21 U.S.C. § 2314: Waivers

Summary

Lets the President temporarily lift sanctions on foreign government–owned companies when that government is working closely with the United States to stop opioid trafficking. The President can waive sanctions for up to 12 months if, at least 15 days before the waiver starts, he certifies to the relevant congressional committees and leaders that the country is cooperating. To qualify, the country must have laws that put all fentanyl analogues under control and must do at least two of these four things: improve rules on chemical and drug production and export, strengthen judicial rules against transnational criminal groups, increase prosecutions of foreign opioid traffickers, or share more intelligence and law enforcement information with the U.S. The President can renew the waiver for more 12‑month periods if, at least 15 days before renewal, the Secretary of State certifies the country is effectively carrying out and enforcing those measures. The President may also waive sanctions if applying them would harm U.S. national security or, with safeguards, would limit Americans’ access to prescription medicines. The President must set up a monitoring program to verify that anyone who gets a waiver for medicine access is not trafficking illegal opioids. The President must notify the same congressional committees and leaders within 15 days after making such a waiver and explain the reasons. For humanitarian needs, the President may waive sanctions for renewable periods of 180 days if he certifies the waiver is necessary to provide humanitarian assistance.

Title 21, §2314

Food and Drugs, Source: USLM XML via OLRC

(a)Waiver for state-owned entities in countries that cooperate in multilateral anti-trafficking efforts

(1)In general

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)Certification

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)Subsequent renewal of waiver

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)Waivers for national security and access to prescription medications

(1)In general

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)Monitoring

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)Notification

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)Humanitarian waiver

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