List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
Bulk Drug Substances Currently Under Review
Bulk Drug Substances Reviewed and Not Listed
These bulk drug substances were determined to meet the criteria for inclusion on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals. FDA does not generally intend to take enforcement action against a state-licensed pharmacy or state-licensed veterinarian using these bulk drug substances to compound the below drug preparations for office stock for the corresponding species and disease indications, as described in Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.
FDA will accept nominations of additional bulk drug substances or additional indications for these 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
DOGS, CATS, HORSES
Bulk Drug Substance (BDS) | Species | Dosage form(s) | Strength/concentration |
---|---|---|---|
Amlodipine besylate (1/19/2023) |
dog, cat | oral solution | 1.25 mg/ml |
oral suspension | 1.25 mg/ml | ||
capsule | 0.625 mg | ||
tablet | 0.625 mg | ||
mini-tab | 0.625 mg | ||
Apomorphine hydrochloride (8/11/2016) |
dog | solution for injection | 2.5 mg/ml |
Chloramphenicol (2/28/2023) |
horse | oral suspension | 15 - 500 mg/ml |
oral paste | 100 - 500 mg/ml | ||
Cisapride (9/6/2016) |
cat | tablets or capsules | 2.5 and 5 mg |
oral suspension | 5-10 mg/ml | ||
Cyclosporine (9/20/2022) |
horse | ophthalmic ointment | 1-2% |
Gabapentin (9/29/2023) |
dog, cat | oral suspension | 50 mg/ml |
Guaifenesin (11/9/2016) |
horse | soluble powder to be reconstituted into a solution for IV infusion with the addition of 500 ml (10%) or 1000 ml (5%) sterile diluent | 50 gm |
Idoxuridine (2/1/2022) |
cat | ophthalmic ointment or solution | 0.1% |
Itraconazole with DMSO (1/31/2022) |
horse | ophthalmic ointment or solution | itraconazole 1%/DMSO 30% |
Methocarbamol (3/29/2023) |
dog, cat | oral suspension | 30 - 300 mg/mL |
Metronidazole benzoate (5/18/2018) |
cat | oral suspension | 80 mg/ml |
Miconazole nitrate (11/23/2016) |
horse | ophthalmic ointment or solution | 1 - 2% |
Mirtazapine (12/6/2022) |
dog, cat | tablet | 1.0 – 3.75 mg |
capsule | 0.5 – 3.75 mg | ||
Potassium bromide (12/21/2016) |
dog | oral solution | 250 mg/ml |
Prazosin (2/28/2023) |
dog, cat | tablet, flavored tablet | 0.25 - 0.5 mg |
capsule | 0.25 - 0.5 mg | ||
oral liquid/suspension | 0.15 - 15 mg/ml | ||
Rifampin (10/20/2022) |
horse | oral suspension | 100 mg/ml |
Tacrolimus (11/23/2016) |
dog | ophthalmic drops | 0.01 - 0.03% |
Thyrotropin-releasing hormone (3/8/2023) |
horse | sterile powder | 25 mg/vial |
sterile liquid | 1 mg/mL |
NONFOOD-PRODUCING MINOR SPECIES
Bulk Drug Substance (BDS) | Species | Dosage form(s) | Strength/concentration |
---|---|---|---|
Azaperone tartrate (2/1/2022) |
zoo animals, captive wildlife species, and laboratory animals | suspension for injection | 40 mg/ml |
Buprenorphine HCl (4/24/2023) |
captive non-human primates, captive marine mammals | injectable polymeric matrix solution | 5.0 – 10 mg/mL |
Diprenorphine (2/1/2022) |
zoo animals and captive wildlife species | solution for injection | 2 mg/ml |
Etorphine hydrochloride (2/1/2022) |
zoo animals and captive wildlife species | solution for injection | 10 mg/ml |
Ketamine hydrochloride (3/8/2022) |
zoo animals and captive wildlife species | solution for injection | 200 mg/ml |
Medetomidine hydrochloride (2/1/2022) |
laboratory non-human primates, and zoo and captive wildlife animals | solution for injection | 10, 20, 40 mg/ml |
Midazolam (2/1/2022) |
large zoo animals and captive wildlife species | solution for injection | 50 mg/ml |
Tolazoline hydrochloride (2/1/2022) |
zoo animals and captive wildlife species | solution for injection | 200 mg/ml |