Medicines for Human use on the “Do Not Compound List” 2015
The Advisory Committee on Compounding along with the FDA have established this current list of drugs
which have been found to be unsafe or ineffective for human use and therefore should not be
compounded. It will be noted that some of the active ingredients on this list are are restricted only in
certain dosage forms, or combinations, while others are restricted for all dosage forms. This list is not
static, it will be updated periodically as required based upon published reports and medical experience.
The List of Drug Products Which Should Not be Compounded for Human Use
Adenosine Phosphate - All dosage forms containing adenosine 5’-monophosphate (AMP), adenosine 5’diphosphate (ADP), and adenosine 5’-triphosphate (ATP)
Adrenal Cortex - All dosage forms
Alatrofloxacin Mesylate - All dosage forms
Aminopyramine - All dosage forms
Astemizole - All dosage forms
Azaribine - All dosage forms
Benoxaprofen - All dosage forms
Bithionol - All dosage forms
Bromfenac Sodium - All dosage forms except ophthalmic solutions
Butamben - All parenterals
Camphorated Oil - All dosage forms
Carbetapentane Citrate - All oral gel forms
Casein, Iodinated - All dosage forms
Cerivastatin Sodium - All dosage forms
Chloramphenicol - All oral dosage forms
Chlorhexidine Gluconate - All tinctures for preoperative skin preparation
Chlormadinone Acetate - All dosage forms
Chloroform - All dosage forms
Cisapride - All dosage forms
Cobalt - All dosage forms containing cobalt salts, except radioactive forms and cobalamins
Dexfenfluramine HCl - All dosage forms
Diamthazole Dihydrochloride - All dosage forms
Compounder’s International Analytical Laboratory 800-788-9922
Page !1 of !4
Medicines for Human use on the “Do Not Compound List” 2015
Dibromsalan- All dosage forms
Diethylstilbestrol - All oral and parenteral forms containing 25mg or more per unit dose
Dihydrostreptomycin Sulfate - All dosage forms
Dipyrone - All dosage forms
Encainide HCl - All dosage forms
Esmolol - All parenteral forms that supply 250mg/mL per 10 mL ampule
Etretinate - All dosage forms
Fenfluramine HCl - All dosage forms
Flosequinan - All dosage forms
Gatifloxacin - All dosage forms except ophthalmic solutions
Gelatin - All intravenous drug products
Glycerol, Iodinated - All dosage forms
Gonadotropin, Chorionic (Of animal origin) - all dosage forms
Grepafloxacin - All dosage forms
Mepazine HCl or Acetate - All dosage forms
Metabromsalan - All dosage forms
Methamphetamine HCl - All parenteral forms
Methapyrilene - All dosage forms
Methopholine - All dosage forms
Methoxyflurane - All dosage forms
Mibefradil HCl - All dosage forms
Nitrofurazone - All dosage forms except topical products formulated for dermatologic applications
Nomifensine Maleate - All dosage forms
Novobiocin Sodium - All dosage forms
Oxycodone - All extended release forms that have not been determined by the FDA to have abusedeterrent properties
Oxyphenisatin or Oxyphenisatin Acetate - All dosage forms
Compounder’s International Analytical Laboratory 800-788-9922
Page !2 of !4
Medicines for Human use on the “Do Not Compound List” 2015
Pemoline - All dosage forms
Pergolide Mesylate - All dosage forms
Phenacetin - All dosage forms
Phenformin HCl - All dosage forms
Phenylpropanolamine - All dosage forms
Pipamazine - All dosage forms
Potassium Arsenite - All dosage forms
Potassium Chloride - All solid oral dosage forms that supply 100mg or more of potassium per dosage
unit, except for controlled-release forms and those formulated for preparation of a solution prior to
ingestion
Propoxyphene - All dosage forms
Povidone - All intravenous dosage forms
Rapacuronium Bromide - All dosage forms
Reserpine - All oral dosage forms containing more than 1mg
Rofecoxib - All dosage forms
Sibutramine HCl - All dosage forms
Sparteine Sulfate - All dosage forms
Sulfadimethoxine - All dosage forms
Sulfathiazole - All dosage forms, except those formulated for vaginal use
Suprofen - All dosage forms, except ophthalmic solutions
Sweet Spirits of Nitre - All dosage forms
Tagaserod Maleate - All dosage forms
Temafloxacin HCl - All dosage forms
Terfenadine - All dosage forms
3, 3’,4’,5-Tetrachlorosalicylanilide - All dosage forms
Tetracycline - All liquid oral forms for pediatric use having greater than 25mg/mL
Ticrynafen - All dosage forms
Tribromsalan - All dosage forms
Compounder’s International Analytical Laboratory 800-788-9922
Page !3 of !4
Medicines for Human use on the “Do Not Compound List” 2015
Trichloroethane - All aerosol inhalation dosage forms
Troglitazone - All dosage forms
Trovafloxacin Mesylate - All dosage forms
Urethane - All dosage forms
Valdecoxib - All dosage forms
Vinyl Chloride - All aerosol dosage forms
Zirconium - All aerosol dosage forms
Zomepirac Sodium - All dosage forms
All formulations containing the combination of:
Polyethylene Glycol 3350,
Sodium Chloride,
Sodium Bicarbonate, and
Potassium Chloride, for oral solution,
and 10mg or more of Bisacodyl delayed release tablet.
(Note: these individual listed ingredients are still suitable for compounding)
Sources for this list:
• Allen LV Jr., Basics of Compounding, The “Negative” List. IJPC Vol. 19 (4); 2015: 311-313
• Brown T, Medscape article “Drug Product Compounding Issues Addressed by FDA Panel”, Feb. 24,
2015
• FDA, CFR - Code of Federal Regulations Title 21, Vol 4, Revised April 1, 2014 CITE: 21CFR216.24
Compounder’s International Analytical Laboratory 800-788-9922
Page !4 of !4