Recall Unsafe Drugs Act of 2023

I 118TH CONGRESS 1ST SESSION H. R. 3688 To provide for the mandatory recall of drugs regulated by the Food and Drug Administration. IN THE HOUSE OF REPRESENTATIVES MAY 25, 2023 Ms. DELAURO introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To provide for the mandatory recall of drugs regulated by the Food and Drug Administration. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SEC. 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Recall Unsafe Drugs 4 Act of 2023’’. 5 SEC. 2. NOTIFICATION, NONDISTRIBUTION, AND RECALL 6 OF ADULTERATED OR MISBRANDED DRUGS. 7 (a) PROHIBITED ACTS.—Section 301 of the Federal 8 Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend- 9 ed by adding at the end the following: 10 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 3688 IH ‘‘(fff) The failure to comply with— 1 ‘‘(1) the notification requirement under section 2 569D(a); 3 ‘‘(2) an order issued under paragraph (1) of 4 section 569D(c), following a hearing, if requested, 5 under paragraph (2)(C) of such section; 6 ‘‘(3) an order amended under paragraph (2) or 7 paragraph (3) of section 569D(c); or 8 ‘‘(4) an emergency order issued under section 9 569D(d). 10 ‘‘(ggg) The failure to have in effect a recall plan 11 under section 569(g).’’. 12 (b) NONDISTRIBUTION AND RECALL OF ADULTER- 13 ATED OR MISBRANDED DRUGS.—Subchapter E of chapter 14 V of the Federal Food, Drug, and Cosmetic Act (21 15 U.S.C. 360bbb et seq.) is amended by adding at the end 16 the following: 17 ‘‘SEC. 569E. NOTIFICATION, NONDISTRIBUTION, AND RE- 18 CALL OF CERTAIN ADULTERATED OR MIS- 19 BRANDED DRUGS. 20 ‘‘(a) NOTIFICATION REGARDING CERTAIN ADULTER- 21 ATED OR MISBRANDED DRUGS.— 22 ‘‘(1) IN GENERAL.—Any person required to reg- 23 ister under section 510 shall, as soon as practicable, 24 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 3688 IH notify the Secretary of the identity and location of 1 a drug, if such person has reason to believe— 2 ‘‘(A) that such drug, when introduced into 3 or while in interstate commerce, or while held 4 for sale (regardless of whether the first sale) 5 after shipment in interstate commerce, is adul- 6 terated or misbranded; and 7 ‘‘(B) there is a reasonable probability that 8 the use or consumption of, or exposure to, the 9 drug (or an ingredient or component used in 10 any such drug) will cause a threat of serious 11 adverse health consequences or death to hu- 12 mans or animals. 13 ‘‘(2) MANNER OF NOTIFICATION.—Notification 14 under paragraph (1) shall be made in such manner 15 and by such means as the Secretary may require by 16 regulation or guidance. 17 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re- 18 quest that any person who distributes a drug that the Sec- 19 retary has reason to believe is adulterated, misbranded, 20 or otherwise in violation of this Act voluntarily— 21 ‘‘(1) recall such drug; and 22 ‘‘(2) provide for notice, including to individuals 23 as appropriate, to persons who may be affected by 24 the recall. 25 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 3688 IH ‘‘(c) ORDER TO CEASE DISTRIBUTION AND RECALL 1 DRUG AND RELATED PROCEDURES.— 2 ‘‘(1) ISSUANCE OF ORDER.—If the Secretary 3 has reason to believe that the use or consumption of, 4 or exposure to, a drug (or an ingredient or compo- 5 nent used in any such drug) may cause serious ad- 6 verse health consequences or death to humans or 7 animals, the Secretary shall have the authority to 8 issue an order requiring any person who distributes 9 such drug— 10 ‘‘(A) to immediately cease distribution of 11 such drug; and 12 ‘‘(B) to provide for notice, including to in- 13 dividuals as appropriate, to persons who may be 14 affected by such cessation of distribution. 15 ‘‘(2) ACTION FOLLOWING ORDER.— 16 ‘‘(A) CEASE DISTRIBUTION AND NOTIFICA- 17 TION.—Any person who is subject to an order 18 under paragraph (1) shall immediately cease 19 distribution of such drug and provide notifica- 20 tion as required by such order. 21 ‘‘(B) APPEAL.—Any person who is subject 22 to an order under paragraph (1) may appeal 23 within 24 hours of issuance such order to the 24 Secretary. Such appeal may include a request 25 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 3688 IH for an informal hearing and a description of 1 any efforts to recall such drug undertaken vol- 2 untarily by the person, including after a request 3 under subsection (b). 4 ‘‘(C) INFORMAL HEARING.—Except as pro- 5 vided in subsection (d), if an appeal made 6 under subparagraph (B) contains a request for 7 an informal hearing, such hearing shall be held 8 as soon as practicable, but not later than 5 cal- 9 endar days, or less as determined by the Sec- 10 retary, after such an appeal is filed, unless the 11 parties jointly agree to an extension. 12 ‘‘(D) DETERMINATION.—After affording 13 an opportunity for an informal hearing, the 14 Secretary shall determine— 15 ‘‘(i) whether— 16 ‘‘(I) the order under paragraph 17 (1) should be amended to require a 18 recall of such drug; or 19 ‘‘(II) inadequate grounds exist to 20 support the actions required by the 21 order; or 22 ‘‘(ii) that the order under paragraph 23 (1) was appropriate as issued. 24 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 3688 IH ‘‘(E) AMENDMENT OR VACATION OF 1 ORDER.— 2 ‘‘(i) AMENDMENT.—In the case of a 3 determination made under subparagraph 4 (D)(i)(I), the Secretary shall amend the 5 order made under paragraph (1) accord- 6 ingly. 