Compounding Today: state board of pharmacy concerns with USP <800>

Each Friday the CompoundingToday Newsletter faithfully appears in my inbox. The newsletter features commentary by Lloyd V. Allen, Jr., Ph.D., RPh, Editor-in-Chief of the International Journal of Pharmaceutical Compounding. Dr. Allen is a legend in the pharmacy compounding world for both sterile and non-sterile products. He was someone that I looked up to during my early years as a pharmacist; still do, as a matter of fact.

Long before USP <795> and <797> existed, he was preaching the gospel of proper compounding technique and the need for specialized training. Truly a visionary man ahead of his time. I hope to meet him in person someday.

So it should come as no surprise that I take seriously every thought and opinion he has. In last week’s Compounding Newsletter, Allen tackled an interesting topic with some thoughtful commentary.

From the newsletter:

Numerous state boards of pharmacy have concerns about United States Pharmacopeia (USP) Chapter <800> Hazardous Drugs-Handling in Healthcare Settings.

– The official chapter goes beyond the walls of the pharmacy and into healthcare settings, including physician offices, clinics, hospitals, treatment centers, etc. where state boards of pharmacy don’t generally have authority for enforcement.

– The requirements of <800> are very strict and extremely costly; many smaller pharmacies will no longer be able to serve their patients who depend upon compounded medications so they will simply cease compounding patient-specific medications, including some hospitals.

– There are some aspects of <800> that should be the burden of manufacturers and distributors, not pharmacies. As an example, no package should be delivered to a pharmacy contaminated with hazardous drug (HD) contents on the package surfaces that exposes pharmacy personnel upon opening. This is the responsibility of the manufacturer and distributor…

– Many of the requirements of <800> are based upon “opinion” and not necessarily upon science as demonstrated by documented, prospective studies.

It’s interesting to note that USP <800> extends into all areas where HD’s may be used, including physician offices. Where will that oversight come from? Will pharmacies be held accountable?

Dr. Allen has always been an advocate for “the little guy” and been cognizant of the balance between practical regulation and overbearing regulation. This is clear in his assessment of many areas within USP <800>. While I don’t necessarily agree with everything he says, I believe that his commitment to pharmacy practice and patient care deserve our attention. As he states, it is possible that the new regulation will simply be too much for some, resulting in the closure of compounding facilities. The greater concern, at least for me, is what impact the new requirements will have on hospital pharmacies where budgets drive change. A shift in budgetary requirements will likely mean that important projects will be postponed or canceled in favor of meeting USP <800>. The untoward consequences could be felt for years to come.(2)

Dr. Allen’s zinger about the lack of science is understandable and shared by many, but I don’t believe that prospective studies are always necessary to begin a process. For example, would you really want a 10-year pilot study showing that healthcare workers in the U.S. exposed to HDs are 10 times more likely to die of cancer than those that don’t before implementing these guidelines?(1) No, of course not. As I’ve said many times before, some fields – clean room procedure and pharmacy technology, for example – cannot be studied and scrutinized in the same manner as therapeutics. We simply can’t wait 5-10 years to change operational practices. With that said, USP <800> probably goes too far too fast in certain aspects of the regulation. Only time will tell whether the new guidelines will have the same impact as USP <797> did back when they were introduced.

Dr. Allen goes on to state: “As state boards of pharmacy have options other than accepting USP <800> in its entirety… The purpose of this document is to simply provide a resource from which state boards of pharmacy can “pick and choose” items to include for their respective state.” While this may be true, it is one area where I disagree with Allen. Giving each state the ability to “pick and choose” how to implement and use USP <800> makes things incredibly difficult. California, for example, has made a complete mess out of their new regulations. Other states will do the same, creating chaos. In Allen’s scenario, moving ten feet across a state boundary could mean following a completely different set of rules. How does that make sense? I recommend developing USP <800> to a point that everyone can live with and use it. Period.

I encourage you to read through the most recent issue of the CompoundingToday Newsletter. I also recommend that you “click subscribe” as well. The information is good and thought-provoking.

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• This is a fictitious example.
• As my friend and colleague, Ray Vrabel likes to say, the clean room is “clean, but deadly”, referring to the fact that we spend all our money on regulation and virtually nothing on technology to improve safety.