Bulk Drug Substances Currently Under Review
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
Bulk Drug Substances Reviewed and Not Listed
These bulk drug substances are currently being evaluated by FDA. While these evaluations are being completed, the agency generally intends to refrain from taking enforcement action when these bulk drug substances are used to compound a finished drug in a state-licensed pharmacy or federal facility or by a state-licensed veterinarian as described in the initial nomination.
Once the evaluation for a given bulk drug substance has been fully completed, those found to meet the criteria for inclusion on a list will be removed from the “Currently Under Review” status and will be added to the appropriate list for nonfood-producing animals, food-producing animals, or free-ranging wildlife species. Those bulk drug substances that are not found to meet the criteria for inclusion on a list will be designated as “Bulk Drug Substances Reviewed and Not Listed.”
FDA will accept nominations of additional bulk drug substances at any time and will continue to review nominations and update lists. For information on how to submit a bulk drug substance nomination, see the appendix to Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.
DOGS, CATS, HORSES
NONFOOD-PRODUCING MINOR SPECIES
FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES
DOGS, CATS, HORSES
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Acepromazine maleate | dog, cat, horse | FDA-2018-N-4626-0114 |
| Acetyl-D-glucosamine | dog, horse | FDA-2018-N-4626-0104 |
| Actinomycin D | dog, cat | FDA-2018-N-4626-0106 |
| Altrenogest | horse | FDA-2018-N-4626-0101 |
| Aluminum hydroxide | dog, cat | FDA-2018-N-4626-0048 |
| Amantadine | dog, horse | FDA-2018-N-4626-0136 |
| Amikacin | dog, cat, horse | FDA-2018-N-4626-0032 |
| Aminocaproic acid | dog, horse | FDA-2018-N-4626-0107 |
| Aminopentamide sulfate | dog, cat | FDA-2018-N-4626-0017 |
| Aminophylline | dog, cat | FDA-2018-N-4626-0069 |
| Amitriptyline HCl | dog, cat | FDA-2018-N-4626-0018 |
| Amlodipine besylate | dog, cat | FDA-2018-N-4626-0011 FDA-2018-N-4626-0013 FDA-2018-N-4626-0084 |
| Apomorphine HCl | dog | FDA-2018-N-4626-0020 |
| Atenolol | dog, cat | FDA-2018-N-4626-0041 |
| Atipamezole | horse | FDA-2018-N-4626-0054 |
| Atovaquone | dog, cat | FDA-2018-N-4626-0146 |
| Azaperone | horse | FDA-2018-N-4626-0013 |
| Azithromycin | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0050 |
| Azithromycin/rifampin | dog, cat, horse | FDA-2018-N-4626-0090 |
| Benazepril HCl | dog, cat | FDA-2018-N-4626-0091 |
| Betamethasone dipropionate | dog, cat, horse | FDA-2018-N-4626-0032 |
| Budesonide | dog, cat | FDA-2018-N-4626-0045 |
| Buprenorphine | dog, cat, horse | FDA-2018-N-4626-0014 FDA-2018-N-4626-0038 |
| Butorphanol tartrate | dog, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Cetirizine HCl | dog, cat, horse | FDA-2018-N-4626-0111 |
| Chlorambucil | dog, cat | FDA-2018-N-4626-0123 |
| Chloramphenicol | dog, cat, horse | FDA-2018-N-4626-0011 FDA-2018-N-4626-0013 FDA-2018-N-4626-0039 |
| Chlorpheniramine maleate | dog, cat | FDA-2018-N-4626-0139 |
| Cidofovir | dog, cat | FDA-2018-N-4626-0032 FDA-2018-N-4626-0040 |
| Cimetidine | dog, cat, horse | FDA-2018-N-4626-0135 |
| Cisapride | dog, cat, horse | FDA-2018-N-4626-0021 |
| Cisplatin | horse | FDA-2018-N-4626-0112 |
| Clarithromycin/rifampin | dog, cat, horse | FDA-2018-N-4626-0100 |
