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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 o Anastrazole o Ciprofloxacin HCl o HCl o Cyclosporine/Cyclosporine A o DHEA (dehydroepiandosterone) o HCl o Dyclonine HCl o o

1 Updated October 31, 2019

503B Category 1: Bulk Drug Substances Under Evaluation

• 5-Methyltetrahydrofolate Calcium • Chromium chloride/ Chromium Chloride • 17-alpha-Hydroxyprogesterone Hexahydrate • • Oleate • Acyclovir • Cimetadine • Adapalene • Ciprofloxacin HCl • Adenosine • Citric Anhydrous • Allantoin • Clindamycin Phosphate • Alpha Lipoic Acid • • Alprostadil • Clobetasol Propionate • Aluminum Chloride Hexahydrate • Hydrochloride • Aluminum potassium • Hydrochloride • HCl • Solution • HCl • Cocaine HCl • Amphotericin B • Cupric Sulfate • Anastrazole • Cyanocobalamin • Arginine Hydrochloride • Hydrochloride • Ascorbic acid • Cyclosporine/Cyclosporine A • Ascorbyl Palmitate • Dapiprazole HCl • Aspartic Acid • • Atenolol • Desoximetasone • sulfate/ Atropine sulfate • Acetate monohydrate • Dexamethasone Sodium Phosphate • Azelaic Acid • Dexpanthenol • • DHEA (dehydroepiandosterone) • • D- • Acetate • • Betamethasone Dipropionate • Dibucaine HCl • Betamethasone Sodium Phosphate • Diclofenac Sodium • Biotin • Diltiazem Hydrochloride • Bismuth Oxide • Dimercapto-1-propanesulfonic acid • Brilliant Blue (DMPS) • Tartrate • Diphenhydramine HCl • sodium (for ophthalmic use) • Diphenylcyclopropenone • maleate, USP • Dipyridamole • • Disulfiram • Bupivacaine Hydrochloride/ Bupivacaine • Dobutamine Hydrochloride Hydrochloride Monohydrate • Dopamine HCl • Caffeine • • Calcipotriene • Dyclonine HCl • Calcium Chloride • Nitrate • Calcium EDTA • Edetate Disodium (EDTA) • • Hydrochloride • Cantharidin • Ephedrine sulfate, USP • Chloroquine Phosphate • Epinephrine • Chlorpheniramine Maleate • Epinephrine Bitartrate • Chloride • Cypionate • Chromic Chloride • Estradiol 2

Updated October 31, 2019 • Estriol • Lincomycin HCl • • L-lysine Hydrochloride • Ethyl Aminobenzoate • • • Lysine Hydrochloride • • Magnesium Chloride • Fentanyl Citrate • /Magnesium Sulfate • Heptahydrate • • Malic Acid • Fluocinolone Acetonide • Manganese Chloride • Fluocinonide • Mannitol • • Medroxyprogesterone Acetate • Propionate • Meperidine Hydrochloride (a.k.a. • Folic Acid Hydrochloride) • • Chloride • Furosemide • / Methionine (L) • • Methylcobalamin/ Methyl B12 • Gentamicin Sulfate • Methylprednisolone Acetate • Glutamic acid • (MSM) • Glutamine • Metoclopramide HCl • • • Glycerin • Hydrochloride • Glycolic Acid • Mineral Oil • Glycopyrrolate/ Glycopyrrolate • • Haloperidol • Mitomycin • sodium • Furoate • sodium salt • Monosodium Glutamate • • Sulfate/ Morphine Sulfate • Hydralazine HCl Pentahydrate • • Moxifloxacin hydrochloride • Hydromorphone Hydrochloride • • • Nalbuphine HCl • Hydrochloride • Hydrochloride Dihydrate • HCl • sulfate • Ibuprofen • Neostigmine Methylsulfate • Hydrochloride • Nepafenac • Imiquimod • • Inositol • Niacinamide • • Nifedipine • • Norepinephrine Bitartrate • • Ondansetron HCl • Hydrochloride • Ornithine Hydrochloride • • HCl • Ketoprofen • Oxytocin • Ketorolac Tromethamine • Pentoxifylline • Labetalol Hydrochloride • • Lactic Acid • Phenoxybenzamine Hydrochloride • Lansoprazole • Phentolamine Mesylate • L-arginine Hydrochloride • HCl • Dihydrochloride • Phytonadione • Hydrochloride • Pitcher Plant

