§2314 — Title 21 Food and Drugs | U.S. Code

Summary

The President can temporarily lift certain sanctions in three situations. First, for up to 12 months the President may waive the sanctions for a foreign-government–owned or controlled entity if, at least 15 days before the waiver starts, the President tells Congress that the foreign government is cooperating closely to stop opioid trafficking. To make that finding, the foreign government must be scheduling all fentanyl-like drugs as controlled substances and must do two or more things like tightening chemical and drug export rules, improving judicial actions against drug networks, increasing prosecutions, or sharing more intelligence and law enforcement help. The waiver can be renewed for additional 12-month periods if the Secretary of State certifies at least 15 days before renewal that the country is actually carrying out those measures. Second, the President may waive sanctions when applying them would harm U.S. national security or would hurt U.S. people’s access to prescription medicines. If a waiver is for protecting access to medicines, the President must set up a monitoring program to make sure the waivered person is not trafficking illegal opioids. The President must tell Congress and explain why within 15 days after making this kind of waiver decision. Third, the President may waive sanctions for humanitarian reasons for renewable 180-day periods if he tells Congress the waiver is needed for humanitarian aid.

Title 21, §2314

Food and Drugs — Source: USLM XML via OLRC

(a)(1)The President may waive for a period of not more than 12 months the application of sanctions under this subchapter with respect to an entity that is owned or controlled, directly or indirectly, by a foreign government or any political subdivision, agency, or instrumentality of a foreign government, if, not less than 15 days before the waiver is to take effect, the President certifies to the appropriate congressional committees and leadership that the foreign government is closely cooperating with the United States in efforts to prevent opioid trafficking.

(2)The President may certify under paragraph (1) that a foreign government is closely cooperating with the United States in efforts to prevent opioid trafficking if that government is—

(A)implementing domestic laws to schedule all fentanyl analogues as controlled substances; and

(B)doing two or more of the following:

(i)Implementing substantial improvements in regulations involving the chemical and pharmaceutical production and export of illicit opioids.

(ii)Implementing substantial improvements in judicial regulations to combat transnational criminal organizations that traffic opioids.

(iii)Increasing efforts to prosecute foreign opioid traffickers.

(iv)Increasing intelligence sharing and law enforcement cooperation with the United States with respect to opioid trafficking.

(3)The President may renew a waiver under paragraph (1) for subsequent periods of not more than 12 months each if, not less than 15 days before the renewal is to take effect, the Secretary of State certifies to the appropriate congressional committees and leadership that the government of the country to which the waiver applies has effectively implemented and is effectively enforcing the measures that formed the basis for the certification under paragraph (2).

(b)(1)The President may waive the application of sanctions under this subchapter if the President determines that the application of such sanctions would harm—

(A)the national security interests of the United States; or

(B)subject to paragraph (2), the access of United States persons to prescription medications.

(2)The President shall establish a monitoring program to verify that a person that receives a waiver under paragraph (1)(B) is not trafficking illicit opioids.

(3)Not later than 15 days after making a determination under paragraph (1), the President shall notify the appropriate congressional committees and leadership of the determination and the reasons for the determination.

(c)The President may waive, for renewable periods of 180 days, the application of the sanctions under this subchapter if the President certifies to the appropriate congressional committees and leadership that the waiver is necessary for the provision of humanitarian assistance.

Notes & Related Subsidiaries

Editorial Notes

References in Text

This subchapter, referred to in subsecs. (a)(1), (b)(1), and (c), was in the original “this subtitle”, meaning subtitle A (§§ 7211–7217) of title LXXII of div. F of Pub. L. 116–92, which is classified principally to this subchapter. For complete classification of subtitle A to the Code, see Tables.

Executive Documents

Delegation of Functions Functions and authorities of President under this section delegated to Secretary of State, in consultation with the Secretary of the Treasury, by section 1(b)(i) of Memorandum of President of the United States, Mar. 31, 2020, 85 F.R. 22343, set out as a note under section 2311 of this title.

§2314 Waivers