Page images
PDF
EPUB

Trade name or other designation

Paminal Elixir..

Pamine PB Elixir..

Pamine PB, Half Strength....

Pediatric Piptal Antipyretic...

Pediatric Piptal with Pheno-
barbital.
Pencetylon....

Pentaerythrityl tetranitrate
with phenobarbital.
Do.....

EXEMPTED PRESCRIPTION DRUGS-Continued

Composition

Manufacturer or supplier

Elixir (5 cc.): Phenobarbital, 8 mg.; methscopol- The Upjohn Co.
amine bromide, 1.25 mg.

Elixir (5 cc.): Phenobarbital, 8 mg.; methscopol-
amine bromide, 1.25 mg.

Tablet: Phenobarbital, 8 mg.; methscopolamine
bromide, 1.25 mg.

Solution (0.6 cc.): Phenobarbital, 3 mg.; pipenzolate
bromide, 5 mg.; acetaminophen, 60 mg.
Solution (0.5 cc.): Phenobarbital, 3 mg.; pipenzolate
bromide, 2 mg.

Tablet: Phenobarbital, 4 gr.; acetylsalicylic acid,
5 gr.

Tablet: Phenobarbital, 16 mg.; pentaerythrityl
tetranitrate, 10 mg.

Tablet: Phenobarbital, 16 mg.; pentaerythrityl
tetranitrate, 20 mg.

Pentratrol with Phenobarbital. Tablet: Phenobarbital, 15 mg.; pentaerythrityl

Pentraline.

Perbuzem..

Peribar L-A No. 1

tetranitrate, 10 mg.

Tablet: Butabarbital sodium, 10 mg.; reserpine,
0.05 mg.; pentaerythrityl tetranitrate, 10 mg.
Tablet: Butabarbital sodium, 15 mg.; pentaery-
thrityl tetranitrate, 10 mg.

Do.

Do.

Lakeside Laboratories, Inc.

Do.

Paul B. Elder Co., Inc.
P. J. Noyes Co.

Do.

North American Pharmacal
Co.

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

[blocks in formation]

Tablet: Phenobarbital, 16.2 mg.; phenacetin, 194 A. H. Robins Co., Inc.
mg.; aspirin, 162 mg.; hyoscyamine sulfate, 0.031
mg.; pheniramine maleate, 12.5 mg.; phenylephrine
hydrochloride, 10 mg.

Phenobarbital and atropine.... Tablet: Phenobarbital, gr.; atropine sulfate, 100

[blocks in formation]

Tablet: Phenobarbital, 4 gr.; belladonna leaves 2 gr.
(total alkaloids 0.0015 gr.).

Tablet: Phenobarbital, 4 gr.; belladonna extract,
8 gr.

Tablet: Phenobarbital, 16 mg.; belladonna extract,
8 mg.

Phenobarbital and Belladonna Tablet: Phenobarbital, 4 gr.; belladonna extract,
No. 2.

[blocks in formation]

Eli Lilly and Co.
The Upjohn Co.

Paul B. Elder Co., Inc.
(Harold M. Harter,
D.V.M.)
Meyer Drug & Surgical
Supply Co.

McNeil Laboratories, 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-
bital.
Probital.

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
salicylate, 0.5 gm.

Tablet: Phenobarbital, 4 gr.; tincture belladonna,
6 minims.

Tablet: Phenobarbital, 4 gr.; atropine sulfate,
1500 gr.; magnesium trisilicate, 4 gr.; aluminum
hydroxide gel, dried, 4 gr.

Tablet: Phenobarbital, 15 mg.; neothylline, 100
mg.; ephedrine sulfate, 25 mg.
Elixir (5cc.): Phenobarbital, 16 mg.; pipenzolate
bromide, 5 mg.

Tablet: Phenobarbital, 16 mg.; pipenzolate bro-
mide, 5 mg.

Tablet: Phenobarbital, 16 mg.; diphemanil methyl-
sulfate, 100 mg.

Tablet: Phenobarbital, 32 mg.; conjugated estro-
gens-equine, 0.625 mg.

Tablet: Phenobarbital, 15 mg.; probanthine, 15 mg..
Tablet: Phenobarbital, 15 mg.; probanthine, 7.5

mg.

