharmacies that compound drug 

15 products; 

16 ‘‘(B) shall enable States and the Secretary 

17 to share information to ensure appropriate 

18 oversight of pharmacies that compound drug 

19 products; 

20 ‘‘(C) shall be used by the Secretary to in21 form the Federal inspection and oversight of 

22 pharmacies that compound drug products to en23 sure that issues and pharmacies identified in 

24 the database receive appropriate oversight; and 


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1 ‘‘(D) shall be accessible, as determined ap2 propriate by the Secretary, to health care pro3 viders and consumers. 

4 ‘‘(h) ACTIVE INGREDIENTS AND DOSAGE FORMS

5 THAT SHOULD NOT BE COMPOUNDED.—The Secretary 

6 shall, after consultation with appropriate stakeholders (in7 cluding pharmacists, patient and public health advocacy 

8 groups, manufacturers, and health care professionals), 

9 promulgate a list of active ingredients and dosage forms 

10 that should not be compounded, because the compounding 

11 of such active ingredient or dosage form is reasonably like12 ly to present a risk to public health. 

13 ‘‘(i) MINIMUM STANDARDS.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall pro15 mulgate minimum standards for the safe production 

16 of compounded drug products under this section. 

17 ‘‘(2) CONTENTS.—The standards under para18 graph (1) shall each specify— 

19 ‘‘(A) the type of compounded drug prod20 ucts to which they apply; and 

21 ‘‘(B) the intended route of administration. 

22 ‘‘(j) TRAINING.—The Secretary shall conduct a series 

23 of regional training opportunities for State agencies that 

24 regulate pharmacies that compound drug products. These 

25 training opportunities shall include information on the 


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1 minimum standards under subsection (i), sample inspec2 tion protocol, and recordkeeping to facilitate the inclusion 

3 of State findings and inspections into the database under 

4 subsection (g).’’. 

5 (b) DEADLINES AND ADVISORY COMMITTEES.— 

6 (1) DEADLINE FOR ISSUANCE OF REGULA7 TIONS.—Not later than 18 months after the date of 

8 enactment of this Act, the Secretary of Health and 

9 Human Services shall issue regulations to imple10 ment— 

11 (A) paragraphs (4) and (5) of section 

12 503A(b) of the Federal Food, Drug, and Cos13 metic Act, as added by subsection (a); and 

14 (B) subsection (g) of section 503A of such 

15 Act. 

16 (2) LABELING ADVISORY COMMITTEE.— 

17 (A) ESTABLISHMENT.—The Secretary of 

18 Health and Human Services shall establish an 

19 advisory committee on labeling (as defined in 

20 section 201 of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 321)) of compounded 

22 drug products and shall consult such committee 

23 in the development of the regulations under 

24 paragraph (1)(A). 


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1 (B) MEMBERSHIP.—The advisory com2 mittee shall include representatives of patients 

3 or consumers, health care providers, 

4 compounding pharmacies, State agencies that 

5 regulate compounding pharmacies, and at least 

6 one member with expertise on clearly commu7 nicating information in such labeling of drugs. 

8 (C) MEETINGS.—The advisory committee 

9 shall hold an initial meeting not later than 6 

10 months after the date of enactment of this Act. 

11 (D) RECOMMENDATIONS.—Not later than 

12 12 months after the date of enactment of this 

13 Act, the advisory committee shall submit to the 

14 Secretary of Health and Human Services rec15 ommendations on the regulations under para16 graph (1)(A), including recommendations on 

17 the type of information and language that 

18 should be included on the labels of drug prod19 ucts that are compounded pursuant to section 

20 503A of the Federal Food, Drug, and Cosmetic 

21 Act. 

22 (E) TERMINATION.—The advisory com23 mittee under this subparagraph shall terminate 

24 upon the submission of the recommendations 

25 under subparagraph (D). 


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1 (3) DATABASE ADVISORY COMMITTEE.— 

2 (A) ESTABLISHMENT.—The Secretary of 

3 Health and Human Services shall establish an 

4 advisory committee on the database described 

5 in section 503A(g) of the Federal Food, Drug, 

6 and Cosmetic Act, as added by subsection (a), 

7 and shall consult such committee in the devel8 opment of the regulations under paragraph 

9 (1)(B). 

