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 • • Desoximetasone • Acetate • Acetate • Betamethasone Dipropionate • Dexamethasone Sodium Phosphate • Betamethasone Sodium Phosphate • Dexpanthenol • Biotin • D- • 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 • • 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

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Updated July 23, 2018 • Ephedrine sulfate, USP • Lansoprazole • Epinephrine • Levocetirizine Dihydrochloride • Epinephrine Bitartrate • Hydrochloride • Estradiol Cypionate • Lincomycin HCl • Estradiol • Lorazepam • Estriol • Magnesium Chloride • Ethanol • /Magnesium Sulfate • Ethyl Aminobenzoate Heptahydrate • Etomidate • Malic Acid • Famotidine • Manganese Chloride • Fentanyl Citrate • Mannitol • Finasteride • Medroxyprogesterone Acetate • Fluconazole • Meperidine Hydrochloride (a.k.a. • Pethidine Hydrochloride) • • 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 • 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 • • Labetalol Hydrochloride • Phenoxybenzamine Hydrochloride • Lactic Acid • Phentolamine Mesylate

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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 • • Terbinafine HCl • Prednisolone Acetate • Testosterone • Prilocaine • Testosterone Cypionate • Procainamide HCl • Testosterone Propionate • Hydrochloride • 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 • • 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

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Updated July 23, 2018

503B Category 2: Bulk Drug Substances that Raise Significant Safety Risks

• Germanium sesquioxide

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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 • • 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 acid calcium salt • Lidocaine, Epinephrine, and Tetracaine 6

Updated July 23, 2018

• Linoleic Acid • Methyl nicotinate • L-Ornithin HCl • Methyl salicylate • Loxasperse • Methylbenzethoniuim chloride • L-Triiodothyronine Sodium • Methylcellulose • Lysine • Methylparaben • Magaldrate • Methypyrilene HCl • Magnesium • Miconazole nitrate • Magnesium aluminum silicate • Microcrystalline Cellulose • Magnesium ascorbate • Milk and molasses • Magnesium bisglycinate • Milk of sulfur • Magnesium bisglycinate dihydrate • Milk solids, dried • Magnesium carbonate • Mineral oil and Lanolin Alcohols • Magnesium citrate • Minerals • Magnesium glycinate • Molasses • Magnesium hydroxide • Molybdenum Glycinate • Magnesium oxide • Mono- and di-glycerides • Magnesium salicylate e • Monosodium L-Aspartate • Magnesium stearate • Monosodium Phosphate • Magnesium trisilicate • Mullein • Malt • Mustard oil (alltlishthiocyanate) • Malt soup extract • Mycozyme • Maltodextrin • Myrrh • Manganese Bisglycinate • Myrrh gum tincture • Manganese citrate • Myrrh tincture • Mannitol and • N-Acetyl-D-Glucosamine • MBK • Naphazoline HCl • m-cresol • Natural estrogenic hormone • Meclizine HCl • Neohesperidine Dihydrochalcone • Medium Cream • Nettle • Menfegol • Nickel-pectin • Menthol • Nicotinamide • Menthol/peppermint oil • Nicotinic Acid • Meradimate (menthyl anthranilate) • Nitromersol • Meralein sodium • Non-Fat Dry Milk • Merbromin • Nonylphenoxypoly (ethyleneoxy) • Mercufenol chloride ethanol iodin • Mercuric chloride • Nonylphenxypoly nonoxynol 9 • Mercuric oxide • Noscapine • Mercuric salicylate • Noscapine HCl • Mercuric sulfide • Nutmeg oil • Mercury • Nux vomica extract • Mercury oleate • Nystatin • Mercury sulfide • Obtundia • Mercury, ammoniated • Octinoxate • Metaproterenol sulfate • Octisalate • Methenamine • Octocrylene • Methoxyphenamine HCl • Octoxynol 9 • Methoxypolyoxyethyleneglycol • Octyl Gallate 350 laurate • Octyl triazone 7