Manufacturer or supplier

Knoll Pharmaceutical Co.
Flint Medical & Surgical
Supply Co.

North American Pharmacal
Inc.

Lemmon Pharmacal Co.
Lakeside Laboratories, Inc.

Do.
Schering Corp.

Ayerst Laboratories.
G. D. Searle & Co.

Do.

Tablet: Phenobarbital sodium, 12 mg.; sodium ni- The Zemmer Co.
trite, 60 mg.; hawthorn berries extract, 120 mg.;
mistletoe extract, 60 mg.

Capsule: Phenobarbital, 65 mg.; belladonna alka-
loids, 0.4 mg. (hyoscyamine sulfate, 0.305 mg.;
atropine sulfate, 0.06 mg., scopolamine hydrobro-
mide, 0.035 mg.).

Smith Kline & French Laboratories.

Tablet: Phenobarbital, 24 mg.; ephedrine hydro- Knoll Pharmaceutical Co.
chloride 24 mg.; theophyline calcium salicylate,
130 mg.: potassium iodide, 300 mg.

Suspension (5 cc.): Phenobarbital, 12 mg.; ephed-
rine hydrochloride, 12 mg.; theophylline calcium
salicylate, 65 mg.; potassium iodide, 160 mg.
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
tetranitrate, 20 mg.; nitroglycerin, 0.4 mg.
Tablet: Phenobarbital, 15 mg.; pentaerythrityl
tetranitrate, 10 mg.

Tablet: Phenobarbital, 15 mg.; pentaerythrityl
tetranitrate, 20 mg.

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.
trate, 30 mg.: ascorbic acid, 10 mg.; rutin, 20 mg.
Tablet: Phenobarbital, 8.0 mg.; mannitol hexani-
trate, 16 mg.; rutin, 10 mg.

Tablet: Phenobarbital, 4 gr.; acetylsalicylic acid,
5 gr.; magnesium trisilicate, 2 gr.
Tablet: Phenobarbital, % gr.; aluminum hydroxide,
5 gr.; belladonna extract, % gr.
Tablet (12 hr.): Amobarbital. 50 mg.; homatropine
methyl bromide, 7.5 mg.

Tablet: Butabarbital sodium, 16 mg.; simethicone,
25 mg.; belladonna extract, 16 mg. (total alkaloids
0.20 mg.).

Pitman-Moore.

Paul B. Elder Co., Inc.

Wyeth Laboratories.
Lemmon Pharmacal Co.
Plough Laboratories, Inc.

Sodium nitrite with phenobar- Tablet: Phenobarbital sodium, % gr.; sodium nitrite, Paine Drug Co.
bital.
1 gr.; sodium bicarbonate, 2 gr.; hawthorn berries,
fluid extract, 4 minim.

Do..

Spasticol PB.

Spastosed...

Synirin.
TCS..

Tedral-25..

Tedral S.A.
Tensodin..

Tensophen....

Tablet: Phenobarbital, 1⁄2 gr.; sodium nitrite, 1 gr....

Tablet: Phenobarbital, 15 mg.; homatropine methyl-
bromide, 2.5 mg.

Tablet: Phenobarbital, 8 mg.; atropine sulfate, 0.13
mg.; calcium carbonate, 227 mg.; magnesium hy-
droxide, 162 mg.

Tablet: Pentobarbital, 8 mg.; aspirin, 324 mg...
Tablet: Phenobarbital 16, mg.; theobromine sali-
cylate, 0.4 gm., calcium salicylate, 0.06 gm.
Tablet: Butabarbital 25 mg.; theophylline, 130 mg.;
ephedrine hydrochloride, 24 mg.

Tablet: Phenobarbital, 25 mg.; theophylline, 180
mg.; ephedrine hydrochloride, 48 mg.

Buffalo Pharmaceutical Sup-
ply Corp.
Key Pharmaceuticals, Inc.
North American Pharmacal,
Inc.

Wm.P.Poythress & Co., Inc.
Do.

Warner-Chilcott Laboratories.

Do.

Tablet: Phenobarbital, 15 mg.; ethaverine hydro- Knoll Pharmaceutical Co. chloride, 30 mg.; theophylline calcium salicylate,

[blocks in formation]

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-
bital No. 1.
Theobromine and sodium ace-
tate with phenobarbital.
Theobromine sodium salicy-
late with phenobarbital.
Theocardone No. 1.
Theocardone No. 2.
Theodide..

