S.Amdt. 3994

SA 3994. Mr. MARKEY (for himself and Mr. Hatch) submitted an
amendment intended to be proposed to amendment SA 3695 proposed by Mr.
Shelby to the bill H.R. 6157, making appropriations for the Department
of Defense for the fiscal year ending September 30, 2019, and for other
purposes; which was ordered to lie on the table; as follows:

At the appropriate place, insert the following:

SEC. __. OPIOID LABELING REQUIREMENTS.

(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).
______