§384f — Title 21 Food and Drugs | U.S. Code

Summary

HHS, through the FDA Commissioner, must work with the Department of Homeland Security and the U.S. Postal Service to make international mail and other import sites better at finding illegal or unsafe drugs. They can use a written agreement between FDA and U.S. Customs and Border Protection to do this. Upgrades must include things like better buildings and security, improved equipment and computer systems to spot fake or unlawful drugs, stronger lab testing capacity, and new technology to share test results and other information quickly with DHS, CBP, and USPS. Any new tech must be able to work with the systems other federal agencies use. “Secretary” means the Secretary of Health and Human Services acting through the FDA Commissioner. A report on progress, including steps toward fast information sharing and tech interoperability, must go 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 no later than 6 months after October 24, 2018.

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.

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.

§384f Strengthening Fda and Cbp Coordination and Capacity

Summary

Title 21, §384f

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Enforcement

Citations & Metadata