Code of Federal Regulations · Section
§ 1702.16 — Petitions Requesting An Exemption For A Drug Or A New Drug
16 C.F.R. § 1702.16
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(a) Where the petition requests an exemption for a drug, as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1), the petitioner shall include those reports required to be filed under the Food and Drug Administration's Adverse Reaction Reporting Program.
(b) [Reserved]
Authorizing Statute
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Definitions; generally21 U.S.C. § 321
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Regulations and hearings21 U.S.C. § 371
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Definitions15 U.S.C. § 1471