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Senate Bill 3428
115th Congress(2017-2018)
LABEL Opioids Act
Introduced
Introduced
Introduced in Senate on Sep 12, 2018
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Introduced in Senate 
Sep 12, 2018
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Introduced in Senate(Sep 12, 2018)
Sep 12, 2018
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S. 3428 (Introduced-in-Senate)


115th CONGRESS
2d Session
S. 3428


To amend the Controlled Substances Act to require warning labels for prescription opioids, and for other purposes.

IN THE SENATE OF THE UNITED STATES

September 12, 2018

Mr. Markey (for himself and Mr. Hatch) 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 Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

This Act may be cited as the “Lessening Addiction by Enhancing Labeling Opioids Act of 2018” or the “LABEL Opioids Act”.

SEC. 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 or III 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).