LP3 Network Free Webinar - Veterinary Compounding, A Customized Approach

Download in electronic PDF format for $25



Search the Complete Journal Archives

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating

Author(s):  Allen Loyd V Jr, Okeke Claudia C

Issue:  Jul/Aug 2008 - Hormone Replacement Therapy
View All Articles in Issue

Abstract:  Beyond-use-dates for sterile preparations are divided into two categories. If a program of sterility testing is not in place, then the short beyond-use dates specified in United States Pharmacopeia Chapter <797> for the different risk levels are to be used. If a program of sterility testing is in place, then the beyond-use dates described in United States Pharmacopeia Chapter <795> for stability of various types of preparations/formulations can be used, which are somewhat longer than those in Chapter <797>. Beyond-use dates are established on the basis of chemical and physical stability aspects of a compounded preparation. If a sterility testing program is in place, then each compounded preparation is considered “sterile” and the areas of concern are chemical and physical stability. In manufacturing, not every dosage unit is tested, only a sample. Similarly, only a sample of compounded preparations is tested. A sterility testing program must be in place to demonstrate that compounding procedures are under con

Related Keywords: Loyd V. Allen, Jr., PhD, RPh, Claudia C. Okeke, PhD, RPh, United States Pharmacopeia, USP Chapter <797>, USP Chapter <795>, sterile preparations, quality control, stability, beyond-use dating, expiration, incompatibility, environmental factors, storage, labeling, standards

Related Categories: STABILITIES, COMPATIBILITIES, STERILE PREPARATIONS, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, PROFESSIONAL ISSUES, STORAGE

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Allen Loyd V Jr, Okeke Claudia C Jul/Aug 2008 344-353 Buy
Basics of Compounding: Considerations for Implementing USP Chapter <797> -- Sterile Preparations, Part 19: Storage and Beyond-Use Dating, Maintaining Sterility, Purity, and Stability of Dispensed and Distributed Compounded Sterile Preparations Okeke Claudia C, Allen Loyd V Jr May/Jun 2010 232-238 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 6: 2008 Revisions to Chapter <797> Allen Loyd V Jr, Okeke Claudia C Mar/Apr 2008 136-144 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 13: Environmental Quality and Control Allen Loyd V Jr, Okeke Claudia C May/Jun 2009 234-238 Buy
Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels Allen Loyd V Jr, Okeke Claudia C Sep/Oct 2007 404-410 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 14: Environmental Quality and Control (Continued) Okeke Claudia C, Allen Loyd V Jr Jul/Aug 2009 322-329 Buy
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 7: Microbial Contamination Risk Levels, 12-Hour Use, and Immediate Use Allen Loyd V Jr, Okeke Claudia C May/Jun 2008 252-257 Buy
Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations Okeke Claudia C Jul/Aug 2007 302-305 Buy
A Primer on USP Chapter 797, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards Newton David W, Trissel Lawrence A Jul/Aug 2004 251 Buy
Basics of Compounding: The Responsibilities of Compounding Personnel in Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 2 Allen Loyd V Jr, Okeke Claudia C Jul/Aug 2007 314-323 Buy