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Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Updated October 31, 2019 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Notice of Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List • Additions to category 1: o Amphotericin B o Anastrazole o Ciprofloxacin HCl o Cocaine HCl o Cyclosporine/Cyclosporine A o DHEA (dehydroepiandosterone) o Diphenhydramine HCl o Dyclonine HCl o Haloperidol o Sodium thiosulfate 1 Updated October 31, 2019 503B Category 1: Bulk Drug Substances Under Evaluation • 5-Methyltetrahydrofolate Calcium • Chromium chloride/ Chromium Chloride • 17-alpha-Hydroxyprogesterone Hexahydrate • Acetylcysteine • Ciclopirox Oleate • Acyclovir • Cimetadine • Adapalene • Ciprofloxacin HCl • Adenosine • Citric Acid Anhydrous • Allantoin • Clindamycin Phosphate • Alpha Lipoic Acid • Clioquinol • Alprostadil • Clobetasol Propionate • Aluminum Chloride Hexahydrate • Clomipramine Hydrochloride • Aluminum potassium sulfate • Clonidine Hydrochloride • Amantadine HCl • Coal Tar Solution • Amitriptyline HCl • Cocaine HCl • Amphotericin B • Cupric Sulfate • Anastrazole • Cyanocobalamin • Arginine Hydrochloride • Cyclobenzaprine Hydrochloride • Ascorbic acid • Cyclosporine/Cyclosporine A • Ascorbyl Palmitate • Dapiprazole HCl • Aspartic Acid • Dapsone • Atenolol • Desoximetasone • Atropine sulfate/ Atropine sulfate • Dexamethasone Acetate monohydrate • Dexamethasone Sodium Phosphate • Azelaic Acid • Dexpanthenol • Baclofen • DHEA (dehydroepiandosterone) • Benzocaine • D-glucose • Betamethasone Acetate • Diazepam • Betamethasone Dipropionate • Dibucaine HCl • Betamethasone Sodium Phosphate • Diclofenac Sodium • Biotin • Diltiazem Hydrochloride • Bismuth Nitrate Oxide • Dimercapto-1-propanesulfonic acid • Brilliant Blue (DMPS) • Brimonidine Tartrate • Diphenhydramine HCl • Bromfenac sodium (for ophthalmic use) • Diphenylcyclopropenone • Brompheniramine maleate, USP • Dipyridamole • Budesonide • Disulfiram • Bupivacaine Hydrochloride/ Bupivacaine • Dobutamine Hydrochloride Hydrochloride Monohydrate • Dopamine HCl • Caffeine • Droperidol • Calcipotriene • Dyclonine HCl • Calcium Chloride • Econazole Nitrate • Calcium EDTA • Edetate Disodium (EDTA) • Calcium Gluconate • Ephedrine Hydrochloride • Cantharidin • Ephedrine sulfate, USP • Chloroquine Phosphate • Epinephrine • Chlorpheniramine Maleate • Epinephrine Bitartrate • Choline Chloride • Estradiol Cypionate • Chromic Chloride • Estradiol 2 Updated October 31, 2019 • Estriol • Lincomycin HCl • Ethanol • L-lysine Hydrochloride • Ethyl Aminobenzoate • Lorazepam • Etomidate • Lysine Hydrochloride • Famotidine • Magnesium Chloride • Fentanyl Citrate • Magnesium Sulfate/Magnesium Sulfate • Finasteride Heptahydrate • Fluconazole • Malic Acid • Fluocinolone Acetonide • Manganese Chloride • Fluocinonide • Mannitol • Flurbiprofen • Medroxyprogesterone Acetate • Fluticasone Propionate • Meperidine Hydrochloride (a.k.a. • Folic Acid Pethidine Hydrochloride) • Formaldehyde • Methacholine Chloride • Furosemide • Methionine/ Methionine (L) • Gabapentin • Methylcobalamin/ Methyl B12 • Gentamicin