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

Apomorphine hydrochloride –
- Indication: For the induction of emesis in dogs.
- Dosage form: 2.5 mg/mL injectable solution.
Cisapride –
- Indication: For management of gastrointestinal disorders in cats, including: general constipation and constipation from megacolon.
- Dosage forms: 2.5 and 5 mg oral tablets or capsules, and 5-10 mg/mL oral suspension.
Guaifenesin –
- Indication: For muscle relaxation in the horse during anesthetic induction and/or surgery.
- Dosage form: 50 g soluble powder to be reconstituted into a solution for IV infusion with the addition of 500 ml (10%) or 1000 ml (5%) sterile diluent.
Idoxuridine –
- Indication: For treatment of feline herpesvirus keratoconjunctivitis in cats.
- Dosage forms: 0.1% ophthalmic ointment or solution.
Itraconazole with DMSO –
- Indication: For treatment of fungal keratomycosis (keratitis) in horses not intended for human consumption.
- Dosage forms: itraconazole (1%) with DMSO (30%) ophthalmic ointment or solution.
Metronidazole benzoate –
- Indication: For the treatment of feline inflammatory bowel disease in cats.
- Dosage form: 80 mg/mL oral suspension.
Miconazole nitrate –
- Indication: For treatment of fungal keratitis in horses.
- Dosage forms: 1% or 2% miconazole nitrate ophthalmic solution or ophthalmic ointment.
Potassium bromide –
- Indication: For initiation of treatment for seizures in dogs.
- Dosage form: 250 mg/mL oral solution.
Tacrolimus –
- Indication: For treatment of dogs with keratoconjunctivitis sicca (KCS) that is non-responsive to cyclosporine.
- Dosage form: 0.01– 0.03% tacrolimus ophthalmic drops.

NONFOOD-PRODUCING MINOR SPECIES

Azaperone tartrate –
- Indication: For the tranquilization and sedation of zoo animals, captive wildlife species, and laboratory animals.
- Dosage form: 40 mg/mL injectable suspension.
Diprenorphine –
- Indication: for reversing the effects of etorphine hydrochloride injection in zoo animals and captive wildlife species.
- Dosage form: 2 mg/mL injectable solution.
Etorphine hydrochloride –
- Indication: For immobilization and anesthesia of zoo animals and captive wildlife species.
- Dosage form: 10 mg/mL injectable solution.
Ketamine hydrochloride –
- Indication: For immobilization and anesthesia of zoo animals and captive wildlife species when a high concentration of ketamine hydrochloride is required due to the size of the animal or remote drug delivery.
- Dosage form: 200 mg/ml injectable solution
Medetomidine hydrochloride –
- Indication: For immobilization, anesthesia, sedation, and analgesia of laboratory non-human primates, and zoo and captive wildlife animals when a high concentration of medetomidine hydrochloride is required due to the size of the animal or remote drug delivery.
- Dosage form: 10, 20, 40 mg/mL injectable solution.
Midazolam –
- Indication: For sedation and anesthesia in large zoo animals and captive wildlife species not intended for food use when a high concentration of midazolam hydrochloride is required due to the size of the animal or remote drug delivery.
- Dosage form: 50 mg/mL injectable solution.
Tolazoline hydrochloride – 
- Indication: For reversal of sedation caused by xylazine in zoo animals and captive wildlife species when a high concentration of tolazoline hydrochloride is required due to the size of the animal.
- Dosage form: 200 mg/mL injectable solution.