| Clenbuterol HCl | horse | FDA-2018-N-4626-0066 |
| Clindamycin HCl | dog, cat | FDA-2018-N-4626-0042 |
| Clomipramine HCl | dog, cat | FDA-2018-N-4626-0058 |
| Clopidogrel bisulfate | dog, cat, horse | FDA-2018-N-4626-0013 |
| Corticotropin (ACTH) | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0055 |
| Cyclophosphamide | dog, cat, horse | FDA-2018-N-4626-0063 |
| Cyclosporine | dog, cat, horse | FDA-2018-N-4626-0030 FDA-2018-N-4626-0032 |
| Cyclosporine/tacrolimus | dog | FDA-2018-N-4626-0108 |
| Cyproheptadine HCl | dog, cat, horse | FDA-2018-N-4626-0102 |
| Dantrolene sodium | dog, cat, horse | FDA-2018-N-4626-0095 |
| Decoquinate | dog, horse | FDA-2018-N-4626-0126 |
| Decoquinate/levamisole HCl | horse | FDA-2018-N-4626-0125 |
| Demecarium bromide | dog | FDA-2018-N-4626-0028 |
| Desmopressin | dog, cat, horse | FDA-2018-N-4626-0031 |
| Dexamethasone | dog, cat, horse horse |
FDA-2018-N-4626-0082 FDA-2018-N-4626-0098 |
| Diazoxide | dog | FDA-2018-N-4626-0096 |
| Diclazuril | dog, cat, horse | FDA-2018-N-4626-0109 |
| Diethylstilbestrol (DES) | dog | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Doxycycline | dog, cat, horse | FDA-2018-N-4626-0011 FDA-2018-N-4626-0015 |
| Doxycycline/clindamycin | dog | FDA-2018-N-4626-0116 |
| Enalapril maleate | dog, cat | FDA-2018-N-4626-0049 |
| Enrofloxacin | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0016 FDA-2018-N-4626-0019 FDA-2018-N-4626-0032 |
| Enrofloxacin/ketoconazole/triamcinolone | dog, cat | FDA-2018-N-4626-0099 |
| Estrone | horse | FDA-2018-N-4626-0117 |
| Famciclovir | cat | FDA-2018-N-4626-0056 |
| Famotidine | dog, cat, horse | FDA-2018-N-4626-0052 |
| Fluconazole | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0059 |
| Flunixin | horse | FDA-2018-N-4626-0025 |
| Fluoxetine HCl | dog, cat, horse | FDA-2018-N-4626-0043 |
| Flurbiprofen | dog, cat | FDA-2018-N-4626-0034 |
| Furosemide | dog, cat, horse | FDA-2018-N-4626-0076 |
| Gabapentin | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0051 FDA-2018-N-4626-0084 |
| Gabapentin/trazodone HCl | dog, cat | FDA-2018-N-4626-0128 |
| Gentamicin | dog, cat | FDA-2018-N-4626-0032 FDA-2018-N-4626-0093 |
| Guaifenesin | horse | FDA-2018-N-4626-0028 |
| Hydrocodone bitartrate | dog | FDA-2018-N-4626-0062 |
| Hydroxyzine HCl | dog, cat, horse | FDA-2018-N-4626-0115 |
| Idoxuridine | cat, horse | FDA-2018-N-4626-0024 |
| Isoflupredone acetate | horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Isoxsuprine HCl | horse | FDA-2018-N-4626-0092 |
| Itraconazole | horse | FDA-2018-N-4626-0011 |
| Itraconazole with DMSO | horse | FDA-2018-N-4626-0028 |
| Ketoconazole | dog, cat, horse | FDA-2018-N-4626-0032 FDA-2018-N-4626-0035 |
| Ketoconazole/chloramphenicol/triamcinolone | dog, cat | FDA-2018-N-4626-0131 |
| Ketoconazole/Enrofloxacin/Triamcinolone | cat | FDA-2018-N-4626-0084 |
| Ketoconazole/gentamicin/triamcinolone | dog, cat | FDA-2018-N-4626-0137 |
| Ketoconazole/mupirocin/triamcinolone | dog, cat | FDA-2018-N-4626-0140 |
| Ketoconazole/ofloxacin/triamcinolone | dog, cat | FDA-2018-N-4626-0138 |
| L-asparaginase | dog, cat | FDA-2018-N-4626-0028 FDA-2018-N-4626-0032 |
| Levamisole HCl | dog, cat, horse | FDA-2018-N-4626-0103 |
| Levetiracetam | dog, cat, horse | FDA-2018-N-4626-0064 |
| Lomustine | dog, cat | FDA-2018-N-4626-0067 |
| Marbofloxacin | dog, cat | FDA-2018-N-4626-0070 |
