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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 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
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