21 U.S.C. § 382 Exports of Certain Unapproved Products

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 382

(a) Drugs or devices intended for human or animal use which require approval or licensing

A drug or device-

(1) which, in the case of a drug-

(A)

(i) requires approval by the Secretary under section 355 of this title before such drug may be introduced or delivered for introduction into interstate commerce; or

(ii) requires licensing by the Secretary under section 262 of title 42 or by the Secretary of Agriculture under the Act of March 4, 1913 [ 21 U.S.C. 151 et seq.] (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce;

(B) does not have such approval or license; and

(C) is not exempt from such sections or Act; and

(2) which, in the case of a device-

(A) does not comply with an applicable requirement under section 360d or 360e of this title;

(B) under section 360j(g) of this title is exempt from either such section; or

(C) is a banned device under section 360f of this title, is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f), authorized under subsection (b), (c), (d), or (e) or section 381(e)(2) of this title. If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) and if an application for such drug or device under section 355 or 360e of this title or section 262 of title 42 was disapproved, the Secretary shall notify the appropriate public health official of the country to which such drug will be exported of such disapproval.

(b) List of eligible countries for export; criteria for addition to list; direct export; petition for exemption

(1)

(A) A drug or device described in subsection (a) may be exported to any country, if the drug or device complies with the laws of that country and has valid marketing authorization by the appropriate authority-

(i) in Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa; or

(ii) in the European Union or a country in the European Economic Area (the countries in the European Union and the European Free Trade Association) if the drug or device is marketed in that country or the drug or device is authorized for general marketing in the European Economic Area.

(B) The Secretary may designate an additional country to be included in the list of countries described in clauses (i) and (ii) of subparagraph (A) if all of the following requirements are met in such country:

(i) Statutory or regulatory requirements which require the review of drugs and devices for safety and effectiveness by an entity of the government of such country and which authorize the approval of only those drugs and devices which have been determined to be safe and effective by experts employed by or acting on behalf of such entity and qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices on the basis of adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs and devices.

(ii) Statutory or regulatory requirements that the methods used in, and the facilities and controls used for-