1 June 2019 saw the publication of new and revised USP 797 standards, with affected users being expected to ensure their compliance with the new requirements by 1 December 2019. The recently revised standards tighten up controls in some areas which directly impact the safety and quality of compounded medicines. The latest changes affect 5 sections of the USP 797 document, and these must be taken into account when preparing CSPs.
Demonstration of Competency
In the previous USP 797 document, there were no annual requirements to demonstrate competency, however in this most recent update, Section 2.1 has been revised to put in place standards which must be met by compounding personnel. Before being permitted to independently prepare CPS, personnel must go through appropriate training and demonstrate their knowledge and proficiency in performing sterile manipulations and in maintaining and achieving the right environmental conditions. This level of competency must be tested on a 12-monthly basis.
Disinfection and Cleaning Requirements
The original Section 4.4 of the USP 797 document did not address the cleaning or disinfection of the sink however the revised version of the chapter requires sink surfaces to be disinfected and cleaned a minimum of once a day, with sporicidal agents being applied at least once per month.
There have also been revisions made to Section 7 of the USP 797 document which add new guidelines as to the frequency of disinfection and cleaning of the PEC. Rather than specifying these tasks are performed at the start of every shift, the updated requirements demand cleansing of all PEC interior surfaces once daily. It also demands that a sterile 70% IPA be applied to horizontal work surfaces every half hour at a minimum whenever the compounding process lasts for under 30 minutes and immediately following compounding when the process takes longer than half an hour.
Mop handles must be disinfected both before and after every use, and reusable cleaning equipment must be fabricated from cleanable materials. Sporicidal agents, EPA registered disinfectants or sterile 70% IPA must be wiped onto any items brought into the cleanroom or SCA whenever packaging integrity won’t be compromised. Low-lint wipers must be used, and the personnel must wear gloves, although the procedure for wiping mustn’t make the label of the product unreadable. Also, critical sites like ampule necks and vial stoppers now need to be wiped with sterile 70% IPA when inside the PEC then permitted to dry prior to opening.
To read the changes in their entirety, click here.
Why Must These Guidelines Be Followed?
The changes to the USP 797 guidelines must be adhered to by any 503b companies if they wish to avoid negative consequences. As demonstrated in the recent PharMedium controversy, companies which fail to comply with the regulations could end up facing violations and possibly even end up being put out of business completely.
The PharMedium Controversy
You may not be aware of the PharMedium controversy; A consent decree was entered against this 503b compounder by the Federal Court after it was determined that the company had manufactured and then distributed drugs like morphine sulfate and oxytocin which were supposed to be produced in sterile conditions in an unsanitary way where they were vulnerable to contamination.
Here at HCICS, we make it our ultimate responsibility to ensure that we are up to date with each and every change within the CSP industry to ensure our complete compliance. Thanks to the high level of experience and training of our team and our dedication to working to the very highest standards, we are partnered with a local 503B compounding facility, Apollo Care, to provide a customized plan for all compounding facilities. This enables them to stay on top of guideline changes and any implications for their CSP preparation.