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	Reasons
Amlodipine besylate (1/19/2023)	dog, cat	oral solution	1.25 mg/ml	Amlodipine besylate in these dosage forms and strengths are needed for urgent use in dogs and cats. No FDA-approved amlodipine drug products in suitable dosage forms and strengths are available for use in these patients.
		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	Apomorphine in a 2.5 mg/ml solution for injection is needed for urgent use in dogs. No FDA-approved injectable apomorphine drug product in this concentration is available for use in dogs.
Chloramphenicol (2/28/2023)	horse	oral suspension	15 - 500 mg/ml	Chloramphenicol in a 15-500 mg/ml oral suspension and 100-500 mg/ml oral paste is needed for urgent use in horses; no FDA-approved chloramphenicol drug product in a suitable dosage form and concentration is available for use in horses.
Chloramphenicol (2/28/2023)	horse	oral paste	100 - 500 mg/ml
Cisapride (9/6/2016)	cat	tablets or capsules	2.5 and 5 mg	Cisapride in these dosage forms may be needed for urgent use in cats; no FDA-approved cisapride drug products are currently marketed.
Cisapride (9/6/2016)	cat	oral suspension	5-10 mg/ml
Clopidogrel (11/15/2023)	dog, cat	oral suspension	2.5 – 200 mg/ml	FDA-approved products are not available in strengths that would be practical or accurate for dosing cats and dogs for urgent use.
		capsule	2 – 40 mg
		tablet	18.75 mg
Cyclosporine (11/30/2023)	dog, cat, horse	ophthalmic ointment	1-2%	Cyclosporine in a 1-2% ophthalmic ointment or solution is needed for urgent use in dogs, cats, and horses; no FDA-approved ophthalmic cyclosporine drug product in these dosage forms and concentrations are available for use in these animals.
Cyclosporine (11/30/2023)	dog, cat, horse	ophthalmic solution	1-2%
Famciclovir (6/6/2023)	cat	oral suspension	25 – 325 mg/ml	Famciclovir oral suspension is needed for use in cats in this dosage form and concentration range to allow accurate dosing of kittens, and to treat cats who cannot be administered tablets, on an urgent basis.
Gabapentin (9/29/2023)	dog, cat	oral suspension	50 mg/ml	Gabapentin in a 50 mg/ml oral suspension may be needed for urgent use in dogs and cats. No FDA-approved gabapentin oral suspension products in this concentration are available that would be universally safe for use in both dogs and cats.
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	Guaifenesin in an injectable dosage form is needed for urgent use in horses; there are no FDA-approved injectable guaifenesin drug products.
Idoxuridine (2/1/2022)	cat	ophthalmic ointment or solution	0.1%	Idoxuridine in a 0.1% ophthalmic ointment or solution is needed for urgent use in cats; no FDA-approved ophthalmic idoxuridine products are currently marketed.
Itraconazole with DMSO (1/31/2022)	horse	ophthalmic ointment or solution	itraconazole 1%/DMSO 30%	Itraconazole with DMSO in a 1%/30% ophthalmic ointment or solution is needed for urgent use in horses; there are no FDA-approved itraconazole or itraconazole/DMSO ophthalmic drug products.
Methocarbamol (3/29/2023)	dog, cat	oral suspension	30 - 300 mg/mL	Methocarbamol in a 30-300 mg/ml oral suspension is needed for urgent use in dogs and cats; there are no FDA-approved methocarbamol oral suspension drug products.
Metronidazole benzoate (5/18/2018)	cat	oral suspension	80 mg/ml	Metronidazole benzoate may be needed in an oral dosage form for urgent use in cats. There are no FDA-approved metronidazole benzoate drug products.
Miconazole nitrate (11/23/2016)	horse	ophthalmic ointment or solution	1 - 2%	Miconazole nitrate in a 1-2% ophthalmic ointment or solution is needed for urgent use in horses; there are no FDA-approved ophthalmic miconazole nitrate drug products.
Mirtazapine (12/6/2022)	dog, cat	tablet	1.0 – 3.75 mg	Mirtazapine in tablet and capsule dosage forms in these strengths are needed for urgent use in small dogs and cats; no FDA-approved mirtazapine drug products in these strengths are available for use in these patients.
Mirtazapine (12/6/2022)	dog, cat	capsule	0.5 – 3.75 mg
Potassium bromide (12/21/2016)	dog	oral solution	250 mg/ml	Potassium bromide in an oral solution is needed for urgent use in dogs; no potassium bromide oral solution is FDA-approved for use in dogs.
