I 

117TH CONGRESS 

1ST SESSION H. R. 3662 

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

have access to certain urgent-use compounded medications, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 1, 2021 

Mr. GRIFFITH (for himself and Mr. CUELLAR) 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 

ensure patients have access to certain urgent-use compounded medications, and for other purposes. 

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 ‘‘Patient Access to Ur5 gent-Use Pharmacy Compounding Act of 2021’’. 


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1 SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRA2 TION IN HOSPITALS OR OTHER CLINICAL 

3 SETTINGS. 

4 Section 503A(a) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 353a(a)) is amended— 

6 (1) in paragraph (1), by striking ‘‘or’’ at the 

7 end; 

8 (2) in paragraph (2)(B)(ii)(II), by striking the 

9 period at the end and inserting ‘‘; or’’; and 

10 (3) by adding at the end the following new 

11 paragraph: 

12 ‘‘(3) notwithstanding the requirement in the 

13 matter preceding paragraph (1) that the drug prod14 uct is compounded for an identified individual pa15 tient based on a valid prescription order or notation 

16 described in such matter, is by a licensed pharmacist 

17 or licensed physician and the compounded drug 

18 product is compounded for distribution in limited 

19 quantities to a licensed prescriber for urgent admin20 istration to a patient in a hospital or other clinical 

21 setting, provided that all of the following are met: 

22 ‘‘(A) The licensed prescriber certifies by 

23 notation on the order to the compounding phar24 macist or physician that the licensed prescriber 

25 has made reasonable attempts to obtain, and 


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1 has not been able to obtain, to address the ur2 gent medical need— 

3 ‘‘(i) a drug product that is approved 

4 or authorized by the Food and Drug Ad5 ministration with the same active ingre6 dient and the same route of administra7 tion; or 

8 ‘‘(ii) a drug product that is com9 pounded by an outsourcing facility in ac10 cordance with section 503B with the same 

11 active ingredient and the same route of ad12 ministration. 

13 ‘‘(B) The compounded drug product is la14 beled with a beyond-use-date in accordance with 

15 applicable United States Pharmacopeia stand16 ards. 

17 ‘‘(C) The licensed pharmacist or licensed 

18 physician marks the packaging of the com19 pounded drug product with text— 

20 ‘‘(i) indicating that the drug product 

21 is provided to the hospital or other clinical 

22 setting only for urgent administration to a 

23 patient; and 

24 ‘‘(ii) requesting that the hospital or 

25 other clinical setting provide to the comVerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3662.IH H3662

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1 pounding pharmacist or physician the 

2 records that identify the patient or pa3 tients to whom the drug products were ad4 ministered within— 

5 ‘‘(I) 7 days of each such patient 

6 receiving such medication; or 

7 ‘‘(II) 7 days of each such patient 

8 being discharged. 

9 ‘‘(D) Upon receipt of records requested 

10 pursuant to subparagraph (C)(ii), the licensed 

11 pharmacist or licensed physician ensures that 

12 the patient information in such records is 

13 linked with the respective order. 

14 ‘‘(E) The licensed pharmacist or licensed 

15 physician reports adverse events associated with 

16 the compounded drug product as soon as pos17 sible but no later than 15 days after becoming 

18 aware of such events to the MedWatch Adverse 

19 Event Reporting program of the Food and 

20 Drug Administration (or any successor pro21 gram).’’. 


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1 SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRA2 TION IN HOSPITALS OR OTHER CLINICAL 

3 SETTINGS. 

4 Paragraph (2) of section 503A(b) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)(2)) is 

6 amended to read as follows: 

7 ‘‘(2) DEFINITION.—For purposes of paragraph 

8 (1)(D), the term ‘essentially a copy of a commer9 cially available drug product’ does not include— 

10 ‘‘(A) a drug product in which there is a 

11 change, made for an identified individual pa12 tient, which produces for that patient a signifi13 cant difference, as determined by the pre14 scribing practitioner, between the compounded 

15 drug and the comparable commercially available 

16 drug product; or 

17 ‘‘(B) a drug product that meets each of 

18 the following conditions: 

19 ‘‘(i) At the time of compounding, dis20 tribution, or dispensing, the drug product 

21 appears on— 

22 ‘‘(I) the drug shortage list in ef23 fect under section 506E; or 

24 ‘‘(II) the drug shortage list main25 tained by the American Society of 

26 Hospital Pharmacists. 


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1 ‘‘(ii) If the drug product is not com2 pounded for an identified individual patient 

3 based on a valid prescription order or nota4 tion, notwithstanding such requirement in 

5 the matter preceding paragraph (1) of sub6 section (a), then the drug product— 

7 ‘‘(I) is labeled in accordance sub8 paragraphs (B) and (C) of subsection 

9 (a)(3); and 

10 ‘‘(II) is documented by the 

11 compounding pharmacist or physician 

12 in accordance with subparagraphs (D) 

13 and (E) of subsection (a)(3).’’. 

Æ 


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