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This month, we talked with many attendees who stopped by the TSI booth at the American Society of Health-System Pharmacists (ASHP) Summer Meeting. The USP <800> December 1, 2019 compliance date came up often in conversation. Few of the pharmacists we met were confident they would finish work on their 503(a) cleanrooms or 503(b) outsourcing facilities in time for the deadline regarding compounding hazardous drugs.
TJC, an inspecting body, delivered a presentation at ASHP that revealed top violations for compounding pharmacies. Two of the top violations were:
Clearly, engineering controls are a key component in complying with USP <800> and USP <797>.
Complying with USP <800> requires good data from reliable instruments. TSI can help you meet requirements for both 503(a) and 503(b) compliance challenges: