21 CFR 1308.22 - Excluded substances.

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§ 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)
Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00
Classic Pharmaceuticals LLC Nasal Decongestant Inhaler/Vapor Inhaler IN Levmetamfetamine (l-Desoxyephedrine) 50.00
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
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
Vicks Chemical Co Vicks Inhaler 23900-0010 IN I-Desoxyephedrine 113.00
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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-08-28; vol. 79 # 167 - Thursday, August 28, 2014
    1. 79 FR 51243 - Schedules of Controlled Substances: Placement of Suvorexant into Schedule IV
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      DEPARTMENT OF JUSTICE, Drug Enforcement Administration
      Final rule.
      Effective Date: September 29, 2014.
      21 CFR Part 1308

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-10-29; vol. 79 # 209 - Wednesday, October 29, 2014
    1. 79 FR 64349 - Schedules of Controlled Substances: Removal of Naloxegol From Control
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      DEPARTMENT OF JUSTICE, Drug Enforcement Admininstration
      Notice of proposed rulemaking.
      Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before November 28, 2014. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Interested persons, defined at 21 CFR 1300.01 as those “adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811)”, may file a request for hearing or waiver of participation pursuant to 21 CFR 1308.44 and in accordance with 21 CFR 1316.45, 1316.47, 1316.48, or 1316.49, as applicable. Requests for hearing, notices of appearance, and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before November 28, 2014.
      21 CFR Part 1308