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Quality-control analytical methods: overview of beyond-use dating for compounded sterile preparations
1TriPharma Research, Ponte Verde Beach, Florida.
Abstract:
United States Pharmacopeia Chapter 797 provides guidelines and standards that deal with the preparation, compounding, and labeling of compounded sterile preparations. These standards ensure patient care and safety by defining safe practice. The Chapter gives instructions on determining beyond-use dates for the different risk categories associated with compounded preparations. Each of these categories has specific aspects of environmental personnel, and situational deterrents that Chapter 797 requires to be taken into account. By following the standards of Chapter 797, compounding pharmacists can alleviate danger to the patient and themselves in any situation.
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