Sulfate • Methylprednisolone Acetate • Glutamic acid • Methylsulfonylmethane (MSM) • Glutamine • Metoclopramide HCl • Glutathione • Metronidazole • Glycerin • Midazolam Hydrochloride • Glycolic Acid • Mineral Oil • Glycopyrrolate/ Glycopyrrolate Bromide • Minoxidil • Haloperidol • Mitomycin • Heparin sodium • Mometasone Furoate • Hyaluronic acid sodium salt • Monosodium Glutamate • Hyaluronidase • Morphine Sulfate/ Morphine Sulfate • Hydralazine HCl Pentahydrate • Hydrocortisone • Moxifloxacin hydrochloride • Hydromorphone Hydrochloride • Mupirocin • Hydroquinone • Nalbuphine HCl • Hydroxocobalamin Hydrochloride • Naloxone Hydrochloride Dihydrate • Hydroxyzine HCl • Neomycin sulfate • Ibuprofen • Neostigmine Methylsulfate • Imipramine Hydrochloride • Nepafenac • Imiquimod • Niacin • Inositol • Niacinamide • Iodoform • Nifedipine • Itraconazole • Norepinephrine Bitartrate • Ivermectin • Ondansetron HCl • Ketamine Hydrochloride • Ornithine Hydrochloride • Ketoconazole • Oxymetazoline HCl • Ketoprofen • Oxytocin • Ketorolac Tromethamine • Pentoxifylline • Labetalol Hydrochloride • Phenol • Lactic Acid • Phenoxybenzamine Hydrochloride • Lansoprazole • Phentolamine Mesylate • L-arginine Hydrochloride • Phenylephrine HCl • Levocetirizine Dihydrochloride • Phytonadione • Lidocaine Hydrochloride • Pitcher Plant 3 Updated October 31, 2019 • Podophyllum • Sodium thiosulfate • Polidocanol • Spironolactone • Polymyxin B Sulfate • Squaric acid dibutyl ester • Potassium Acetate • Succinylcholine Chloride • Potassium chloride • Succinylcholine Chloride Dihydrate • Potassium Phosphate Monobasic • Sufentanil Citrate [KH2PO4] • Sulfacetamide Sodium Monohydrate • Potassium Phosphate Dibasic [K2HPO4]/ • Sulfan Blue Potassium Phosphate Dibasic Anhydrous • Tacrolimus • Precipitated Sulfur • Taurine • Prednisolone • Tazarotene • Prednisolone Acetate • Terbinafine HCl • Prilocaine • Testosterone • Procainamide HCl • Testosterone Cypionate • Procaine Hydrochloride • Testosterone Propionate • Progesterone • Tetracaine Hydrochloride • Promethazine Hydrochloride • Tetracycline Hydrochloride • Proparacaine HCl • Theophylline • Propranolol hydrochloride • Thiamine HCl (vitamin B1) • Prostaglandin E1 • Thymol iodide • Pyridoxal 5-Phosphate Monohydrate • Tolnaftate • Pyridoxine HCl • Tramadol Hydrochloride • Remifentanil Hydrochloride • Tretinoin • Riboflavin 5 PO4 • Triamcinolone Acetonide • Rocuronium Bromide • Triamcinolone diacetate • Ropivacaine Hydrochloride • Tromethamine • Salicylic Acid • Tropicamide • Scopolamine hydrobromide • Trypan Blue • Sincalide • Urea • Sodium Acetate Anhydrous • Vancomycin Hydrochloride • Sodium Ascorbate • Verapamil HCl • Sodium Benzoate • Vecuronium Bromide • Sodium Bicarbonate • Vitamin A acetate • Sodium Chloride • Vitamin D3 • Sodium Citrate • Ziconotide • Sodium Citrate Dihydrate • Zinc Oxide • Sodium L-Aspartate Monohydrate • Zinc Sulfate • Sodium phosphate/ Sodium Phosphate Monobasic Anhydrous • Sodium Tetradecyl Sulfate 4 Updated October 31, 2019 503B Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Germanium sesquioxide 5 Updated October 31, 2019 503B Category 