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 |
|---|---|---|---|
| Aluminum hydroxide | dog, cat | capsules | 30 – 525 mg |
| oral powder | 30 – 2500 mg/dose | ||
| oral suspension | 30 – 375 mg/ml | ||
| soft chew treat | 25 – 500 mg | ||
| 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 | ||
| Aminophylline | dog, cat | capsules | 10 – 400 mg |
| oral suspension | 16 – 300 mg/ml | ||
| soft chew treat | 50 mg | ||
| tablet, flavored, quadrisected | 100 mg | ||
| transdermal gel | 250 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 | ||
| Atipamezole | horse | solution for injection | 25 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% | ||
| Azithromycin | dog, cat, horse | capsules | 12 – 450 mg |
| dog, cat, horse | oral paste | 20 – 360 mg/ml | |
| dog | mucoadhesive paste | 100 mg/ml | |
| dog, cat | periodontal gel | 8.5% | |
| dog, cat, horse | oral powder | 1 gm/dose | |
| dog, cat, horse | oral suspension | 10 – 250 mg/ml | |
| dog | soft chew treat | 25 – 200 mg | |
| dog | tablet | 25 – 50 mg | |
| Betamethasone dipropionate | dog, cat, horse | otic ointment/suspension | 0.05 - 1% |
| Budesonide | dog, cat | capsules | 0.1 – 5 mg |
| oral paste | 10 mg/ml | ||
| oral suspension | 0.3 – 50 mg/ml | ||
| soft chew treat | 0.2 – 6 mg | ||
| tablet | 0.5 – 3 mg | ||
| oral gel | 0.025 – 0.075 mg/ml | ||
| rectal suppository | 3 mg | ||
| 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 | ||
| Clenbuterol HCl | horse | oral solution | 72.5 mcg/ml |
| 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 | ||
| Clomipramine HCl | dog, cat | capsules | 1.25 – 250 mg |
| oral suspension | 0.5 – 160 mg/ml | ||
| soft chew treat | 2 – 100 mg | ||
| tablet, unflavored | 2.5 – 60 mg | ||
| tablet, flavored | 10 mg | ||
| transdermal gel | 10 – 150 mg/ml | ||
| 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 |
| dog, cat, horse | injection | 40 - 80 units/ml | |
| Cyclophosphamide | dog, cat, horse | capsule | 0.48 – 350 mg |
| oral suspension | 2 – 150 mg/ml | ||
| dog, cat | soft chew treat | 5 – 80 mg | |
| 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 | ||
| Enalapril maleate | dog, cat | capsules | 0.2 – 3 0 mg |
| oral suspension | 0.3 – 50 mg/ml | ||
| soft chew treat | 1 – 10 mg | ||
| tablet | 1 – 20 mg | ||
| transdermal gel | 12.5 – 100 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% | ||
| Famciclovir | cat | capsule | 45 mg – 2.5 gm |
| oral paste | 125 – 500 mg/ml | ||
| oral powder | 125 mg – 1 gm | ||
| oral suspension | 25 – 312.5 mg/ml | ||
| soft chew treat | 60 – 325 mg | ||
| tablet, unflavored | 62.5 mg | ||
| tablet, flavored, quadrisected | 250 mg | ||
| Famotidine | dog, cat, horse | capsules | 1 – 15 mg |
| oral paste | 10 mg/ml | ||
| oral suspension | 0.5 – 300 mg/ml | ||
| soft chew treat | 1 – 10 mg | ||
| dog, cat | tablet, flavored | 20 mg | |
| transdermal gel | 20 – 200 mg/ml | ||
| 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 | ||
| Fluconazole | dog, cat, horse | capsules | 10 – 780 mg |
| oral paste | 140 – 400 mg/ml | ||
| oral powder | 100 mg – 3 gm | ||
| oral suspension | 5 – 337 mg/ml | ||
| soft chew treat | 25– 330 mg | ||
| tablet, unflavored | 25 mg | ||
| tablet, flavored | 50 – 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% |
| Furosemide | dog, cat, horse | capsules | 1.25 – 150 mg |
| oral paste | 100 – 250 mg/ml | ||
| oral suspension | 1 – 125 mg/ml | ||