| Maropitant | dog, cat | FDA-2018-N-4626-0134 |
| Mebendazole | dog, cat | FDA-2018-N-4626-0032 |
| Mechlorethamine HCl | dog, cat | FDA-2018-N-4626-0105 |
| Meloxicam | dog, cat | FDA-2018-N-4626-0013 FDA-2018-N-4626-0029 FDA-2018-N-4626-0046 |
| Methimazole | cat | FDA-2018-N-4626-0011 FDA-2018-N-4626-0013 |
| Metoclopramide HCl | dog, cat, horse | FDA-2018-N-4626-0077 |
| Metronidazole benzoate | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Minocycline HCl | dog, cat, horse | FDA-2018-N-4626-0124 |
| Mirtazapine | dog, cat | FDA-2018-N-4626-0013 |
| Misoprostol | dog, cat, horse | FDA-2018-N-4626-0127 |
| Mitotane | dog | FDA-2018-N-4626-0144 |
| Mupirocin | dog, cat | FDA-2018-N-4626-0033 |
| Neomycin/tetracaine/triamcinolone | dog, cat, horse | FDA-2018-N-4626-0120 |
| Nitenpyram | dog, cat | FDA-2018-N-4626-0033 |
| Omeprazole | dog, cat | FDA-2018-N-4626-0145 |
| Oseltamivir | dog | FDA-2018-N-4626-0033 |
| Oxantel pamoate | dog, cat | FDA-2018-N-4626-0033 |
| Oxantel pamoate/praziquantel/pyrantel pamoate | dog, cat | FDA-2018-N-4626-0130 |
| Penicillamine | dog, cat | FDA-2018-N-4626-0141 |
| Pentosan polysulfate sodium | dog, cat | FDA-2018-N-4626-0053 |
| Pentoxifylline | dog, cat, horse | FDA-2018-N-4626-0119 |
| Pergolide mesylate | horse | FDA-2018-N-4626-0129 |
| Phenobarbital | dog. cat | FDA-2018-N-4626-0080 |
| Phenoxybenzamine HCl | dog, cat | FDA-2018-N-4626-0068 |
| Phenylbutazone | horse | FDA-2018-N-4626-0028 |
| Phenylpropanolamine | dog, cat | FDA-2018-N-4626-0087 |
| Pimobendan | dog, cat | FDA-2018-N-4626-0013 |
| Piroxicam | dog, cat, horse | FDA-2018-N-4626-0068 |
| Ponazuril | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 FDA-2018-N-4626-0073 |
| Potassium bromide | dog, horse | FDA-2018-N-4626-0073 |
| Potassium chloride | dog, cat | FDA-2018-N-4626-0118 |
| Praziquantel | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0086 |
| Praziquantel/pyrantel pamoate | dog, cat | FDA-2018-N-4626-0133 |
| Prazosin | dog, cat | FDA-2018-N-4626-0033 FDA-2018-N-4626-0083 FDA-2018-N-4626-0084 |
| Prednisolone | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0036 FDA-2018-N-4626-0074 |
| Prednisone | dog | FDA-2018-N-4626-0075 |
| Pregabalin | dog, cat | FDA-2018-N-4626-0089 |
| Protirelin acetate (thyrotropin-releasing hormone) | horse | FDA-2018-N-4626-0047 |
| Pyrantel pamoate | dog, cat, horse | FDA-2018-N-4626-0033 |
| Pyrimethamine | dog, cat, horse | FDA-2018-N-4626-0078 |
| Reserpine | horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Rifampin | dog, cat | FDA-2018-N-4626-0061 |
| Romifidine HCl | horse | FDA-2018-N-4626-0113 |
| Ronidazole | dog, cat | FDA-2018-N-4626-0142 |
| Secnidazole | dog, cat | FDA-2018-N-4626-0033 |
| Sildenafil citrate | dog, cat | FDA-2018-N-4626-0072 |
| Sodium bromide | dog | FDA-2018-N-4626-0088 |
| Spironolactone | dog, cat | FDA-2018-N-4626-0143 |
| Stanozolol | dog, cat | FDA-2018-N-4626-0081 |
| Sucralfate | dog, cat, horse | FDA-2018-N-4626-0097 |
| Tacrolimus | dog | FDA-2018-N-4626-0023 |
| Theophylline | dog, cat | FDA-2018-N-4626-0033 FDA-2018-N-4626-0037 |
| Thyrotropin releasing hormone | horse | FDA-2018-N-4626-0084 |
| Toceranib phosphate | dog, cat | FDA-2018-N-4626-0079 |
| Tolazoline HCl | horse | FDA-2018-N-4626-0028 |
| Toltrazuril | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Tramadol | dog, cat, horse | FDA-2018-N-4626-0012 FDA-2018-N-4626-0033 FDA-2018-N-4626-0065 |
