List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals

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	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	dog	solution for injection	2.5 mg/ml
Cisapride	cat	tablets or capsules	2.5 and 5 mg
Cisapride	cat	oral suspension	5-10 mg/ml
Cyclosporine	horse	ophthalmic ointment	1-2%
Gabapentin	dog, cat	oral suspension	50 mg/ml
Guaifenesin	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	cat	ophthalmic ointment or solution	0.1%
Itraconazole with DMSO	horse	ophthalmic ointment or solution	itraconazole 1%/DMSO 30%
Metronidazole benzoate	cat	oral suspension	80 mg/ml
Miconazole nitrate	horse	ophthalmic ointment or solution	1 - 2%
Mirtazapine	dog, cat	tablet	1.0 – 3.75 mg
Mirtazapine	dog, cat	capsule	0.5 – 3.75 mg
Potassium bromide	dog	oral solution	250 mg/ml
Rifampin	horse	oral suspension	100 mg/ml
Tacrolimus	dog	ophthalmic drops	0.01 - 0.03%

NONFOOD-PRODUCING MINOR SPECIES

Bulk Drug Substance (BDS)	Species	Dosage form(s)	Strength/concentration
Azaperone tartrate	zoo animals, captive wildlife species, and laboratory animals	suspension for injection	40 mg/ml
Diprenorphine	zoo animals and captive wildlife species	solution for injection	2 mg/ml
Etorphine hydrochloride	zoo animals and captive wildlife species	solution for injection	10 mg/ml
Ketamine hydrochloride	zoo animals and captive wildlife species	solution for injection	200 mg/ml
Medetomidine hydrochloride	laboratory non-human primates, and zoo and captive wildlife animals	solution for injection	10, 20, 40 mg/ml
Midazolam	large zoo animals and captive wildlife species	solution for injection	50 mg/ml
Tolazoline hydrochloride	zoo animals and captive wildlife species	solution for injection	200 mg/ml