With the new revision of USP<797> on its way, many pharmacists are concerned about how these new regulations will affect their business. But what exactly has changed within the new revision? Among the most significant changes is the removal of low, medium, and high risk CSP categories. These designations have been replaced with category 1 and category 2 CSPs. The categories are now dictated by the BUD and the environment in which the product was compounded. The chart below shows the major differences between category 1 and 2 CSPs:
Another major change within the new USP<797> revision is the frequency at which environmental and personnel viable monitoring must be done. Current USP<797> protocols state that media fill testing and fingertip testing of all compounding personnel must be done either annually or semi-annually – depending on the risk level. New USP revisions call for these test to be done by all personnel quarterly, regardless of the category designation of the product. The frequency at which viable air sampling must be done has also increased. Although air sampling for cleanroom certification remains semi-annually, air sampling to evaluate air cleanliness must be done monthly by the pharmacist. This inherently creates issues for pharmacists that have not previously had to do their own air sampling. In addition to monthly viable air sampling, monthly surface samples must also be taken within each area of the cleanroom.
Many other smaller changes have been made within the USP<797> revision. For example, master formulation records must be kept for all manipulations made of any compounds, including non-sterile manipulations and dilution processes. A new concept called “in-use time” has also been introduced in the revision which regulates the amount of time that a sterile product can be used once opened or pierced.
Although the new regulations will require more testing and documentation to comply with regulations, the FDA is hoping that implementation of the revised USP<797> will reduce illness and death associated with sterile compounding. With the implementation of these new regulations in the now foreseeable future, pharmacists must begin preparing to comply with the new USP standards. Since environmental and personnel monitoring must be done monthly by the pharmacist, a suitable supplier of media and laboratory services is necessary. LAB 797 offers quality media and laboratory services – including speciation of all viable organisms recovered. Revision of internal SOPs is also crucial to comply with these changes. Although a specific release date has not been set by USP and the FDA, pharmacists are encouraged to begin considering these new regulations now – inherently saving time and stress when the official revision is published.
For more information on USP 797 and updated revisions release dates, check out USP’s website