Theoglycinate with Phenobarbital.

Theoglycinate with Racephedrine and Phenobarbital.

Theoplaphen..

Theominal.

Theominal M.
Theominal R S.

Theophen

Theorate.

Thymodyne...----

Trocinate with Phenobarbital.

Tricoloid

Triophen..

Valpin-PB..

Vasorutin..

Veralzem

Veratrite..

Veritag..
Vertegus...

Veruphen....
Viritin..

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.
of sodium barbital and 0.75 gm. of barbital; other
drugs and components.
Tablet: Phenobarbital, 8 mg.; theophylline, hy-
drous, 100 mg.; ephedrine hydrochloride, 25 mg.
Tablet: Phenobarbital, 32 mg.; theobromine, 325 mg.

Tablet: Phenobarbital, 10 mg.; reserpine, 0.1 mg.;
theobromine, 324 mg.

Tablet: Phenobarbital, 16 mg.; theobromine, 325 mg.
Tablet: Phenobarbital, 16 mg.; theobromine, 0.3 gm.

Tablet: Phenobarbital, 30 mg.; theobromine, 0.3 gm.
Tablet: Phenobarbital, 32 mg.; theobromine, 324 mg
Tablet: Phenobarbital, 4 gr.; theobromine, 21⁄2 gr.;
potassium iodide, 21⁄2 gr.; potassium bicarbonate,
2 gr.

Tablet: Phenobarbital, 15 mg.; theobromine, 324 mg.
Tablet: Phenobarbital, 1⁄4 gr.; theobromine and
sodium acetate, 3 gr.

Tablet: Phenobarbital, 15 mg.; theobromine sodium
salicylate, 300 mg.

Tablet: Phenobarbital, 15 mg.; theobromine, 300 mg.
Tablet: Phenobarbital, 30 mg.; theobromine, 300 mg.
Tablet: Phenobarbital, 4 gr.; potassium iodide, 21⁄2
gr.; theobromine sodium salicylate, 21⁄2 gr.
Tablet: Phenobarbital, 16 mg.; theophylline-sodium
glycinate, 324 mg.

Tablet: Phenobarbital, 16 mg.; theophylline-sodium
glycinate, 324 mg.; racephedrine hydrochloride, 24

mg.

Tablet: Phenobarbital, 15 mg.; theobromine sodium
salicylate, 0.2 gm.; calcium lactate, 0.1 gm.
Tablet: Phenobarbital, 32 mg.; theobromine, 320 mg.
Tablet: Phenobarbital, 15 mg.; theobromine, 320 mg.
Tablet: Phenobarbital, 10 mg.; theobromine, 320
mg.; alseroxylon, 1.5 mg.

Tablet: Phenobarbital, 4 gr.; theobromine sodium
salicylate, 5 gr.; calcium carbonate, 21⁄2 gr.
Tablet: Phenobarbital, 16.2 mg.; theobromine, 324

mg.

Tablet: Phenobarbital, 32 mg.; theophylline anhy-
drous, 130 mg.; ephedrine sulfate, 24 mg.
Tablet: Phenobarbital, 16 mg.; thiphenamil hydro-
chloride, 100 mg.

Tablet: Phenobarbital, 16 mg.; tricyclamol chloride,
50 mg.

Tablet: Phenobarbital,

gr.; antropine sulfate, 500
gr.; magnesium trisilicate, 7 gr.
Tablet or elixir (5 cc.): Phenobarbital, 8 mg.; aniso-
tropine methylbromide, 10 mg.
Tablet: Diallylbarbituric acid, 4 gr.; nitroglycerin,
1250 gr.; sodium nitrite, 1 gr.; tincture crataegus,
2 minims; rutin, 20 mg.

Tablet: Phenobarbital, 15 mg.; veratrum viride, 50
mg.; sodium nitrite, 60 mg.
Tablet: Phenobarbital, 4 gr.; cryptenamine, 40
CSR (carotid sinus reflex) units; sodium nitrite,
1 gr.

Tablet: Phenobarbital, 16 mg.; veratrum viride, 40
mg.; sodium nitrite, 65 mg.

