Updated July 30, 2020 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: Betahistine Hydrochloride L-Proline Citrulline Papaverine Hydrochloride* Copper Gluconate Phosphatidylcholine Diiodohydroxyquinoline Podophyllum Resin Glucosamine Sulfate Potassium Chloride Sodium Molybdate Glucosamine Sulfate Sodium Chloride Sodium Nitroprusside Hydrochloric Acid* Sodium Selenite/Sodium Selenite Pentahydrate* Ibutamoren Mesylate Trichloroacetic Acid* L-Citrulline* Ubidecarenone (Coenzyme Q10)* L-Lysine * Bulk drug substance is currently in Category 3 and is being moved to Category 1. • Minor revision to entry in Category 1 to correct a misspelling: o Correct the misspelling of “cimatidine” to “cimetidine” 1 Updated July 30, 2020 503B Category 1: Bulk Drug Substances Under Evaluation • 5-Methyltetrahydrofolate Calcium • Chromic Chloride • 17-alpha-Hydroxyprogesterone • Chromium chloride/ Chromium Chloride • Acetylcysteine Hexahydrate • Acyclovir • Ciclopirox Oleate • Adapalene • Cimetidine • Adenosine • Ciprofloxacin HCl • Allantoin • Citric Acid Anhydrous • Alpha Lipoic Acid • Citrulline/L-Citrulline • Alprostadil • Clindamycin Phosphate • Aluminum Chloride Hexahydrate • Clioquinol • Aluminum potassium sulfate • Clobetasol Propionate • Amantadine HCl • Clomipramine Hydrochloride • Amitriptyline HCl • Clonidine Hydrochloride • Amphotericin B • Coal Tar Solution • Anastrazole • Cocaine HCl • Arginine Hydrochloride • Copper Gluconate • Ascorbic acid • Cupric Sulfate • Ascorbyl Palmitate • Cyanocobalamin • Aspartic Acid • Cyclobenzaprine Hydrochloride • Atenolol • Cyclosporine/Cyclosporine A • Atropine sulfate/ Atropine sulfate • Dapiprazole HCl monohydrate • Dapsone • Azelaic Acid • Desoximetasone • Baclofen • Dexamethasone Acetate • Benzocaine • Dexamethasone Sodium Phosphate • Betahistine Hydrochloride • Dexpanthenol • Betamethasone Acetate • DHEA (dehydroepiandosterone) • Betamethasone Dipropionate • D-glucose • Betamethasone Sodium Phosphate • Diazepam • Biotin • Dibucaine HCl • Bismuth Nitrate Oxide • Diclofenac Sodium • Brilliant Blue • Diiodohyroxyquinolone • Brimonidine Tartrate • Diltiazem Hydrochloride • Bromfenac sodium (for ophthalmic use) • Dimercapto-1-propanesulfonic acid • Brompheniramine maleate, USP (DMPS) • Budesonide • Diphenhydramine HCl • Bupivacaine Hydrochloride/ Bupivacaine • Diphenylcyclopropenone Hydrochloride Monohydrate • Dipyridamole • Caffeine • Disulfiram • Calcipotriene • Dobutamine Hydrochloride • Calcium Chloride • Dopamine HCl • Calcium EDTA • Droperidol • Calcium Gluconate • Dyclonine HCl • Cantharidin • Econazole Nitrate • Chloroquine Phosphate • Edetate Disodium (EDTA) • Chlorpheniramine Maleate • Ephedrine Hydrochloride • Choline Chloride • Ephedrine sulfate, USP 2 Updated July 30, 2020 • Epinephrine • Ketoprofen • Epinephrine Bitartrate • Ketorolac Tromethamine • Estradiol Cypionate • Labetalol Hydrochloride • Estradiol • Lactic Acid • Estriol • Lansoprazole • Ethanol • L-arginine Hydrochloride • Ethyl Aminobenzoate • Levocetirizine Dihydrochloride • Etomidate • Lidocaine