Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances
Nominated Bulk Drug Substances That May NOT Be Used to Compound Office Stock Drugs or Antidotes for Use in Animals
Nominated Bulk Drug Substances Currently Under Review
Bulk Drug Substances Nominated Without Sufficient Supporting Evidence
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 or Antidotes for Food-Producing Animals. FDA does not generally intend to take enforcement action, when draft GFI #256 is finalized, against a state-licensed pharmacy or state-licensed veterinarian using these bulk drug substances to compound the below drug preparations for office stock or antidotes, for the corresponding species and disease indications, provided the conditions in draft GFI #256 and all applicable requirements of the FD&C Act are met.
For information on how to submit a bulk drug substance nomination, see the appendix of draft Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.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 form: 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.
- Metronidazole benzoate – Indication: For the treatment of feline inflammatory bowel disease in cats. Dosage form: 80 mg/ml suspension.
- Miconazole nitrate – Indication: For treatment of fungal keratitis in horses. Dosage form: 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.
- Please note that Dipyrone (Dipyrone – Indication: For the treatment of severe, acute fever in Shar-Pei dogs and Shar-Pei mixed breed dogs suffering from Shar-Pei fever. Dosage form: 250 and 500 mg/ml injectable solution) has been removed from the list. Reason: The FDA-approved drug product Zimeta (dipyrone 500 mg/ml) (NADA 141-513) can be used in an extralabel manner under 21 CFR 530.
- Please note that apomorphine hydrochloride (apomorphine hydrochloride – Indication: For the induction of emesis in dogs. Dosage forms: 3.125-6.25 mg/ml subconjunctival solution, 6.25 mg subconjunctival tablets) have been removed from the list. Reason: Clevor (ropinirole ophthalmic solution) 30 mg/ml (NADA 141-534) is now FDA-approved for induction of emesis in dogs.
NON FOOD-PRODUCING MINOR SPECIES
- Awaiting nominations
- Awaiting nominations