Download in electronic PDF format for $25

Kalchem International - Chemicals and Compounding Supplies

Search the Complete Journal Archives

Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating

Author(s):  Martin Matt

Issue:  Jul/Aug 2018 - Volume 22, Number 4
View All Articles in Issue

Abstract:  Compounding pharmacists must separately and collectively evaluate multiple aspects of a compounded sterile preparation when determining their beyond-use date. Considerations include the microbiological risk level, storage temperature, chemical stability, batch size, and whether or not a sterility test will be performed. The United States Pharmacopeia Chapter <797> provides guidance on the maximum beyond-use date allowed solely based on the microbiological risk level associated with the compounding of a sterile preparation. Compounders should select the shortest beyond-use date between the risk-level based beyond-use date and the chemical stability of the compound. When compounding pharmacists intend to provide a compounded sterile preparation with a beyond-use date that exceeds the risk-level based recommendations in United States Pharmacopeia Chapter <797>, they must ensure that their formulations are sterility tested in compliance with United States Pharmacopeia Chapter <71>. United States Pharmacopeia Chapter <71> compliance includes conducting method suitability that is applicable to the strength and batch size that they plan to prepare. Chemical stability must be a separate consideration for each formulation.

Related Keywords: Matt Martin, PharmD, compounded sterile preparations, beyond-use date, microbial contamination, storage temperature, chemical stability, sterility testing, United States Pharmacopeia Chapter <797>, USP, United States Pharmacopeia Chapter <71> Sterility Tests, US Food and Drug Administration Form 483, microbiological risk, batch size

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

Printer-Friendly Version

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Basics of Sterile Compounding: Criteria for Determining Beyond-use Dating Martin Matt Jul/Aug 2018 303-312 Buy
Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests Kupiec Thomas C Sep/Oct 2007 400-403 Buy
Basics of Sterile Compounding. Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 2 Martin Matt Nov/Dec 2018 475-478 Buy
Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1 Martin Matt Sep/Oct 2018 401-404 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
Misinterpretation of United States Pharmacopeia Chapter <797> McElhiney Linda F Jan/Feb 2012 6-10 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 8; Stability and Beyond-Use Dating Allen Loyd V Jr, Okeke Claudia C Jul/Aug 2008 344-353 Buy
USP Chapter <797>: Practical Solutions for Microbiology, Sterility, and Pyrogen Testing Caputo Ross A, Huffman Anne, Reich Robert Jan/Feb 2005 11-13 Buy
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards Kastango Eric S May/Jun 2008 216-229 Buy