U.S. flag An official website of the United States government
  1. Home
  2. Animal & Veterinary
  3. Compliance & Enforcement
  4. Unapproved Animal Drugs
  5. Animal Drug Compounding
  6. Bulk Drug Substances Currently Under Review
  1. Animal Drug Compounding

Bulk Drug Substances Currently Under Review

List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species

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
Aluminum hydroxide dog, cat FDA-2018-N-4626-0048
Amikacin dog, cat, horse FDA-2018-N-4626-0032
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
Azaperone horse FDA-2018-N-4626-0013
Azithromycin dog, cat, horse FDA-2018-N-4626-0032
FDA-2018-N-4626-0050
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
Chloramphenicol dog, cat, horse FDA-2018-N-4626-0011
FDA-2018-N-4626-0013
FDA-2018-N-4626-0039
Cidofovir dog, cat FDA-2018-N-4626-0032
FDA-2018-N-4626-0040
Cisapride dog, cat, horse FDA-2018-N-4626-0021
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
Demecarium bromide dog FDA-2018-N-4626-0028
Desmopressin dog, cat, horse FDA-2018-N-4626-0031
Dexamethasone dog, cat, horse FDA-2018-N-4626-0082
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
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
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
Gentamicin dog, cat FDA-2018-N-4626-0032
Guaifenesin horse FDA-2018-N-4626-0028
Hydrocodone bitartrate dog FDA-2018-N-4626-0062
Idoxuridine cat, horse FDA-2018-N-4626-0024
Isoflupredone acetate horse FDA-2018-N-4626-0012
FDA-2018-N-4626-0019
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/Enrofloxacin/Triamcinolone cat FDA-2018-N-4626-0084
L-asparaginase dog, cat FDA-2018-N-4626-0028
FDA-2018-N-4626-0032
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
Mebendazole dog, cat FDA-2018-N-4626-0032
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
Mirtazapine dog, cat FDA-2018-N-4626-0013
Mupirocin dog, cat FDA-2018-N-4626-0033
Nitenpyram dog, cat FDA-2018-N-4626-0033
Oseltamivir dog FDA-2018-N-4626-0033
Oxantel pamoate dog, cat FDA-2018-N-4626-0033
Pentosan polysulfate sodium dog, cat FDA-2018-N-4626-0053
Phenobarbital dog. cat FDA-2018-N-4626-0080
Phenoxybenzamine HCl dog, cat FDA-2018-N-4626-0068
Phenylbutazone horse FDA-2018-N-4626-0028
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
Praziquantel dog, cat, horse FDA-2018-N-4626-0033
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
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, horse FDA-2018-N-4626-0011
FDA-2018-N-4626-0061
Secnidazole dog, cat FDA-2018-N-4626-0033
Sildenafil citrate dog, cat FDA-2018-N-4626-0072
Stanozolol dog, cat FDA-2018-N-4626-0081
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
Triamcinolone acetonide dog, cat, horse FDA-2018-N-4626-0033
Tylosin dog, cat FDA-2018-N-4626-0071
Ursodiol dog, cat, horse FDA-2018-N-4626-0033
FDA-2018-N-4626-0044
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 camelids, carnivores, captive zoo species FDA-2018-N-4626-0054
Azaperone 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
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 tartrate elephants, rhinos, camelids, minor carnivore species, zoo/captive goat species  FDA-2018-N-4626-0013
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 FDA-2018-N-4626-0082
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
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
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 FDA-2018-N-4626-0033
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 FDA-2018-N-4626-0033
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
Xylazine 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 African and North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlife FDA-2018-N-4626-0054
Azaperone African and 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 tartrate African and North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0013
Xylazine African and North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep FDA-2018-N-4626-0028
Back to Top