Updated July 23, 2018 • Oil of erigeron • Phenylephrine bitratrate • Opium powder • Phenylmercuric Borate • Opium tincture • Phenylmercuric cetate • Organic vegetables • Phenylmercuric nitrate • Orthophosphoric acid • Phenylpropanolamine bitartrate • Ox bile • Phenylpropanolamine HCl • Ox bile extract • Phenylpropanolamine maleate • Oxitriptan • Phenyltoloxamine citrate • Oxybenzone • Phenyltoloxamine dihydrogen citrate • Oxyquinoline • Phenyltoloxamine HCl • Oxytetracycline HCl • Phosphate fluoride • Padimate a • Phosphorated carbohydrate • Padimate o • Phosphoric acid • Pambron • Phosphorus • Pancreatin • Phytolacca • Pancrelipase • Picrotoxin • Panthenol • Pilocarpine Nitrate • Pantothenic acid • Pimobendan • Papain • Pine tar • Papaverine HCl • Pineapple enzymes • Papaya enzymes • Piperazine citrate • Papaya, natural • Piperocaine HCl • Para-chloromercuriphenol • Piperonyl butoxide • Paraffin • Pipsissewa • Paregoric • Piracetam • Parethoxycaine HCl • Piracetam dihydrogen citrate • Parsley • Piscidia erythrina • Passion flower extract • Plantago ovata husks • Patchouli Essential Oil • Plantago seed • Pectin • Poloxamer • Pennyroyal Oil • Poloxamer-iodine complex • Pentylenetetrazole • Poly (DL-Lactic Acid) • Peppermint • Poly(methyl vinyl ether/maleic • Peppermint Oil anhydride) • Peppermint Spirit • Polycarbophil • Pepsin • Polydimethylsiloxane and poloxamer • Peruvian Balsam • 1450 • Petrolatum • Polyethylene Glycol 300 • Phenacaine HCl • Polyethylene Glycol 400 • Phenindamine Tartrate • Polyethylene Glycol 6000 • Pheniramine Maleate • Polyols, liquid • Phenobarbital • Polyoxeythylene laurate • Phenolate sodium • Polysorbate 20 • Phenolphthalein • Polysorbate 80 • Phenoxyacetic acid • Polyvinyl alcohol • Phenyl salicylate • Potash Lye • Phenylalanine • Potassium bicarbonate 8

Updated July 23, 2018 • Potassium bitartrate • Potassium bromide • Potassium carbonate • Resveratrol • Potassium chlorate • Retinoic Acid-All Trans • Potassium citrate • Rhubarb fluid extract • Potassium ferrocyanide • Rhubarb, Chinese • Potassium guaiacolsulfonate • Rice polishings • Potassium hydroxide • Romohydrate • Potassium iodide • Sabadilla, alkaloids • Potassium nitrate • 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 • , human 99% • Propionic acid • Selenium • Propylene glycol • Selenium sulfide • Propylhexedrine • 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 • Pseudoephedrine HCl • Sesame Oil • Pseudoephedrine Sulfate • Sesame Seed • Psyllium • Shark liver oil • Psyllium hydrophilic mucilloid • Shea Butter, Organic • Psyllium seed • Short Chain Fatty Acid • P-T-butyl-m-cresol • Silver Bulk Drug Substance • Pyrantel pamoate • Silver nitrate • Pyrethrum extract • Silver protein mild • Pyridoxine • Silver, colloidal • Pyrilamine maleate • Silver[1] (Canadian_License_Sovereign_) • Pyrithione zinc • Simethicone • Pyrrolidone • Simplgel 30 • Pyruvic Aldehyde 40% Aqueous • Skin protectant 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

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Updated July 23, 2018 • Sodium bromide • Sulfobutylether B-Cyclodextrin • Sodium caprylate • Sulfur • Sodium carbonate • Sulisobenzone • Sodium carboxymethylcellulose • Supposibase-F • Sodium caseinate • T3 Sodium Dilution • Sodium diacetate • Talc • Sodium dichromate • Tannic acid • Sodium dihydrogen phosphate • Tannic acid glycerite • Sodium dihydrogen phosphate • Taraxacum officinale monohydrate • Tartaric acid • Sodium fluoride • Tartrate • Sodium hyaluronate • Tea Tree Oil • Sodium monofluoro phosphate • Teaberry Oil • Sodium nitrate • Terpin hydrate preparations • Sodium octanoate • Tetrafluoroethane • Sodium oleate • Tetrahydrochloride • Sodium para-amino benzoate • Thaumatin • Sodium perborate • Thenyldiamine HCl • Sodium perborate monohydrate • Theobromine Sodium Salicylate • Sodium phosphate dibasic • Theophylline calcium salicylate • Sodium phosphate monobasic • Theophylline sodium glycinate • Sodium potassium tartrate • Theophylline, anhydrous • Sodium priopionate • Theophyllline compound with ethylenediamine • Sodium salicylate • Thiamine mononitrate (vitamin B1) • Sodium sulfide • Thimerosal • Sodium thiosulfate • 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 • Strontium chloride • Tricaprylin • Strychnine • Trichloroacetic Acid • Sublimed sulfur • Triclocarban • Sucrose • Triclosan • Sugars • Triethanolamine • Sulfacetamide sodium • Triglycerides • Sulferated oils of turpentine • Trillium 10

