PostScription: Experts Everywhere
Download in electronic PDF format for $75
Abstract: Recent articles by individuals associated with the Controlled Environmental Testing Association (CETA) offer recommendations for barrier isolators used in pharmacy compounding. These recommendations are based, however, on misinterpretations of US Food and Drug Administration (FDA) policy, confusing guidelines for manufacturing with guidelines for compounding. United States Pharmacopeia (USP) Chapter <797> is an enforceable standard for compounding sterile preparations, while FDA regulations govern drug manufacturing processes. Great care has been taken in the construction of USP Chapter <797> to separate the requirements of manufacturing from the pharmacist’s right to compound. Compounding under the definitions and requirements outlined in USP Chapter <797> provide a safe environment without adding the more stringent requirements of the manufacturing environment. Confusing the requirements, as in the CETA documents, not only creates confusion but also endangers the intended separation of manufacturing and compounding.
Related Keywords:
barrier isolators, cleanroom, United States Pharmacopeia, USP Chapter <797>, US Food and Drug Administration, FDA, airflow, sterile preparation
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
|
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
|
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
Pg. 401-404
|
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
|
PostScription: Experts Everywhere
Rahe Hank
|
Mar/Apr 2005
Pg. 167
|
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
Pg. 251-263
|
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
|
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
|
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
|
United States Pharmacopeia Chapter <797> Timeline: 1989 to 2013
Newton David W
|
Jul/Aug 2013
Pg. 283-288
|
The U.S. Food and Drug Administration Takes Aim at Compounded Thyroid Hormone
Brunner Scott
|
Jan/Feb 2023
Pg. 22-23
|
Discrepancies in the Law and the U.S. Food and Drug Administration Pharmacy Compounding Compliance Policy Guidelines
Allen Loyd V Jr
|
Jul/Aug 2016
Pg. 351
View Sample |
PreScription: 2017 Pharmacy Compounding Issues: The U.S. Food and Drug Administration, Harzardous Drugs, and Wasted Drugs
Allen Loyd V Jr
|
Sep/Oct 2017
Pg. 356
|
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
|
Microbial Air-Sampling Equipment, Part 1: Meeting United States Pharmacopeia Chapter <797> Standards
Kastango Eric S
|
May/Jun 2008
Pg. 216-229
|
Technology Spotlight: Barrier Isolators
Moussa Magdy, Rahe Hank, Lo Katharine
|
Jan/Feb 2003
Pg. 42-43
|
Proposed Revisions to USP Chapter <797> Pharmaceutical Compounding--Sterile Preparations
Newton David W
|
Mar/Apr 2005
Pg. 127-130
|
Misinterpretation of United States Pharmacopeia Chapter <797>
McElhiney Linda F
|
Jan/Feb 2012
Pg. 6-10
|
A Needle-free Reconstitution and Transfer System for Compounded Sterile Intravenous Drug Solutions: In Compliance with United States Pharmacopeia Chapter <797> Standards
Marks Zach
|
Mar/Apr 2014
Pg. 94-99
|
U.S. Food and Drug Administration Proposed Guidance Document: Compounding Animal Drugs from Bulk Substances
Miller David G
|
Jul/Aug 2015
Pg. 303-305
|
Return to Top |