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  1. Animal Drug Compounding

Bulk Drug Substances Reviewed and Not Listed

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

List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species

Bulk Drug Substances Currently Under Review

FDA reviewed these bulk drug substances and is not including them on either 1) The List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals, or 2) The List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species. Therefore, these bulk drug substances are not covered by the enforcement discretion policy described in Guidance for Industry #256 Compounding Animal Drugs from Bulk Drug Substances. These substances may be nominated again for re-evaluation by FDA using the nomination procedure described in the appendix to GFI #256.

FDA will accept nominations of additional 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

  • 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 (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 and is not needed for urgent or immediate treatment to prevent animal suffering or death.
  • 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 part 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 forms: 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 Salmonellosis.
    • Dosage forms: 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 forms: 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.
  • 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, effectiveness, and stability of voriconazole ophthalmic ointment compounded using the bulk drug substance voriconazole.

NONFOOD-PRODUCING MINOR SPECIES

  • Butorphanol-Azaperone-Medetomidine (BAM) – 
    • Indication: For sedation and anesthesia in laboratory animals (mice, rats, and rabbits). 
    • Dosage form: butorphanol (27.3 mg/mL)-azaperone (9.1 mg/mL)-medetomidine (10.9 mg/mL) in a fixed-combination injectable solution.
    • Reason: Butorphanol and medetomidine are FDA-approved animal drugs available in concentrations that can be used in an extralabel manner under 21 CFR part 530 for sedation and anesthesia in laboratory animals. While FDA-approved azaperone is not marketed in the United States, azaperone tartrate is included on the List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals and can be used to compound office stock for use in laboratory animals.  
  • Haloperidol – 
    • Indication: for treatment of stress in large herbivores (zoo hoofed stock) or for feather picking in exotic pet birds.  
    • Dosage form: injectable (lactate, aqueous, 20 mg/mL) and oral (capsules - 60 mg; oral solution - 6 strengths from 0.1 mg/mL to 2 mg/mL; oral suspension - 2 mg/mL). 
    • Reason: haloperidol is available as FDA-approved human drug products that can be used as formulated or used to compound a different concentration or to add flavor if needed.  
  • Naloxone hydrochloride – 
    • Indication: Anesthetic reversal agent for bears, birds, camelids, canids, pocket pets, cervids, otters, primates, rabbits, lab rodents, ratites, sheep, and free-ranging wild animals. 
    • Dosage form: 1 mg/mL injectable solution. 
    • Reason: There are FDA-approved naloxone 1 mg/mL injection products that can be used in animals in an extralabel manner under 21 CFR part 530.

FOOD-PRODUCING ANIMALS OR FREE-RANGING WILDLIFE SPECIES

  • Naloxone hydrochloride – 
    • Indication: Anesthetic reversal agent for sheep, and free-ranging wild animals. 
    • Dosage form: 1 mg/mL injectable solution. 
    • Reason: There are FDA-approved naloxone 1 mg/mL injection products that can be used in animals in an extralabel manner under 21 CFR part 530.

These bulk drug substances were nominated without sufficient supporting information for FDA to evaluate them. These substances are not covered by FDA’s enforcement discretion policy described in GFI #256. FDA will consider them for inclusion on any List if they are nominated again with complete information, using the nomination procedure described in the appendix to GFI #256.

FDA will accept nominations of additional 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.

To view information that was previously submitted for these nominations, click on the hyperlinked Docket ID for each of these nominations, below.

Docket ID: FDA-2015-N-1196-0005
Substance(s): Prednisolone and prednisone 2.5mg, 5mg, 10mg, 20mg, 50mg, doxycycline 50mg, 100mg, 200mg, ketoconazole 200mg, cyclosporin 2% ophthalmic suspension

Docket ID: FDA-2015-N-1196-0006
Substance(s): Lanolin, enrofloxacin, triamcinolone, and neomycin in combination

Docket ID: FDA-2015-N-1196-0007
Substance(s): Doxycycline, metronidazole, methimazole, ponazuril

Docket ID: FDA-2015-N-1196-0009
Substance(s): List of 85 bulk drug substances

Docket ID: FDA-2015-N-1196-0017
Substance(s): Copper peptide, Superoxide dismutase

Docket ID: FDA-2015-N-1196-0018
Substance(s): Ophthalmic: idoxuridine, cidofivir, cyclosporine 2%, tacrolimus 2%, fluconazole, voriconazole

Docket ID: FDA-2015-N-1196-0019
Substance(s): List of 23 bulk drug substances

Docket ID: FDA-2015-N-1196-0020
Substance(s): Methimazole, amlodipine, ondansetron, prednisolone, prednisone, metronidazole, griseofulvin, cyproheptadine, mirtazapine, doxycycline

Docket ID: FDA-2015-N-1196-0021
Substance(s): Apomorphine, methocarbamol, buprenorphine, antibiotics, fentanyl, morphine

Docket ID: FDA-2015-N-1196-0024
Substance(s): Metronidazole, baytril, buprenorphine, morphine, prazosin, prednisone, methocarbamol, omeprazole

Docket ID: FDA-2015-N-1196-0036
Substance(s): Tylan soluble powder

Docket ID: FDA-2015-D-1176-0113
Substance(s): Diclofena

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