21 U.S.C. § 2314 (FOOD AND DRUGS)
§ 2314. Waivers
(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.
(Pub. L. 116–92, div. F, title LXXII, § 7214, Dec. 20, 2019, 133 Stat. 2267.)
heading: References in Text
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.