116 S1449 IS: Lessening Addiction By Enhancing Labeling Opioids Act of 2019 U.S. Senate 2019-05-14 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II116th CONGRESS1st SessionS. 1449IN THE SENATE OF THE UNITED STATESMay 14, 2019Mr. Markey (for himself and Mr. Braun) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo amend the Controlled Substances Act to require warning labels for prescription opioids, and for other purposes.

1.

Short title

This Act may be cited as the Lessening Addiction By Enhancing Labeling Opioids Act of 2019 or the LABEL Opioids Act.

2.

Amendment

(a)

In general

Section 305(c) of the Controlled Substances Act (21 U.S.C. 825(c)) is amended— (1)by inserting (1) before The Secretary; and (2)by adding at the end the following: (2)The label of any container or package containing an opioid or opiate listed in schedule II, III, IV, or V shall, when dispensed (other than administered) to or for a patient, contain a clear, concise warning, in a manner specified by the Secretary by regulation, that the opioids or opiates dispensed can cause dependence, addiction, and overdose.. (b)

Regulations

(1)

Regulations

The Secretary of Health and Human Services shall prescribe regulations under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) to implement the amendment made by subsection (a) and such regulations shall be effective not later than 2 years after the date of enactment of this Act. (2)

Interim rules

The Secretary of Health and Human Services may issue the regulations required under paragraph (1) by interim rule to the extent necessary to comply with the timing requirement in paragraph (1).