FDA Policy/General

Animal Drug Compounding Guidance

FDA has issued a draft guidance, Compounding Animal Drugs from Bulk Drug Substances, to describe agency policy on the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or licensed pharmacists. The document says FDA has generally exercised enforcement discretion with regard to animal drug compounding from bulk drug substances under certain circumstances when no other medically appropriate treatment option exists. The guidance continues that practice and is intended to provide additional information and clarity to veterinarians and pharmacists about the agency’s current thinking on animal drug compounding from bulk drug substances.

FDA says its policies address agency concerns with compounding animal drugs from bulk substances, including significant concerns with such drugs when they: (1) present particular human or animal safety concerns; (2) are intended for use in food-producing animals; (3) are copies of marketed FDA-approved, conditionally approved, or indexed drugs; or (4) are compounded without a patient-specific prescription.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome