sign in sign up
<<
Home , Azelaic acid, Diiodohydroxyquinoline, Merbromin, Monosodium phosphate, Nitromersol, Phenylmercuric borate

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* Gluconate Phosphatidylcholine Diiodohydroxyquinoline Podophyllum Resin Glucosamine Sulfate Chloride Molybdate Glucosamine Sulfate Sodium Nitroprusside Hydrochloric Acid* /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 “”

1

Updated July 30, 2020

503B Category 1: Bulk Drug Substances Under Evaluation

• 5-Methyltetrahydrofolate • Chromic Chloride • 17-alpha-Hydroxyprogesterone • chloride/ Chromium Chloride • Acetylcysteine Hexahydrate • Acyclovir • Oleate • • Cimetidine • Adenosine • Ciprofloxacin HCl • Allantoin • Citric Acid Anhydrous • Alpha Lipoic Acid • Citrulline/L-Citrulline • Alprostadil • • Aluminum Chloride Hexahydrate • • Aluminum potassium sulfate • Clobetasol Propionate • Amantadine HCl • Clomipramine Hydrochloride • Amitriptyline HCl • Clonidine Hydrochloride • • Coal Tar • Anastrazole • Cocaine HCl • Arginine Hydrochloride • • Ascorbic acid • Cupric Sulfate • Ascorbyl Palmitate • Cyanocobalamin • Aspartic Acid • Cyclobenzaprine Hydrochloride • Atenolol • Cyclosporine/Cyclosporine A • Atropine sulfate/ Atropine sulfate • Dapiprazole HCl monohydrate • • 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 • Sodium • Brilliant Blue • Diiodohyroxyquinolone • Brimonidine Tartrate • Diltiazem Hydrochloride • 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 • • Dopamine HCl • Calcium EDTA • Droperidol • • Dyclonine HCl • Cantharidin • Nitrate • Chloroquine Phosphate • Edetate Disodium (EDTA) • Chlorpheniramine Maleate • Ephedrine Hydrochloride • Choline Chloride • Ephedrine sulfate, USP 2

Updated July 30, 2020 • Epinephrine • • Epinephrine Bitartrate • Tromethamine • Cypionate • Labetalol Hydrochloride • Estradiol • • Estriol • Lansoprazole • • L-arginine Hydrochloride • Ethyl Aminobenzoate • Levocetirizine Dihydrochloride • Etomidate • Hydrochloride • Famotidine • Lincomycin HCl • Fentanyl Citrate • L-Lysine • • L-lysine Hydrochloride • Fluconazole • Lorazepam • Fluocinolone Acetonide • L-Proline • Fluocinonide • Lysine Hydrochloride • • Chloride • Fluticasone Propionate • /Magnesium Sulfate • Folic Acid Heptahydrate • Formaldehyde • Malic Acid • Furosemide • Manganese Chloride • Gabapentin • Mannitol • Gentamicin Sulfate • Medroxyprogesterone Acetate • Glucosamine Sulfate • 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 • • (MSM) • Glycopyrrolate/ Glycopyrrolate Bromide • Metoclopramide HCl • Haloperidol • • Heparin sodium • Midazolam Hydrochloride • Hyaluronic acid sodium • Oil • Hydralazine HCl • Minoxidil • Hydrochloric Acid • Mitomycin • Hydrocortisone • Mometasone Furoate • Hydromorphone Hydrochloride • Monosodium Glutamate • • Morphine Sulfate/Morphine Sulfate • Hydroxocobalamin Hydrochloride Pentahydrate • Hydroxychloroquine Sulfate • Moxifloxacin hydrochloride • Hydroxyzine HCl • • • Nalbuphine HCl • Ibutamoren Mesylate • Naloxone Hydrochloride Dihydrate • Imipramine Hydrochloride • sulfate • Imiquimod • Neostigmine Methylsulfate • Inositol • Nepafenac • Iodoform • Niacin • Itraconazole • Niacinamide • Ivermectin • Nifedipine • Ketamine Hydrochloride • Norepinephrine Bitartrate • • Ondansetron HCl 3

