S.Amdt. 4017

SA 4017. Mr. MARKEY (for himself and Mr. Hatch) submitted an
amendment intended to be proposed to amendment SA 4013 proposed by Mr.
Alexander to the bill H.R. 6, to provide for opioid use disorder
prevention, recovery, and treatment, and for other purposes; which was
ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. LABELING OF PRESCRIPTION OPIOIDS.

(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).
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