| soft chew treat | 3 – 50 mg | ||
| tablet | 6.25 mg | ||
| dog, cat | transdermal gel | 50 – 375 mg/ml | |
| 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 | ||
| Gabapentin | dog, cat, horse | capsules | 1 – 1000 mg |
| horse | injectable | 100 mg/ml | |
| dog, cat, horse | oral paste | 50 – 310 mg/ml | |
| dog, cat, horse | oral powder | 10 mg– 12 gm/dose | |
| dog, cat | oral gel | 100 – 300 mg/ml | |
| dog, cat, horse | oral suspension | 1 – 400 mg/ml | |
| dog, cat, horse | soft chew treat | 5 – 400 mg | |
| dog, cat | tablet, unflavored | 25 – 75 mg | |
| dog, cat | tablet, flavored | 25 – 200 mg | |
| dog, cat | transdermal gel | 100 – 270 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%) |
| Hydrocodone bitartrate | dog | tablet, quadrisected | 5 mg |
| 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 | ||
| Levetiracetam | dog, cat, horse | capsules | 25 – 660 mg |
| oral paste | 454.66 mg/ml | ||
| oral solution | 100 mg/ml | ||
| oral suspension | 20 – 400 mg/ml | ||
| soft chew treat | 50 – 300 mg | ||
| transdermal gel | 400 mg/ml | ||
| rectal suppository | 100 mg | ||
| Lomustine | dog, cat | capsules | 0.7 – 110 mg |
| oral suspension | 5 – 60 mg/ml | ||
| soft chew treat | 8 – 40 mg | ||
| Marbofloxacin | dog, cat | capsules | 6 - 1750 mg |
| oral paste | 10 – 100 mg/ml | ||
| oral suspension | 5 – 320 mg/ml | ||
| soft chew treat | 10 – 200 mg | ||
| tablet, flavored, quadrisected | 220 mg | ||
| otic solution/suspension/ointment | 1 - 3% | ||
| 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 |
| Meloxicam | dog | capsules | 0.1 – 6.5 mg |
| oral suspension | 0.07 – 6 mg/ml | ||
| soft chew treat | 0.08 – 3 mg | ||
| transdermal gel | 2 – 30 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 | ||
| Metoclopramide HCl | dog, cat | capsules | 0.4 – 30 mg |
| dog, cat, horse | oral solution | 0.5 – 20 mg/ml | |
| dog, cat | soft chew treat | 1 – 2.5 mg | |
| transdermal gel | 10 – 100 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 | ||
| Pentosan polysulfate sodium | dog, cat | capsule | 10 – 800 mg |
| dog, horse | injection solution | 100 – 250 mg/ml | |
| dog, cat | oral suspension | 75 – 400 mg/ml | |
| Phenoxybenzamine HCl | dog, cat | capsule | 1 – 45 mg |
| oral suspension | 1 – 100 mg/ml | ||
| soft chew treat | 2.5 – 20 mg | ||
| tablet, unflavored | 2.5 mg | ||
| tablet, flavored | 5 mg | ||
| transdermal gel | 50 – 100 mg/ml | ||
| 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 | ||
| Piroxicam | dog, cat, horse | capsule | 0.25 – 160 mg |
| oral paste | 20 – 40 mg/ml | ||
| oral powder | 20 – 100 mg | ||
| oral suspension | 0.2 – 100 mg/ml | ||
| soft chew treat | 0.8 – 80 mg | ||
| dog | suppository | 10 mg | |
| dog, cat | tablet, unflavored | 2 -5 mg | |
| tablet, flavored | 6 – 10 mg | ||
| transdermal gel | 6 – 27 mg/ml | ||
| Ponazuril | horse | capsule | 30 – 875 mg |
| oral suspension | 1 – 406 mg/ml | ||
| oral paste | 5 – 300 mg/ml | ||
| oral powder | 1.8 – 3 gm/dose | ||
| 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% |
| Prednisolone | dog cat, horse | capsules | 0.2 – 300 mg |
| injection suspension | 25 - 50 mg/ml | ||
| oral paste | 5 – 50 mg/ml | ||
| horse | oral powder | 100 – 1000 mg/dose | |
| oral granules | 100 – 1000 mg/dose | ||
| dog, cat, horse | oral solution | 0.5 – 20 mg/ml | |
| oral suspension | 0.5 – 300 mg/ml | ||
| oral gel | 12 – 150 mg/ml | ||
