Patient Access to Urgent-Use Pharmacy Compounding Act of 2021

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 com- pounded medications, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Patient Access to Ur- 4 gent-Use Pharmacy Compounding Act of 2021’’. 5 VerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3662.IH H3662 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3662 IH SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRA- 1 TION IN HOSPITALS OR OTHER CLINICAL 2 SETTINGS. 3 Section 503A(a) of the Federal Food, Drug, and Cos- 4 metic Act (21 U.S.C. 353a(a)) is amended— 5 (1) in paragraph (1), by striking ‘‘or’’ at the 6 end; 7 (2) in paragraph (2)(B)(ii)(II), by striking the 8 period at the end and inserting ‘‘; or’’; and 9 (3) by adding at the end the following new 10 paragraph: 11 ‘‘(3) notwithstanding the requirement in the 12 matter preceding paragraph (1) that the drug prod- 13 uct is compounded for an identified individual pa- 14 tient based on a valid prescription order or notation 15 described in such matter, is by a licensed pharmacist 16 or licensed physician and the compounded drug 17 product is compounded for distribution in limited 18 quantities to a licensed prescriber for urgent admin- 19 istration to a patient in a hospital or other clinical 20 setting, provided that all of the following are met: 21 ‘‘(A) The licensed prescriber certifies by 22 notation on the order to the compounding phar- 23 macist or physician that the licensed prescriber 24 has made reasonable attempts to obtain, and 25 VerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3662.IH H3662 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3662 IH has not been able to obtain, to address the ur- 1 gent medical need— 2 ‘‘(i) a drug product that is approved 3 or authorized by the Food and Drug Ad- 4 ministration with the same active ingre- 5 dient and the same route of administra- 6 tion; or 7 ‘‘(ii) a drug product that is com- 8 pounded by an outsourcing facility in ac- 9 cordance with section 503B with the same 10 active ingredient and the same route of ad- 11 ministration. 12 ‘‘(B) The compounded drug product is la- 13 beled with a beyond-use-date in accordance with 14 applicable United States Pharmacopeia stand- 15 ards. 16 ‘‘(C) The licensed pharmacist or licensed 17 physician marks the packaging of the com- 18 pounded drug product with text— 19 ‘‘(i) indicating that the drug product 20 is provided to the hospital or other clinical 21 setting only for urgent administration to a 22 patient; and 23 ‘‘(ii) requesting that the hospital or 24 other clinical setting provide to the com- 25 VerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3662.IH H3662 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3662 IH pounding pharmacist or physician the 1 records that identify the patient or pa- 2 tients to whom the drug products were ad- 3 ministered within— 4 ‘‘(I) 7 days of each such patient 5 receiving such medication; or 6 ‘‘(II) 7 days of each such patient 7 being discharged. 8 ‘‘(D) Upon receipt of records requested 9 pursuant to subparagraph (C)(ii), the licensed 10 pharmacist or licensed physician ensures that 11 the patient information in such records is 12 linked with the respective order. 13 ‘‘(E) The licensed pharmacist or licensed 14 physician reports adverse events associated with 15 the compounded drug product as soon as pos- 16 sible but no later than 15 days after becoming 17 aware of such events to the MedWatch Adverse 18 Event Reporting program of the Food and 19 Drug Administration (or any successor pro- 20 gram).’’. 21 VerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3662.IH H3662 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3662 IH SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRA- 1 TION IN HOSPITALS OR OTHER CLINICAL 2 SETTINGS. 3 Paragraph (2) of section 503A(b) of the Federal 4 Food, Drug, and Cosmetic Act (21 U.S.C. 353a(b)(2)) is 5 amended to read as follows: 6 ‘‘(2) DEFINITION.—For purposes of paragraph 7 (1)(D), the term ‘essentially a copy of a commer- 8 cially available drug product’ does not include— 9 ‘‘(A) a drug product in which there is a 10 change, made for an identified individual pa- 11 tient, which produces for that patient a signifi- 12 cant difference, as determined by the pre- 13 scribing practitioner, between the compounded 14 drug and the comparable commercially available 15 drug product; or 16 ‘‘(B) a drug product that meets each of 17 the following conditions: 18 ‘‘(i) At the time of compounding, dis- 19 tribution, or dispensing, the drug product 20 appears on— 21 ‘‘(I) the drug shortage list in ef- 22 fect under section 506E; or 23 ‘‘(II) the drug shortage list main- 24 tained by the American Society of 25 Hospital Pharmacists. 26 VerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3662.IH H3662 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 3662 IH ‘‘(ii) If the drug product is not com- 1 pounded for an identified individual patient 2 based on a valid prescription order or nota- 3 tion, notwithstanding such requirement in 4 the matter preceding paragraph (1) of sub- 5 section (a), then the drug product— 6 ‘‘(I) is labeled in accordance sub- 7 paragraphs (B) and (C) of subsection 8 (a)(3); and 9 ‘‘(II) is documented by the 10 compounding pharmacist or physician 11 in accordance with subparagraphs (D) 12 and (E) of subsection (a)(3).’’. 13 Æ VerDate Sep 11 2014 04:51 Jun 26, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H3662.IH H3662 kjohnson on DSK79L0C42PROD with BILLS