16 C.F.R. § 1702.16 Petitions requesting an exemption for a drug or a new drug.
Title 16 - Commercial Practices
(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] [45 FR 13064, Feb. 28, 1980, as amended at 66 FR 40115, Aug. 2, 2001]
Title 16: Commercial Practices
PART 1702—PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS
§ 1702.16 Petitions requesting an exemption for a drug or a new drug.
