[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR216.24]

[Page 137-138]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 216--PHARMACY COMPOUNDING--Table of Contents
 
                   Subpart B--Compounded Drug Products
 
Sec. 216.24  Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    The following drug products were withdrawn or removed from the 
market because such drug products or components of such drug products 
were found to be unsafe or not effective. The following drug products 
may not be compounded under the exemptions provided by section 503A(a) 
of the Federal Food, Drug, and Cosmetic Act:

Adenosine phosphate: All drug products containing adenosine phosphate.
Adrenal cortex: All drug products containing adrenal cortex.
Azaribine: All drug products containing azaribine.
Benoxaprofen: All drug products containing benoxaprofen.
Bithionol: All drug products containing bithionol.
Bromfenac sodium: All drug products containing bromfenac sodium.
Butamben: All parenteral drug products containing butamben.
Camphorated oil: All drug products containing camphorated oil.
Carbetapentane citrate: All oral gel drug products containing 
carbetapentane citrate.
Casein, iodinated: All drug products containing iodinated casein.
Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate 
formulated for use as a patient preoperative skin preparation.
Chlormadinone acetate: All drug products containing chlormadinone 
acetate.
Chloroform: All drug products containing chloroform.
Cobalt: All drug products containing cobalt salts (except radioactive 
forms of cobalt and its salts and cobalamin and its derivatives).
Dexfenfluramine hydrochloride: All drug products containing 
dexfenfluramine hydrochloride.
Diamthazole dihydrochloride: All drug products containing diamthazole 
dihydrochloride.
Dibromsalan: All drug products containing dibromsalan.
Diethylstilbestrol: All oral and parenteral drug products containing 25 
milligrams or more of diethylstilbestrol per unit dose.

[[Page 138]]

Dihydrostreptomycin sulfate: All drug products containing 
dihydrostreptomycin sulfate.
Dipyrone: All drug products containing dipyrone.
Encainide hydrochloride: All drug products containing encainide 
hydrochloride.
Fenfluramine hydrochloride: All drug products containing fenfluramine 
hydrochloride.
Flosequinan: All drug products containing flosequinan.
Gelatin: All intravenous drug products containing gelatin.
Glycerol, iodinated: All drug products containing iodinated glycerol.
Gonadotropin, chorionic: All drug products containing chorionic 
gonadotropins of animal origin.
Mepazine: All drug products containing mepazine hydrochloride or 
mepazine acetate.
Metabromsalan: All drug products containing metabromsalan.
Methamphetamine hydrochloride: All parenteral drug products containing 
methamphetamine hydrochloride.
Methapyrilene: All drug products containing methapyrilene.
Methopholine: All drug products containing methopholine.
Mibefradil dihydrochloride: All drug products containing mibefradil 
dihydrochloride.
Nitrofurazone: All drug products containing nitrofurazone (except 
topical drug products formulated for dermatalogic application).
Nomifensine maleate: All drug products containing nomifensine maleate.
Oxyphenisatin: All drug products containing oxyphenisatin.
Oxyphenisatin acetate: All drug products containing oxyphenisatin 
acetate.
Phenacetin: All drug products containing phenacetin.
Phenformin hydrochloride: All drug products containing phenformin 
hydrochloride.
Pipamazine: All drug products containing pipamazine.
Potassium arsenite: All drug products containing potassium arsenite.
Potassium chloride: All solid oral dosage form drug products containing 
potassium chloride that supply 100 milligrams or more of potassium per 
dosage unit (except for controlled-release dosage forms and those 
products formulated for preparation of solution prior to ingestion).
Povidone: All intravenous drug products containing povidone.
Reserpine: All oral dosage form drug products containing more than 1 
milligram of reserpine.
Sparteine sulfate: All drug products containing sparteine sulfate.
Sulfadimethoxine: All drug products containing sulfadimethoxine.
Sulfathiazole: All drug products containing sulfathiazole (except those 
formulated for vaginal use).
Suprofen: All drug products containing suprofen (except ophthalmic 
solutions).
Sweet spirits of nitre: All drug products containing sweet spirits of 
nitre.
Temafloxacin hydrochloride: All drug products containing temafloxacin.
Terfenadine: All drug products containing terfenadine.
 3,3',4',5-tetrachlorosalicylanilide: All drug products containing 
3,3',4',5-tetrachlorosalicylanilide.
Tetracycline: All liquid oral drug products formulated for pediatric use 
containing tetracycline in a concentration greater than 25 milligrams/
milliliter.
Ticrynafen: All drug products containing ticrynafen.
Tribromsalan: All drug products containing tribromsalan.
Trichloroethane: All aerosol drug products intended for inhalation 
containing trichloroethane.
Urethane: All drug products containing urethane.
Vinyl chloride: All aerosol drug products containing vinyl chloride.
Zirconium: All aerosol drug products containing zirconium.
Zomepirac sodium: All drug products containing zomepirac sodium.