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Updated October 31, 2019 • Podophyllum • • Polidocanol • • 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 • • Precipitated • Taurine • • Tazarotene • Prednisolone Acetate • HCl • Prilocaine • • Procainamide HCl • Testosterone Cypionate • Procaine Hydrochloride • Testosterone Propionate • • Tetracaine Hydrochloride • Hydrochloride • Hydrochloride • Proparacaine HCl • Theophylline • hydrochloride • HCl (vitamin B1) • Prostaglandin E1 • • Pyridoxal 5-Phosphate Monohydrate • • Pyridoxine HCl • Hydrochloride • Remifentanil Hydrochloride • Tretinoin • Riboflavin 5 PO4 • Acetonide • • Triamcinolone diacetate • Ropivacaine Hydrochloride • Tromethamine • • • hydrobromide • Trypan Blue • • • Anhydrous • Vancomycin Hydrochloride • Sodium Ascorbate • Verapamil HCl • • • • Vitamin A acetate • • Vitamin D3 • Sodium Citrate • Ziconotide • Sodium Citrate Dihydrate • 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 Micronized • Attapulgite • Acacia Gum, Spray-Dried Powder • Barosma • Acacia Syrup • Basic Fuchsin • Acesulfame Potassium • Beachwood creosote • Acetanilide • Bean • • • • Betamechlomathasone • Acetone • Beta- Adenine Dinucleotide • Acetyl Hexapeptide-3 • Disodium Salt Trihydrate • Acidophilus Lactobacillus • • 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 • • Calcium Folinate • Aliphatic Polyesters • Calcium glycinate • Almadrate sulfate • Capsules, Empty Gelatin Vegetable • Aloin • Carbamide • Alpha Ketoglutaric acid • Carbazochrome • Alumina Powder, hydrated • • Aluminum acetate • Carbolic Acid • Aluminum chloride • Carbomer 940 • Aluminum phosphate • Caustic Potash • Aluminum sulfate • Caustic Soda () • Aminacrine HCl • Cedarwood Essential Oil • Aminoacetic acid • Ceratonia • solution, strong • Ceresin • Ammonium Alginate • • • Diacetate Hydrate • Ammonium chloride • Choline Bitartrate • Ammonium hydroxide • Choline magnesium trisalicylate • Amylase • 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 • solution • Corn Starch • Formal • Corn Starch and Pregelatinized Starch • Glyceryl Monostearate • Cottonseed Oil • Glyceryl Palmitostearate • , Monohydrate • Glycofurol • Cucumber Melon Fragrancce • Glydiazinamide • • Grape seed oil • Decyl Oleate • Gum Arabic • Decylmethylsulfoxide • Hectorite • Deoxy-D-Glucose • Heptafluoropropane • Desonide • • Diaminopyridine (3,4-) • Hyaluronidase, salt free • Dichloroacetic Acid • sulfate • Difluoroethane • Hydrochloric Acid • Diindolymethane • Hydroxyethylpiperazine Ethane Sulfonic Acid • • Hydroxymethylmethyl • 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 • HCl • Iopanoic Acid • Dinitrochlorobenzene • Glycinate Chelate • Diphenhydramine • Isopropyl Isostearate • Dipropylene Glycol • Kaolin, Colloidal Powder • Disodium Hydrogen Phosphate • Karaya Gum • • 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 • 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- • Gamma Aminobutyric Acid • Soya Granular • GHRP-2 • GHRP-6 • Ginger root powder 7

