21 C.F.R. § 1308.32

Exempted prescription products

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The compounds, mixtures, or preparations that contain a nonnarcotic controlled substance listed in § 1308.12(e) or in § 1308.13(b) or (c) or in § 1308.14 or in § 1308.15 listed in the Table of Exempted Prescription Products have been exempted by the Administrator from the application of sections 302 through 305, 307 through 309, and 1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and §§ 1301.13, 1301.22, and §§ 1301.71 through 1301.76 of this chapter for administrative purposes only. An exception to the above is that those products containing butalbital shall not be exempt from the requirement of 21 U.S.C. 952-954 concerning importation, exportation, transshipment and in-transit shipment of controlled substances. Any deviation from the quantitative composition of any of the listed drugs shall require a petition of exemption in order for the product to be exempted. A listing of the Exempted Prescription Products may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.

[75 FR 10679, Mar. 9, 2010]

Notes of Decisions

Cited in 3 cases, 2014–2017 · leading case: United States v. Akinyoyenu

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United States v. Akinyoyenu (2016) dcd · cites it 11× “This is because the Attorney General has issued a regulation exempting certain such combination drugs, see 21 C.F.R. § 1308.32 , and published a list of those drugs, a list that includes Fiori-cet.”

United States v. Riccio (2014) nysd · cites it 2× “” 21 C.F.R. § 1308.32 . Defendant contends that the regulatory exemption renders Fioricet a non-controlled substance for the purposes of the criminal statutes charged in the Indict *305 ment.”

United States v. Michael (2017) kywd · cites it 3× “Alternatively, the defendants urge that even if Fiorieet was a controlled substance, it was not illegal to dispense it without a valid prescription, as Fiorieet was exempted from the prescription and registration requirements by virtue of regulation 21 C.F.R. 1308.32. DN 50-1,…”

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