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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 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
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