Code of Federal Regulations · Section
§ 1702.11 — Product Specifications
16 C.F.R. § 1702.11
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Each petition for an exemption shall include:
(a) A complete quantitative formula for the product, including inert ingredients, diluents, and solvents. (Petitioners should refer to § 1702.6 for information regarding trade secrets.)
(b) A listing of all physical forms or dosage forms (whichever is appropriate) in which the product is available.
Authorizing Statute
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Regulations and hearings21 U.S.C. § 371
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Definitions15 U.S.C. § 1471