Late last year, FDA released a revised draft guidance entitled “Compounding Animal Drugs from Bulk Drug Substances” that outlines circumstances under which the agency will exercise enforcement discretion for compounding of animal drugs from bulk substances where no other medically appropriate treatment exists. The guidance addresses compounding of patient-specific prescriptions for non-food producing animals; compounding of “office stock” from bulk drug substances for non-food producing animals; and compounding of antidotes for food-producing animals. Speakers will address FDA’s goals for animal drug compounding under the guidance and how it differs from compounding of human drugs, industry reaction to the guidance, and specific industry concerns such as the requirement to start from an FDA-approved drug rather than an API and the criteria for office use. The deadline to submit comments to FDA on the draft guidance is June 17, 2020.
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