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United States • Title 21 CFR • Part 290
Part 290 of Title 21 CFR outlines regulations for controlled drugs, primarily focusing on prescription requirements and specific labeling warnings. It details which controlled substances require a prescription and provides an exemption for certain preparations containing codeine. Additionally, it mandates a specific warning statement on the labels of dispensed controlled substances and defines what constitutes an emergency situation for authorizing oral prescriptions of Schedule II controlled substances.
Any drug that is a controlled substance listed in schedule II, III, IV, or V of the Federal Controlled Substances Act or implementing regulations must be dispensed by prescription only as required by section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act unless specifically exempted in § 290.2. [67 FR 4906, Feb. 1, 2002]
emergency situationFor the purposes of authorizing an oral prescription of a controlled substance listed in schedule II of the Federal Controlled Substances Act, the term means those situations in which the prescribing practitioner determines: (a) That immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and (b) That no appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under schedule II of the Act, and (c) That it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.
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]
The label of any drug listed as a “controlled substance” in schedule II, III, or IV of the Federal Controlled Substances Act shall, when dispensed to or for a patient, contain the following warning: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” This statement is not required to appear on the label of a controlled substance dispensed for use in clinical investigations which are “blind.”
By direction of section 305(c) of the Federal Controlled Substances Act, § 290.5, promulgated under section 503(b) of the Federal Food, Drug, and Cosmetic Act, requires the following warning on the label of certain drugs when dispensed to or for a patient: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” The Spanish version of this is: “Precaucion: La ley Federal prohibe el transferir de esta droga a otra persona que no sea el paciente para quien fue recetada.”
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