Two documents, five lists. Each with its date.
What does each list mean?
The regulation names what is on the 503A bulks list and what FDA decided to leave off. The categories document sorts the rest of the nominations while FDA evaluates them.
| List | What it means, in FDA's terms | Where it is printed |
|---|---|---|
| On the 503A bulks list6 names | Named in the regulation as a bulk drug substance that can be used in compounding under section 503A(b)(1)(A)(i)(III). | 21 CFR 216.23(a) Regulation, last amended March 21, 2019 |
| Evaluated and not included4 names | Named in the regulation as a substance FDA evaluated and decided not to include on the 503A bulks list. | 21 CFR 216.23(b) Regulation, last amended March 21, 2019 |
| Category 149 names | FDA: may be eligible for the list and nominated with enough support to evaluate. Under the interim policy FDA does not intend to take action when all four circumstances it lists are present. It is not the 503A bulks list. | FDA's categories document Updated May 14, 2026, as printed |
| Category 26 names | FDA: nominated with enough support to evaluate, but FDA has identified significant safety risks in compounding, and the interim policy for Category 1 does not reach it. | FDA's categories document Updated May 14, 2026, as printed |
| Category 3311 names | FDA: nominated without enough supporting information for FDA to evaluate. It can be nominated again with that information. The interim policy for Category 1 does not reach it. | FDA's categories document Updated May 14, 2026, as printed |
A name can have a lawful route without appearing here at all: a substance that meets a USP or NF monograph, or is a component of a drug marketed under an FDA application, needs no list. Names with a recorded route of that kind, or on 21 CFR 216.23(a), link to a page of their own.
Every name, as FDA prints it. 376 rows.
Where does a substance stand?
Type part of a name to find it. Spelling, capitals and slashes are FDA's own, so search the way the document prints it.
Showing all 376 names.
| Name, as printed | List or category |
|---|---|
| On the 503A bulks list, 21 CFR 216.23(a) 6 names | |
| Brilliant Blue G, also known as Coomassie Brilliant Blue G-250 | On the list, 21 CFR 216.23(a) A route is recorded; see its page |
| Cantharidin (for topical use only) | On the list, 21 CFR 216.23(a) A route is recorded; see its page |
| Diphenylcyclopropenone (for topical use only) | On the list, 21 CFR 216.23(a) A route is recorded; see its page |
| N-acetyl-D-glucosamine (for topical use only) | On the list, 21 CFR 216.23(a) A route is recorded; see its page |
| Squaric acid dibutyl ester (for topical use only) | On the list, 21 CFR 216.23(a) A route is recorded; see its page |
| Thymol iodide (for topical use only) | On the list, 21 CFR 216.23(a) A route is recorded; see its page |
| Evaluated and not included, 21 CFR 216.23(b) 4 names | |
| Oxitriptan | Not included, 21 CFR 216.23(b) |
| Piracetam | Not included, 21 CFR 216.23(b) |
| Silver Protein Mild | Not included, 21 CFR 216.23(b) |
| Tranilast | Not included, 21 CFR 216.23(b) |
| Category 1: under evaluation 49 names | |
| 7 Keto Dehydroepiandrosterone | Category 1 |
| Acetyl L Carnitine/Acetyl-L- carnitine Hydrochloride | Category 1 |
| Alanyl-L-Glutamine | Category 1 |
| Aloe Vera/ Aloe Vera 200:1 Freeze Dried | Category 1 |
| Alpha Lipoic Acid | Category 1 |
| Ammonium Tetrathiomolybdate | Category 1 |
| Artemisia/Artemisinin | Category 1 |
| Astragalus Extract 10:1 | Category 1 |
| Boswellia | Category 1 |
| Choline Chloride | Category 1 |
| Chondroitin Sulfate | Category 1 |
| Chrysin | Category 1 |
| Coenzyme Q10 | Category 1 |
| Creatine Monohydrate | Category 1 |
| Curcumin | Category 1 |
| Deoxy-D-Glucose | Category 1 |
| Dichloroacetate | Category 1 |
| Diindolylmethane | Category 1 |
| Dimercapto-1- propanesulfonic acid (DMPS) | Category 1 |
| EGCg | Category 1 |
| Enclomiphene Citrate | Category 1 |
| Ferric Subsulfate | Category 1 |
| GHK-Cu (except for injectable routes of administration) | Category 1 |
| Glutaraldehyde | Category 1 |
| Glutathione | Category 1 |
| Glycolic Acid | Category 1 |
| Glycyrrhizin | Category 1 |
| Kojic Acid | Category 1 |
| L-Citrulline | Category 1 |
| L-Theanine | Category 1 |
| Melatonin | Category 1 |
| Methylcobalamin | Category 1 |
| Methylsulfonylmethane (MSM) | Category 1 |
| Nettle leaf (Urtica dioica subsp. dioica leaf) | Category 1 |
| Nicotinamide Adenine Dinucleotide (NAD) | Category 1 |
| Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH) | Category 1 |
| Pregnenolone | Category 1 |
| Pyridoxal 5-Phosphate Monohydrate | Category 1 |
| Pyruvic Acid | Category 1 |
| Quercetin/Quercetin Dihydrate | Category 1 |
| Quinacrine Hydrochloride (except for intrauterine administration) | Category 1 |
| Resveratrol | Category 1 |
| Ribose (D) | Category 1 |
| Rubidium Chloride | Category 1 |
| Tea tree oil (Melaleuca alternifolia leaf oil) | Category 1 |
| Trichloroacetic Acid | Category 1 |
| Ubiquinol 30% Powder | Category 1 |
| Vanadium | Category 1 |
| Vasoactive Intestinal Peptide | Category 1 |
| Category 2: significant safety risks 6 names | |
| Cesium Chloride | Category 2 |
| Domperidone | Category 2 |
| Germanium Sesquioxide | Category 2 |
| Ibutamoren Mesylate | Category 2 |
| Kisspeptin-10 | Category 2 |
| Quinacrine Hydrochloride for intrauterine administration | Category 2 |
| Category 3: nominated without adequate support 311 names | |
| Acetanilide | Category 3 |
| Adenosine-5-triphosphate disodium salt | Category 3 |
| Alcloxa | Category 3 |
| Aldioxa | Category 3 |
| Aldosterone | Category 3 |
| Alfalfa | Category 3 |
| Alfalfa leaves | Category 3 |
| Almadrate sulfate | Category 3 |
| Aloin | Category 3 |
| Alpha Ketoglutaric acid | Category 3 |
| Alumina Powder, hydrated | Category 3 |
| Aluminum phosphate | Category 3 |
| Aluminum phosphate, Adjuvant | Category 3 |
| Aminacrine Hydrochloride | Category 3 |
| Ammonium bromide | Category 3 |
| Ammonium hydroxide | Category 3 |
| Anise seed | Category 3 |
| Argentyn | Category 3 |
| Aromatic powder | Category 3 |
| Asafetida | Category 3 |
| Asafetida tincture | Category 3 |
| Asclepias tuberosa | Category 3 |
| Asparagus | Category 3 |
| Attapulgite | Category 3 |
| Barosma | Category 3 |
| Bean | Category 3 |
| Beechwood creosote | Category 3 |
| Betamechlomathasone | Category 3 |
| Beta-Nicotinamide Adenine Dinucleotide Disodium Salt Trihydrate | Category 3 |
| Bichloroacetic acid/ Dichloroacetic acid | Category 3 |
| Calcium Folinate | Category 3 A route is recorded; see its page |
| Calcium Glycinate | Category 3 |
| Capsaicin palmitate | Category 3 |
