Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals
Nominated Bulk Drug Substances Currently Under Review
Bulk Drug Substances Nominated Without Sufficient Supporting Evidence
FDA reviewed these nominated bulk drug substances and determined they do not 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; therefore, these bulk drug substances cannot be used to compound animal drugs for office stock or antidotes. These substances may be nominated again for re-evaluation by FDA, using the nomination procedure described in the appendix of draft GFI # 256.
For information on how to submit a bulk drug substance nomination, see the appendix of draft Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances.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
- Amlodipine – Indication: For emergency treatment of systemic hypertension in cats. Dosage form: 0.0625 mg/0.1 ml transdermal preparation. Reason: There are human FDA-approved amlodipine products that can be used to compound 0.0625 mg/0.1 ml transdermal amlodipine.
- 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. Reason: Clevor (ropinirole ophthalmic solution) 30 mg/ml (NADA 141-534) is now FDA-approved for induction of emesis in dogs.
- Budesonide – Indication: For emergency treatment of acute inflammatory gastrointestinal conditions in cats. Dosage forms: oral suspension, tablets, and capsules (specific concentrations not indicated), dosage 1mg/cat indicated. Reasons:
- Capsules and tablets - Budesonide oral capsules can be compounded by reformulating human FDA-approved capsules. The reformulated budesonide capsules can be used in place of budesonide tablets compounded from bulk.
- Suspension - Budesonide is inactivated in the stomach and proximal intestine if not protected by an enteric coating.
- Chloramphenicol – Indication: For the treatment of ocular bacterial infections in horses. Dosage form: 1% ophthalmic (conjunctival) solution. Reason: There are human and animal FDA-approved products for initial empirical treatment, there are human health risks associated with administration of chloramphenicol, and in instances where chloramphenicol may be indicated based on culture and sensitivity results, this preparation can be compounded on an individual patient basis.
- Dexamethasone – Indication: For emergency treatment of histamine reactions in horses. Dosage form: 10 mg oral powder packets. Reason: FDA-approved human oral tablets can be used to compound 10 mg oral powder doses.
- 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). 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.
- Doxycycline – Indication: For emergency antibiotic treatment (Lyme disease, Anaplasma phagocytophilum, and Neorickettsia risticii), and for cases where there is a need for a tetracycline antibiotic in the presence of renal failure. Dosage form: oral powder, tablets, and solution (no strengths indicated). Reason: FDA-approved human products can be combined to reach an appropriate dose concentration by directly administering the tablets or capsules, or used to compound a powder or suspension for oral administration.
- Enrofloxacin – Indication: For use in horses for treatment of respiratory infections and other life-threatening bacterial infections, including enteric gram negative infections such as Salmonella. Dosage form: 100-200 mg/ml oral paste and suspension. Reason: There are FDA-approved enrofloxacin products that can be used extralabel, or used to compound enrofloxacin paste and suspension.
- Gabapentin – Indication: For treatment of severe neuropathic pain in cats. Dosage form: 100 mg/ml suspension and 12.5 mg oral capsules. Reason: There are human FDA-approved capsules and tablets that can be used to compound a suspension or oral capsule.
- Idoxuridine - Indication: For treatment of feline herpesvirus keratoconjunctivitis. Dosage form: 0.1% ophthalmic solution or ointment. Reason: There are FDA-approved human drugs that can be used extralabel to treat feline herpesvirus keratoconjunctivitis in cats.
- Itraconazole with DMSO – Indication: For emergency treatment of fungal keratomycosis (keratitis) in horses. Dosage form: Itraconazole (1%) with DMSO (30%) ophthalmic ointment or solution. Reason: Lack of an explanation, supported by appropriate scientific data, of why itraconazole (1%) with DMSO (30%) cannot be compounded from FDA-approved drugs, and the availability of an alternative compounded ophthalmic drug for keratomycosis in horses that can be compounded using the FDA-approved drug product Vfend.®
- Voriconazole – Indication: For treatment of ophthalmic fungal infections in horses. Dosage form: 1% ophthalmic ointment. Reason: Voriconazole ophthalmic ointment (1%) can be compounded using FDA-approved injectable product, and there is lack of published data on the safety, efficacy, and stability of voriconazole ophthalmic ointment compounded using the bulk drug substance voriconazole.
NON FOOD-PRODUCING MINOR SPECIES
- Awaiting nominations
- Awaiting nominations