7 ‘‘(ii) VACATION.—In the case of a de- 8 termination made under subparagraph 9 (D)(i)(II), the Secretary shall vacate the 10 order made under paragraph (1). 11 ‘‘(3) ORDER TO RECALL.— 12 ‘‘(A) AMENDMENT.—Except as provided 13 under subsection (d), if after providing an op- 14 portunity for an informal hearing under para- 15 graph (2)(C), the Secretary determines that the 16 order should be amended to include a recall of 17 the drug with respect to which the order was 18 issued, the Secretary shall amend the order to 19 require a recall. 20 ‘‘(B) CONTENTS.—An amended order 21 under subparagraph (A) shall— 22 ‘‘(i) specify a timetable in which the 23 recall will occur; 24 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 3688 IH ‘‘(ii) require periodic reports to the 1 Secretary describing the progress of the re- 2 call; and 3 ‘‘(iii) provide for notice, including to 4 individuals as appropriate, to persons who 5 may be affected by the recall. 6 In providing for such notice, the Secretary may 7 allow for the assistance of health professionals, 8 State or local officials, or other individuals des- 9 ignated by the Secretary. 10 ‘‘(C) NONDELEGATION.—An amended 11 order under this paragraph shall be ordered by 12 the Secretary or an official designated by the 13 Secretary. An official may not be so designated 14 unless the official is the director of the district 15 under this Act in which the drug involved is lo- 16 cated, or is an official senior to such director. 17 ‘‘(d) EMERGENCY RECALL ORDER.— 18 ‘‘(1) IN GENERAL.—If the Secretary has cred- 19 ible evidence or information that a drug subject to 20 an order under subsection (c)(1) presents an immi- 21 nent threat of serious adverse health consequences 22 or death to humans or animals, the Secretary may 23 issue an order requiring any person who distributes 24 such drug— 25 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 8 •HR 3688 IH ‘‘(A) to immediately recall such drug; and 1 ‘‘(B) to provide for notice, including to in- 2 dividuals as appropriate, to persons who may be 3 affected by the recall. 4 ‘‘(2) ACTION FOLLOWING ORDER.— 5 ‘‘(A) RECALL AND NOTIFICATION.—Any 6 person who is subject to an emergency recall 7 order under this subsection shall immediately 8 recall such drug and provide notification as re- 9 quired by such order. 10 ‘‘(B) APPEAL.— 11 ‘‘(i) TIMING.—Any person who is sub- 12 ject to an emergency recall order under 13 this subsection may appeal within 24 hours 14 after issuance such order to the Secretary. 15 ‘‘(ii) CONTINUATION OF RECALL.— 16 The person subject to an emergency recall 17 order shall conduct the recall notwith- 18 standing the pendency of any appeal of 19 such order. 20 ‘‘(C) INFORMAL HEARING.—An informal 21 hearing shall be held as soon as practicable but 22 not later than 5 calendar days, or less as deter- 23 mined by the Secretary, after an appeal under 24 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 9 •HR 3688 IH subparagraph (B) is filed, unless the parties 1 jointly agree to an extension. 2 ‘‘(D) DETERMINATION.—After affording 3 an opportunity for an informal hearing, the 4 Secretary shall determine— 5 ‘‘(i) whether— 6 ‘‘(I) the order under paragraph 7 (1) should be amended to require a 8 recall of such drug; or 9 ‘‘(II) inadequate grounds exist to 10 support the actions required by the 11 order; or 12 ‘‘(ii) that the order under paragraph 13 (1) was appropriate as issued. 14 ‘‘(E) AMENDMENT OR VACATION OF 15 ORDER.— 16 ‘‘(i) AMENDMENT.—In the case of a 17 determination made under subparagraph 18 (D)(i)(I), the Secretary shall amend the 19 order made under paragraph (1) accord- 20 ingly. 21 ‘‘(ii) VACATION.—In the case of a de- 22 termination made under subparagraph 23 (D)(i)(II), the Secretary shall vacate the 24 order made under paragraph (1). 25 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 10 •HR 3688 IH ‘‘(3) NONDELEGATION.—An order under this 1 subsection shall be issued by the Commissioner of 2 Food and Drugs, the Principal Deputy Commis- 3 sioner, or the Associate Commissioner for Regu- 4 latory Affairs of the Food and Drug Administration. 5 ‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI- 6 CIALS.—The Secretary shall, as the Secretary determines 7 to be necessary, provide notice of a recall order under this 8 section to consumers to whom the drug was, or may have 9 been, distributed and to appropriate State and local health 10 officials. 11 ‘‘(f) SAVINGS CLAUSE.—Nothing contained in this 12 section shall be construed as limiting— 13 ‘‘(1) the authority of the Secretary to issue an 14 order to cease distribution of, or to recall, a drug 15 under any other provision of this Act or the Public 16 Health Service Act; or 17 ‘‘(2) the ability of the Secretary to request any 18 person to perform a voluntary activity related to any 19 drug subject to this Act or the Public Health Service 20 Act. 21 ‘‘(g) RECALL PLAN.—Any person required to register 22 under section 510 shall have in effect a recall plan con- 23 sistent with the requirements of this section.’’. 24 VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB 11 •HR 3688 IH (c) DELAYED APPLICABILITY.—The amendments 1 made by this section apply beginning on the date that is 2 one year after the date of the enactment of this Act. 3 Æ VerDate Sep 11 2014 04:01 Jun 17, 2023 Jkt 039200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6301 E:\BILLS\H3688.IH H3688 pbinns on DSKJLVW7X2PROD with $$_JOB