21 C.F.R. § 290.2 Exemption from prescription requirements.
Title 21 - Food and Drugs
The prescription-dispensing requirements of section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to a compound, mixture, or preparation containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams that also includes one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by codeine alone. [67 FR 4907, Feb. 1, 2002]
Title 21: Food and Drugs
PART 290—CONTROLLED DRUGS
Subpart A—General Provisions
§ 290.2 Exemption from prescription requirements.
