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Title 21, Food and DrugsRelease 119-110

§384g Restricting Entrance of Illicit Drugs

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER VIII — IMPORTS AND EXPORTS › § 384g

Last updated Sep 22, 2026|Official source

Summary

The head of Health and Human Services, through the FDA Commissioner and working with U.S. Customs and Border Protection, must create and regularly update a shared list of controlled drugs. When packages sent by international mail look like they break the Controlled Substances Act, the Controlled Substances Import and Export Act, the Federal Food, Drug, and Cosmetic Act, or other laws, the FDA must send items on that list to U.S. Customs and Border Protection. If other packages look the same, those can be sent too. Customs must accept them under the Controlled Substances Act. Within 9 months after October 24, 2018, the Secretary, through the FDA Commissioner and with the Secretary of Homeland Security, had to report to the Committee on Energy and Commerce of the House and the Committee on Health, Education, Labor, and Pensions of the Senate about how this was carried out.

Full Legal Text

Title 21, §384g

Food and Drugs, Source: USLM XML via OLRC

(a)Food and Drug Administration and U.S. Customs and Border Protection cooperation
(1)In general
The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs and in consultation with the U.S. Customs and Border Protection, shall develop and periodically update a mutually agreed upon list of the controlled substances that the Secretary will refer to U.S. Customs and Border Protection, unless the Secretary and U.S. Customs and Border Protection agree otherwise, when such substances are offered for import via international mail and appear to violate the Controlled Substances Act (21 U.S.C. 801 et seq.), the Controlled Substances Import and Export Act (21 U.S.C. 951 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or any other applicable law. The Secretary shall transfer controlled substances on such list to the U.S. Customs and Border Protection. If the Secretary identifies additional packages that appear to be the same as such package containing a controlled substance, such additional packages may also be transferred to U.S. Customs and Border Protection. The U.S. Customs and Border Protection shall receive such packages consistent with the requirements of the Controlled Substances Act (21 U.S.C. 801 et seq.).
(2)Report
Not later than 9 months after October 24, 2018, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Secretary of Homeland Security, shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the implementation of this section.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

References in Text

The Controlled Substances Act, referred to in subsec. (a)(1), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see

Short Title

note set out under section 801 of this title and Tables. The Controlled Substances Import and Export Act, referred to in subsec. (a)(1), is title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285, which is classified principally to subchapter II (§ 951 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see

Short Title

note set out under section 951 of this title and Tables. The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (a)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.

Statutory Notes and Related Subsidiaries

Codification Section was enacted as part of the Stop Counterfeit Drugs by Regulating and Enhancing

Enforcement

Now Act, also known as the SCREEN Act, and also as part of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Reference

Citations & Metadata

Citation

21 U.S.C. § 384g

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110