3: Bulk Drug Substances Nominated Without Adequate Support • 4-Aminopyridine • Aspartame • 7-Keto Dehydroepiandrosterone, • Aspergillus oryza enzymes Micronized • Attapulgite • Acacia Gum, Spray-Dried Powder • Barosma • Acacia Syrup • Basic Fuchsin • Acesulfame Potassium • Beachwood creosote • Acetanilide • Bean • Acetic acid • Benzalkonium Chloride • Acetone • Betamechlomathasone • Acetone Sodium Bisulfite • Beta-Nicotinamide Adenine Dinucleotide • Acetyl Hexapeptide-3 • Disodium Salt Trihydrate • Acidophilus Lactobacillus • Bethanechol • Adenosine-5-triphosphate disodium salt • Bichloroacetic Acid • Agar • Bipeptide Biocosmetic • Alcloxa • Bronopol • Aldioxa • Buffer Solution, pH Buffer Acid • Aldosterone • Butylated Hydroxytoluene • Alfalfa • Butylene Glycol • Alfalfa leaves • Calcium Alginate • Alginic acid • Calcium Folinate • Aliphatic Polyesters • Calcium glycinate • Almadrate sulfate • Capsules, Empty Gelatin Vegetable • Aloin • Carbamide • Alpha Ketoglutaric acid • Carbazochrome • Alumina Powder, hydrated • Carbimazole • Aluminum acetate • Carbolic Acid • Aluminum chloride • Carbomer 940 • Aluminum phosphate • Caustic Potash • Aluminum sulfate • Caustic Soda (sodium hydroxide) • Aminacrine HCl • Cedarwood Essential Oil • Aminoacetic acid • Ceratonia • Ammonia solution, strong • Ceresin • Ammonium Alginate • Cetrimide • Ammonium bromide • Chlorhexidine Diacetate Hydrate • Ammonium chloride • Choline Bitartrate • Ammonium hydroxide • Choline magnesium trisalicylate • Amylase • Chondroitin Sulfate • Anise oil • Chromium glycinate • Anise seed • Chrysin • Argentyn • Cidofovir • Arginine • Cocoa butter • Aromatic powder • Coconut Oil Edible • Asafetida • Coenzyme Q10 • Ascelepias tuberosa • Coenzyme Q50 • Asefetida Tincture • Collagenase • Asparagus • Colophony • Copper 6 Updated October 31, 2019 • Copper Bisglycinate • Ginko Biloba Standardized Extract • Copper Hydrosol • Gloconic acid calcium salt • Corn Oil • Glutaraldehyde solution • Corn Starch • Glycerol Formal • Corn Starch and Pregelatinized Starch • Glyceryl Monostearate • Cottonseed Oil • Glyceryl Palmitostearate • Creatine, Monohydrate • Glycofurol • Cucumber Melon Fragrancce • Glydiazinamide • Cyclopentolate • Grape seed oil • Decyl Oleate • Gum Arabic • Decylmethylsulfoxide • Hectorite • Deoxy-D-Glucose • Heptafluoropropane • Desonide • Hexetidine • Diaminopyridine (3,4-) • Hyaluronidase, salt free • Dichloroacetic Acid • Hydrazine sulfate • Difluoroethane • Hydrochloric Acid • Diindolymethane • Hydroxyethylpiperazine Ethane Sulfonic Acid • Dimercaptosuccinic acid • Hydroxymethylmethyl Cellulose • Dimethyl Ether (aka Methoxymethane) • Ichthammol • Dimethyl Ketone • ICU Bottom Paste (Maalox) • Dimethyl Phthalate • Indigo Carmine • Dimethylacetamide • Indole-3-carbinol • Dimethylaminoethanol Bitartrate • Inositol Hexanicotinate • Dimethylaminoethanol Complex • Iodochlorhydroxyquin • Dimethylglycine HCl • Iopanoic Acid • Dinitrochlorobenzene • Iron Glycinate Chelate • Diphenhydramine • Isopropyl Isostearate • Dipropylene Glycol • Kaolin, Colloidal Powder • Disodium
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