| Trazodone HCl | dog, cat, horse | FDA-2018-N-4626-0110 |
| Triamcinolone acetonide | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0094 |
| Tylosin | dog, cat | FDA-2018-N-4626-0071 |
| Ursodiol | dog, cat, horse | FDA-2018-N-4626-0033 FDA-2018-N-4626-0044 |
| Voriconazole | dog, cat, horse | FDA-2018-N-4626-0122 |
| Xylazine | horse | FDA-2018-N-4626-0028 |
| Yohimbine HCl | dog, cat, horse | FDA-2018-N-4626-0013 |
| Zonisamide | dog, cat | FDA-2018-N-4626-0057 |
NONFOOD-PRODUCING MINOR SPECIES
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Aluminum hydroxide | rodents, small mammals | FDA-2018-N-4626-0048 |
| Amikacin | bird, reptile, snake, turtle/tortoise, guinea pig, chinchilla, hamster, rat, mouse, fish | FDA-2018-N-4626-0032 |
| Amitriptyline HCl | bird | FDA-2018-N-4626-0018 |
| Apomorphine HCl | ferret | FDA-2018-N-4626-0020 |
| Atipamezole | African hoof stock, camelids, carnivores, captive zoo species | FDA-2018-N-4626-0054 |
| Azaperone | African hoof stock, camelids, minor carnivore spp., and small mammals | FDA-2018-N-4626-0013 |
| Azithromycin | guinea pigs, birds, captive exotic and zoo species | FDA-2018-N-4626-0050 |
| Azithromycin/rifampin | bird | FDA-2018-N-4626-0090 |
| Buprenorphine | large cats, bears, small exotic mammal pets, rodents, ferrets, primates, marine mammals, large zoo animals, avian, reptiles, small animals, various exotic and zoo species | FDA-2018-N-4626-0014 FDA-2018-N-4626-0038 |
| Butorphanol/azaperone/medetomidine (BAM) | African hoof stock, camelids, carnivores, feral horses, and small mammals | FDA-2018-N-4626-0085 |
| Butorphanol tartrate | African hoof stock, elephants, rhinos, camelids, minor carnivore species, zoo/captive goat species | FDA-2018-N-4626-0013 |
| Chlorambucil | ferret | FDA-2018-N-4626-0123 |
| Chloramphenicol | avian, small mammals | FDA-2018-N-4626-0039 |
| Cisapride | rodents, other small mammals and marine mammals | FDA-2018-N-4626-0021 |
| Clindamycin HCl | avian, ferret, reptiles, assorted exotic and zoo species | FDA-2018-N-4626-0042 |
| Clomipramine HCl | avian | FDA-2018-N-4626-0058 |
| Corticotropin (ACTH) | bird | FDA-2018-N-4626-0032 FDA-2018-N-4626-0055 |
| Cyclophosphamide | ferret | FDA-2018-N-4626-0063 |
| Dexamethasone | ferret, rodents camelids |
FDA-2018-N-4626-0082 FDA-2018-N-4626-0098 |
| Diazoxide | ferret, guinea pig, small mammals | FDA-2018-N-4626-0096 |
| Doxycycline | rodents, small mammals, birds, reptiles, other exotic and zoo animals | FDA-2018-N-4626-0015 |
| Enalapril maleate | ferret, bird | FDA-2018-N-4626-0049 FDA-2018-N-4626-0084 |
| Enrofloxacin | birds (raptors, Psittaciformes, pet birds, etc.), ferrets, rodents, and small mammals, reptiles, assorted exotic and zoo species | FDA-2018-N-4626-0016 FDA-2018-N-4626-0032 FDA-2018-N-4626-0084 |
| Famotidine | small animal | FDA-2018-N-4626-0052 |
| Fluconazole | bird, exotics, small mammal, exotics, captive zoo species, reptile | FDA-2018-N-4626-0032 FDA-2018-N-4626-0059 |
| Flunixin | ferrets, rodents, chinchillas, small mammals, zoo, exotic, and wildlife species | FDA-2018-N-4626-0025 |
| Furosemide | ferret, small mammals, bird, reptile | FDA-2018-N-4626-0076 |
| Gabapentin | avian, exotics, zoo animals | FDA-2018-N-4626-0051 |
| Hydroxyzine HCl | bird, ferret | FDA-2018-N-4626-0115 |
| Isoxsuprine HCl | bird | FDA-2018-N-4626-0092 |
| Ketoconazole | bird, exotics, zoo species, rodents, reptiles, small animals | FDA-2018-N-4626-0032 FDA-2018-N-4626-0035 |