| Carbazochrome | Category 3 |
| Carbimazole | Category 3 |
| Carbolic Acid | Category 3 |
| Carbomer Gel - Aqueous | Category 3 |
| Carbomer Gel - Hydroalcoholic | Category 3 |
| Cedarwood Essential Oil | Category 3 |
| Chlorhexidine Diacetate Hydrate | Category 3 |
| Choline bitartrate | Category 3 |
| Choline magnesium trisalicylate | Category 3 |
| Chromium glycinate | Category 3 |
| Cibinetide (ARA-290) | Category 3 |
| Coenzyme Q50 | Category 3 |
| Copper | Category 3 |
| Magnesium ascorbate | Category 3 |
| Copper Bisglycinate | Category 3 |
| Copper Hydrosol | Category 3 |
| DL-Phenylalanine | Category 3 |
| Decylmethylsulfoxide | Category 3 |
| Diaminopyridine (3,4-) | Category 3 |
| Dimethyl Ketone | Category 3 |
| Dimethylaminoethanol Bitartrate | Category 3 |
| Dimethylglycine Hydrochloride | Category 3 |
| Dinitrochlorobenzene | Category 3 |
| Edetate tetrasodium tetrahydrate | Category 3 |
| Ethanolamine | Category 3 |
| Folinic Acid Calcium Salt | Category 3 |
| Fructose and Pregelatinized Starch | Category 3 |
| Gamma Aminobutyric Acid | Category 3 |
| GHRP-2 | Category 3 |
| GHRP-6 | Category 3 |
| Ginger root powder | Category 3 |
| Ginkgo Biloba Standardized Extract | Category 3 |
| Gluconic acid calcium salt | Category 3 |
| Glycerol Formal | Category 3 |
| Glydiazinamide | Category 3 |
| Grape seed oil | Category 3 |
| Gum Arabic | Category 3 |
| Heart-leaf nettle leaf (Urtica chamaedryoides leaf) | Category 3 |
| Hyaluronic Acid Sodium Salt | Category 3 |
| Hydrazine sulfate | Category 3 |
| Iodochlorhydroxyquin | Category 3 |
| Indigo Carmine | Category 3 |
| Indole-3-carbinol | Category 3 |
| Inositol Hexanicotinate | Category 3 |
| Iron Glycinate Chelate | Category 3 |
| Karaya Gum | Category 3 |
| L-Carnosine | Category 3 |
| L-Ornithine Hydrochloride | Category 3 |
| Levulose | Category 3 |
| L-Histidine Monohydrochloride, Monohydrate | Category 3 |
| Lactose, Monohydrate and Corn Starch | Category 3 |
| Lactose, Monohydrate and Microcrystalline Cellulose | Category 3 |
| Lactose, Monohydrate and Powdered Cellulose | Category 3 |
| Lactose, spray dried | Category 3 |
| L-Aspartic Acid Sodium Salt | Category 3 |
| Levomenthol | Category 3 |
| Liquid Paraffin | Category 3 A route is recorded; see its page |
| Lysine aspirin | Category 3 |
| Natural estrogenic hormone | Category 3 |
| Magnesium bisglycinate | Category 3 |
| Magnesium bisglycinate dehydrate | Category 3 |
| Magnesium glycinate | Category 3 |
| Magnesium glycinate 15% | Category 3 |
| Malt | Category 3 |
| Malt soup extract | Category 3 |
| Maltodextrin | Category 3 |
| Manganese Bisglycinate | Category 3 |
| Manganese citrate | Category 3 |
| m-cresol | Category 3 |
| Mechano growth factor (MGF) | Category 3 |
| Menfegol | Category 3 |
| Menthol/peppermint oil | Category 3 |
| Meralein sodium | Category 3 |
| Merbromin | Category 3 |
| Mercufenol chloride | Category 3 |
| Mercuric chloride | Category 3 |
| Mercuric oxide | Category 3 |
| Mercuric salicylate | Category 3 |
| Mercuric sulfide, red/Mercury sulfide | Category 3 |
| Mercury | Category 3 |
| Mercury-containing ingredient | Category 3 |
| Mercury oleate | Category 3 |
| Methapyrilene fumarate | Category 3 |
| Methapyrilene Hydrochloride | Category 3 |
| Methoxyphenamine Hydrochloride | Category 3 |
