21 C.F.R. § 1308.22
Excluded substances
The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):
| Company | Trade name | NDC code | Form | Controlled substance | (mg or mg/ml) |
|---|---|---|---|---|---|
| Aphena Pharma Solutions—New York, LLC | Nasal Decongestant Inhaler/Vapor Inhaler | IN | Levmetamfetamine (l-Desoxyephedrine) | 50.00 | |
| Bioline Laboratories | Theophed | 00719-1945 | TB | Phenobarbital | 8.00 |
| Goldline Laboratories | Guiaphed Elixir | 00182-1377 | EL | Phenobarbital | 4.00 |
| Goldline Laboratories | Tedrigen Tablets | 00182-0134 | TB | Phenobarbital | 8.00 |
| Hawthorne Products Inc | Choate's Leg Freeze | LQ | Chloral hydrate | 246.67 | |
| Parke-Davis & Co | Tedral | 00071-0230 | TB | Phenobarbital | 8.00 |
| Parke-Davis & Co | Tedral Elixir | 00071-0242 | EX | Phenobarbital | 40.00 |
| Parke-Davis & Co | Tedral S.A. | 00071-0231 | TB | Phenobarbital | 8.00 |
| Parke-Davis & Co | Tedral Suspension | 00071-0237 | SU | Phenobarbital | 80.00 |
| Parmed Pharmacy | Asma-Ese | 00349-2018 | TB | Phenobarbital | 8.10 |
| Procter & Gamble Co., The | Vicks VapoInhaler | 37000-686-01 | IN | Levmetamfetamine ( | 50.00 |
| Rondex Labs | Azma-Aids | 00367-3153 | TB | Phenobarbital | 8.00 |
| Smith Kline Consumer | Benzedrex | 49692-0928 | IN | Propylhexedrine | 250.00 |
| Sterling Drug, Inc | Bronkolixir | 00057-1004 | EL | Phenobarbital | 0.80 |
| Sterling Drug, Inc | Bronkotabs | 00057-1005 | TB | Phenobarbital | 8.00 |
| White Hall Labs | Primatene (P-tablets) | 00573-2940 | TB | Phenobarbital | 8.00 |
Notes of Decisions
Cited in 21
cases (3 in the last 5 years), 1988–2026 · leading case: United States v. Bonnie Ann Durham, United States of Am. v. Jerome Sherman Stanley, 941 F.2d 886 (9th Cir. 1991).
United States v. Bonnie Ann Durham, United States of Am. v. Jerome Sherman Stanley, 941 F.2d 886 (9th Cir. 1991). “21 C.F.R. § 1308.22 . Basically Stanley argues that methamphetamine is not a Schedule II controlled substance.”
United States v. Wayne Eugene Walker & Joe Guerra, United States of Am. v. Robert Bouvier, 960 F.2d 409 (5th Cir. 1992). “7 WALKER’S SUFFICIENCY OF THE EVIDENCE CLAIM Defendant Walker contends that even if methamphetamine is properly scheduled as a controlled substance, the evidence at trial was insufficient to show that the methamphetamine introduced by the government was not one of the substances…”
Crosswhite v. State, 732 So. 2d 856 (Miss. 1998). “§ 41-29-122 (1993), which reads: Any material, compound, mixture or preparation which contains any quantity of a controlled substance and is listed as an exempt substance in 21 C.F.R., section 1308.22, shall be exempted from the provisions of the Uniform Controlled Substances…”
United States v. William Clinton Roark, 924 F.2d 1426 (8th Cir. 1991). “Both Rynal and Vicks Inhaler nose sprays were legally sold over the counter pursuant to 21 C.F.R. 1308.22, the Federal Regulation which implements 21 U.”
State v. Erban, 429 N.W.2d 408 (N.D. 1988). “Erban argued that the substance 1-de-soxyephedrine was excluded from the federal schedules, and thus from the state schedules, pursuant to the regulation codified at 21 C.F.R. § 1308.22 (1988), which excluded from all schedules certain nonnarcotic substances which may be…”
Elisio Atenia Lorenzo v. Jefferson Sessions, III, 902 F.3d 930 (9th Cir. 2018). “In accordance with this statutory requirement, the Attorney General has promulgated 21 C.F.R. § 1308.22 , which excludes 17 over- the-counter pharmaceutical products from the CSA schedules, including Levmetamfetamine (l- Desoxyephedrine), or “L-meth,” a substance used in a nasal…”
United States v. Martin Vega-Ortiz, 822 F.3d 1031 (9th Cir. 2016). “” Vega-Ortiz’s argument is premised on the content of 21 C.F.R. § 1308.22 , which provides: “The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act ( 21 U.”
United States v. Domingo Valdez Martinez, United States of Am. v. Guadalupe Castro, United States of Am. v. Raul Ybarra, 950 F.2d 222 (5th Cir. 1991). “21 C.F.R. § 1308.22 (1976). 1 Appellants contend that the descheduling of these forms of methamphetamine extends to all forms of methamphetamine because § 811(g) provides only for the exclusion of a “substance,” and methamphetamine is the “substance” at issue, not just Rynal or…”
United States v. Sherrod, 964 F.2d 1501 (5th Cir. 1992). “§ 811 (g)(1) allows the Attorney General to exclude by regulation “any nonnarcotic substance from a schedule if such substance may, under the Federal Food, Drug, and Cosmetic Act, be lawfully sold over the counter without a prescription.” At the time of the defendants’ activity,…”
Prince v. BF Ascher Co., Inc., 2004 OK CIV APP 39 (Okla. Civ. App. 2004). “21 C.F.R. § 1308.22 . The FDA has concluded propyl-hexedrine is safe in the dosage ranges rised as a nasal decongestant.”
Illinois v. Hanna, 693 N.E.2d 470 (Ill. App. Ct. 1998). “22 of title 21 of the Code of Federal Regulations (Code) ( 21 C.F.R. § 1308.22 (1994)). That section of the Code excludes “I-Desoxyephedrine” ( 21 C.”
People v. Hanna, 679 N.E.2d 812 (Ill. App. Ct. 1997). “22 of title 21 of the Code of Federal Regulations (Code) ( 21 C.F.R. § 1308.22 (1994)). That section of the Code excludes "I-Desoxyephedrine" ( 21 C.”
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