| dog, cat | soft chew treat | 0.625 – 20 mg | |
| dog, cat, horse | tablets, flavored or scented | 2.5 – 100 mg | |
| tablets, unflavored | 2.5 – 5 mg | ||
| dog, cat | transdermal gel | 5 – 250 mg/ml | |
| Prednisone | dog | capsules | 0.25 – 7.5 mg |
| injection suspension | 40 – 50 mg/ml | ||
| oral paste | 50 mg/ml | ||
| oral suspension | 0.5 – 100 mg/ml | ||
| soft chew treat | 0.5 – 40 mg | ||
| transdermal gel | 5 – 200 mg/ml | ||
| oral gel | 100 mg/ml | ||
| Protirelin acetate (thyrotropin-releasing hormone) | horse | solution for injection | 1 mg/ml |
| Pyrantel pamoate | dog, cat, horse | capsule | 10 – 175 mg |
| liquid | 5 – 150 mg/ml | ||
| tablet | 22.7 mg/45.4 mg | ||
| Pyrimethamine | dog, cat, horse | capsule | 2 – 40 mg/cap |
| horse | oral paste | 16.67 – 50 mg/ml | |
| oral powder | 500 – 600 mg/dose | ||
| dog, cat, horse | oral suspension | 1 – 25 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 |
| Rifampin | dog, cat, horse | soft chewable treat | 40 – 100 mg |
| oral suspension | 20 – 314 mg/ml | ||
| oral paste | 100 – 250 mg/ml | ||
| oral powder | 100 – 600 mg/dose | ||
| Secnidazole | dog, cat | capsule | 30 – 500 mg |
| liquid | 50 – 140 mg/ml | ||
| Sildenafil citrate | dog, cat | capsules | 1 – 160 mg |
| oral suspension | 1 – 200 mg/ml | ||
| soft chew treat | 1.5 - 100 mg | ||
| tablet, flavored, quadrisected | 10 – 30 mg | ||
| tablet, unflavored | 10 mg | ||
| 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 | ||
| Toceranib phosphate | dog, cat | capsules | 2 – 180 mg |
| oral suspension | 5 – 115 mg/ml | ||
| soft chew treat | 7 – 65 mg | ||
| 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 | ||
| Tramadol | dog, cat, horse | capsules | 5 - 500 mg |
| oral suspension | 1 – 225 mg/ml | ||
| soft chew treat | 15 – 150 mg | ||
| dog, cat | tablet, flavored | 5 – 10 mg | |
| tablet, unflavored | 10 mg | ||
| transdermal gel | 25 – 250 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 | ||
| Tylosin | dog, cat | capsules | 10 – 750 mg |
| oral paste | 50 – 150 mg/ml | ||
| oral powder | 60 – 900 mg/dose | ||
| oral solution | 100 – 320 mg/ml | ||
| oral suspension | 10 – 375 mg/ml | ||
| soft chew treat/gummy | 10 – 500 mg | ||
| tablet, flavored chewable | 50 – 350 mg | ||
| tablet, flavored quadrisected | 200 – 500 mg | ||
| Ursodiol | dog, cat | unflavored tablet | 50/90/100/150/300 mg |
| flavored tablet | 100 mg | ||
| liquid | 10 – 300 mg/ml | ||
| capsule | 10 – 550 mg | ||
| Ursodiol | dog, cat, horse | capsule | 5 – 750 mg |
| oral powder | 15 mg – 6 gm | ||
| oral suspension | 5 – 450 mg/ml | ||
| soft chew treat | 15 – 750 mg | ||
| tablet, unflavored | 30 – 75 mg | ||
| tablet, flavored | 100 – 300 mg | ||
| transdermal gel | 200 – 250 mg/ml | ||
| Xylazine | horse | aqueous injection | 300 mg/ml |
| Yohimbine HCl | dog, cat, horse | injectable solution | 2 mg/ml |
| Zonisamide | dog, cat | capsules | 8 – 800 mg |
| oral suspension | 10 – 250 mg/ml | ||
| soft chew treat | 20 – 300 mg | ||
| transdermal gel | 100 – 250 mg/ml |
NONFOOD-PRODUCING MINOR SPECIES
| Bulk Drug Substance (BDS) | Species | Dosage form(s) | Strength/concentration |
|---|---|---|---|
| Aluminum hydroxide | rabbits, rodents, small mammals | oral suspension | 30 – 375 mg/ml |
| 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 |
| Atipamezole | camelids, carnivores, captive zoo species | solution for injection | 25 mg/ml |