10 (B) MEMBERSHIP.—The advisory com11 mittee shall include representatives of patients 

12 or consumers, health care providers, 

13 compounding pharmacies, State agencies that 

14 regulate compounding pharmacies, and informa15 tion technology experts. 

16 (C) MEETINGS.—The advisory committee 

17 shall hold an initial meeting not later than 6 

18 months after the date of enactment of this Act. 

19 (D) RECOMMENDATIONS.—Not later than 

20 12 months after the date of enactment of this 

21 Act, the advisory committee shall submit to the 

22 Secretary of Health and Human Services rec23 ommendations on the regulations under para24 graph (1)(B). 


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1 (E) TERMINATION.—The advisory com2 mittee under this subparagraph shall terminate 

3 upon the submission of the recommendations 

4 under subparagraph (D). 

5 (4) PERMANENT ADVISORY COMMITTEE ON

6 PHARMACY COMPOUNDING.—The Secretary shall 

7 convene the Advisory Committee on Pharmacy 

8 Compounding as appropriate to consider issues re9 lated to the safety and availability of compounded 

10 drug products. 

11 SEC. 3. REPORTS AND STUDIES. 

12 (a) BIANNUAL REPORTS.—Not later than 6 months 

13 after the date of enactment of this Act, and at the end 

14 of each succeeding 6-month period that ends before the 

15 25th month after the date of enactment of this Act, the 

16 Secretary of Health and Human Services shall submit to 

17 the Congress a report on the status of the implementation 

18 of the requirements of this Act, and the amendments made 

19 by this Act. 

20 (b) THIRD-PARTY ACCREDITATION.—Not later than 

21 12 months after the date of enactment of this Act, the 

22 Secretary shall submit to the Congress a report that con23 tains— 


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1 (1) a review of the standards used by organiza2 tions that provide accreditation to compounding 

3 pharmacies; and 

4 (2) an evaluation of the effectiveness of such 

5 standards in ensuring the production of safe and ef6 fective compounded drug products. 

7 (c) STRUCTURE OF STATE OVERSIGHT.—Not later 

8 than 18 months after the date of enactment of this Act, 

9 the Secretary shall submit to the Congress a report that 

10 contains— 

11 (1) a review of the models used by States to 

12 structure their oversight of pharmacies that com13 pound drug products, including the structure of the 

14 agency or office responsible for oversight and its re15 lationship with the industry that it regulates; and 

16 (2) consideration of how the structure and rela17 tionship of State regulators may impact the develop18 ment and enforcement of regulations to ensure safe 

19 compounded drug products. 

20 (d) GAO REPORT.—The Comptroller General of the 

21 United States shall review— 

22 (1) the extent to which Federal health care pro23 grams (as such term is defined in section 1128B(f) 

24 of the Social Security Act (42 U.S.C. 1320a–7b)) 

25 ensure that compounded drug products which are 


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1 paid for by such programs are compounded in facili2 ties that comply with the requirements of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 

4 et seq.); 

5 (2) whether the reimbursement rates for com6 pounded drug products under such Federal health 

7 care programs are appropriate, taking into consider8 ation the cost of production of such compounded 

9 drug products; and 

10 (3) whether such Federal health care programs 

11 encourage the use of compounded drug products in 

12 place of otherwise available lawfully marketed drug 

13 products. 

14 SEC. 4. PROHIBITIONS AND PENALTIES. 

15 (a) PROHIBITION OF VIOLATIONS OF SECTION

16 503A.—Section 301(d) of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 331(d)) is amended by inserting 

18 ‘‘503A,’’ before ‘‘505,’’. 

19 (b) PENALTIES.—Section 303(b) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is 

21 amended by adding at the end the following: 

22 ‘‘(8) Notwithstanding subsection (a), any per23 son who violates section 301(d) with respect to any 

24 compounded drug product— 


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1 ‘‘(A) knowingly and intentionally to de2 fraud or mislead; or 

3 ‘‘(B) with conscious or reckless disregard 

4 of a risk of death or serious bodily injury, 

5 shall be fined under title 18, United States Code, 

6 imprisoned for not more than 10 years, or both.’’. 

Æ 


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