Answers for 503B Outsourcing

The Science of Sterile Compounding: to ensure the highest level of patient safety, now is more critical than ever to fall in line with requirements and optimize methods given changing and more strict rules and regulations.
Sterile compounding, drug shortages, and pharmacy technician turnover are top issues for hospitals and health systems pharmacy
A study showed that 61% of hospitals report they fall below current draft USP <797> requirements—these requirements are poised to get even more strict with the pending final USP <797> guidance.
The FDA and USP seem to be converging on similar compounding standards for hospital and health system based compounding
503A compounding operations in hospitals and health systems could be subject to FDA inspection—some already are
The US Office of Inspector General (OIG) issued a report showing Only 2% of hospitals are considering building their own 503B operation, given equipment, facility design, and “huge leap in cost and talent” are major limitations.
Hospital C-suite and pharmacy executives are attuned to and worried about some similar issues like “governmental mandates” (e.g., State and Federal requirements), personnel shortages, patient safety, drug shortages.
More than ever, hospital executives are called to recognize risks and opportunities associated with sterile compounding and take action to achieve compliance to optimize patient safety<797> guidance.
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Leaders in 503B Compounding