Updated October 31, 2019 • Lecithin Organogel • Methenamine • Levomenthol • Methoxyphenamine HCl • Levulose • Methoxypolyoxyethyleneglycol • L- Monohydrochloride, 350 laurate Monohydrate • Methyl nicotinate • Lidocaine, Epinephrine, and Tetracaine • Methyl salicylate • Linoleic Acid • Methylbenzethoniuim chloride • L-Ornithin HCl • Methylcellulose • Loxasperse • Methylparaben • L- Sodium • Methypyrilene HCl • Lysine • nitrate • Magaldrate • Microcrystalline Cellulose • Magnesium • Milk and molasses • Magnesium aluminum silicate • Milk of sulfur • Magnesium ascorbate • Milk solids, dried • Magnesium bisglycinate • Mineral oil and Lanolin • Magnesium bisglycinate dihydrate • Minerals • Magnesium carbonate e • Molasses • Magnesium citrate • Molybdenum Glycinate • Magnesium glycinate • Mono- and di-glycerides • Magnesium hydroxide • Monosodium L-Aspartate • Magnesium oxide • • Magnesium salicylate • Mullein • Magnesium stearate • Mustard oil (alltlishthiocyanate) • Magnesium trisilicate • Mycozyme • Malt • Myrrh • Malt soup extract • Myrrh gum tincture • Maltodextrin • Myrrh tincture • Manganese Bisglycinate • N-Acetyl-D-Glucosamine • Manganese citrate • HCl • Mannitol and • Natural estrogenic hormone • MBK • Neohesperidine Dihydrochalcone • m-cresol • Nettle • HCl • Nickel-pectin • Medium Cream • Nicotinamide • Menfegol • Nicotinic Acid • • • Menthol/peppermint oil • Non-Fat Dry Milk • Meradimate (menthyl anthranilate) • Nonylphenoxypoly (ethyleneoxy) ethanol • Meralein sodium iodin • • Nonylphenxypoly nonoxynol 9 • Mercufenol chloride • Noscapine • Mercuric chloride • Noscapine HCl • Mercuric oxide • Nutmeg oil • Mercuric salicylate • Nux vomica extract • Mercuric sulfide • • • Obtundia • Mercury oleate • Octinoxate • • Octisalate • Mercury, ammoniated • Octocrylene • Metaproterenol sulfate • Octoxynol 9 8

Updated October 31, 2019 • Octyl Gallate • Phenylalanine • Octyl triazone • Phenylephrine bitratrate • Oil of erigeron • Phenylmercuric • Opium powder • Phenylmercuric cetate • Opium tincture • • Organic vegetables • bitartrate • Orthophosphoric acid • Phenylpropanolamine HCl • Ox bile • Phenylpropanolamine maleate • Ox bile extract • citrate • Oxitriptan • Phenyltoloxamine dihydrogen citrate • Oxybenzone • Phenyltoloxamine HCl • Oxyquinoline • Phosphate fluoride • Oxytetracycline HCl • Phosphorated carbohydrate • Padimate a • Phosphoric acid • Padimate o • Phosphorus • Pambron • Phytolacca • Pancreatin • Picrotoxin • Pancrelipase • Nitrate • • Pimobendan • • Pine tar • Papain • Pineapple enzymes • Papaverine • Piperazine citrate • Papaverine HCl • Piperocaine HCl • Papaya enzymes • Piperonyl butoxide • Papaya, natural • Pipsissewa • Para-chloromercuriphenol • Piracetam • Paraffin • Piracetam dihydrogen citrate • Paregoric • Piscidia erythrina • Parethoxycaine HCl • Plantago ovata husks • Parsley • Plantago seed • Passion flower extract • Poloxamer • Patchouli Essential Oil • Poloxamer- complex • Pectin • Poly (DL-Lactic Acid) • Pennyroyal Oil • Poly(methyl vinyl ether/maleic anhydride) • Pentylenetetrazole • Polycarbophil • Peppermint • Polydimethylsiloxane and poloxamer • Peppermint Oil • 1450 • Peppermint Spirit • Polyethylene Glycol 300 • Pepsin • Polyethylene Glycol 400 • Peruvian Balsam • Polyethylene Glycol 6000 • Petrolatum • Polyols, liquid • Phenacaine HCl • Polyoxeythylene laurate • Tartrate • Polysorbate 20 • Maleate • Polysorbate 80 • • Polyvinyl • Phenolate sodium • Potash Lye • Phenolphthalein • Potassium bicarbonate • Phenoxyacetic acid • Potassium bitartrate • Phenyl salicylate •