| Methoxypolyoxyethyleneglycol 350 laurate | Category 3 |
| Methyl nicotinate | Category 3 |
| Milk and molasses | Category 3 |
| Milk of sulfur | Category 3 |
| milk solids, dried | Category 3 |
| Mineral Oil and Lanolin Alcohols | Category 3 |
| Molasses | Category 3 |
| Myrrh gum tincture | Category 3 |
| Monosodium L-Aspartate | Category 3 |
| Mullein | Category 3 |
| Molybdenum Glycinate | Category 3 |
| Mycozyme | Category 3 |
| Myrrh tincture | Category 3 |
| Mustard oil (alltlishthiocyanate) | Category 3 |
| Phenyltoloxamine dihydrogen citrate | Category 3 |
| Phenyltoloxamine Hydrochloride | Category 3 |
| Phosphate fluoride | Category 3 |
| Phosphorated carbohydrate | Category 3 |
| Phosphorus | Category 3 |
| Phytolacca | Category 3 |
| Picrotoxin | Category 3 |
| Pimobendan | Category 3 A route is recorded; see its page |
| Pine tar | Category 3 |
| Piperocaine Hydrochloride | Category 3 |
| Nickel-pectin | Category 3 |
| Non-Fat Dry Milk | Category 3 |
| Nonylphenoxypoly (ethyleneoxy) ethanol iodine | Category 3 |
| Nonylphenoxypoly nonoxynol 9 | Category 3 |
| Noscapine Hydrochloride | Category 3 |
| Nutmeg oil | Category 3 |
| Nux vomica extract | Category 3 |
| Obtundia | Category 3 |
| Octyl triazone | Category 3 |
| Oil of erigeron | Category 3 |
| Organic vegetables | Category 3 |
| Orthophosphoric acid | Category 3 |
| Ox bile | Category 3 |
| Ox bile extract | Category 3 |
| Oxyquinoline | Category 3 |
| Padimate a | Category 3 |
| Pambron | Category 3 |
| Pantothenic acid | Category 3 |
| Papaya enzymes | Category 3 |
| Papaya, natural | Category 3 |
| P-T-butyl-m-cresol | Category 3 |
| Para-chloromercuriphenol | Category 3 |
| Parethoxycaine Hydrochloride | Category 3 |
| Parsley | Category 3 |
| Passion flower extract | Category 3 |
| Pennyroyal Oil | Category 3 |
| Pentylenetetrazole | Category 3 |
| Peppermint Oil and Sage Oil | Category 3 |
| Peruvian balsam (Myroxylon balsamum var. pereirae balsam) | Category 3 |
| Peruvian balsam oil | Category 3 |
| Petrolatum and Lanolin Alcohols | Category 3 |
| Phenacaine Hydrochloride | Category 3 |
| Phenindamine Tartrate | Category 3 |
| Phenolate sodium | Category 3 |
| Phenolphthalein | Category 3 |
| Phenoxyacetic acid | Category 3 |
| Phenyl salicyiate (Salol) | Category 3 |
| Phenyl salicylate | Category 3 |
| Shark liver oil | Category 3 |
| Shark liver oil (combination only) | Category 3 |
| Skin protectant | Category 3 |
| Senecio aureus | Category 3 |
| Senna syrup | Category 3 |
| Serotonin Hydrochloride | Category 3 |
| Sesame Seed | Category 3 |
| Short Chain Fatty Acid | Category 3 |
| Silver (see also argentyn) | Category 3 |
| Silver, colloidal | Category 3 |
| Sodium | Category 3 |
| Pipsissewa | Category 3 |
| Piracetam dihydrogen citrate | Category 3 |
| Piscidia erythrina | Category 3 |
| Plantago ovata husks | Category 3 |
| Poloxamer-iodine complex | Category 3 |
| Polydimethylsiloxane and poloxamer | Category 3 |
| Polyols, liquid | Category 3 |
| Polyoxeythylene laurate | Category 3 |
| Potash Lye | Category 3 |
| Potassium chlorate | Category 3 |
| Potassium ferrocyanide | Category 3 |
| Potassium salicylate | Category 3 |
| Povidone-vinylacetate copolymers | Category 3 |
| Prolase | Category 3 |
| Protease | Category 3 |
| Prune concentrate dehydrate | Category 3 |
| Prune powder | Category 3 |
