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Beyond-use date: establishment and maintenance
1Narcotics, Sterile, and Nonsterile Compounding, Vanderbilt University Medical Center, Nashville, Tennessee 37240-7610, USA. richard.osteen@vanderbilt.edu
International Journal of Pharmaceutical Compounding
|December 25, 2012
Summary
Extending beyond-use dates for compounded sterile preparations requires end-point sterility testing. Pharmacists need specialized analytical skills to ensure drug stability and compliance with USP <795> and <797> standards.
Area of Science:
- Pharmaceutical Compounding
- Drug Stability Analysis
- Sterility Testing
Background:
- United States Pharmacopeia (USP) Chapters <795> and <797> emphasize drug stability in pharmacy compounding.
- Beyond-use dating (BUD) and expiration dating are critical for compounded sterile preparations (CSPs).
- Extending BUDs necessitates rigorous analytical approaches to ensure product integrity.
Purpose of the Study:
- To discuss the analytical requirements for extending beyond-use dates of CSPs.
- To highlight the specialized skill set pharmacists need for drug stability testing.
- To ensure compliance with USP <795> and <797> guidelines.
Main Methods:
- Analytical methodologies for end-point sterility testing of CSPs.
- Evaluation of drug stability parameters.
- Implementation of quality control processes for compounding.
Main Results:
- End-point sterility testing is a prerequisite for BUD extension in CSPs.
- A specific analytical approach is required for successful BUD extension.
- Pharmacists must possess unique skills to manage these stability processes.
Conclusions:
- Extending beyond-use dates for compounded sterile preparations requires specialized analytical skills and sterility testing.
- Pharmacists play a crucial role in ensuring drug stability and patient safety through advanced compounding practices.
- Adherence to USP standards is paramount for maintaining the integrity of compounded medications.
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