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Adequate labeling of compounded animal drug (Guidance for Industry (Draft) (#230) 2015).
In May 2015 FDA issued a draft guidance on compounding animal drugs from bulk drug substances (Guidance for Industry (Draft) (#230) 2015).
The compounding facility would need to have a prescription from a veterinarian for an individually identified animal patient or an order from veterinarian for veterinarian office use (Guidance for Industry (Draft) (#230) 2015).
Additionally, these products may undermine the incentives to develop and submit new animal drug applications to FDA containing data and information to demonstrate that the product is safe, effective, properly manufactured, and accurately labeled (Guidance for Industry (Draft) (#230) 2015).
That amount should not exceed the amount of drug product that the state-licensed pharmacy compounded based on a patient-specific prescriptions and the history of receipt of such patient-specific prescriptions for that drug product over any consecutive 14-day period within the previous 6 months (Guidance for Industry (Draft) (#230) 2015).
Under the proposed guidance, FDA does not intend to take action under sections 512(a), 501(a)(5), and 501(a)(2)(B) of the FD&C Act (FD&C Act Chapter V) if an outsourcing facility compounds animal drugs from bulk drug substances in accordance with the defined applicable conditions published in the document (Guidance for Industry (Draft) (#230) 2015).
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