Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased 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

Page(s):  344-353

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 1
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 2
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 3
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 4
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 5
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 6
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 7
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 8
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 9
Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 8; Stability and Beyond-Use Dating Page 10

Download in electronic PDF format for $75

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/Author
(Click for Abstract / Details / Purchase)
Issue/​Page
View/Buy
PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>,<797>, and <825>: Part 1
Allen Loyd V Jr
Mar/Apr 2020
Pg. 92

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
Pg. 404-410

PreScription: Formal Appeals to United States Pharmacopeia Regarding USP Chapters <795>, <797>, and <825>: Part 2
Allen Loyd V Jr
May/Jun 2020
Pg. 180

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
Pg. 344-353

Basics of Sterile Compounding: Intravenous Admixture Preparation, Part 12: United States Pharmacopeia Chapters Referenced in the Current United States Pharmacopeia Chapter <797> Pharmaceutical Compounding -- Sterile Preparations
Allen Loyd V Jr
Nov/Dec 2021
Pg. 491-496

Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding--Nonsterile Preparations, Part 3
Allen Loyd V Jr
Nov/Dec 2011
Pg. 488-496

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
Pg. 252-257

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
Pg. 136-144

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 9: Immediate-Use Compounded Sterile Preparations
Allen Loyd V Jr
, Okeke Claudia C
Sep/Oct 2008
Pg. 440-443

Update on the Proposed Revision Process for United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations
Okeke Claudia C
Jul/Aug 2007
Pg. 302-305

Basics of Compounding: Implementing United States Pharmacopeia Chapter <1163> Quality Assurance in Pharmaceutical Compounding, Part 1
Allen Loyd V Jr
Mar/Apr 2012
Pg. 146-150

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
Pg. 232-238

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 4: Considerations in Selection and Use of Disinfectants and Antiseptics
Allen Loyd V Jr
, Okeke Claudia C
Nov/Dec 2007
Pg. 492-499

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
Pg. 234-238

Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding–Nonsterile Preparations, Part 4
Allen Loyd V Jr
Jan/Feb 2012
Pg. 64-68

Basics of Compounding: Implementing United States Pharmacopeia Chapter <795> Pharmaceutical Compounding--Nonsterile Preparations, Part 1
Allen Loyd V Jr
Jul/Aug 2011
Pg. 328-331

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
Pg. 322-329

Basics of Compounding: Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 11: Hazardous Drugs
Allen Loyd V Jr
, Okeke Claudia C
Jan/Feb 2009
Pg. 56-62

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
Pg. 314-323

Quality Control: Minor Chapters, Major Impacts: What United States Pharmacopeia Chapters <51>, <61>, <62>, and <1207> Mean for Your Compounding Practice
Kelley Brian
Mar/Apr 2021
Pg. 115-124

Return to Top