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 | Dosage form(s) | Strength/concentration |
|---|---|---|---|
| Aminopentamide sulfate | dog, cat | oral suspension | 0.2 – 0.4 mg/ml |
| capsule/tablet | 0.2 – 0.4 mg | ||
| injection | 0.5 mg/ml | ||
| transdermal gel | 2-4 mg/ml | ||
| Amitriptyline HCl | dog, cat | oral solution | 1 – 100 mg/ml |
| oral suspension | 2.5 – 20 mg/ml | ||
| oral paste | 10 mg/ml | ||
| oral gel/paste | 10 – 150 mg/ml | ||
| tablet, catnip scented | 5 mg | ||
| soft chewable treat | 2 – 50 mg | ||
| transdermal gel | 14 – 240 mg/ml | ||
| Amlodipine besylate | dog, cat | oral solution | 0.125 – 12.5 mg/ml |
| oral suspension | 0.4 – 15 mg/ml | ||
| oral paste | 2.5 mg/ml | ||
| capsule | 0.2 mg – 6.75 mg | ||
| tablet | 0.625 – 1.25 mg | ||
| soft chewable treat | 0.3 – 3.6 mg | ||
| transdermal gel | 2.5 – 100 mg/ml | ||
| Apomorphine HCl | dog | solution for injection | 1 – 6 mg/ml |
| Azaperone | horse | solution for injection | 50 mg/ml |
| Buprenorphine | dog, horse | injectable polymeric matrix solution | 0.5 – 10 mg/ml ER |
| Butorphanol tartrate | dog | capsules | 0.25 – 10 mg |
| oral suspension | 0.5 – 20 mg/ml | ||
| oral oil suspension | 0.5 – 20 mg/ml | ||
| soft chewable treat | 1 – 10 mg | ||
| tablet | 1 – 10 mg | ||
| Butorphanol tartrate | horse | aqueous injection | 30 mg/ml, 50 mg/ml vial |
| Chloramphenicol | horse | oral suspension | 15 – 500 mg/ml |
| oral paste | 100 – 500 mg/ml | ||
| oral powder | 10 g powder | ||
| topical ointment | 1% | ||
| ophthalmic ointment/solution | 1% | ||
| Cisapride | dog, cat, horse | capsule | 0.5 – 40 mg |
| soft chewable treat | 1 – 25 mg | ||
| transdermal gel | 5 – 150 mg/ml | ||
| tablet | 2.5 – 10 mg | ||
| oral suspension | 0.1 – 90 mg/ml | ||
| oral paste | 2.5 – 25 mg/ml | ||
| oral powder | 0.5 – 40 mg | ||
| Clopidogrel bisulfate | dog, cat, horse | oral suspension | 2.5 – 200 mg/ml |
| capsule | 2 - 40 mg | ||
| transdermal gel | 180 – 187.5 mg/ml | ||
| tablet | 18.75 mg | ||
| soft chewable treat | 4 – 37.5 mg | ||
| Cyclosporine | horse | ophthalmic ointment | 1-2% |
| Demecarium bromide | dog | ophthalmic solution | 0.125 - 0.25% |
| Diethylstilbestrol (DES) | dog | capsule | 0.02-10 mg |
| soft chewable treat | 0.06 -5 mg | ||
| oral solution | 0.1– 5 mg/ml | ||
| tablet | 0.5 – 1 mg | ||
| Doxycycline | dog, cat, horse | capsule | 5 – 750 mg |
| soft chewable treat | 10 – 350 mg | ||
| oral paste | 50 – 500 mg/ml | ||
| oral powder | 1.8 – 10 gm/dose | ||
| otic suspension | 1% | ||
| tablet, flavored | 50 – 400 mg | ||
| tablet, unflavored | 25 – 200 mg | ||
| oral granule | 1.25 - 9.2 gm/dose | ||
| oral suspension (as calcium) | 1 – 333 mg/ml | ||
| oral suspension | 50 mg/ml | ||
| Enrofloxacin | horse | oral paste | 100 - 300 mg/ml |
| oral powder | 500 mg/dose – 6 gm/dose | ||
| oral suspension | 100 - 400 mg/ml | ||
| Enrofloxacin | dog, cat | capsule | 15 – 860 mg |
| soft chewable treat/gummy | 10 – 408 mg | ||
| oral gel | 150 – 280 mg/ml | ||
| oral suspension | 0.5 – 400 mg/ml | ||
| oral paste | 5 – 100 mg/ml | ||
| otic ointment/gel/suspension | 0.5-5% | ||
| tablet | 204 mg | ||
| Flunixin | horse | capsule | 125 - 300 mg |
| oral granules | 250 mg/dose | ||
| oral paste | 10 - 50 mg/ml | ||
| oral powder packet | 250 - 500 mg/dose | ||
| otic solution/suspensions | 0.25 - 1% | ||
| topical gel/ointment/solution | 1% | ||
| Gabapentin | dog, cat | oral suspension | 50 mg/ml |
| Guaifenesin | horse | solution for injection | 50 mg/ml (5%) |
