§ 384e. Recognition of foreign government inspections

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 title VII § 712 · 126 Stat. 993

   Enacted · 21 U.S.C. § 384e

   June 25, 1938, ch. 675, § 809, as added Pub. L. 112–144, title VII, § 712, July 9, 2012, 126 Stat. 1072

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 809, as added Pub. L. 112–144, title VII, § 712, July 9, 2012, 126 Stat. 1072

   Enacted provision · exact public law section
   SEC. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.   Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following: “SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS. “(a) Inspection.— The Secretary— “(1) may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under section 510(i) in order to facilitate risk-based inspections in accordance with the schedule established in section 510(h)(3); “(2) may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conduction inspections that meet the applicable requirements of this Act; and “(3) Reviews. Audits. shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this Act. “(b) Results of Inspection.— The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as— “(1) evidence of compliance with section 501(a)(2)(B) or section 801(r); and “(2) for any other purposes as determined appropriate by the Secretary.” .

2. 2016

   21st Century Cures Act

   Pub. L. 114–255 div. A title III § 3101(a)(2)(X) · 130 Stat. 1033

   Substituted · 21 U.S.C. § 384e(a)(2)

   Pub. L. 114–255 substituted “conducting” for “conduction”

   Source evidence

   Code amendment note
   Subsec. (a)(2). Pub. L. 114–255 substituted “conducting” for “conduction”.

   Enacted provision · exact public law section
   (X) Recognition of foreign government inspections.— Section 809(a)(2) (21 U.S.C. 384e(a)(2)) is amended by striking “conduction” and inserting “conducting”.

3. 2017

   FDA Reauthorization Act of 2017

   Pub. L. 115–52 title VII § 701(b) · 131 Stat. 1005

   Substituted · 21 U.S.C. § 384e(a)(1)

   Pub. L. 115–52 substituted “paragraph (2) or (3) of section 360(h)” for “section 360(h)(3)”

   Source evidence

   Code amendment note
   Subsec. (a)(1). Pub. L. 115–52 substituted “paragraph (2) or (3) of section 360(h)” for “section 360(h)(3)”.

   Enacted provision · exact public law section
   (b) Foreign Inspections.— Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by striking “section 510(h)(3)” and inserting “paragraph (2) or (3) of section 510(h)”.

4. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3613(c)(1) · 136 Stat. 4459

   Inserted · 21 U.S.C. § 384e(a)(1)

   Pub. L. 117–328, § 3613(c)(1), inserted “preapproval or” before “risk-based inspections”

   Source evidence

   Code amendment note
   Subsec. (a)(1). Pub. L. 117–328, § 3613(c)(1), inserted “preapproval or” before “risk-based inspections”.

   Enacted provision · exact public law section
   (1) in subsection (a)(1), by inserting “preapproval or” before “risk-based inspections”; and

5. 2022

   Food and Drug Omnibus Reform Act of 2022

   Pub. L. 117–328 § 3613(c)(2) · 136 Stat. 4459

   Added · 21 U.S.C. § 384e(c)

   Pub. L. 117–328, § 3613(c)(2), added subsec. (c)

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 117–328, § 3613(c)(2), added subsec. (c).

   Enacted provision · exact public law section
   (2) by adding at the end the following: “(c) Periodic Review.— “(1) In general.— Beginning not later than 1 year after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, the Secretary shall periodically assess whether additional arrangements and agreements with a foreign government or an agency of a foreign government, as allowed under this section, are appropriate. “(2) Reports to congress.— Beginning not later than 4 years after the date of the enactment of the Food and Drug Omnibus Reform Act of 2022, and every 4 years thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report describing the findings and conclusions of each review conducted under paragraph (1).” .

5 of 5 references resolved to an enrolled provision