| Azaperone | camelids, minor carnivore spp., and small mammals | solution for injection | 50 mg/ml |
| Azithromycin | captive exotic and zoo species | capsules | 12 – 450 mg |
| rabbits, guinea pigs, birds, captive exotic and zoo species | oral paste | 20 – 360 mg/ml | |
| captive exotic and zoo species | oral powder | 1 gm/dose | |
| rabbits, guinea pigs, birds, captive exotic and zoo species | oral suspension | 10 – 250 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 | 125 – 500g/ml |
| 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 | ||
| Clomipramine HCl | avian | oral suspension | 0.5 – 160 mg/ml |
| Corticotropin (ACTH) | bird | injection | 40 mg/ml, 80 mg/ml |
| injection | 40-80 units/ml | ||
| Cyclophosphamide | rabbit, ferret | oral suspension | 2 – 150 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 | ||
| Enalapril maleate | ferret, bird | oral suspension | 0.3 – 50 mg/ml |
| ferret | soft chew treat | 1 – 10 mg | |
| 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% | ||
| Famotidine | small animal | oral paste | 10 mg/ml |
| oral suspension | 0.5 – 300 mg/ml | ||
| soft chew treat | 1 – 10 mg | ||
| 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 | ||
| Fluconazole | small mammal, exotics, captive zoo species | capsules | 10 – 780 mg |
| avian, reptile, small mammal, exotics, captive zoo species | oral paste | 140 – 400 mg/ml | |
| oral powder | 100 mg – 3 gm | ||
| avian, reptile, small mammal, exotics, captive zoo species | oral suspension | 5 – 337 mg/ml | |
| avian, reptile, small mammal, exotics, captive zoo species | soft chew treat | 25– 330 mg | |
| small mammal, exotics, captive zoo species | tablet, unflavored | 25 mg | |
| small mammal, exotics, captive zoo species | tablet, flavored | 50 – 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% | ||
| Furosemide | ferret, small mammals, bird, reptile | capsules | 1.25 – 150 mg |
| oral paste | 100 – 250 mg/ml | ||
| oral suspension | 1 – 125 mg/ml | ||
| ferret, small animal | soft chew treat | 3 – 50 mg | |
| small mammal | tablet | 6.25 mg | |
| Gabapentin | exotics, zoo animals | capsules | 1 – 1000 mg |
| avian, exotics, zoo animals | oral paste | 50 – 310 mg/ml | |
| exotics, zoo animals | oral powder | 10 mg– 12 gm/dose | |
| avian, exotics, zoo animals | oral gel | 100 – 300 mg/ml | |
| avian, exotics, zoo animals | oral suspension | 1 – 400 mg/ml | |
| exotics, zoo animals | soft chew treat | 5 – 400 mg | |
| exotics, zoo animals | tablet, unflavored | 25 – 75 mg | |
| exotics, zoo animals | tablet, flavored | 25 – 200 mg | |
| 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 | ||
| Marbofloxacin | assorted captive exotic and zoo species | capsules | 6 - 1750 mg |
| avian, rabbits, reptiles, assorted captive exotic and zoo species | oral paste | 10 – 100 mg/ml | |
| avian, rabbits, reptiles, assorted captive exotic and zoo species | oral suspension | 5 – 320 mg/ml | |
| rabbits, assorted captive exotic and zoo assorted | soft chew treat | 10 – 200 mg | |
| captive exotic and zoo species | tablet, flavored, quadrisected | 220 mg | |
| assorted captive exotic and zoo species | otic solution/suspension/ointment | 1 - 3% | |
| 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 | |
| Meloxicam | small mammals, assorted exotic and zoo animals | capsules | 0.1 - 6.5 mg |
| avian, ferrets, small mammals, reptiles, assorted exotic and zoo animals | oral suspension | 0.07 – 6 mg/ml | |