| Psyllium hydrophillic mucilloid | Category 3 |
| Pyruvic aldehyde | Category 3 |
| Pyruvic Aldehyde 40% Aqueous Solution | Category 3 |
| Racephedrine hydrochloride | Category 3 |
| Red petrolatum | Category 3 |
| Reosote | Category 3 |
| Rhubarb fluid extract | Category 3 |
| Rhubarb, Chinese | Category 3 |
| Rice pollishings | Category 3 |
| Romohydrate | Category 3 |
| Sabadilla, alkaloids | Category 3 |
| Sage oil | Category 3 |
| Salicyl alcohol | Category 3 |
| Sanguinaria extract | Category 3 |
| Saw palmetto | Category 3 |
| Scopolamine aminoxide Hydrobromide | Category 3 |
| Sea mineral | Category 3 |
| Secretin, human 99% | Category 3 |
| Selenium | Category 3 |
| Theophylline calcium salicylate | Category 3 |
| Thiocyanoacetate | Category 3 |
| Thonzylamine Hydrochloride | Category 3 |
| Thylene blue | Category 3 |
| Thymulin acetate | Category 3 |
| Tolindate | Category 3 |
| Toltrazuril | Category 3 |
| Tolu preparations | Category 3 |
| Tricalcium phosphate | Category 3 |
| Triethanolamine | Category 3 |
| Trillium | Category 3 |
| Triple dye | Category 3 |
| Triticum | Category 3 |
| Turpentine Oil | Category 3 |
| Sodium 3, 4-dimethylphenyl-glyoxylate | Category 3 |
| Sodium acetylsalicylate | Category 3 |
| Sodium aluminum chlorohydroxy lactate | Category 3 |
| Sodium aspartate | Category 3 |
| Sodium biphosphate | Category 3 |
| Sodium bisulfate | Category 3 |
| Sodium borate monohydrate | Category 3 |
| Sodium caseinate | Category 3 |
| Sodium diacetate | Category 3 |
| Sodium dichromate | Category 3 |
| Sodium dihydrogen phosphate monohydrate | Category 3 |
| Sodium Hydroxide 1N | Category 3 |
| Sodium nitrate | Category 3 |
| Sodium octanoate | Category 3 |
| Sodium oleate | Category 3 |
| Sodium para-amino benzoate | Category 3 |
| Sodium perborate | Category 3 |
| Sodium perborate monohydrate | Category 3 |
| Sodium phosphate | Category 3 A route is recorded; see its page |
| Sodium salicylic acid phenolate | Category 3 |
| Sodium potassium tartrate | Category 3 |
| Soft Paraffin | Category 3 |
| Sols, secondary | Category 3 |
| Soy meal | Category 3 |
| Soybean protein | Category 3 |
| Stannous pyrophosphate and zinc citrate | Category 3 |
| Stevia Powder Extract | Category 3 |
| Strychnine | Category 3 |
| Sucros | Category 3 |
| Sugars | Category 3 |
| Sulferated oils of turpentine | Category 3 |
| Squill preparations | Category 3 |
| Sulfobutylether B-Cyclodextrin | Category 3 |
| Tannic acid glycerite | Category 3 |
| Taraxacum officinale | Category 3 |
| Tartrate (acid or salt) | Category 3 |
| Tetrahydrochloride | Category 3 |
| Thenyldiamine Hydrochloride | Category 3 |
| Theobromine Sodium Salicylate | Category 3 |
| Turpentine Oil (oral) | Category 3 |
| Turpentine Oil (rectified) | Category 3 |
| Turpentine Oil (spirits of turpentine) | Category 3 |
| Turpentine Oil (spirits of turpentine, oral) | Category 3 |
| Turpentine Oil (spirits of turpentine, topical) | Category 3 |
| Turpentine, Venice | Category 3 |
| Uinolinium bromide | Category 3 |
| Ulose | Category 3 |
| Uva ursi, extract of | Category 3 |
| Uva ursi, potassium extract | Category 3 |
| Valic acid | Category 3 |
| Vegetable (green) | Category 3 |
| Verapamil | Category 3 |
| Vitamin A acetate | Category 3 |
| Vitromersol | Category 3 |
| Wax, Anionic Emulsifying | Category 3 |
