Regulatory interest in compounding practices remains high, as most inspections include queries related to <797> compliance. Notably, regulatory actions increased this year although they remain uncommon overall. Recommendations were received for various infractions including improper dating on labels, temperature and humidity issues, and documentation gaps.
State boards are aggressively querying <797> compliance with a focus on written policies and procedures, cleaning practices, and evidence of staff competency. Accreditor inspections commonly focused on MDV and SDV usage, hood maintenance, and aseptic technique. Likewise, CMS commonly queried BUD, MDV and SDV use, and product handling and storage practices.
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