LABEL Opioids Act

II 116TH CONGRESS 1ST SESSION S. 1449 To amend the Controlled Substances Act to require warning labels for prescription opioids, and for other purposes. IN THE SENATE OF THE UNITED STATES MAY 14, 2019 Mr. MARKEY (for himself and Mr. BRAUN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Controlled Substances Act to require warning labels for prescription opioids, 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 2019’’ or the 5 ‘‘LABEL Opioids Act’’. 6 SEC. 2. AMENDMENT. 7 (a) IN GENERAL.—Section 305(c) of the Controlled 8 Substances Act (21 U.S.C. 825(c)) is amended— 9 VerDate Sep 11 2014 04:25 May 24, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1449.IS S1449 lotter on DSKBCFDHB2PROD with BILLS 2 •S 1449 IS (1) by inserting ‘‘(1)’’ before ‘‘The Secretary’’; 1 and 2 (2) by adding at the end the following: 3 ‘‘(2) The label of any container or package containing 4 an opioid or opiate listed in schedule II, III, IV, or V shall, 5 when dispensed (other than administered) to or for a pa- 6 tient, contain a clear, concise warning, in a manner speci- 7 fied by the Secretary by regulation, that the opioids or 8 opiates dispensed can cause dependence, addiction, and 9 overdose.’’. 10 (b) REGULATIONS.— 11 (1) REGULATIONS.—The Secretary of Health 12 and Human Services shall prescribe regulations 13 under section 503(b) of the Federal Food, Drug, 14 and Cosmetic Act (21 U.S.C. 353(b)) to implement 15 the amendment made by subsection (a) and such 16 regulations shall be effective not later than 2 years 17 after the date of enactment of this Act. 18 (2) INTERIM RULES.—The Secretary of Health 19 and Human Services may issue the regulations re- 20 quired under paragraph (1) by interim rule to the 21 extent necessary to comply with the timing require- 22 ment in paragraph (1). 23 Æ VerDate Sep 11 2014 05:41 May 22, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6301 E:\BILLS\S1449.IS S1449 lotter on DSKBCFDHB2PROD with BILLS