Tablet: Phenobarbital, 4 gr.; veratrum viride, 34
gr.; sodium nitrite, 1 gr.; mistletoe, 1⁄2 gr.; haw-
thorn berries, 1⁄2 gr.

Tablet: Phenobarbital, 15 mg.; rutin, 20 mg.; vera-
trum viride, 15 mg.; sodium nitrite, 60 mg.
Tablet: Phenobarbital, 15 mg.; mannitol hexani-
trate, 30 mg.; veratrum viride alkaloids, 1.5 mg.;
rutin, 20 mg.

Powder (4 gm.): Phenobarbital, 15 mg.; belladonna
extract, 10 mg. (0.12 mg. belladonna alkaloids);
benzocaine, 15 mg.; calcium carbonate, 1.55 gm.;
magnesium oxide, 0.5 gm.; aluminum hydroxide
gel, dried, 60 mg.

Tablet: Phenobarbital, 16 gr.; belladonna extract,
124 gr.; benzocaine, 16 gr.; calcium carbonate, 6
gr.; magnesium trisilicate, 334 gr.; aluminum
hydroxide gel, dried, 21⁄2 gr.; chlorophyll extract,
1%.

The Zemmer Co.

Mallinckrodt Chemical
Works.
Do.

Do.

P. J. Noyes Co.

The S. E. Massengill Co.
The Upjohn Co.
Do.

Buffington's, Inc.

Paul B. Elder Co., Inc.
The Zemmer Co.

Haack Laboratories, Inc.
Do.

The Vale Chemical Co., Inc.
Brayten Pharmaceutical Co.

Do.

The S. E. Massengill Co.
Winthrop Laboratories.

Do.
Do.

The Vale Chemical Co., Inc.
Whittier Laboratories, Inc.
P. J. Noyes Co.

Wm. P. Poythress & Co.,
Inc.

Burroughs Wellcome & Co.

The Vale Chemical Co., Inc.
Endo Laboratories Inc.
Buffington's, Inc.

The Zemmer Co.

Neisler Laboratories, Inc.

S. J. Tutag and Co.
Burt Krone Co.

The Zemmer Co.

Lemmon Pharmacal Co.

Warren-Teed

Pharmaceuticals Inc.

Do.

Tablet: Phenobarbital, 16.2 mg.; theobromine, 162 Pitman-Moore.
mg.; ethylenediaminé dihydriodide, 32.4 mg.

Trade name or other designation

Zallogen Compound...
Zantrate.....

Zem-Dab.

No. 23.

No. 35.

No. 36..

No. 65.

No. 66.

No. 75..
No. 88.
No. 89.

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.
The Upjohn Co.

Tablet: Phenobarbital, 8 mg.; tocamphyl, 75 mg.;
homatropine methylbormide, 2.5 mg.
Tablet: Cyclopentenylallylbarbituric acid, 1⁄2 gr.;
ephedrine sulfate, % gr.; theophylline anhydrous,
2 gr.
Tablet: Butabarbital sodium, 10 mg.; dehydrocholic The Zemmer Co.
acid, 60 mg.; ox bile desiccated, 120 mg.; homatro-
pine methylbromide, 2.5 mg.

Tablet: Phenobarbital, 1⁄2 gr.; aminophylline, 3 gr.
Tablet: Phenobarbital, 8 gr.; aminophylline, 1.5
gr.; ephedrine sulfate, 3% gr.

Tablet: Pentabarbital sodium, 4 gr.; ephedrine
sulfate, 3% gr.; aminophylline, 3 gr.

Tablet: Phenobarbital, gr.; extract belladonna,
1⁄44 gr.

Tablet: Phenobarbital, 4 gr.; extract belladonna,
1⁄44 gr.
Tablet: Phenobarbital, 4 gr.; belladonna, 16 gr.............
Tablet: Phenobarbital, 4 gr.; aminophylline, 1.5 gr.
Tablet: Phenobarbital, 1⁄2 gr.; aminophylline, 1.5 gr..
Tablet: Phenobarbital, 1⁄2 gr.; ephedrine sulfate,

[blocks in formation]

Rx. No. 4108..

[blocks in formation]

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.
ladonna, 10 mg.

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.

[blocks in formation]

[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]

[blocks in formation]

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,
Washington, D.C. 20537.

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:

[blocks in formation]

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

« PreviousContinue »