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
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 |
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 |
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 |
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 |
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 |
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 |