Drug Origin Transparency Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3810 To amend the Federal Food, Drug, and Cosmetic Act to enhance drug manufacturing amount information reporting, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 5, 2023 Ms. ESHOO 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 enhance drug manufacturing amount information report- ing, 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 ‘‘Drug Origin Trans- 4 parency Act of 2023’’. 5 SEC. 2. ENHANCED DRUG MANUFACTURING AMOUNT IN- 6 FORMATION REPORTING. 7 (a) IN GENERAL.—Section 510(j)(3) of the Federal 8 Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)(3)) is 9 amended— 10 VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3810.IH H3810 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 3810 IH (1) in subparagraph (A), by adding ‘‘or (2)’’ 1 after ‘‘paragraph (1)’’; and 2 (2) by adding at the end the following: 3 ‘‘(C) Each report submitted pursuant to sub- 4 paragraph (A) with respect to a drug shall— 5 ‘‘(i) include additional information as may 6 be specified by the Secretary in regulation or 7 guidance regarding the supply chain for such 8 drug, such as— 9 ‘‘(I) the identity of the respective sup- 10 pliers of each active pharmaceutical ingre- 11 dient, active pharmaceutical ingredient in- 12 termediate, and in-process material used in 13 such manufacture, preparation, propaga- 14 tion, compounding, or processing of the 15 drug; and 16 ‘‘(II) the respective amounts of such 17 drug that were manufactured, prepared, 18 propagated, compounded, or processed 19 using an active pharmaceutical ingredient, 20 active pharmaceutical ingredient inter- 21 mediate, and in-process material from each 22 such identified supplier; and 23 ‘‘(ii) be submitted more frequently than 24 annually, in accordance with a reporting sched- 25 VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3810.IH H3810 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 3810 IH ule as may be specified by the Secretary in such 1 regulation or guidance, but not more frequently 2 than 4 times per year. 3 ‘‘(D) Any additional information specified in 4 regulation or guidance pursuant to subparagraph 5 (C) shall be a required element of reports under this 6 paragraph not earlier than 6 months after the date 7 on which such regulation or guidance is issued in 8 final form (and in no event shall the absence of any 9 regulation or guidance issued under subparagraph 10 (C) affect the requirement to report as described in 11 subparagraph (A)).’’. 12 (b) CONFORMING AMENDMENT.—Section 13 510(j)(3)(B) of the Federal Food, Drug, and Cosmetic 14 Act (21 U.S.C. 510(j)(3)(B)) is amended by striking ‘‘sub- 15 paragraph (A)’’ and inserting ‘‘this paragraph’’. 16 SEC. 3. REQUIRE DRUG LABELING TO INCLUDE ORIGINAL 17 MANUFACTURER AND SUPPLY CHAIN INFOR- 18 MATION. 19 Section 502 of the Federal Food, Drug, and Cosmetic 20 Act (21 U.S.C. 352) is amended— 21 (1) in paragraph (b)— 22 (A) by striking ‘‘(b) If in a package’’ and 23 inserting ‘‘(b)(1) If in a package’’; 24 VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3810.IH H3810 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 3810 IH (B) by striking ‘‘a label containing (1) the 1 name and place’’ and inserting ‘‘a label con- 2 taining— 3 ‘‘(A) the name and place’’; 4 (C) by striking ‘‘or distributor; and (2) an 5 accurate statement’’ and inserting ‘‘or dis- 6 tributor; and 7 ‘‘(B) an accurate statement’’; 8 (D) by striking ‘‘under clause (2) of this 9 paragraph’’ and inserting ‘‘under this clause’’; 10 and 11 (E) by inserting at the end the following: 12 ‘‘(2)(A) Subject to clause (C), if it is a drug, 13 including an active pharmaceutical ingredient, unless 14 it bears a label containing the name and place of 15 business, and unique facility identifier of the original 16 manufacturer of such drug or active pharmaceutical 17 ingredient, except that the Secretary may provide, 18 by regulation, for reasonable variations in the imple- 19 mentation of such labeling requirements. 20 ‘‘(B) Subject to clause (C), if it is a drug that 21 is an active pharmaceutical ingredient, unless any 22 accompanying certificate of analysis contains the 23 name and place of business, and unique facility iden- 24 VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3810.IH H3810 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 3810 IH tifier of the original manufacturer of the active 1 pharmaceutical ingredient. 2 ‘‘(C) The Secretary may provide, by regulation, 3 for reasonable variations in the implementation of 4 labeling requirements specified in this subpara- 5 graph.’’; and 6 (2) by inserting after paragraph (c) the fol- 7 lowing: 8 ‘‘(d)(1) Subject to subparagraph (2), if it is a drug, 9 including an active pharmaceutical ingredient, unless it 10 bears labeling containing the name and place of business 11 of— 12 ‘‘(A) the original manufacturer of each active 13 pharmaceutical ingredient; 14 ‘‘(B) each manufacturer, if different from the 15 original manufacturer; and 16 ‘‘(C) the packer or distributor, if any. 17 ‘‘(2) The Secretary may provide, by regulation, for 18 reasonable variations or an alternative placement for the 19 labeling requirements specified in subparagraph (1), in- 20 cluding by electronic means.’’. 21 Æ VerDate Sep 11 2014 05:08 Jun 28, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\H3810.IH H3810 kjohnson on DSK79L0C42PROD with BILLS