117 S2353 IS: Lessening Addiction By Enhancing Labeling Opioids Act of 2021 U.S. Senate 2021-07-15 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.

II 117th CONGRESS1st Session S. 2353 IN THE SENATE OF THE UNITED STATES July 15, 2021 Mr. Markey (for himself, Mr. Braun, and Mr. Manchin) 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 dispensers of certain opioids to affix on the container or package thereof a clear, concise warning that the opioid can cause dependence, addiction, and overdose, and for other purposes.

1.

Short title

This Act may be cited as the Lessening Addiction By Enhancing Labeling Opioids Act of 2021 or the LABEL Opioids Act of 2021.

2.

Lessening addiction by enhancing labeling of opioids

(a)

In general

Section 305(c) of the Controlled Substances Act (21 U.S.C. 825(c)) is amended by striking which shall provide that the label and all that follows and inserting the following: which shall provide that— (1)the label of a drug listed in schedule II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is a crime to transfer the drug to any person other than the patient; and (2)the label of any container or package containing an opioid listed in schedule II, III, IV, or V (other than a drug that is approved, or authorized for emergency use, by the Food and Drug Administration for the treatment of addiction or an opioid use disorder) shall, when dispensed to or for a patient, contain a clear, concise warning that the opioid dispensed can cause dependence, addiction, and overdose.. (b)

Prohibited act

Section 402(a)(3) of the Controlled Substances Act (21 U.S.C. 842(a)(3)) is amended by inserting or dispense after distribute. (c)

Regulations

(1)

Regulations

Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall prescribe final regulations to implement the amendments made by subsections (a) and (b), which regulations shall be effective beginning on the date that is 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 that paragraph. (d)

Applicability

The amendment made by subsection (b) applies beginning on the date that is 2 years after the date of enactment of this Act.