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21 U.S.C. § 384fStrengthening FDA and CBP coordination and capacity

submitted 8 years ago by Pub. L. 115-271 to r/title-21-FOOD-AND-DRUGS · 455 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law requires the FDA to work with Customs and Border Protection to improve facilities and technology for catching illegal drug imports, especially at international mail centers. It also requires a report to Congress on progress.

(a) In general. The Secretary of Health and Human Services, acting through the FDA Commissioner, must coordinate with the Secretary of Homeland Security on activities related to customs, border protection, and responding to illegal controlled substances and drug imports — including at import sites like international mail facilities — to improve those facilities, their technology, and their inspection ability. These two Secretaries may do this work through a memorandum of understanding between the FDA and Customs and Border Protection. (b) FDA import facilities and inspection capacity. (1) The Secretary, working with the Secretary of Homeland Security and the Postmaster General, must make sure FDA-run import facilities inside international mail facilities get: (A) upgrades and better capacity to improve inspection and detection, which may include facility renovations and maintenance to improve coordination between agencies; better equipment and information technology to spot unapproved, counterfeit, or illegal controlled substances for destruction; new or upgraded lab space for testing imported goods; security upgrades; and new technology to share information between the FDA, Homeland Security, and the Postal Service in near-real time; and (B) new technology, including equipment to detect and test controlled substances, so the FDA can share near-real-time information, including test results, with Customs and Border Protection. (2) Any technology used under (1)(B) must work together with technology used by other relevant federal agencies, including Customs and Border Protection, as the Secretary decides is practical. (c) Report. Within 6 months of October 24, 2018, the Secretary, working with the Secretary of Homeland Security and the Postmaster General, must report to four congressional committees on how this section is being carried out, including progress toward near-real-time information sharing and compatible technology.
the actual law source: uscode.house.gov ↗public domain
(a) 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, 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) FDA import facilities and inspection capacity
(1) In general

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) Innovative technology

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) Report

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.

Source credit: (Pub. L. 115–271, title III, § 3014, Oct. 24, 2018, 132 Stat. 3937.)

history & why it existsrecord from the source credit
  • 2018Enacted · Pub. L. 115-271 · 132 Stat. 3937

A history note hasn’t been published yet. The record shows enactment by Pub. L. 115-271 on 2018-10-24.

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