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 Dosage form(s) Strength/concentration
Amikacin dog, cat, horse otic ointment 0.67 - 5%
otic solution 0.67 - 5%
injection 200 mg/ml
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
Atenolol dog, cat capsules 1 – 35 mg
oral paste 12.5 – 125 mg/ml
oral suspension 1 – 125 mg/ml
soft chew treat 0.4 – 25 mg
tablet, unflavored 6.25 – 12.5 mg
tablet, flavored 25 mg
transdermal gel 20 – 150 mg/ml
Azaperone horse solution for injection 50 mg/ml
Azithromycin dog, cat, horse capsule 10 – 500 mg
liquid 1 – 250 mg/ml
flavored tablet 25 mg, 50 mg
tablet 225 mg
otic ointment/solution 0.5 - 5%
Betamethasone dipropionate dog, cat, horse otic ointment/suspension 0.05 - 1%
Buprenorphine dog, horse injectable polymeric matrix solution 0.5 – 10 mg/ml ER
Buprenorphine dog, cat, horse injectable 0.6 mg/ml
oral solution 0.03 – 1 mg/ml
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 gm powder
topical ointment 1%
ophthalmic ointment/solution 1%
Chloramphenicol dog, cat capsule 30 – 1000 mg
oral suspension 125 – 500 mg/ml
otic ointment/solution/suspension 1 - 2%
Cidofovir dog, cat ophthalmic suspension 0.5%
cat ophthalmic solution 0.5%
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
Clindamycin HCl dog, cat capsules 12.5 – 600 mg
oral paste 50 – 400 mg/ml
oral solution 35 – 400 mg/ml
oral suspension 30 – 300 mg/ml
soft chew treat 10 – 300 mg
otic solution 1%
tablets, flavored, quadrisected 100 – 300 mg
tablets, unflavored 50 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
Corticotropin (ACTH) dog, horse injection 40 mg/ml, 80 mg/ml
Cyclosporine horse ophthalmic ointment 1-2%
Cyclosporine dog, cat, horse ophthalmic gel 0.2%
ophthalmic ointment 1% - 2%
ophthalmic solution 0.1% - 2%
ophthalmic solution 1%, 2%
ophthalmic suspension 1% - 2%
Demecarium bromide dog ophthalmic solution 0.125 - 0.25%
Desmopressin dog, cat, horse capsule 0.0015 – 0.6 mg
chew treat 0.1 – 0.4 mg
injectable 0.01%
ophthalmic solution 0.01 - 0.04%
oral suspension 0.05 mcg/ml – 1 mg/ml
flavored tablet 0.2 mg
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
Enrofloxacin dog, cat oral suspension 10 – 300 mg/ml
otic ointment 0.23 - 5%
unflavored tablet 204 mg
capsule 10 – 600 mg
oral powder 500 mg – 10 gm
anal sac ointment 0.23 - 1%
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%
Fluconazole dog, cat, horse capsule 10 – 650 mg
unflavored tablet 75/300/400 mg
oral suspension 1 – 200 mg/ml
otic ointment/solution/suspension 0.5 - 5%
scoop powder 100 mg - 2.5 gm
chewable 20 – 400 mg
Fluoxetine HCl dog, cat, horse capsules 0.5 – 100 mg
oral paste 20 – 300 mg/ml
oral suspension 0.5 – 250 mg/ml
soft chew treat 0.5 – 100 mg
tablet, unflavored 2.5 – 5 mg
tablet, flavored 5 – 64 mg
transdermal gel 5 – 320 mg/ml
Flurbiprofen dog, cat ophthalmic solution 0.04%
Gabapentin dog, cat oral suspension 50 mg/ml
Gabapentin dog, cat flavored tablet 25 mg, 50 mg
unflavored tablet 50 mg, 150 mg
suspension 10 – 200 mg/ml
capsule 10 – 500 mg
transdermal gel 25 – 300 mg/ml
Gentamicin dog, cat otic ointment and solution 0.3 - 1%
anal sac ointment 0.3 - 1%
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/suspension 1%/10%
Ketoconazole dog, cat, horse capsule 10 – 500 mg
tablet 100 mg
suspension 1 – 200 mg/ml
otic ointment 0.5 - 5%
scoop powder 100 mg – 5 gm
Ketoconazole dog, cat, horse capsule 10 – 500 mg
oral suspension 5 – 300 mg/ml
soft chew treat 5 – 200 mg
flavored tablet 100 – 400 mg
L-asparaginase dog, cat powder for reconstitution 10,000 units/vial
injectable 15,000 units/3 ml kit
Mebendazole dog, cat capsule 100 – 350 mg
liquid 10 – 100 mg/ml
tablet 50 mg
Meloxicam horse oral paste 80-100 mg/ml
oral powder 100-900 mg/scoop
oral suspension 68 -100 mg/ml
Meloxicam dog, horse polymeric matrix injection solution 10 mg/ml ER
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
Mupirocin dog, cat otic ointment/solution 1 - 3%
Nitenpyram dog, cat liquid 22.8 mg/ml
rectal gel 11.4 mg/57 mg
Oseltamivir dog reconstituted liquid 50 mg/ml
Oxantel pamoate dog, cat capsule 50 – 500 mg
liquid 10 mg/ml – 100 mg/ml
tablet 90 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
Praziquantel dog, cat, horse injectable 50 mg/ml
liquid 1 – 250 mg/ml
capsule 10 – 500 mg
chewable 5 – 100 mg
tablet 68 mg
scoop powder 500 mg - 5 gm
Prazosin dog, cat flavored tablet 0.25 mg/0.5 mg