| Idoxuridine | cat, horse | ophthalmic solution | 0.1 - 0.5% |
| ophthalmic ointment | 0.1 - 0.5% | ||
| Isoflupredone acetate | horse | aqueous suspension for injection | 2 mg/ml |
| Itraconazole | horse | oral paste | 300 mg/ml |
| Itraconazole with DMSO | horse | ophthalmic ointment and solution | 1%/10% |
| L-asparaginase | dog, cat | powder for reconstitution | 10,000 units/vial |
| Meloxicam | horse | oral paste | 80-100 mg/ml |
| oral powder | 100-900 mg/scoop | ||
| oral suspension | 68 -100 mg/ml | ||
| Methimazole | cat | capsule | 0.6 - 7.5 mg |
| soft chewable treat | 0.625 – 20 mg | ||
| tablets, flavored | 2.5 – 10 mg | ||
| oral paste | 2.5 – 100 mg/ml | ||
| oral suspension | 1 – 60 mg/ml | ||
| oral solution | 2.5 – 25 mg/ml | ||
| transdermal gel | 2 – 200 mg/ml | ||
| Metronidazole benzoate | dog, cat, horse | oral suspension | 1 – 250 mg/ml |
| oral powder | 500 mg/dose – 20 gm/dose | ||
| oral paste | 50 – 500 mg/ml | ||
| soft chewable treat | 18 – 250 mg | ||
| tablets | 25 – 250 mg | ||
| Mirtazapine | dog, cat | capsule | 0.5 – 3.75 mg |
| soft chewable treat | 1 – 3.75 mg | ||
| transdermal gel | 5 – 150 mg/ml | ||
| oral suspension | 0.5 – 37.7 mg/ml | ||
| oral paste | 1.875 mg/ml | ||
| tablet | 1 – 3.75 mg | ||
| Pimobendan | dog, cat | capsule | 0.25 – 30 mg |
| oral suspension | 0.25 – 40 mg/ml | ||
| soft chewable treat | 0.6 – 20 mg | ||
| transdermal gel | 5 – 50 mg/ml | ||
| tablets, unflavored | 0.625 -15 mg | ||
| Ponazuril | dog, cat | oral suspension | 1 – 406 mg/ml |
| capsule | 30 – 875 mg | ||
| soft chewable treat | 55 – 300 mg | ||
| Potassium bromide | dog, horse | capsule | 25 – 2000 mg |
| soft chewable treat | 25 – 500 mg | ||
| oral powder | 1 – 20 gm/dose | ||
| oral solution | 30 – 500 mg/ml | ||
| Reserpine | horse | oral oil suspension | 1 – 2.5 mg/ml |
| oral paste | 0.25 – 0.5 mg/ml | ||
| oral powder | 1 – 3.75 mg/dose | ||
| oral granules | 0.3 – 2.5 mg/dose | ||
| capsule | 0.25 – 1.5 mg | ||
| tablet | 0.25 mg | ||
| solution for injection | 2.5 mg/ml | ||
| Rifampin | horse | oral suspension | 100 mg/ml |
| Tacrolimus | dog | ophthalmic emulsion | 0.03% |
| ophthalmic solution | 0.01 - 1% | ||
| ophthalmic suspension | 0.01 - 0.1% | ||
| ophthalmic ointment | 0.02 - 03% | ||
| Tolazoline HCl | horse | injection solution | 100 mg/ml |
| Toltrazuril | dog, cat, horse | oral suspension | 1.5 – 250 mg/ml |
| oral paste | 227 – 416 mg/ml | ||
| oral powder | 1 gm/dose | ||
| capsule | 40 mg | ||
| Xylazine | horse | aqueous injection | 300 mg/ml |
| Yohimbine HCl | dog, cat, horse | injectable solution | 2 mg/ml |
NONFOOD-PRODUCING MINOR SPECIES
| Bulk Drug Substance (BDS) | Species | Dosage form(s) | Strength/concentration |
|---|---|---|---|
| Amitriptyline HCl | bird | oral solution | 1 – 100 mg/ml |
| oral suspension | 2.5 – 20 mg/ml | ||
| Apomorphine HCl | ferret | solution for injection | 1 – 6 mg/ml |
| Atipamezole | nonfood-producing minor species | injectable solution | 50 mg/ml |
| Azaperone | camelids, minor carnivore spp., and small mammals | solution for injection | 50 mg/ml |
| Buprenorphine | large cats, bears, rabbits, small exotic mammal pets, rodents, ferrets, primates, marine mammals, large zoo animals | injectable polymeric matrix solution | 0.5 – 10 mg/ml ER |
| Butorphanol tartrate | African and North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, elephants, rhinos, camelids, minor carnivore species, zoo/captive goat species | aqueous injection | 30 mg/ml, 50 mg/ml |
| Cisapride | rodents, rabbits, other small mammals and marine mammals | capsule | 0.5 – 40 mg |
