H. R. 2732
IN THE HOUSE OF REPRESENTATIVES
May 14, 2019
Mr. Stanton (for himself and Mr. McAdams) introduced the following bill; which was referred to the Committee 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 jurisdiction of the committee concerned
To amend the Controlled Substances Act to require warning labels for prescription opioids, and for other purposes.
This Act may be cited as the
Lessening Addiction By Enhancing Labeling Opioids Act of 2019 or the
LABEL Opioids Act.
Section 305(c) of the Controlled Substances Act (21 U.S.C. 825(c)) is amended—
The Secretary; and
by adding at the end the following:
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.
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.
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).