Tuesday, June 9, 2015

FDA releases draft compounding guidance

Historically, when a veterinarian needed to compound drugs from bulk substances to meet a patient’s needs, he was breaking a federal law. Now, the Federal Drug Administration (FDA) is recognizing the need for that “lawless” act. On May 18, the FDA released Guidance for Industry #230 (GFI #230) on animal drug compounding from bulk drug substances. It also admitted that in limited circumstances, an animal drug compounded from bulk drug substances may be an appropriate treatment option. ...more


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