Comment from American Pharmacists Association (APhA)
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Summary: The American Pharmacists Association (APhA) supports the draft guidance but requests greater clarity on whether it applies to 503A and 503B compounding facilities. They also urge the FDA to balance information needs with regulatory burdens and to collaborate with state boards of pharmacy to ensure alignment.
Dear Deputy Commissioner Graham,
The American Pharmacists Association (APhA) appreciates the opportunity to provide FDA comments on the “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry.”
APhA represents pharmacists, student pharmacists, and pharmacy technicians in all practice settings, including but not limited to community pharmacies, hospitals, long-term care facilities, specialty pharmacies, community health centers, physician offices, ambulatory clinics, managed care organizations, hospice settings, and government facilities. Our members strive to improve medication use, advance patient care, and enhance public health.
Full comments are attached.