Article

The Great Debate of USP <797> and the Requirements to Sterile Compounding

March 03, 2022 Anita Boye

After many years of anticipation, there is still no official targeted publication date for the proposed revision to the new standards and requirements of USP's chapter of <797> Pharmaceutical Compounding - Sterile Preparations.


Latest information

With the ever-changing revision and publication timeline of compliance rules and dates, public comments for the 2021 revisions to USP <797> are currently set to close on March 17, 2022, but it looks like we will not see anything official come through until at least late Q2 (if the current date is maintained). The Compounding Expert Committee will then meet to address the comments and make another round of revisions based on those remarks. Once the revisions are published, there will be a six-month waiting period before any of the revisions can become official.


So, what does that mean for me?

Although the proposed revision calls for the removal of some information and/or clarification of certain requirements, the focus on patient access to safe medications–especially those requiring sterile compounding–has not changed. Whether the public comments are revised or not, there are still important aspects to USP <797> that must be adhered to. The best way to handle future USP <797> compliance today is to make sure you are not compromising the sterility and safety procedures in order to ensure your end-users remain safe from contaminated drugs and your practice is not affected.


But how?

Here are a few situations that could resonate with you:

Training is an absolute must. Invest in and ensure adequate training of personnel in the skills of garbing and aseptic work practices. And, be sure to follow cleaning and disinfection procedures to maintain classified environmental conditions.

Never assume hygiene is up to par. Continuously evaluate and train sterile compounding personnel on cross-contamination by way of personal hygiene to include gloved hands during operations. Inadequate temperature and humidity controls affecting personnel behavior in the control environment, such as excessive sweating, can contribute to excursions exceeding action levels.

One of the major changes to USP <797> is the identification of excursions from microbial air and surface monitoring. Previously, any excursion from environmental monitoring sampling undergoes microbial identification, irrespective of the action level. This new revision requires only microbial excursions exceeding action levels to be identified, which is a big sigh of relief for some facilities. Whilst this revision may be true, it is still imperative to know what may be lurking in your environment and how it impacts the quality and safety of your end product. I believe the saying that “whatever is in your environment, has a potential of adversely impacting the outcome of expectation,”... especially so with microorganisms. Be vigilant, know the environment you are compounding in, and maintain the conditions in providing safe sterile compounded drugs.

Routine sampling can utilize one type of media or two. The accepted method of testing from Azzur Labs is one-plate testing using RODAC plates, for a few specific reasons. Using the one-plate method saves on materials and manpower. But, most importantly, the one-plate method saves on time and greatly reduces the risk of contamination by the sampler. Utilizing a general-use media, such as RODAC, supports the growth of all microbes, eliminating the need for more testing on more than one media.


How can we help?

Azzur Group offers contract laboratory services with locations nationwide that can be a resource for you to ensure regulatory compliance. Azzur Labs provides surface testing for hazardous drugs, environmental monitoring, gowning validation, personnel training and monitoring, and drug testing for potency, sterility, and endotoxin.

Azzur Training Center (ATC) is a resource we provide to organizations performing aseptic activities. ATC offers aseptic gowning training, aseptic behavior and process training, and qualification programs tailored specifically to client procedures. We take the risk out of contaminating an operational facility while qualifying personnel to meet client-specific requirements.

If you need guidance or assistance on how to move forward with the revisions to USP <797>, contact a team member here to get started.


Anita Boye Headshot

Anita Boye

Anita has more than 15 years of hands-on experience in the regulated microbiology and analytical laboratory space. As Senior Director, she oversees operations and client relations for Azzur Labs Dallas. For more than a decade before coming to Azzur Labs, Anita served as a laboratory manager and technical director for a leading laboratory specializing in nutraceuticals, dietary supplements, personal care products, and food analysis. There, she not only oversaw GxP laboratory operations and client relations, but also the re-built, transfer, and qualification of two full-scale facilities. Anita is an active member of the American Society for Quality (ASQ) and is Food Safety Modernization (FSMA) certified.
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