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Updated October 31, 2019 • Potassium carbonate • monoacetate • Potassium chlorate • Resveratrol • Potassium citrate • -All Trans • Potassium ferrocyanide • Rhubarb fluid extract • Potassium guaiacolsulfonate • Rhubarb, Chinese • Potassium hydroxide • Rice polishings • • Romohydrate • Potassium nitrate • Sabadilla, alkaloids • Potassium Phosphate Tribasic [K3PO4] • Saccharin • Potassium salicylate • Sage Oil • Povidone • Salicyl alcohol • Povidone-iodine • Salicylamide • Povidone-vinylacetate copolymers • Salsalate • Powdered Cellulose • Sanguinaria extract • Pracasil Plus • Saponite • Pramoxine HCl • Saw palmetto • Pregnenolone micronized • Sea mineral • Prolase • Secretin, human 99% • Propionic acid • • Propylene glycol • Selenium sulfide • • Senecio aureus • Propylparaben • Senna • Protease • Senna fluid extract • Protein hydrolysate • Senna pod concentrate • Protirelin • Senna syrup • Prune concentrate dehydrate • Sennosides a and b • Prune powder • Serotonin HCl • HCl • Sesame Oil • Pseudoephedrine Sulfate • Sesame Seed • Psyllium • Shark liver oil • Psyllium hydrophilic mucilloid • Shea Butter, Organic • Psyllium seed • Short Chain • P-T-butyl-m-cresol • Bulk Drug Substance • pamoate • • Pyrethrum extract • Silver protein mild • Pyridoxine • Silver, colloidal • Pyrilamine maleate • Silver[1] (Canadian_License_Sovereign_) • zinc • Simethicone • Pyrrolidone • Simplgel 30 • Pyruvic Aldehyde 40% Aqueous • protectant Solution • Sodium • • Sodium 3, 4-dimethylphenyl-glyoxylate • Racemethionine • Sodium acetylsalicylate • Racephpedrine HCl • Sodium aluminum chlorohydroxy lactate • Raffinose • Sodium aspartate • Red petrolatum • Sodium biphosphate • Reosote (Creosote?) • • Resorcinol • Sodium borate 10 Updated October 31, 2019 • Sodium borate monohydrate • • Sulisobenzone • Sodium caprylate • Supposibase-F • • T3 Sodium Dilution • Sodium carboxymethylcellulose • Talc • Sodium caseinate • Tannic acid • Sodium diacetate • Tannic acid glycerite • • Taraxacum officinale • Sodium dihydrogen phosphate • Tartaric acid • Sodium dihydrogen phosphate monohydrate • Tartrate • • • Sodium monofluoro phosphate • Teaberry Oil • • Terpin hydrate preparations • Sodium octanoate • Tetrafluoroethane • Sodium oleate • Tetrahydrochloride • Sodium para-amino benzoate • Thaumatin • • Thenyldiamine HCl • Sodium perborate monohydrate • Theobromine • Sodium phosphate dibasic • Theophylline calcium salicylate • Sodium phosphate monobasic • Theophylline sodium glycinate • Sodium potassium tartrate • Theophylline, anhydrous • Sodium priopionate • Theophyllline compound with • Sodium salicylate ethylenediamine • • Thiamine mononitrate (vitamin B1) • • Thimerosal • Soft Paraffin • Thioctic • Sols, secondary • Thiocyanoacetate • Sorbitol • HCl • Soy meal • Threonine • Soybean oil • Thylene blue • Soybean protein • Thymol • Splenda • Titanium dioxide • Squill preparations • Tolindate • Stannous fluoride • Toltrazuril • Stannous pyrophosphate • Tolu balsam • Stearyl alcohol • Tommy • Stem • Topical starch • Stevia Powder Extract • Tranilast • Strawberry • Triacetin • Strontium chloride • Tricalcium phosphate • Strychnine • Tricaprylin • Sublimed sulfur • Trichloroacetic Acid • Sucrose • • Sugars • • Sulfacetamide sodium • Triethanolamine • Sulferated oils of turpentine • Triglycerides • Sulfobutylether B-Cyclodextrin • Trillium • Sulfur • Trilostane 11 Updated October 31, 2019 • Triolein • Wheat germ • HCl • White ointment • Triple • White petrolatum • HCl • Witch hazel (hamamelis ) • Triticum • Witch hazel skin • Trolamine salicylate (triethanolamine • Woodruff salicylate) • Xanthan gum • Tryptophan • HCl • Turpantine Oil • Yeast • Turpantine, Venice • Yeast derivative • • Yellow mercuric oxide • Uinolinium bromide • Zinc • Ulose • Zinc acetate • Undecoylium chlorideiodine complex • Zinc caprylate • • Zinc carbonate • Uva ursi, extract of • Zinc chloride • Valic acid • Zinc citrate • Valine • Zinc phenol sulfonate • Vitamin A palmitate • Zinc picolinate • Vitamin E • Zinc propionate • Vitromersol • • Water and additives • Zinc stearate • Water, purified • Zinc sulfide • Wax, Anionic Emulsifying • Zinc undecylenate • Wax, white • Zirconium oxide • Wax, yellow • Zyloxin

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