Updated July 30, 2020 • Hydrochloride • Sodium Molybdate • Oxymetazoline HCl • Sodium Nitroprusside • Oxytocin • Sodium phosphate/ Sodium Phosphate • Papaverine Hydrochloride Monobasic Anhydrous • Pentoxifylline • Sodium Selenite/Sodium Selenite • Pentahydrate • Phenoxybenzamine Hydrochloride • Sodium Tetradecyl Sulfate • Phentolamine Mesylate • Sodium thiosulfate • Phenylephrine HCl • • Phosphatidylcholine • Squaric acid dibutyl ester • Phytonadione • Succinylcholine Chloride • Pitcher Plant • Succinylcholine Chloride Dihydrate • Podophyllum/Podophyllum Resin • Sufentanil Citrate • Polidocanol • Sodium Monohydrate • Polymyxin B Sulfate • Sulfan Blue • Potassium Acetate • Tacrolimus • Potassium chloride • • Potassium Phosphate Monobasic • [KH2PO4] • Terbinafine HCl • Potassium Phosphate Dibasic [K2HPO4]/ • Potassium Phosphate Dibasic Anhydrous • Testosterone Cypionate • Precipitated • Testosterone Propionate • Prednisolone • Tetracaine Hydrochloride • Prednisolone Acetate • Hydrochloride • Prilocaine • Theophylline • Procainamide HCl • Thiamine HCl (vitamin B1) • Procaine Hydrochloride • Thymol iodide • Progesterone • Tolnaftate • Promethazine Hydrochloride • Tramadol Hydrochloride • Proparacaine HCl • • Propranolol hydrochloride • Triamcinolone Acetonide • 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 • • • Vancomycin Hydrochloride • Scopolamine hydrobromide • Verapamil HCl • Sincalide • Vecuronium Bromide • Sodium Acetate Anhydrous • Vitamin A acetate • Sodium Ascorbate • Vitamin D3 • Sodium Benzoate • Ziconotide • Sodium Bicarbonate • Oxide • Sodium Chloride • • 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 , Micronized • Barosma • Acacia Gum, Spray-Dried Powder • Basic Fuchsin • Acacia Syrup • Beachwood creosote • Acesulfame Potassium • Bean • • • • Betamechlomathasone • Acetone • Beta- Adenine • Acetone Sodium Bisulfite Dinucleotide • Acetyl Hexapeptide-3 • • 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 () • Aluminum sulfate • Cedarwood Essential Oil • Aminacrine HCl • Ceratonia • Aminoacetic acid • Ceresin • Ammonia solution, strong • • Ammonium Alginate • Diacetate Hydrate • Ammonium bromide • Choline Bitartrate • • 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 • Corn Oil 6

Updated July 30, 2020 • Corn Starch • solution • Corn Starch and Pregelatinized Starch • 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 • Heptafluoropropane • Diaminopyridine (3,4-) • Hexetidine • Dichloroacetic Acid • Hyaluronidase, salt free • Difluoroethane • Hydrazine sulfate • 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 • Glycinate Chelate • Diphenhydramine • Isopropyl Isostearate • Dipropylene Glycol • Kaolin, Colloidal Powder • Disodium Hydrogen Phosphate • Karaya Gum • • Ketoifen Fumarate • Disodium Salt Trihydrate • Kojic Acid • DL-Phenylalanine • Lactose Monohydrate • Docosanol • Lactose, Monohydrate and Corn Starch • Dodecyl Gallate • Lactose, Monohydrate and Microcrystalline • Domperidone Cellulose • Edetate tetrasodium tetrahydrate • Lactose, Monohydrate and Powdered Cellulose • Ethanolamine Lactose, Spray-Dried • Ethyl Lactate • Lanolin, Hydrous • Ethylene Vinyl Acetate • L-Aspartic Acid Sodium Salt • Ferric subsulfate • Lavender Oil • Ferric sulfate hydrate • L-Carnitine • Ferric sulfate solution • L-Carnosine • Folinic acid calcium salt • L-Cysteine • Formoterol Fumarate Dihydrate • Lecithin Soya Granular • Fructose and Pregelatinized Starch • Lecithin Organogel • Gamma Aminobutyric Acid • Levomenthol • GHRP-2 • Levulose • GHRP-6 • L-Histidine Monohydrochloride, Monohydrate • Ginger root powder • Lidocaine, Epinephrine, and Tetracaine • Ginko Biloba Standardized Extract • • Gloconic acid calcium salt • L-Ornithin HCl 7