Prazosin (2/28/2023)	dog, cat	tablet, flavored tablet	0.25 - 0.5 mg	Prazosin in tablets, capsules, and oral liquid suspension in these strengths and concentrations are needed for urgent use in small dogs and cats; no prazosin oral products are FDA-approved in these sizes.
		capsule	0.25 - 0.5 mg
		oral liquid/suspension	0.15 - 15 mg/ml
Rifampin (10/20/2022)	horse	oral suspension	100 mg/ml	Rifampin in a 100 mg/ml oral suspension is needed for urgent use in horses; there are no FDA-approved rifampin oral suspension drug products.
Tacrolimus (11/23/2016)	dog	ophthalmic drops	0.01 - 0.03%	Tacrolimus in a 0.01-0.03% ophthalmic solution is needed for urgent use in dogs; there are no FDA-approved tacrolimus ophthalmic products.
Thyrotropin-releasing hormone (3/8/2023)	horse	sterile powder	25 mg/vial	Injectable thyrotropin-releasing hormone is needed for urgent use in horses; there are no FDA-approved drug products containing thyrotropin releasing hormone.
Thyrotropin-releasing hormone (3/8/2023)	horse	sterile liquid	1 mg/mL

NONFOOD-PRODUCING MINOR SPECIES

Bulk Drug Substance (BDS)	Species	Dosage form(s)	Strength/concentration	Reasons
Azaperone tartrate (2/1/2022)	zoo animals, captive wildlife species, and laboratory animals	suspension for injection	40 mg/ml	Azaperone tartrate is needed for use in the tranquilization and sedation of nonfood-producing minor species. There is no FDA-approved or indexed azaperone product currently marketed.
Buprenorphine HCl (4/24/2023)	captive non-human primates, captive marine mammals	injectable polymeric matrix solution	5.0 – 10 mg/mL	Buprenorphine in an extended release formulation in this concentration range is needed for these species. No FDA-approved or indexed buprenorphine is available in an extended release in this concentration.
Diprenorphine (2/1/2022)	zoo animals and captive wildlife species	solution for injection	2 mg/ml	Diprenorphine is needed for reversing the effects of etorphine in zoo and captive wildlife species. There is no FDA-approved or indexed diprenorphine product currently marketed.
Enrofloxacin (4/11/2024)	ferrets, chinchillas, gerbils, guinea pigs, hamsters, mice, rats	oral suspension	22 - 34 mg/ml	There are no FDA-approved antimicrobial drugs for use in these species, and no indexed products that would be a suitable alternative to enrofloxacin. FDA-approved enrofloxacin products are generally not practical for extralabel use in these species and/or are associated with known adverse effects. A compounded oral suspension may be needed for urgent use in these patients.
Etorphine hydrochloride (2/1/2022)	zoo animals and captive wildlife species	solution for injection	10 mg/ml	Etorphine hydrochloride is needed for use in the immobilization and anesthesia of zoo and captive wildlife species. There is no FDA-approved or indexed etorphine product currently marketed.
Ketamine hydrochloride (3/8/2022)	zoo animals and captive wildlife species	solution for injection	200 mg/ml	Ketamine in a highly concentrated injectable formulation is needed for the immobilization and anesthesia of zoo and captive wildlife species. There is no FDA-approved or indexed ketamine product currently marketed in this concentration.
Medetomidine hydrochloride (2/1/2022)	laboratory non-human primates, and zoo and captive wildlife animals	solution for injection	10, 20, 40 mg/ml	Medetomidine HCl is not FDA-approved in these concentrations, which are needed for the immobilization, anesthesia, sedation, and analgesia of laboratory non-human primates, and zoo and captive wildlife animals.
Metronidazole benzoate (4/18/2024)	avian (captive, non-food only)	suspension (oral)	50 mg/ml	Metronidazole benzoate 50 mg/ml solution is needed for urgent use in small captive avian species; there is no FDA-approved metronidazole drug product in this strength available for use in these patients.
Midazolam (2/1/2022)	large zoo animals and captive wildlife species	solution for injection	50 mg/ml	Midazolam is needed in a higher concentration for sedation and anesthesia of large zoo animals and captive wildlife species. There are no FDA-approved or indexed midazolam products in this concentration.
Tolazoline hydrochloride (2/1/2022)	zoo animals and captive wildlife species	solution for injection	200 mg/ml	Tolazoline is needed in this concentration for the reversal of sedation caused by xylazine in zoo animals and captive wildlife species. No FDA-approved or indexed tolazoline products are currently marketed.