The response to my editorial in the June issue, “Immediate action required for CSPs,” touched off much more of a response than I expected, but certainly not more than the issue deserves. I assure you that the subject will not now be set aside in “drive-by-media” fashion.
Letters came down on both sides of the issue and some with a vehemence, I’m flattered to say, I thought was reserved for pundits at the level of “The Factor.” I won’t respond to all of the points and comments made-you can read them for yourself in their entirety in our letters section-but I do want to make clear that I am in no way impugning the operations or dedication of those compounding pharmacies and pharmacists who are conscientiously and professionally adopting and adhering to the highest standards of contamination control and sterility assurance. My concern is with those who aren’t, and with ensuring that there is an unambiguous system in place to ensure that these slackers are first rapidly identified and then either forced to get their act together or summarily shut down. I would expect the former group to support this action rather than stand against it.
I also, in somewhat puzzled fashion, want to note that one lengthy letter, while ostensibly taking issue with the facts of my remarks, actually repeats them. The one clear point of disagreement is whether the FDA should have the responsibility of setting national, mandatory, enforceable sterility assurance standards for compounding pharmacies. My position remains the same: clearly yes. As for anyone suggesting that this discussion has anything to do with NDA approval or that “compounding be banned or made illegal,” I can only say, “Huh?”
In fairness, there’s a lot of misleading and misunderstood information out there when it comes to USP-797 and CSP regulation, even for intelligent and engaged individuals. Defining, regulating and enforcing good CSP practices is without question critically important, but it’s also a complex and emotional subject. For example, as discussed by Hank Rahe in last month’s issue, the core element of the debate, USP-797 itself, is a source of major contention. In early May of this year, USP published the proposed changes to General Chapter 797, and the deadline for comment was August 15. The comments are now being taken under review by the Expert Committee, and it could be up to a year before a revised version of the chapter is published.
In the meantime, everyone with an interest in the outcome should become actively involved in learning everything there is to know about the technologies and requirements in question and the actual potential nationwide implications. CleanRooms wants to make sure you have that opportunity. On October 18, we are hosting a dedicated interactive Webcast by the industry’s leading experts titled “USP-797 – Facts & Fallacies.” Free to all registrants (see the ad in this issue), it’s an opportunity you should not miss. I know I won’t, and I hope to hear from you there as well.
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John Haystead,
Editor-in-Chief