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