Pharmacy OneSource Blog

Believe It or Not, the Glass is Half-Full

Posted on 10/19/15

Since June 2008, in collaboration with the FDA, members of the USP Sterile Compounding and Microbiology Expert Committees, have worked on the long-awaited revisions to USP 797 Pharmaceutical Compounding – Sterile Preparations PF 41(6). The proposed chapter has been published and has been available online since September 25, 2015. The public comment period ends January 31, 2016 and I strongly encourage you to read and comment on these proposed revisions as they will have a major impact on your compounding operation.

As a member of the USP Compounding Expert Committee from 2005 to 2013, I have been involved with this chapter for quite some time and am very excited about many of the changes in this revision. While I’m not saying that all of these proposed revisions are perfect, many of the changes have made the proposed chapter clearer and more robust than the current chapter.

First, the FDA has had greater influence on this version than in the past. Many of the chapter’s core principles survived the FDA’s critical review. In fact, beyond-use dating for compounded sterile preparations (CSPs), especially those stored at room temperature, has been extended from 48 hours to 6 days. Unlike the current beyond-use dates, which end at the beginning of administration, the proposed beyond-use dates include the time over which the CSP is used. The proposed chapter also provides specific guidance on the use of stock dilution bags, sterility testing of batches less than 40 units, as well as the requirement for Master Formulation Records and Compounding Logs.

That said, I cannot endorse the change in risk levels to 2 neutral categories. I believe that the proposed chapter may require too much personnel and environmental sampling for pharmacies performing Category 1 compounding and far too little sampling in pharmacies performing Category 2 compounding with non-sterile ingredients. After the profession finally accepted the risk levels, this proposed change is misguided. It runs contrary to the principles of Quality Risk Management where there is a hierarchy of risk from low to moderate to high.

Based on the current USP Chapter 797, the activities described below in the quotation below are not exempt from the requirements of the chapter:

“Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling” [21 USC 321 (k) and (m)].

The proposed revisions to the chapter permits the reconstitution the medications outside of an ISO Class 5 environment as long as aseptic technique is used (without a definition or list of critical behaviors that in total comprise aseptic technique) and performed for one patient for immediate use. The FDA considers this a function of medication administration. My critical analysis tells me that this process falls under what is currently low-risk level compounding. Ultimately risks are associated with different activities during handling and preparation of sterile injectable medications.

The table below provides a summary of the major changes to the chapter: 

Table of Major Changes to the Proposed USP Chapter <797>, September 2015

Three risk levels changed to 2 categories distinguished by conditions under which they are made and time within which used

Removal of HD handling section and cross-referenced to USP 800

Quarterly requirement for Personnel Monitoring (visual observation of hand hygiene and garbing, MFT and ongoing GFS)

Quarterly requirement for Viable Air sampling and Surface sampling

BUD and Storage times changed with a maximum BUD of 45 days regardless of sterility testing

Introduction of “In-Use time” (time before which conventionally manufactured product or compounded dilution bag must be used after it is punctured)

Master formulation and compounding records will be required for all batch and non-sterile compounding

New guidance for sterility testing of CSP prepared in batch sizes of less than 40. (10% rule)

New placement requirements on use of isolators

Requirement for sterile wipers and cleaning tools that need to be re-sterilized but not sterile disinfectants


Please download the proposed chapter then read it multiple times. Be part of the process and let your voice be heard. Submit comments to the USP Compounding Expert Committee to offer your suggestions. Comments must be submitted on Comment Submission Template by email to [email protected] by January 31, 2016. Be sure to include line numbers for your comments.

Thanks for fighting the good fight every day for your patients. Please take charge of our compounding standards. They are the cornerstone of our profession and if we don’t shape it, others will!


Topics: Sterile Compounding

About the Author

Eric S. Kastango RPh, MBA, FASHP is president of Clinical IQ LLC, a health care consulting firm and CriticalPoint, LLC, a web-based education company. He is an active member and Fellow of the American Society of Healthcare Pharmacists and served on the USP Sterile Compounding Committee from 2005-2010 and was recently re-elected to the 2010-2015 USP Council of Experts, Compounding Expert Committee and served until April 2013.