Hydrochloride • Famotidine • Lincomycin HCl • Fentanyl Citrate • L-Lysine • Finasteride • L-lysine Hydrochloride • Fluconazole • Lorazepam • Fluocinolone Acetonide • L-Proline • Fluocinonide • Lysine Hydrochloride • Flurbiprofen • Magnesium Chloride • Fluticasone Propionate • Magnesium Sulfate/Magnesium Sulfate • Folic Acid Heptahydrate • Formaldehyde • Malic Acid • Furosemide • Manganese Chloride • Gabapentin • Mannitol • Gentamicin Sulfate • Medroxyprogesterone Acetate • Glucosamine Sulfate Potassium Chloride • Meperidine Hydrochloride (a.k.a. • Glucosamine Sulfate Sodium Chloride Pethidine Hydrochloride) • Glutamic acid • Methacholine Chloride • Glutamine • Methionine/Methionine (L) • Glutathione • Methylcobalamin/Methyl B12 • Glycerin • Methylprednisolone Acetate • Glycolic Acid • Methylsulfonylmethane (MSM) • Glycopyrrolate/ Glycopyrrolate Bromide • Metoclopramide HCl • Haloperidol • Metronidazole • Heparin sodium • Midazolam Hydrochloride • Hyaluronic acid sodium salt • Mineral Oil • Hydralazine HCl • Minoxidil • Hydrochloric Acid • Mitomycin • Hydrocortisone • Mometasone Furoate • Hydromorphone Hydrochloride • Monosodium Glutamate • Hydroquinone • Morphine Sulfate/Morphine Sulfate • Hydroxocobalamin Hydrochloride Pentahydrate • Hydroxychloroquine Sulfate • Moxifloxacin hydrochloride • Hydroxyzine HCl • Mupirocin • Ibuprofen • Nalbuphine HCl • Ibutamoren Mesylate • Naloxone Hydrochloride Dihydrate • Imipramine Hydrochloride • Neomycin sulfate • Imiquimod • Neostigmine Methylsulfate • Inositol • Nepafenac • Iodoform • Niacin • Itraconazole • Niacinamide • Ivermectin • Nifedipine • Ketamine Hydrochloride • Norepinephrine Bitartrate • Ketoconazole • Ondansetron HCl 3 Updated July 30, 2020 • Ornithine Hydrochloride • Sodium Molybdate • Oxymetazoline HCl • Sodium Nitroprusside • Oxytocin • Sodium phosphate/ Sodium Phosphate • Papaverine Hydrochloride Monobasic Anhydrous • Pentoxifylline • Sodium Selenite/Sodium Selenite • Phenol Pentahydrate • Phenoxybenzamine Hydrochloride • Sodium Tetradecyl Sulfate • Phentolamine Mesylate • Sodium thiosulfate • Phenylephrine HCl • Spironolactone • Phosphatidylcholine • Squaric acid dibutyl ester • Phytonadione • Succinylcholine Chloride • Pitcher Plant • Succinylcholine Chloride Dihydrate • Podophyllum/Podophyllum Resin • Sufentanil Citrate • Polidocanol • Sulfacetamide Sodium Monohydrate • Polymyxin B Sulfate • Sulfan Blue • Potassium Acetate • Tacrolimus • Potassium chloride • Taurine • Potassium Phosphate Monobasic • Tazarotene [KH2PO4] • Terbinafine HCl • Potassium Phosphate Dibasic [K2HPO4]/ • Testosterone Potassium Phosphate Dibasic Anhydrous • Testosterone Cypionate • Precipitated Sulfur • Testosterone Propionate • Prednisolone • Tetracaine Hydrochloride • Prednisolone Acetate • Tetracycline Hydrochloride • Prilocaine • Theophylline • Procainamide HCl • Thiamine HCl (vitamin B1) • Procaine Hydrochloride • Thymol iodide • Progesterone • Tolnaftate • Promethazine Hydrochloride • Tramadol Hydrochloride • Proparacaine HCl • Tretinoin • Propranolol hydrochloride • Triamcinolone Acetonide • Prostaglandin E1 • Triamcinolone diacetate • Pyridoxal 5-Phosphate Monohydrate • Trichloroacetic Acid • Pyridoxine HCl • Tromethamine • Remifentanil Hydrochloride • Tropicamide • Riboflavin 5 PO4 • Trypan Blue • Rocuronium Bromide • Ubidecarenone (Coenzyme Q10) • Ropivacaine Hydrochloride • Urea • Salicylic Acid • Vancomycin Hydrochloride • Scopolamine hydrobromide • Verapamil HCl • Sincalide • Vecuronium Bromide • Sodium Acetate Anhydrous • Vitamin A acetate • Sodium Ascorbate • Vitamin D3 • Sodium Benzoate • Ziconotide • Sodium Bicarbonate • Zinc Oxide • Sodium Chloride • Zinc Sulfate • Sodium Citrate • Sodium Citrate Dihydrate • Sodium L-Aspartate Monohydrate 4 Updated July 30, 2020 503B Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Germanium sesquioxide 5 Updated July 30, 2020 503B Category 3: Bulk Drug Substances Nominated Without Adequate Support • 4-Aminopyridine • Attapulgite • 7-Keto Dehydroepiandrosterone, Micronized • Barosma • Acacia Gum, Spray-Dried Powder • Basic Fuchsin • Acacia Syrup • Beachwood creosote • Acesulfame Potassium • Bean • Acetanilide • Benzalkonium Chloride • Acetic acid • Betamechlomathasone • Acetone • Beta-Nicotinamide Adenine • Acetone Sodium Bisulfite Dinucleotide • Acetyl Hexapeptide-3 • Bethanechol • Acidophilus Lactobacillus • Bichloroacetic Acid • Adenosine-5-triphosphate disodium salt • Bipeptide Biocosmetic • Agar • Bronopol • Alcloxa • Buffer Solution, pH Buffer Acid • Aldioxa • Butylated Hydroxytoluene • Aldosterone • Butylene Glycol • Alfalfa • Calcium Alginate • Alfalfa leaves • Calcium Folinate • Alginic acid • Calcium glycinate • Aliphatic Polyesters • Capsules, Empty Gelatin Vegetable • Almadrate sulfate • Carbamide • Aloin • Carbazochrome • Alpha Ketoglutaric acid • Carbimazole • Alumina Powder, hydrated • Carbolic Acid • Aluminum acetate • Carbomer 940 • Aluminum chloride • Caustic Potash • Aluminum phosphate • Caustic Soda (sodium hydroxide) • Aluminum sulfate • Cedarwood Essential Oil • Aminacrine HCl • Ceratonia • Aminoacetic acid • Ceresin • Ammonia solution, strong • Cetrimide • Ammonium Alginate • Chlorhexidine Diacetate Hydrate • Ammonium bromide • Choline Bitartrate • Ammonium chloride • Choline magnesium trisalicylate • Ammonium hydroxide • Chondroitin Sulfate • Amylase • Chromium glycinate • Anise oil • Chrysin • Anise seed • Cidofovir • Argentyn • Cocoa butter • Arginine • Coconut Oil Edible • Aromatic powder • Coenzyme Q50 • Asafetida • Collagenase • Ascelepias tuberosa • Colophony • Asefetida Tincture • Copper • Asparagus • Copper Bisglycinate • Aspartame • Copper Hydrosol • Aspergillus oryza enzymes • Corn Oil 6 Updated July 30, 2020 • Corn Starch • Glutaraldehyde solution • Corn Starch and Pregelatinized Starch • Glycerol Formal • Cottonseed Oil • Glyceryl Monostearate • Creatine, Monohydrate • Glyceryl Palmitostearate • Cucumber Melon Fragrancce • Glycofurol • Cyclopentolate • Glydiazinamide • Decyl Oleate • Grape seed oil • Decylmethylsulfoxide • Gum Arabic • Deoxy-DGlucose • Hectorite • Desonide