LABEL Opioids Act

I 117TH CONGRESS 1ST SESSION H. R. 1026 To amend the Controlled Substances Act to require dispensers of certain opioids and opiates to affix on the container or package thereof a clear, concise warning that the opioid or opiate can cause dependence, addic- tion, and overdose, and for other purposes. IN THE HOUSE OF REPRESENTATIVES FEBRUARY 11, 2021 Mr. STANTON introduced the following bill; which was referred to the Com- mittee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the juris- diction of the committee concerned A BILL To amend the Controlled Substances Act to require dis- pensers of certain opioids and opiates to affix on the container or package thereof a clear, concise warning that the opioid or opiate can cause dependence, addic- tion, and overdose, 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 ‘‘Lessening Addiction 4 By Enhancing Labeling Opioids Act of 2021’’ or the 5 ‘‘LABEL Opioids Act’’. 6 VerDate Sep 11 2014 18:10 Mar 10, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1026.IH H1026 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1026 IH SEC. 2. LESSENING ADDICTION BY ENHANCING LABELING 1 OF OPIOIDS. 2 (a) IN GENERAL.—Section 305(c) of the Controlled 3 Substances Act (21 U.S.C. 825(c)) is amended by striking 4 ‘‘which shall provide that the label’’ and all that follows 5 through the period and inserting the following: ‘‘which 6 shall provide that— 7 ‘‘(1) the label of a drug listed in schedule II, 8 III, or IV shall, when dispensed to or for a patient, 9 contain a clear, concise warning that it is a crime 10 to transfer the drug to any person other than the 11 patient; and 12 ‘‘(2) the label of any container or package con- 13 taining an opioid or opiate listed in schedule II, III, 14 IV, or V (other than a drug that is approved or au- 15 thorized by the Food and Drug Administration for 16 the treatment of addiction or an opioid use disorder) 17 shall, when dispensed to or for a patient, contain a 18 clear, concise warning that the opioids or opiates 19 dispensed can cause dependence, addiction, and 20 overdose.’’; 21 (b) PROHIBITED ACT.—Section 402(a)(3) of the 22 Controlled Substances Act (21 U.S.C. 842(a)(3)) is 23 amended after ‘‘distribute’’ by inserting ‘‘or dispense’’. 24 (c) REGULATIONS.— 25 VerDate Sep 11 2014 18:10 Mar 10, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1026.IH H1026 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 1026 IH (1) REGULATIONS.—Not later than 1 year after 1 the date of enactment of this Act, the Secretary of 2 Health and Human Services shall prescribe final 3 regulations to implement the amendments made by 4 subsections (a) and (b), which regulations shall be 5 effective beginning on the date that is 2 years after 6 the date of enactment of this Act. 7 (2) INTERIM RULES.—The Secretary of Health 8 and Human Services may issue the regulations re- 9 quired under paragraph (1) by interim rule to the 10 extent necessary to comply with the timing require- 11 ment in paragraph (1). 12 (d) APPLICABILITY.—The amendment made by sub- 13 section (b) applies beginning on the date that is 2 years 14 after the date of enactment of this Act. 15 Æ VerDate Sep 11 2014 18:10 Mar 10, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\H1026.IH H1026 pamtmann on DSKBC07HB2PROD with BILLS