Updated July 30, 2020 • Loxasperse • • L-Triiodothyronine Sodium • Methylbenzethoniuim chloride • Lysine • Methylcellulose • Magaldrate • Methylparaben • Magnesium • Methypyrilene HCl • Magnesium aluminum silicate • nitrate • Magnesium ascorbate • Microcrystalline Cellulose • Magnesium bisglycinate • Milk and molasses • Magnesium bisglycinate dihydrate • Milk of sulfur • Magnesium carbonate • Milk solids, dried • • Mineral oil and Lanolin • • Minerals • • Molasses • • Molybdenum Glycinate • • Mono- and di-glycerides • Magnesium stearate • Monosodium L-Aspartate • Magnesium trisilicate • • Malt e • Mullein • Malt soup extract • Mustard oil (alltlishthiocyanate) • Maltodextrin • Mycozyme • Manganese Bisglycinate • Myrrh • Manganese citrate • Myrrh gum tincture • Mannitol and sorbitol • Myrrh tincture • MBK • N-Acetyl-D-Glucosamine • m-cresol • Naphazoline HCl • Meclizine HCl • Natural estrogenic • Medium Cream • Neohesperidine Dihydrochalcone • Menfegol • Nettle • Menthol • Nickel-pectin • Menthol/peppermint oil • Nicotinamide • Meradimate (menthyl anthranilate) • Nicotinic Acid • Meralein sodium • • • Non-Fat Dry Milk • Mercufenol chloride • Nonylphenoxypoly (ethyleneoxy) ethanol • Mercuric chloride iodin • Mercuric oxide • Nonylphenxypoly nonoxynol 9 • Mercuric salicylate • Noscapine • Mercuric sulfide • Noscapine HCl • • Nutmeg oil • Mercury oleate • Nux vomica extract • • • Mercury, ammoniated • Obtundia • Metaproterenol sulfate • Octinoxate • Methenamine • Octisalate • Methoxyphenamine HCl • Octocrylene • Methoxypolyoxyethyleneglycol • Octoxynol 9 350 laurate • Octyl Gallate • Methyl nicotinate • Octyl triazone 8

Updated July 30, 2020 • Oil of erigeron • Phenylmercuric cetate • Opium powder • • Opium tincture • Phenylpropanolamine bitartrate • Organic vegetables • Phenylpropanolamine HCl • Orthophosphoric acid • Phenylpropanolamine maleate • Ox bile • Phenyltoloxamine citrate • Ox bile extract • Phenyltoloxamine dihydrogen citrate • Oxitriptan • Phenyltoloxamine HCl • Oxybenzone • Phosphate fluoride • Oxyquinoline • Phosphorated carbohydrate • HCl • • Padimate a • • Padimate o • Phytolacca • Pambron • Picrotoxin • Pancreatin • Pilocarpine Nitrate • Panthenol • Pimobendan • Pantothenic acid • Pine tar • Papain • Pineapple enzymes • Papaverine • Piperazine citrate • Papaya enzymes • Piperocaine HCl • Papaya, natural • Piperonyl butoxide • Para-chloromercuriphenol • Pipsissewa • Paraffin • Piracetam • Paregoric • Piracetam dihydrogen citrate • Parethoxycaine HCl • Piscidia erythrina • Parsley • Plantago ovata husks • Passion flower extract • Plantago seed • Patchouli Essential Oil • Poloxamer • Pectin • Poloxamer- complex • Pennyroyal Oil • Poly (DL-Lactic Acid) • Pentylenetetrazole • Poly(methyl vinyl ether/maleic anhydride) • Peppermint • Polycarbophil • Peppermint Oil • Polydimethylsiloxane and poloxamer • Peppermint Spirit • 1450 • Pepsin • Polyethylene Glycol 300 • Peruvian Balsam • Polyethylene Glycol 400 • Petrolatum • Polyethylene Glycol 6000 • Phenacaine HCl • Polyols, liquid • Phenindamine Tartrate • Polyoxeythylene laurate • Pheniramine Maleate • Polysorbate 20 • Phenobarbital • Polysorbate 80 • Phenolate sodium • Polyvinyl alcohol • Phenolphthalein • Potash Lye • Phenoxyacetic acid • • Phenyl salicylate • • Phenylalanine • Potassium bromide • Phenylephrine bitratrate • Potassium carbonate • • Potassium chlorate 9

