The U.S. Food and Drug Administration is withdrawing draft Guidance for Industry (GFI) #230, “Compounding Animal Drugs from Bulk Drug Substances.”
According to FDA’s announcement, it’s withdrawing the draft Guidance for Industry (GFI) “in order to clarify the agency does not plan to finalize the current draft; but, instead intends to issue a new draft for public comment next year.”
From IACP Executive Vice President Cynthia Blankenship: Due to the overwhelming comments and concerns expressed by the International Academy of Compounding Pharmacists (IACP), other organizations and YOU, FDA has announced it is withdrawing the animal compounding GFI. Please see the comments IACP submitted to FDA on November 16, 2015.
IACP expressed these concerns to FDA in face-to-face meetings as well as via submitted comments. We hope that FDA will clearly state that the Drug Quality & Security Act (DQSA) does not apply to animal compounding, and help remedy the mass confusion the GFI and other FDA announcements and statements, intermingling human and animal compounding have caused for the States, providers, patients, and pharmacists.
We hope to work with FDA on both human and animal compounding activities to make certain that DQSA is implemented pursuant to Congressional intent, and patient access is preserved for these vital, life-saving medications. Patient access to compounded medications is a patient safety issue.
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Patient access to compounded medications is a patient safety issue.