(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.

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(b) [Reserved]

[45 FR 13064, Feb. 28, 1980, as amended at 66 FR 40115, Aug. 2, 2001]