Updated July 23, 2018 • Trilostane • Wax, yellow • Triolein • Wheat germ • Tripelennamine HCl • White ointment • Triple dye • White petrolatum • Triprolidine HCl • Witch hazel (hamamelis water) • Triticum • Witch hazel skin • Trolamine salicylate (triethanolamine • Woodruff salicylate) • Xanthan gum • Tryptophan • Xylometazoline HCl • Turpantine Oil • Yeast • Yeast cell derivative • Turpantine, Venice • Yellow mercuric oxide • Tyrosine • Zinc • Uinolinium bromide • Zinc acetate • Ulose • Zinc caprylate • Undecoylium chlorideiodine complex • Zinc carbonate • Undecylenic acid • Zinc chloride • Uva ursi, extract of • Zinc citrate • Valic acid • Zinc phenol sulfonate • Valine • Zinc picolinate • Vitamin A palmitate • Zinc propionate • Vitamin E • Zinc pyrithione • Vitromersol • Zinc stearate • Water and additives • Zinc sulfide • Water, purified • Zinc undecylenate • Wax, Anionic Emulsifying • Zirconium oxide • Wax, white • Zyloxin

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Updated July 23, 2018

Notice of Updates to Section 503B Categories

The information below describes the updates FDA announced in July 2018 to the categories of bulk drug substances under its interim policy on compounding bulk drug substances under section 503B of the Federal Food, Drug, and Cosmetic Act.

 Categorization into category 1 – nominated with adequate support o 5-methyltetrahydrofolate calcium o Acyclovir o Adapalene o Amantadine HCl o Benzocaine o Betamethasone diproprionate o Brimonidine tartrate o Calcipotriene o Ciclopirox oleate o Cimetidine o Clioquinol o Clobetasol propionate o Coal tar solution o Dapsone o Desoximetasone o Dibucaine HCl o Dipyridamole o Dobutamine HCl o Econazole nitrate o Finasteride o Fluconazole o Fluocinolone acetonide o Fluocinonide o Hydrocortisone o Hydroquinone o Ibuprofen o Imiquimod o Ivermectin o Ketoconazole o Lactic acid o Levocetirizine Dihydrochloride o Metronidazole o Minoxidil o Mometasone furoate o Mupirocin o Nepafenac o Pentoxifylline o Prilocaine o Spironolactone

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Updated July 23, 2018 o Sulfacetamide sodium monohydrate o Tacrolimus o Tazarotene o Terbinafine HCl o Tretinoin  Recategorization from category 3 to category 1 – renominated with adequate support o Allantoin o Ascorbyl palmitate o Azelaic acid o Glycolic acid o Precipitated sulfur o Tolnaftate o Urea o Zinc oxide  Categorization to category 3 – nominated with inadequate support o Papaverine  Removal from category 3 o Bromelain – biologic; ineligible for compounding under section 503B o Scopolamine HBr – duplicate entry  Recategorization from category 3 to category 1 – FDA determined, after further review, that these were nominated with adequate support o Chromic chloride o Cupric sulfate o Magnesium sulfate o Manganese chloride o Mannitol o Metoclopramide HCl o Potassium acetate o Pyridoxine HCl o Sincalide o Succinylcholine chloride o Testosterone cypionate o Theophylline  Recategorization from category 1 to category 3 after 30 calendar days – FDA determined, after further review, that these were nominated with inadequate support1 o Caustic soda (sodium hydroxide) o Choline bitartrate o Cyclopentolate o Papaverine o Potassium Phosphate Tribasic [K3PO4] o Sodium Selenite  Removal from category 1 after 30 calendar days

1 Nominators of these substances have been notified and given an opportunity to provide additional information. Additionally, these substances may be renominated with information sufficient for FDA to evaluate it. Comments and renominations may be submitted to the docket [FDA-2015-N-3469] at www.regulations.gov. These substances will no longer be eligible for the interim policy for Category 1 Substances after they are removed from Category 1. 13

Updated July 23, 2018 o Vanadium – submitted to the wrong docket

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