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Title 21 — Food and DrugsRelease 119-73

§384f Strengthening FDA and CBP coordination and capacity

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER VIII— - IMPORTS AND EXPORTS › § 384f

Last updated Apr 6, 2026|Official source

Summary

The Secretary of Health and Human Services must work with the Secretary of Homeland Security so FDA and Customs and Border Protection can better stop illegal drugs coming into the United States, especially at places that handle international mail. They may use a written agreement between FDA and CBP to do this. Working with DHS and the Postmaster General, they must upgrade import sites where FDA works to boost inspection and detection. Upgrades can include fixing or expanding facilities, better testing and lab equipment, stronger security, improved IT, and new technology to spot and destroy unapproved or fake drugs and to share test results and other information almost immediately with FDA, DHS, USPS, and CBP. The technology must be able to work with systems used by other federal agencies when practical. Within 6 months after October 24, 2018, the Secretary must report to the House Committees on Energy and Commerce and on Homeland Security, and to the Senate Committees on Health, Education, Labor, and Pensions and on Homeland Security and Governmental Affairs, on how this work is going and progress on fast information sharing and system compatibility.

Full Legal Text

Title 21, §384f

Food and Drugs — Source: USLM XML via OLRC

(a)The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, shall coordinate with the Secretary of Homeland Security to carry out activities related to customs and border protection and in response to illegal controlled substances and drug imports, including at sites of import (such as international mail facilities), that will provide improvements to such facilities, technologies, and inspection capacity. Such Secretaries may carry out such activities through a memorandum of understanding between the Food and Drug Administration and the U.S. Customs and Border Protection.
(b)(1)In carrying out this section, the Secretary shall, in collaboration with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, provide that import facilities in which the Food and Drug Administration operates or carries out activities related to drug imports within the international mail facilities include—
(A)facility upgrades and improved capacity in order to increase and improve inspection and detection capabilities, which may include, as the Secretary determines appropriate—
(i)improvements to facilities, such as upgrades or renovations, and support for the maintenance of existing import facilities and sites to improve coordination between Federal agencies;
(ii)improvements in equipment and information technology enhancement to identify unapproved, counterfeit, or other unlawful controlled substances for destruction;
(iii)the construction of, or upgrades to, laboratory capacity for purposes of detection and testing of imported goods;
(iv)upgrades to the security of import facilities; and
(v)innovative technology and equipment to facilitate improved and near-real-time information sharing between the Food and Drug Administration, the Department of Homeland Security, and the United States Postal Service; and
(B)innovative technology, including controlled substance detection and testing equipment and other applicable technology, in order to collaborate with the U.S. Customs and Border Protection to share near-real-time information, including information about test results, as appropriate.
(2)Any technology used in accordance with paragraph (1)(B) shall be interoperable with technology used by other relevant Federal agencies, including the U.S. Customs and Border Protection, as the Secretary determines appropriate and practicable.
(c)Not later than 6 months after October 24, 2018, the Secretary, in consultation with the Secretary of Homeland Security and the Postmaster General of the United States Postal Service, shall report to the Committee on Energy and Commerce and the Committee on Homeland Security of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Homeland Security and Governmental Affairs of the Senate on the implementation of this section, including a summary of progress made toward near-real-time information sharing and the interoperability of such technologies.

Legislative History

Notes & Related Subsidiaries

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. § 384f

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73