Updated July 23, 2018 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act 503B Category 1 – Bulk Drug Substances Under Evaluation • 5-Methyltetrahydrofolate Calcium • Chloroquine Phosphate • 17-alpha-Hydroxyprogesterone • Chlorpheniramine Maleate • Acetylcysteine • Choline Bitartrate • Acyclovir • Choline Chloride • Adapalene • Chromic Chloride • Adenosine • Chromium chloride/ Chromium Chloride • Allantoin Hexahydrate • Alpha Lipoic Acid • Ciclopirox Oleate • Alprostadil • Cimetadine • Aluminum Chloride Hexahydrate • Citric Acid Anhydrous • Aluminum potassium sulfate • Clindamycin Phosphate • Amantadine HCl • Clioquinol • Amitriptyline HCl • Clobetasol Propionate • Ascelepias tuberosa • Clomipramine Hydrochloride • Ascorbic acid • Clonidine Hydrochloride • Ascorbyl Palmitate • Coal Tar Solution • Aspartic Acid • Cupric Sulfate • Atenolol • Cyanocobalamin • Atropine sulfate/ Atropine sulfate • Cyclobenzaprine Hydrochloride monohydrate • Cyclopentolate • Azelaic Acid • Dapiprazole HCl • Baclofen • Dapsone • Benzocaine • Desoximetasone • Betamethasone Acetate • Dexamethasone Acetate • Betamethasone Dipropionate • Dexamethasone Sodium Phosphate • Betamethasone Sodium Phosphate • Dexpanthenol • Biotin • D-glucose • Bismuth Nitrate Oxide • Diazepam • Brilliant Blue • Dibucaine HCl • Brimonidine Tartrate • Diclofenac Sodium • Bromfenac sodium (for ophthalmic use) • Diltiazem Hydrochloride • Brompheniramine maleate, USP • Dimercapto-1-propanesulfonic acid • Budesonide (DMPS) • Bupivacaine Hydrochloride/ Bupivacaine • Diphenylcyclopropenone Hydrochloride Monohydrate • Dipyridamole • Caffeine • Disulfiram • Calcipotriene • Dobutamine Hydrochloride • Calcium Chloride • Dopamine HCl • Calcium EDTA • Droperidol • Calcium Gluconate • Econazole Nitrate • Cantharidin • Edetate Disodium (EDTA) • Caustic Soda (sodium hydroxide) • Ephedrine Hydrochloride 1 Updated July 23, 2018 • Ephedrine sulfate, USP • Lansoprazole • Epinephrine • Levocetirizine Dihydrochloride • Epinephrine Bitartrate • Lidocaine Hydrochloride • Estradiol Cypionate • Lincomycin HCl • Estradiol • Lorazepam • Estriol • Magnesium Chloride • Ethanol • Magnesium Sulfate/Magnesium Sulfate • Ethyl Aminobenzoate Heptahydrate • Etomidate • Malic Acid • Famotidine • Manganese Chloride • Fentanyl Citrate • Mannitol • Finasteride • Medroxyprogesterone Acetate • Fluconazole • Meperidine Hydrochloride (a.k.a. • Fluocinolone Acetonide Pethidine Hydrochloride) • Fluocinonide • Methacholine Chloride • Flurbiprofen • Methionine/ Methionine (L) • Fluticasone Propionate • Methylcobalamin/ Methyl B12 • Folic Acid • Methylprednisolone Acetate • Formaldehyde • Methylsulfonylmethane (MSM) • Furosemide • Metoclopramide HCl • Gabapentin • Metronidazole • Gentamicin Sulfate • Midazolam Hydrochloride • Glutamic acid • Mineral Oil • Glutamine • Minoxidil • Glutathione • Mitomycin • Glycerin • Mometasone Furoate • Glycolic Acid • Monosodium Glutamate • Glycopyrrolate/ Glycopyrrolate Bromide • Morphine Sulfate/ Morphine Sulfate • Heparin sodium Pentahydrate • Hyaluronic acid sodium salt • Moxifloxacin hydrochloride • Hyaluronidase • Mupirocin • Hydralazine HCl • Nalbuphine HCl • Hydrocortisone • Naloxone Hydrochloride Dihydrate • Hydromorphone Hydrochloride • Neomycin sulfate • Hydroquinone • Neostigmine Methylsulfate • Hydroxocobalamin Hydrochloride • Nepafenac • Hydroxyzine HCl • Niacin • Ibuprofen • Niacinamide • Imipramine Hydrochloride • Nicardipine hydrochloride • Imiquimod • Nifedipine • Inositol • Norepinephrine Bitartrate • Iodoform • Ondansetron HCl • Itraconazole • Ornithine Hydrochloride • Ivermectin • Oxymetazoline HCl • Ketamine Hydrochloride • Oxytocin • Ketoconazole • Papaverine • Ketoprofen • Pentoxifylline • Ketorolac Tromethamine • Phenol • Labetalol Hydrochloride • Phenoxybenzamine Hydrochloride • Lactic Acid • Phentolamine Mesylate 2 Updated July 23, 2018 • Phenylephrine HCl • Sodium Tetradecyl Sulfate • Phytonadione • Spironolactone • Pitcher Plant • Squaric acid dibutyl ester • Podophyllum • Succinylcholine Chloride • Polidocanol • Succinylcholine Chloride Dihydrate • Polymyxin B Sulfate • Sufentanil Citrate • Potassium Acetate • Sulfacetamide Sodium Monohydrate • Potassium chloride • Sulfan Blue • Potassium phosphate/ Potassium • Tacrolimus Phosphate Dibasic Anhydrous • Taurine • Precipitated Sulfur • Tazarotene • Prednisolone • Terbinafine HCl • Prednisolone Acetate • Testosterone • Prilocaine • Testosterone Cypionate • Procainamide HCl • Testosterone Propionate • Procaine Hydrochloride • Tetracaine Hydrochloride • Progesterone • Tetracycline Hydrochloride • Promethazine Hydrochloride • Theophylline • Proparacaine HCl • Thiamine HCl (vitamin B1) • Propranolol hydrochloride • Thymol iodide • Prostaglandin E1 • Tolnaftate • Pyridoxal 5-Phosphate Monohydrate • Tramadol Hydrochloride • Pyridoxine HCl • Tretinoin • Remifentanil Hydrochloride • Triamcinolone Acetonide • Riboflavin 5 PO4 • Triamcinolone diacetate • Rocuronium Bromide • Tromethamine • Ropivacaine Hydrochloride • Tropicamide • Salicylic Acid • Trypan Blue • Scopolamine hydrobromide • Urea • Sincalide • Vanadium • Sodium Acetate Anhydrous • Vancomycin Hydrochloride • Sodium Ascorbate • Vasopressin • Sodium Benzoate • Verapamil HCl • Sodium Bicarbonate • Vecuronium Bromide • Sodium Chloride • Vitamin A acetate • Sodium Citrate • Vitamin D3 • Sodium Citrate Dihydrate • Ziconotide • Sodium L-Aspartate Monohydrate • Zinc Oxide • Sodium phosphate/ Sodium Phosphate • Zinc Sulfate Monobasic Anhydrous • Sodium Selenite 3 Updated July 23, 2018 503B Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Germanium sesquioxide 4 Updated July 23, 2018 503B Category 3: Bulk Drug Substances Nominated Without Adequate Support • 4-Aminopyridine • Aspergillus oryza enzymes • 7-Keto Dehydroepiandrosterone, • Attapulgite 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 Dinucleotide • Acetone Sodium Bisulfite Disodium Salt Trihydrate • 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 • Cedarwood Essential Oil • Aluminum sulfate • Ceratonia • Aminacrine HCl • Ceresin • Aminoacetic acid • Cetrimide • Ammonia solution, strong • Chlorhexidine Diacetate Hydrate • Ammonium Alginate • Choline magnesium trisalicylate • Ammonium bromide • Chondroitin Sulfate • Ammonium chloride • Chromium glycinate • Ammonium hydroxide • Chrysin • Amylase • Cidofovir • Anise oil • Cocoa butter • Anise seed • Coconut Oil Edible • Argentyn • Coenzyme Q10 • Arginine • Coenzyme Q50 • Aromatic powder • Collagenase • Asafetida • Colophony • Asefetida Tincture • Copper • Asparagus • Copper Bisglycinate • Aspartame 5 Updated July 23, 2018 • Copper Hydrosol • Glutaraldehyde solution • Corn Oil • Glycerol Formal • Corn Starch • Glyceryl Monostearate • Corn Starch and Pregelatinized Starch • Glyceryl Palmitostearate • Cottonseed Oil • Glycofurol • Creatine, Monohydrate • Glydiazinamide • Cucumber Melon Fragrancce • 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 Hydrogen Phosphate • Karaya Gum • Disodium Phosphate • Ketoifen Fumarate • DL-Phenylalanine • Kojic Acid • Docosanol • Lactose Monohydrate • Dodecyl Gallate • Lactose, Monohydrate and Corn Starch • Domperidone • Lactose, Monohydrate and Microcrystalline • Edetate tetrasodium tetrahydrate Cellulose • Ethanolamine • Lactose, Monohydrate and Powdered • Ethyl Lactate Cellulose Lactose, Spray-Dried • Ethylene Vinyl Acetate • Lanolin, Hydrous • Ferric subsulfate • L-Aspartic Acid Sodium Salt • Ferric sulfate hydrate • Lavender Oil • Ferric sulfate solution • L-Carnitine • Folinic acid calcium salt • L-Carnosine • Formoterol Fumarate Dihydrate • L-Citrulline • Fructose and Pregelatinized Starch • L-Cysteine • Gamma Aminobutyric Acid • Lecithin Soya Granular • GHRP-2 • Lecithin Organogel • GHRP-6 • Levomenthol • Ginger root powder • Levulose • Ginko Biloba Standardized Extract • L-Histidine Monohydrochloride, Monohydrate • Gloconic