Abstract

Sterile Product Compounding: A Comparison of ASHP and USP Guidelines

Author(s): Lima Hetty A

Issue: Jul/Aug 1999 - Compounding Parenteral Products

Page(s): 270-273

Download in electronic PDF format for $75

Abstract

There are no professional standards of practice dealing with sterile products. The author discusses regulations, guideline scope (of the American Society of Hospital Pharmacists Technical Assistance Bulletin), guideline classification, and policy and procedures. Tables provide guideline content and provide comparisons/contrasts between the two sets of guidelines (the American Society of Hospital Pharmacists and the United States Pharmacopeial Convention). The author concludes that pharmacists who prepare sterile products should read both guidelines and determine the appropriate risk level of the sterile products they prepare. Pharmacists should ensure that the products they prepare are categorized into the appropriate category based upon multiple compounding breaks, complexity of compounding, high-risk administration sites and any extenuating circumstances. Professional judgment should be exercised when applying the guidelines to specific pharmacy practice settings to ensure the highest level of product quality.

Related Keywords

Related Categories

Printer-Friendly Version

Related Articles from IJPC

Issue/Page View/Buy	Title/Author (Click for Abstract / Details / Purchase)
Jul/Aug 1999 Pg. 270-273	Sterile Product Compounding: A Comparison of ASHP and USP Guidelines Author(s): Lima Hetty A
Jul/Aug 2004 Pg. 292-293	Standard Operating Procedure: Determining and Documenting the Commercial Unavailability of a Manufactured Drug Product Author(s): Allen Loyd V Jr
Mar/Apr 1997 Pg. 75-77	NABP Guidelines: Good Compounding Practices Applicable to State-Licensed Pharmacies Author(s): Allen Loyd V Jr
Jul/Aug 2004 Pg. 251-263	A Primer on USP Chapter 797, "Pharmaceutical Compounding - Sterile Preparations," and USP Process for Drug and Practice Standards Author(s): Newton David W, Trissel Lawrence A
May/Jun 2013 Pg. 210-219	Quality Control Analytical Methods: A Summarized Discussion of Current Good Manufacturing Practice Regulations Author(s): Allen Loyd V Jr
Jul/Aug 2016 Pg. 351 View Sample	Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines Author(s): Allen Loyd V Jr
Jul/Aug 2001 Pg. 246-253	Quality Assurance for Sterile Products Author(s): Kastango Eric S, Douglass Kate
May/Jun 2003 Pg. 228-229	Standard Operating Procedure: Incubator Temperature Monitoring Author(s): Allen Loyd V Jr
Jan/Feb 1998 Pg. 78	Standard Operating Procedure for Particulate Testing for Sterile Products Author(s): Allen Loyd V Jr
Mar/Apr 2015 Pg. 127-138	Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing Author(s): Akers Michael J
Sep/Oct 2019 Pg. 356	PreScription: Regulations, Laws, Standards, Guidelines, Procedures, Etc Author(s): Allen Loyd V Jr
Jul/Aug 2023 Pg. 305-313	Sterile Basics of Compounding: Intravenous Admixture Compounding, Part 3: Preparation Procedures Author(s): Allen Loyd V Jr
Mar/Apr 2004 Pg. 89-94	Overview of Chapter <797> "Pharmaceutical Compounding - Sterile Preparations": The Potential Impact for Compounding Pharmacists Author(s): Rahe Hank
Sep/Oct 2006 Pg. 381	Standard Operating Procedure: Procedures in the Event of Nonconformance of Bulk Chemicals or Compounded Preparations Author(s): Allen Loyd V Jr
Sep/Oct 2007 Pg. 404-410	Considerations for Implementing United States Pharmacopeia Chapter <797> Pharmaceutical Compounding--Sterile Preparations, Part 3: Risk Levels Author(s): Allen Loyd V Jr, Okeke Claudia C
May/Jun 2024 Pg. 229-240	Basics of Sterile Compounding: Sterilization Methods in Sterile Product Manufacturing Author(s): Akers Michael J
May/Jun 2010 Pg. 232-238	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 Author(s): Okeke Claudia C, Allen Loyd V Jr
Mar/Apr 2017 Pg. 133-142	Accuracy Considerations in Sterile Compounding Author(s): Akers Michael J
Sep/Oct 2007 Pg. 397-398	Obtaining Accreditation by the Pharmacy Compounding Accreditation Board, Part 2: Developing Essential Standard Operating Procedures Author(s): Cabaleiro Joe
May/Jun 2006 Pg. 218	Standard Operating Procedure: Sterility Test for Ophthalmic Solutions Author(s): Allen Loyd V Jr