| Wheat germ | Category 3 |
| Wheat germ (triticum aestivum/vulgare extract) | Category 3 |
| White ointment | Category 3 |
| Woodruff | Category 3 |
| Yeast | Category 3 |
| Yellow mercuric oxide | Category 3 |
| Zinc | Category 3 |
| Zinc caprylate | Category 3 |
| Zinc citrate | Category 3 |
| Zinc phenol sulfonate | Category 3 |
| Zinc picolinate | Category 3 |
| Zinc propionate | Category 3 |
| Zinc sulfide | Category 3 |
| Zirconium oxide | Category 3 |
| Zyloxin | Category 3 |
As printed by FDA on May 14, 2026, not a ruling. FDA's three categories are its interim policy for nominated substances, not the 503A bulks list. FDA's guidance says of itself that it contains nonbinding recommendations.
What changed, and when. Kept from October 21, 2026.
What has FDA changed?
Each day FDA's file is fetched and compared by its SHA-256 fingerprint. New bytes are read in full; a reading that is not whole is never shown, and the last good copy stays.
| Date | What changed | Source |
|---|---|---|
| October 21, 2026 | First reading of FDA's document as printed on May 14, 2026: 49 names in Category 1, 6 in Category 2 and 311 in Category 3. | FDA, updated May 14, 2026 |
FDA explains its latest change in its own words at the top of its document, updated May 14, 2026. FDA keeps no earlier versions; the dated entries above are this page's own record.
Watch the list. One email when it changes.
How do I hear about a change?
Leave an email for the whole list or for one substance. You confirm once; after that an email is sent only when FDA's document changes for what you watch.
As printed, not a ruling. The pharmacist decides.
How should this page be read?
As a dated copy of what FDA printed. It reads the documents; it decides nothing about a preparation.
The three doors. Section 503A names three routes for a bulk substance: it meets a USP or NF monograph, or it is a component of a drug marketed under an FDA application, or it is on the list FDA develops through regulations (21 U.S.C. 353a(b)(1)(A)(i)). The list is the third door only.
Advice is not the list. A vote of FDA's Pharmacy Compounding Advisory Committee (PCAC) is advice to FDA. The 503A bulks list is developed through regulations (21 U.S.C. 353a(b)(1)(A)(i)(III) and (c)) and printed at 21 CFR 216.23, so it changes only by rulemaking.
The categories. FDA's three categories are its interim policy for nominated substances, not the 503A bulks list. FDA's guidance says of itself that it contains nonbinding recommendations. For Category 1, FDA lists four circumstances under which it does not intend to take action, among them that every manufacturer is registered and that the substance comes with a valid certificate of analysis.
The other conditions. A route through any door still leaves the rest of section 503A: a registered maker, a valid certificate of analysis for each bulk substance, and the conditions on the preparation itself.
Whether a substance may be compounded is the pharmacist's call, on the facts of the preparation. This page reads FDA's documents; it decides nothing. Veritura reads documents. It does not test material.
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A substance, the maker its certificate names and the lot: each source with the date it was read, on one page you can print and file with the lot.