Bot Detector
Download FREE Sample Issue or Article
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date

Author(s):  Thomson Cassandra Marie, Savji Taslim

Issue:  Nov/Dec 2014 - Volume 18, Number 6
View All Articles in Issue

Abstract:  The establishment of both a beyond-use date and the extension of a beyond-use date need to be scientifically based. What is accepted as scientific evidence is at times misleading. The pharmacist may have the right to utilize some degree of professional judgment in both establishing and extending a beyond-use date, after a review of appropriate scientific literature. Notwithstanding this scientific review, it is the concept of professional judgment that seemingly needs to be better defined. A new-found appreciation for professional judgment will bring us to the understanding that a validated stability-indicating assay is the correct manner in which to extend a beyond-use date. This article addresses and discusses the recommendations and rigor required to establish and extend a beyond-use date. The perspectives of the pharmacist and physician are explored, as well as the impact of an extended beyond-use date, or lack thereof, are discussed. The application of a set of fundamental principles will be revealed, which will lead to finite conclusions as to the necessary methodology to establish as well as extend a beyond-use date.

Related Keywords: Cassandra Marie Thomson, BSc, MSc, Taslim Savji, BSc, beyond-use date, drug safety, chemical stability, drug degradation pathways, validated stability-indicating assay, high-performance liquid chromatography, HPLC, stability studies


Printer-Friendly Version

Download in electronic PDF format for $55

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Standards of Practice, Professional Judgment, and Scientific Evidence to Establish and Extend a Beyond-Use Date Thomson Cassandra Marie, Savji Taslim Nov/Dec 2014 456-460 Buy
Development and Application of a High-Performance Liquid Chromatography Stability-Indicating Assay for Beyond-Use Date Determination of Compounded Topical Gels Containing Multiple Active Drugs Gorman Gregory, Sokom Simara, Coward Lori, Arnold John J Mar/Apr 2017 164-170 Buy
Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design Patel Gopesh, Davis Countaney, Liu Yi, Ip Kendice, Debideen Krystal E, Anderson Stephanie, Byrne Robert, Herr Dylan, Rhoads Melissa Merrell, Caputo Ross, Banov Daniel, Bassani August S Jan/Feb 2021 73-81 Buy
Quality-Control Analytical Methods: High-Performance Liquid Chromatography Kupiec Thomas C May/Jun 2004 223-227 Buy
Stability of an Oral Liquid Dosage Form of Trovafloxacin Mesylate and Its Quantitation in Tablets Using High-Performance Liquid Chromatography Gupta Vishnu D May/Jun 2000 233-235 Buy
Assignment of a Beyond-Use Date for Compounded Preparations Allen Loyd V Jr Nov/Dec 2000 474-475 Buy
Identifying the Criteria of a Valid Stability Study Williams LaVonn A, Hastings Mitchell Blaine Jan/Feb 2009 32-36 Buy
Beyond-use Date: Establishment and Maintenance Osteen Richard Nov/Dec 2012 471-474 Buy
Quantitation of Testosterone-Cypionate-in-Oil Injection using High Performance Liquid Chromatography Gupta Vishnu D, Pramar Y Jul/Aug 1999 314-315 Buy
Quantitation of Testosterone Propionate in an Injection Using High Performance Liquid Chromatography Gupta Vishnu D Mar/Apr 1999 158-159 Buy