21 CFR 290.2
§ 290.2 Exemption from prescription requirements.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 290.2, § 290.2 Exemption from prescription requirements, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86193
- Permanent ID
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.