| Marbofloxacin | avian, reptiles, assorted captive exotic and zoo species | FDA-2018-N-4626-0070 |
| Meloxicam | birds, rats, mice, gerbils, hamsters, other small mammals, marine mammals, large zoo animals and captive wildlife, ferrets, reptiles, assorted exotic and zoo animals | FDA-2018-N-4626-0029 FDA-2018-N-4626-0046 |
| Metoclopramide HCl | small mammals | FDA-2018-N-4626-0077 |
| Metronidazole benzoate | small mammals, exotic species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Metronidazole | minor species: avian or other wildlife species | FDA-2018-N-4626-0084 |
| Oxantel pamoate/praziquantel/pyrantel pamoate | ferret, reptile | FDA-2018-N-4626-0130 |
| Penicillamine | avian | FDA-2018-N-4626-0141 |
| Piroxicam | small mammals | FDA-2018-N-4626-0068 |
| Ponazuril | small mammals, reptiles, assorted exotic species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Praziquantel | camelids, avian, rodents, small mammals, ferrets, snakes, amphibians, tortoises captive exotic and zoo species, small mammals, avian, rodents |
FDA-2018-N-4626-0033 FDA-2018-N-4626-0086 |
| Praziquantel/pyrantel pamoate | ferret, reptile | FDA-2018-N-4626-0133 |
| Prednisolone | avian, rodents, small mammals, reptiles, other exotic and zoo species | FDA-2018-N-4626-0074 |
| Prednisone | avian, rodents, small mammals | FDA-2018-N-4626-0075 |
| Pyrantel pamoate | donkeys, llama, avian, rodents, small mammals, reptiles | FDA-2018-N-4626-0033 FDA-2018-N-4626-0132 |
| Pyrimethamine | avian, exotics | FDA-2018-N-4626-0078 |
| Sildenafil citrate | assorted exotic and captive zoo species | FDA-2018-N-4626-0072 |
| Sodium chloride/edetate disodium | captive marine mammals | FDA-2018-N-4626-0028 |
| Stanozolol | small mammals | FDA-2018-N-4626-0081 |
| Toltrazuril | small mammals, reptiles, camelids, assorted large and small exotic/zoo species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 |
| Tramadol HCl | avian, sea turtle, ungulates, small mammals, reptiles, captive zoo and exotic species | FDA-2018-N-4626-0012 FDA-2018-N-4626-0019 FDA-2018-N-4626-0033 FDA-2018-N-4626-0065 |
| Tylosin | ferrets, exotic and captive zoo species | FDA-2018-N-4626-0071 |
| Ursodiol | bird | FDA-2018-N-4626-0044 |
| Voriconazole | bird | FDA-2018-N-4626-0122 |
| Xylazine | African hoof stock, zoo species including camelids, minor carnivore spp., goats, and small mammals | FDA-2018-N-4626-0028 |
| Yohimbine HCl | small mammals, zoo/captive bird species, pet birds, captive swine species, llama, large and small exotic/zoo species | FDA-2018-N-4626-0013 |
FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES
| Bulk Drug Substance (BDS) | Species | Nomination |
|---|---|---|
| Alpha-chloralose | Sandhill Cranes | CVM-initiated internal review |
| Atipamezole | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlife | FDA-2018-N-4626-0054 |
| Azaperone | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, free-ranging goat species | FDA-2018-N-4626-0013 |
| Buprenorphine | wildlife species | FDA-2018-N-4626-0014 |
| Butorphanol/azaperone/medetomidine (BAM) | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and small mammals | FDA-2018-N-4626-0085 |
| Butorphanol tartrate | North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep | FDA-2018-N-4626-0013 |
| Xylazine | North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep | FDA-2018-N-4626-0028 |