21 CFR 1308.22 - Excluded substances.

Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 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)):

Excluded Nonnarcotic Products

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 (l-Desoxyephedrine) 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
[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 44283, Aug. 28, 2009; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, Feb. 8, 2016]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1308 after this date.

  • 2015-11-16; vol. 80 # 220 - Monday, November 16, 2015
    1. 80 FR 70680 - Schedules of Controlled Substances: Placement of Eluxadoline Into Schedule IV
      GPO FDSys XML | Text
      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      21 CFR Part 1308