| ferrets, small mammals, reptiles, assorted exotic and zoo animals | soft chew treat | 0.08 – 3 mg | |
| ferrets | transdermal gel | 2 – 30 mg/ml | |
| Metoclopramide HCl | small mammals | capsules | 0.4 – 30 mg |
| oral solution | 0.5 – 20 mg/ml | ||
| soft chew treat | 1 – 2.5 mg | ||
| transdermal gel | 10 – 100 mg/ml | ||
| 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 | ||
| Piroxicam | small mammals | capsule | 0.25 – 160 mg |
| oral paste | 20 – 40 mg/ml | ||
| oral powder | 20 – 100 mg | ||
| oral suspension | 0.2 – 100 mg/ml | ||
| soft chew treat | 0.8 – 80 mg | ||
| 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, sheep, goats, 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 | ||
| Prednisolone | avian, rabbits, rodents, small mammals, reptiles, other exotic and zoo species | injection suspension | 25 - 50 mg/ml |
| oral paste | 5 – 50 mg/ml | ||
| exotic and zoo species | oral powder | 100 – 1000 mg/dose | |
| avian, rabbits, rodents, small mammals, reptiles, other exotic and zoo species | oral granules | 100 – 1000 mg/dose | |
| oral solution | 0.5 – 20 mg/ml | ||
| oral suspension | 0.5 – 300 mg/ml | ||
| oral gel | 12 – 150 mg/ml | ||
| rabbits, exotic and zoo species | soft chew treat | 0.625 – 20 mg | |
| rabbits, exotic and zoo species | tablets, flavored or scented | 2.5 – 100 mg | |
| tablets, unflavored | 2.5 – 5 mg | ||
| Prednisone | avian, rabbits, rodents, small mammals | injection suspension | 40 – 50 mg/ml |
| oral paste | 50 mg/ml | ||
| oral suspension | 0.5 – 100 mg/ml | ||
| small mammals | soft chew treat | 0.5 – 40 mg | |
| avian, rabbits, rodents, small mammals | oral gel | 100 mg/ml | |
| 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 | ||
| Pyrimethamine | exotics | capsule | 2 – 40 mg |
| avian | oral suspension | 1 – 25 mg/ml | |
| Sildenafil citrate | assorted exotic and captive zoo species | capsules | 1 – 160 mg |
| oral suspension | 1 – 200 mg/ml | ||
| soft chew treat | 1.5 - 100 mg | ||
| tablet, flavored, quadrisected | 10 – 30 mg | ||
| tablet, unflavored | 10 mg | ||
| Sodium chloride/edetate disodium | captive marine mammals | ophthalmic gel | 5%/0.5% |
| 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 | ||
| 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 | ||
| Tramadol | captive zoo and exotic species | capsules | 5 - 500 mg |
| avian, small mammals, reptiles, captive zoo and exotic species | oral suspension | 1 – 225 mg/ml | |
| small mammals, captive zoo and exotic species | soft chew treat | 15 – 150 mg | |
| small mammals, reptiles, captive zoo and exotic species | tablet, flavored | 5 – 10 mg | |
| tablet, unflavored | 10 mg | ||
| transdermal gel | 25 – 250 mg/ml | ||
| Tylosin | ferrets, exotic and captive zoo species | capsules | 10 – 750 mg |
| oral paste | 50 – 150 mg/ml | ||
| oral powder | 60 – 900 mg/dose | ||
| oral solution | 100 – 320 mg/ml | ||
| oral suspension | 10 – 375 mg/ml | ||
| soft chew treat/gummy | 10 – 500 mg | ||
| tablet, flavored chewable | 50 – 350 mg | ||
| tablet, flavored quadrisected | 200 – 500 mg | ||
| Ursodiol | bird | oral suspension | 5 – 450 mg/ml |
| 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 |
| Atipamezole | African and North American hoof stock, large ungulates including deer, elk, moose, bighorn sheep, goats, and other free-ranging wildlife | solution for injection | 25 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 |