Trade name or other designation Paminal Elixir.. Pamine PB Elixir.. Pamine PB, Half Strength.... Pediatric Piptal Antipyretic... Pediatric Piptal with Pheno- Pentaerythrityl tetranitrate EXEMPTED PRESCRIPTION DRUGS-Continued Composition Manufacturer or supplier Elixir (5 cc.): Phenobarbital, 8 mg.; methscopol- The Upjohn Co. Elixir (5 cc.): Phenobarbital, 8 mg.; methscopol- Tablet: Phenobarbital, 8 mg.; methscopolamine Solution (0.6 cc.): Phenobarbital, 3 mg.; pipenzolate Tablet: Phenobarbital, 4 gr.; acetylsalicylic acid, Tablet: Phenobarbital, 16 mg.; pentaerythrityl Tablet: Phenobarbital, 16 mg.; pentaerythrityl Pentratrol with Phenobarbital. Tablet: Phenobarbital, 15 mg.; pentaerythrityl Pentraline. Perbuzem.. Peribar L-A No. 1 tetranitrate, 10 mg. Tablet: Butabarbital sodium, 10 mg.; reserpine, Do. Do. Lakeside Laboratories, Inc. Do. Paul B. Elder Co., Inc. Do. North American Pharmacal McNeil Laboratories, Inc. The Zemmer Co. Tablet: Phenobarbital, 48.6 mg.; pentaerythrityl Whittier Laboratories, Inc. tetranitrate, 30 mg. Peritrate with Phenobarbital.. Tablet: Phenobarbital, 15 mg.: pentaerythrityl Warner-Chilcott Tablet: Phenobarbital, 16.2 mg.; phenacetin, 194 A. H. Robins Co., Inc. Phenobarbital and atropine.... Tablet: Phenobarbital, gr.; atropine sulfate, 100 Tablet: Phenobarbital, 4 gr.; belladonna leaves 2 gr. Tablet: Phenobarbital, 4 gr.; belladonna extract, Tablet: Phenobarbital, 16 mg.; belladonna extract, Phenobarbital and Belladonna Tablet: Phenobarbital, 4 gr.; belladonna extract, Eli Lilly and Co. Paul B. Elder Co., Inc. McNeil Laboratories, Inc. Do. Tablet: Phenobarbital, 1⁄4 gr.; sodium nitrite, 1 gr.... P. J. Noyes Co. Trade name or other designation Phenobarbital Theocalcin. Phenodonna Tablets.. Phenodrox. Phyldrox..... Piptal PHB Elixir. Piptal PHB Tablets.. Prantal with Phenobarbital.... Premarin with Phenobarbital.. Probanthine with phenobar- Propenite.. Prydonnal Spansule.. Quadrinal.... Do... Quintrate with Nitroglycerin and Phenobarbital. Quintrate with Phenobarbital. Do.. Robinul-PH.. Robinul-PH Forte. Ruhexatal.. Rutol. Salisil with Phenobarbital. Selbella.. Sed-Tens Sibena. EXEMPTED PRESCRIPTION DRUGS-Continued Composition Tablet: Phenobarbital, 15 mg.; theobromine calcium Tablet: Phenobarbital, 4 gr.; tincture belladonna, Tablet: Phenobarbital, 4 gr.; atropine sulfate, Tablet: Phenobarbital, 15 mg.; neothylline, 100 Tablet: Phenobarbital, 16 mg.; pipenzolate bro- Tablet: Phenobarbital, 16 mg.; diphemanil methyl- Tablet: Phenobarbital, 32 mg.; conjugated estro- Tablet: Phenobarbital, 15 mg.; probanthine, 15 mg.. mg. Manufacturer or supplier Knoll Pharmaceutical Co. North American Pharmacal Lemmon Pharmacal Co. Do. Ayerst Laboratories. Do. Tablet: Phenobarbital sodium, 12 mg.; sodium ni- The Zemmer Co. Capsule: Phenobarbital, 65 mg.; belladonna alka- Smith Kline & French Laboratories. Tablet: Phenobarbital, 24 mg.; ephedrine hydro- Knoll Pharmaceutical Co. Suspension (5 cc.): Phenobarbital, 12 mg.; ephed- Tablet: Phenobarbital, 15 mg.; pentaerythrityl Do. Paul B. Elder Co., Inc. (Glynn A. Beard). Do. Do. Tablet: Phenobarbital, 16.2 mg.; glycopyrrolate, A. H. Robins Co., Inc. 1.0 mg. Tablet: Phenobarbital, 16.2 mg.; glycopyrrolate, 2.0 mg. Do. Tablet: Phenobarbital, 15 mg.; mannitol hexani- Lemmon Pharmacal Co. Tablet: Phenobarbital, 4 gr.; acetylsalicylic acid, Tablet: Butabarbital sodium, 16 mg.; simethicone, Pitman-Moore. Paul B. Elder Co., Inc. Wyeth Laboratories. Sodium nitrite with phenobar- Tablet: Phenobarbital sodium, % gr.; sodium nitrite, Paine Drug Co. Do.. Spasticol PB. Spastosed... Synirin. Tedral-25.. Tedral S.A. Tensophen.... Tablet: Phenobarbital, 1⁄2 gr.; sodium nitrite, 1 gr.... Tablet: Phenobarbital, 15 mg.; homatropine methyl- Tablet: Phenobarbital, 8 mg.; atropine sulfate, 0.13 Tablet: Pentobarbital, 8 mg.; aspirin, 324 mg... Tablet: Phenobarbital, 25 mg.; theophylline, 180 Buffalo Pharmaceutical Sup- Wm.P.Poythress & Co., Inc. Warner-Chilcott Laboratories. Do. Tablet: Phenobarbital, 15 mg.; ethaverine hydro- Knoll Pharmaceutical Co. chloride, 30 mg.; theophylline calcium salicylate, Trade name or other designation Tetralute I. Thedrizem.. Theobarb.. Theobarb-R. Theobarb Special. Theobromine and phenobarbital. Theobromine-Phenobarbital. Do... Theobromine-Phenobarbital Compound. Theobromine with Phenobar- Theoglycinate with Phenobarbital. Theoglycinate with Racephedrine and Phenobarbital. Theoplaphen.. Theominal. Theominal M. Theophen Theorate. Thymodyne...