Updated July 30, 2020 • • Rhubarb fluid extract • Potassium ferrocyanide • Rhubarb, Chinese • Potassium guaiacolsulfonate • Rice polishings • Potassium hydroxide • Romohydrate • • Sabadilla, alkaloids • Potassium nitrate • Saccharin • Potassium Phosphate Tribasic [K3PO4] • Sage Oil • Potassium salicylate • Salicyl alcohol • Povidone • • Povidone-iodine • • Povidone-vinylacetate copolymers • Sanguinaria extract • Powdered Cellulose • Saponite • Pracasil Plus • Saw palmetto • Pramoxine HCl • Sea mineral • Pregnenolone micronized • Secretin, human 99% • Prolase • • Propionic acid • Selenium sulfide • Propylene glycol • Senecio aureus • Propylhexedrine • Senna • Propylparaben • Senna fluid extract • Protease • Senna pod concentrate • Protein hydrolysate • Senna syrup • Protirelin • Sennosides a and b • Prune concentrate dehydrate • Serotonin HCl • Prune powder • Sesame Oil • Pseudoephedrine HCl • Sesame Seed • Pseudoephedrine Sulfate • Shark liver oil • Psyllium • Shea Butter, Organic • Psyllium hydrophilic mucilloid • Short Chain • Psyllium seed • Bulk Drug Substance • P-T-butyl-m-cresol • • Pyrantel pamoate • Silver protein mild • Pyrethrum extract • Silver, colloidal • Pyridoxine • Silver[1] (Canadian_License_Sovereign_) • Pyrilamine maleate • Simethicone • Pyrithione zinc • Simplgel 30 • Pyrrolidone • protectant • Pyruvic Aldehyde 40% Aqueous Solution • Sodium • Quinine • Sodium 3, 4-dimethylphenyl-glyoxylate • Racemethionine • Sodium acetylsalicylate • Racephpedrine HCl • Sodium aluminum chlorohydroxy lactate • Raffinose • Sodium aspartate • Red petrolatum • Sodium biphosphate • Reosote (Creosote?) • Sodium bisulfate • Resorcinol • Sodium borate • Resorcinol monoacetate • Sodium borate monohydrate • • • Retinoic Acid-All Trans • Sodium caprylate 10

Updated July 30, 2020 • Sodium carbonate • Tannic acid • Sodium carboxymethylcellulose • Tannic acid glycerite • Sodium caseinate • Taraxacum officinale • Sodium diacetate • Tartaric acid • Sodium dichromate • Tartrate • Sodium dihydrogen phosphate • • Sodium dihydrogen phosphate monohydrate • Teaberry Oil • • Terpin hydrate preparations • Sodium monofluoro phosphate • Tetrafluoroethane • Sodium nitrate • Tetrahydrochloride • Sodium octanoate • Thaumatin • Sodium oleate • Thenyldiamine HCl • Sodium para-amino benzoate • Theobromine • Sodium perborate • Theophylline calcium salicylate • Sodium perborate monohydrate • Theophylline sodium glycinate • Sodium phosphate dibasic • Theophylline, anhydrous • Sodium phosphate monobasic • Theophyllline compound with • Sodium potassium tartrate ethylenediamine • Sodium priopionate • Thiamine mononitrate (vitamin B1) • Sodium salicylate • Thimerosal • Sodium sulfide • Thioctic • Soft Paraffin • Thiocyanoacetate • Sols, secondary • Thonzylamine HCl • Sorbitol • Threonine • Soy meal • Thylene blue • Soybean oil • Thymol • Soybean protein • Titanium dioxide • Splenda • Tolindate • Squill preparations • Toltrazuril • Stannous fluoride • Tolu balsam • Stannous pyrophosphate • Tommy gel • Stearyl alcohol • Topical starch • Stem bromelain • Tranilast • Stevia Powder Extract • Triacetin • Strawberry • Tricalcium phosphate • chloride • Tricaprylin • Strychnine • • Sublimed sulfur • • Sucrose • Triethanolamine • Sugars • Triglycerides • Sulfacetamide sodium • Trillium • Sulferated oils of turpentine • • Sulfobutylether B-Cyclodextrin • Triolein • Sulfur • Tripelennamine HCl • Sulisobenzone • Triple dye • Supposibase-F • Triprolidine HCl • T3 Sodium Dilution • Triticum • Talc 11

Updated July 30, 2020 • Trolamine salicylate (triethanolamine • Witch hazel (hamamelis water) salicylate) • Witch hazel skin • Tryptophan • Woodruff • Turpantine Oil • Xanthan gum • Turpantine, Venice • Xylometazoline HCl • Tyrosine • • Uinolinium bromide • Yeast cell derivative • Ulose • Yellow mercuric oxide • Undecoylium chlorideiodine complex • Zinc • Undecylenic acid • • Uva ursi, extract of • Zinc caprylate • Valic acid • Zinc carbonate • Valine • Zinc chloride • Vitamin A palmitate • Zinc citrate • Vitamin E • Zinc phenol sulfonate • Vitromersol • Zinc picolinate • Water and additives • Zinc propionate • Water, purified • Zinc pyrithione • Wax, Anionic Emulsifying • Zinc stearate • Wax, white • Zinc sulfide • Wax, yellow • Zinc undecylenate • germ • Zirconium oxide • White ointment • Zyloxin • White petrolatum

12