liquid 0.25 – 5 mg/ml
capsule 0.25 - 0.5 mg
Prednisolone dog, cat suspension 1- 50 mg
flavored tablet 2.5 mg/5 mg
transdermal gel 10 – 250 mg/ml
powder 100 – 1000 mg
ophthalmic 1.25%
injectable 50 mg/ml
Prednisolone dog, cat, horse ophthalmic suspension 1.25 - 1.5%
Pyrantel pamoate dog, cat, horse capsule 10 – 175 mg
liquid 5 – 150 mg/ml
tablet 22.7 mg/45.4 mg
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
Secnidazole dog, cat capsule 30 – 500 mg
liquid 50 – 140 mg/ml
Tacrolimus dog ophthalmic emulsion 0.03%
ophthalmic solution 0.01 - 1%
ophthalmic suspension 0.01 - 0.1%
ophthalmic ointment 0.02 - 03%
Theophylline dog, cat flavored tablet 25 mg
unflavored tablet 50/75/150 mg
suspension 10 – 200 mg/ml
capsule 5 – 450 mg
transdermal gel 25 – 300 mg/ml
Theophylline dog, cat capsule 5 – 500 mg
oral paste 100 mg/ml
oral suspension 5 – 350 mg/ml
soft chewable treat 10 – 200 mg
flavored and unflavored tablets 25 – 200 mg
transdermal gel 150 – 300 mg/ml
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
Tramadol dog, cat liquid 25 mg/ml, 50 mg/ml
flavored tablet 5 mg, 10 mg
transdermal 125 mg/ml
injection 50 mg/ml
Triamcinolone acetonide dog, cat, horse capsule 0.25 -10 mg
liquid 0.5 – 20 mg
injection 4 mg/ml
tablet 1.5 mg
otic ointment/solution 0.1 - 5%
transdermal gel 1 – 50 mg/ml
Ursodiol dog, cat unflavored tablet 50/90/100/150/300 mg
flavored tablet 100 mg
liquid 10 – 300 mg/ml
capsule 10 – 550 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
Amikacin bird, reptile, snake, turtle/tortoise, rabbit, guinea pig, chinchilla, hamster, rat, mouse, fish otic ointment/solution 0.67-5%
injection 200 mg/ml
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
Buprenorphine avian, rabbit, rodents, reptiles, small animals, various exotic and zoo species injectable 0.6 mg/ml
oral solution 0.03 – 1 mg/ml
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
Chloramphenicol avian oral suspension 1 - 2%
small mammals capsule 30 – 1000 mg
oral suspension 125 – 500 mg/ml
otic ointment/solution/suspension  1 - 2%
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
Clindamycin HCl avian, ferret, reptiles, assorted exotic and zoo species capsules 12.5 – 600 mg
oral paste 50 – 400 mg/ml
oral solution 35 – 400 mg/ml
oral suspension 30 – 300 mg/ml
soft chew treat 10 – 300 mg
otic solution 1%
tablets, flavored, quadrisected 100 – 300 mg
tablets, unflavored 50 mg
Corticotropin (ACTH) bird injection 40 mg/ml, 80 mg/ml
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
Enrofloxacin avian, exotics oral suspension 10 – 300 mg/ml
otic ointment 0.23 - 5%
unflavored tablet 204 mg
capsule 10 – 600 mg
oral powder 500 mg – 10 gm
anal sac ointment 0.23 - 1%
Fluconazole bird, exotics capsule 10 – 650 mg
unflavored tablet 75/300/400 mg
oral suspension 1 – 200 mg/ml
otic ointment/solution/suspension 0.5 - 5%
scoop powder 100 mg - 2.5 gm
chewable 20 – 400 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%
Ketoconazole bird, exotics capsule 10 – 500 mg
tablet 100 mg
suspension 1 – 200 mg/ml
otic ointment 0.5 - 5%
scoop powder 100 mg – 5 gm
Ketoconazole exotic and zoo species capsule 10 – 500 mg
avian, rabbit, rodents, reptiles, small animals, various exotic and zoo species oral suspension 5 – 300 mg/ml
small animals, various exotic and zoo species soft chew treat 5 – 200 mg
flavored tablet 100 – 400 mg
Meloxicam rats, mice, gerbils, rabbits, hamsters, and other small mammals polymeric matrix injection solution 2 mg/ml ER
marine mammals, large zoo animals and captive wildlife polymeric matrix injection solution 10 mg/ml ER
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 – 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
Praziquantel camelids, avian, rabbits, rodents, small mammals, ferrets, snakes, amphibians, tortoises injectable 50 mg/ml
liquid 1 – 250 mg/ml
capsule 10 – 500 mg
chewable 5 – 100 mg
tablet 68 mg
scoop powder 500 mg - 5 gm
Pyrantel pamoate donkeys, llama, avian, rabbit, rodents, small mammals capsule 10 – 175 mg
liquid 5 – 150 mg/ml
tablet 22.7 mg/45.4 mg
Sodium chloride/edetate disodium captive marine mammals ophthalmic gel 5%/0.5%
Tramadol HCl sea turtle, ungulates solution for injection 50 mg/ml
Tramadol avian, exotics liquid 25 mg/ml, 50 mg/ml
flavored tablet 5 mg, 10 mg
transdermal 125 mg/ml
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
Back to Top