---- Trocinate with Phenobarbital. Tricoloid Triophen.. Valpin-PB.. Vasorutin.. Veralzem Veratrite.. Veritag.. Veruphen.... W-T. W-T. Xaniophen... EXEMPTED PRESCRIPTION DRUGS-Continued Composition Manufacturer or supplier One bottle of buffer compound containing 4.15 gm. Miles Laboratories, Inc. Tablet: Phenobarbital, 10 mg.; reserpine, 0.1 mg.; Tablet: Phenobarbital, 16 mg.; theobromine, 325 mg. Tablet: Phenobarbital, 30 mg.; theobromine, 0.3 gm. Tablet: Phenobarbital, 15 mg.; theobromine, 324 mg. Tablet: Phenobarbital, 15 mg.; theobromine sodium Tablet: Phenobarbital, 15 mg.; theobromine, 300 mg. Tablet: Phenobarbital, 16 mg.; theophylline-sodium mg. Tablet: Phenobarbital, 15 mg.; theobromine sodium Tablet: Phenobarbital, 4 gr.; theobromine sodium mg. Tablet: Phenobarbital, 32 mg.; theophylline anhy- Tablet: Phenobarbital, 16 mg.; tricyclamol chloride, Tablet: Phenobarbital, gr.; antropine sulfate, 500 Tablet: Phenobarbital, 15 mg.; veratrum viride, 50 Tablet: Phenobarbital, 16 mg.; veratrum viride, 40 Tablet: Phenobarbital, 4 gr.; veratrum viride, 34 Tablet: Phenobarbital, 15 mg.; rutin, 20 mg.; vera- Powder (4 gm.): Phenobarbital, 15 mg.; belladonna Tablet: Phenobarbital, 16 gr.; belladonna extract, The Zemmer Co. Mallinckrodt Chemical Do. P. J. Noyes Co. The S. E. Massengill Co. Buffington's, Inc. Paul B. Elder Co., Inc. Haack Laboratories, Inc. The Vale Chemical Co., Inc. Do. The S. E. Massengill Co. Do. The Vale Chemical Co., Inc. Wm. P. Poythress & Co., Burroughs Wellcome & Co. The Vale Chemical Co., Inc. The Zemmer Co. Neisler Laboratories, Inc. S. J. Tutag and Co. The Zemmer Co. Lemmon Pharmacal Co. Warren-Teed Pharmaceuticals Inc. Do. Tablet: Phenobarbital, 16.2 mg.; theobromine, 162 Pitman-Moore. Trade name or other designation Zallogen Compound... Zem-Dab. No. 23. No. 35. No. 36.. No. 65. No. 66. No. 75.. No. 111. No. 136.. No. 643.. Rx. No. 4104. Rx. No. 4105... EXEMPTED PRESCRIPTION DRUGS-Continued Composition Manufacturer or supplier The S. E. Massengill Co. Tablet: Phenobarbital, 8 mg.; tocamphyl, 75 mg.; Tablet: Phenobarbital, 1⁄2 gr.; aminophylline, 3 gr. Tablet: Pentabarbital sodium, 4 gr.; ephedrine Tablet: Phenobarbital, gr.; extract belladonna, Tablet: Phenobarbital, 4 gr.; extract belladonna, Rx. No. 4108.. Rx. No. 4123.. Capsule: Phenobarbital, 4 gr.; bismuth subgallate, Do. 5 gr.: extract belladenna, 16 gr. Rx. No. 4126.. Capsule: Pentobarbital sodium, 15 mg.; extract bel- The Zemmer Co. Rx. No. 4143.. Capsule: Phenobarbital, 4 gr.; aminophylline, 1.5 Do. gr.; potassium iodide, 1 gr. Rx. No. 4152.. Tablet: Phenobarbital, 4 gr.; atropine sulfate, 200 Do. [36 F.R. 7802, Apr. 24, 1971, as amended at 36 F.R. 13387, July 21, 1971; 36 F.R. 18734, Sept. 21, 1971; 36 F.R. 21337, Nov. 6, 1971; 36 F.R. 22830, Dec. 1, 1971] In any case where the Director shall hold a hearing on the issuance, amendment, or repeal of rules pursuant to section 201 of the Act, the procedures for such hearing and accompanying proceedings shall be governed generally by the rule making procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by section 201 of the Act (21 U.S.C. 811), by §§ 308.42-308.51, and by §§ 316.41-316.67 of this chapter. § 308.42 Purpose of hearing. If requested by any interested person after proceedings are initiated pursuant to $308.44, the Director shall hold a hearing for the purpose of receiving fac tual evidence and expert