| soft chewable treat | 1 – 25 mg | ||
| transdermal gel | 5 – 150 mg/ml | ||
| tablet | 2.5 – 10 mg | ||
| oral suspension | 0.1 – 90 mg/ml | ||
| oral paste | 2.5 – 25 mg/ml | ||
| oral powder | 0.5 – 40 mg | ||
| Doxycycline | rabbits, rodents, small mammals, birds, reptiles, other exotic and zoo animals | capsule | 5 – 750 mg |
| soft chewable treat | 10 – 350 mg | ||
| oral paste | 50 – 500 mg/ml | ||
| oral powder | 1.8 – 10gm/dose | ||
| otic suspension | 1% | ||
| tablet, flavored | 50 – 400 mg | ||
| tablet, unflavored | 25 – 200 mg | ||
| oral granule | 1.25 - 9.2 gm/dose | ||
| oral suspension (as calcium) | 1 – 333 mg/ml | ||
| oral suspension | 50 mg/ml | ||
| Enrofloxacin | birds (raptors, Psittaciformes, pet birds, etc.), ferrets, rabbits, rodents, and small mammals, reptiles, assorted exotic and zoo species | capsule | 15 – 860 mg |
| soft chewable treat/gummy | 10 – 408 mg | ||
| oral gel | 150 – 280 mg/ml | ||
| oral suspension | 0.5 – 400 mg/ml | ||
| oral paste | 5 – 100 mg/ml | ||
| otic ointment/gel/suspension | 0.5-5% | ||
| tablet | 204 mg | ||
| Flunixin | ferrets, rabbits, rodents, chinchillas, small mammals, zoo, exotic, and wildlife species | capsule | 125 - 300 mg |
| oral granules | 250 mg/dose | ||
| oral paste | 10 - 50 mg/ml | ||
| oral powder packet | 250 - 500 mg/dose | ||
| otic solution/suspensions | 0.25 - 1% | ||
| topical gel/ointment/solution | 1% | ||
| Metronidazole benzoate | small mammals, exotic species | oral suspension | 1 – 250 mg/ml |
| oral powder | 500 mg/dose – 20 gm/dose | ||
| oral paste | 50 – 500 mg/ml | ||
| soft chewable treat | 18 – 250 mg | ||
| tablets | 25 – 250 mg | ||
| Phenylbutazone | horse | oral paste, flavored | 100 mg – 200 mg/ml |
| oral powder, flavored | 100 mg – 2 gm/dose | ||
| oral suspension | 200 mg/ml | ||
| tablets, flavored | 1 gm | ||
| Ponazuril | small mammals, reptiles, assorted exotic species | oral suspension | 1 – 406 mg/ml |
| capsule | 30 – 875 mg | ||
| soft chewable treat | 55 – 300 mg | ||
| Sodium chloride/edetate disodium | captive marine mammals | ophthalmic gel | 5%/5% |
| Tramadol HCl | sea turtle, ungulates | solution for injection | 50 mg/ml |
| Toltrazuril | small mammals, reptiles, camelids, assorted large and small exotic/zoo species | oral suspension | 1.5 – 250 mg/ml |
| oral paste | 227 – 416 mg/ml | ||
| oral powder | 1 gm/dose | ||
| capsule | 40 mg | ||
| Xylazine | zoo species including camelids, minor carnivore spp., goats, and small mammals | aqueous injection | 300 mg/ml |
| Yohimbine HCl | small mammals, zoo/captive bird species, pet birds, captive swine species, llama, large and small exotic/zoo species | injectable solution | 2 mg/ml |
FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES
| Bulk Drug Substance (BDS) | Species | Dosage form(s) | Strength/concentration |
|---|---|---|---|
| Atipamezole HCl | Free-ranging wildlife | injectable solution | 10 mg/ml |
| Azaperone | African and North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, free-ranging goat species | solution for injection | 50 mg/ml |
| Buprenorphine | wildlife species | injectable polymeric matrix solution | 0.5 – 10 mg/ml ER |
| Butorphanol tartrate | African and North American hoof stock; large ungulates including deer, elk, moose, bighorn sheep; minor carnivore species, free-ranging goat species | aqueous injection | 30 mg/ml, 50 mg/ml |
| Xylazine | African and North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep | aqueous injection | 300 mg/ml |