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  1. Animal Drug Compounding

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

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

Bulk Drug Substances Currently Under Review

Bulk Drug Substances Reviewed and Not Listed

These bulk drug substances were determined to meet the criteria for inclusion on the List of Bulk Drug Substances for Compounding Drugs for Use in Food-Producing Animals or Free-Ranging Wildlife Species. 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 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 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.

FOOD-PRODUCING ANIMALS (ANTIDOTES)

  • Copper glycinate – 
    • Indication: For the prevention and/or treatment of copper deficiency in due to molybdenum toxicity in beef calves and beef cattle. 
    • Dosage form: 200 mg/mL injection.
    • Withdrawal time: 30 days.

FREE-RANGING WILDLIFE SPECIES (SEDATIVES AND ANESTHETICS)

  • Azaperone tartrate –
    • Indication: For the tranquilization and sedation of free-ranging wildlife species. 
    • Dosage form: 40 mg/mL injectable suspension. 
    • Withdrawal time: Not to be used in free-ranging wildlife within 30 days of hunting season. If this is not feasible due to an emergency situation, any animal administered azaperone tartrate alone or in combination with other drugs should be tagged with an ear tag that has the following language: ‘DO NOT CONSUME if harvested before MM-DD-YYY. Call xxx-xxx-xxx.’ The tag should include a date that is at least 30 days after the date of administration of the drug and the phone number of the veterinarian or person in charge. 
  • Diprenorphine – 
    • Indication: For reversing the effects of etorphine hydrochloride injection. 
    • Dosage form: 2 mg/mL injectable solution.
    • Withdrawal time: Not to be used in free-ranging wildlife within 30 days of hunting season. If this is not feasible due to an emergency situation, any animal administered diprenorphine alone or in combination with other drugs should be tagged with an ear tag that has the following language: ‘DO NOT CONSUME if harvested before MM-DD-YYY. Call xxx-xxx-xxx.’ The tag should include a date that is at least 30 days after the date of administration of the drug and the phone number of the veterinarian or person in charge.
  • Etorphine hydrochloride –
    • Indication: For immobilization and anesthesia of free-ranging wildlife species. 
    • Dosage form: 10 mg/mL injectable solution.
    • Withdrawal time: Not to be used in free-ranging wildlife within 30 days of hunting season. If this is not feasible due to an emergency situation, any animal administered etorphine hydrochloride alone or in combination with other drugs should be tagged with an ear tag that has the following language: ‘DO NOT CONSUME if harvested before MM-DD-YYY. Call xxx-xxx-xxx.’ The tag should include a date that is at least 30 days after the date of administration of the drug and the phone number of the veterinarian or person in charge.
  • Ketamine hydrochloride – 
    • Indication: For immobilization and anesthesia of free-ranging 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
    • Withdrawal time: Not to be used in free-ranging wildlife within 30 days of hunting season. If this is not feasible due to an emergency situation, any animal administered ketamine hydrochloride alone or in combination with other drugs should be tagged with an ear tag that has the following language: ‘DO NOT CONSUME if harvested before MM-DD-YYY. Call xxx-xxx-xxx.’ The tag should include a date that is at least 30 days after the date of administration of the drug and the phone number of the veterinarian or person in charge.
  • Medetomidine hydrochloride – 
    • Indication: For immobilization, anesthesia, sedation, and analgesia of free-ranging wildlife 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. 
    • Withdrawal time: Not to be used in free-ranging wildlife within 30 days of hunting season. If this is not feasible due to an emergency situation, any animal administered medetomidine hydrochloride alone or in combination with other drugs should be tagged with an ear tag that has the following language: ‘DO NOT CONSUME if harvested before MM-DD-YYY. Call xxx-xxx-xxx.’ The tag should include a date that is at least 30 days after the date of administration of the drug and the phone number of the veterinarian or person in charge. 
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