Focus on compounding


This month’s issue of CleanRooms magazine will receive special bonus distribution at the American Society of Health-System Pharmacists (ASHP) Summer Meeting and Exhibition in San Francisco, June 24-27. And CleanRooms will be there as well to keep a close eye on this very important industry for contamination control professionals and companies. As described in this month’s special report, the creation and adoption of USP <797> standards and practices is already having a dramatic impact on improving the safety of sterile products produced in hospital pharmacies and other compounding facilities. And, with the release of the revisions, currently under active review by the USP <797> committee, there will also be substantial improvements to the safety levels of pharmacists performing the work, as well as anyone potentially coming into, or near, compounding spaces-particularly when hazardous compounds are being handled.

There are still questions that remain to be answered, however-one of which is the question of enforcement, which has been raised on this page before. The FDA has already cited USP <797> as its guidance document for compounding pharmacies, and a number of state boards of pharmacy have also either adopted or referenced the document. Still, much still needs to be done to establish a uniform national policy of inspection and enforcement. Some good news in the right direction is that the FDA is now considering the possibility of providing standardized training in USP <797> certification to state inspectors, in lieu of having FDA personnel actually perform the inspections themselves. While perhaps not the best solution, it may be the only realistic one given FDA’s manpower limitations. Another positive indication may be found in the Senate’s recent passage of the “FDA Revitalization Act,” which although it may not provide direct support for compounding concerns, does provide the FDA with some attention and relief in regard to its existing role in overseeing the overall approval, manufacture, and control of pharmaceuticals-a critical factor in protecting the public from potentially dangerous drugs but also in ensuring the rapid development and delivery of revolutionary new treatments into the arsenals of the medical community.

As evidenced by the increasing number of contamination control companies exhibiting at and attending ASHP events, there is also a clear recognition on the part of our industry that there are a great many opportunities in and existing technological benefits available to compounding pharmacies. While the USP <797> document gives guidance on what levels of protection must be achieved and maintained, it leaves plenty of options open as to how this is accomplished, and certainly the wide variety of facility constraints, locations, sizes, and applications means there are also a great many viable solutions possible for meeting them. I’ll be looking forward to seeing and hearing about many of them at the ASHP show and also in the pages of this magazine going forward.

John Haystead,