opinion regarding the issues involved in the issuance, amendment or repeal of a rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law. [36 F.R. 7802, Apr. 24, 1971, as amended at 36 F.R. 18734, Sept. 21, 1971] § 308.43 Waiver or modification of rules. The Director or the presiding officer (with respect to matters pending before him) may modify or waive any rule in this part by notice in advance of the hearing, if he determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing. § 308.44 Initiation of proceedings for rule making. (a) Any interested person may submit a petition to initiate proceedings for the issuance, amendment, or repeal of any rule or regulation issuable pursuant to the provisions of section 201 of the Act. (b) Petitions shall be submitted in quintuplicate to the Director in the following form: (Date) DIRECTOR, BUREAU OF NARCOTICS AND DANGEROUS DRUGS Department of Justice, DEAR SIR: The undersigned__. hereby petitions the Director to initiate proceedings for the issuance (amendment or repeal) of a rule or regulation pursuant to section 201 of the Controlled Substances Act. Attached hereto and constituting a part of this petition are the following: (A) The proposed rule in the form proposed by the petitioner. (If the petitioner seeks the amendment or repeal of an existing rule, the existing rule, together with a reference to the section in the Code of Federal Regulations where it appears, should be included.) (B) A statement of the grounds which the petitioner relies for the issuance (amendment or repeal) of the rule. (Such grounds shall include a reasonably concise statement of the facts relied upon by the petitioner, including a summary of any relevant medical or scientific evidence known to petitioner.) the All notices to be sent regarding this petition should be addressed to: tioner desires, he may amend the petition to meet the requirements of paragraph (b) of this section. If accepted for filing, a petition may be denied by the Director within a reasonable period of time thereafter if he finds the grounds upon which the petitioner relies are not sufficient to justify the initiation of proceedings. (d) The Director shall, before initiating proceedings for the issuance, amendment, or repeal of any rule either to control a drug or other substance, or to transfer a drug or other substance from one schedule to another, or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation and the Secretary's recommendations as to whether such drug or other substance should be so controlled, transferred, or removed as a controlled substance. The recommendations of the Secretary to the Director shall be binding on the Director as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Director shall not control that drug or other substance. (e) If the Director determines that the scientific and medical evaluation and recommendations of the Secretary and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or additional control over the drug or other substance, or substantial evidence that the drug or other substance should be subjected to lesser control or removed entirely from the schedules, he shall initiate proceedings for control, transfer, or removal as the case may be. (f) If and when the Director determines to initiate proceedings, he shall publish in the FEDERAL REGISTER general notice of any proposed rule making to issue, amend, or repeal any rule pursuant to section 201 of the Act. Such published notice shall include a statement of the time, place, and nature of any hearings on the proposal in the event a hearing is requested pursuant to § 308.45. Such hearings may not be commenced until after the expiration of at least 30 days from the date the general notice is published in the FEDERAL REGISTER. Such published notice shall also include a reference to the legal authority under which the rule is proposed, a statement of the proposed rule, and, in the discre |