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There can be absolutely no excuse or justification for the lack of a federally mandated and strictly enforced code of federal regulations for the compounding of sterile preparations (CSPs) across this country. With the number of CSPs being prescribed and administered growing dramatically everyday, together with the number of facilities and people preparing them, the odds of a major and deadly incident occurring due to a lack of strict regulations and regulatory enforcement are swinging inexorably toward just-a-matter-of-time.
Yet when asked about CSP regulation, most government officials and industry spokespeople like to reference the progress of USP Chapter 797, which became effective (whatever that actually means) on January 1, 2004. (It is now under revision with comments from the public due by August 15.) However, what they fail to point out is that the state of this document has nothing at all to do with the issue at hand-which is that there are two distinctly different sets of rules for the preparation of sterile drugs: the FDA’s cGMP regulations, which regulate “manufactured” drugs, and the USP 797 sterility standard, which applies to CSPs. And, as stated so vehemently by the International Academy of Compounding Pharmacists (IACP), “compounding pharmacies are not required to conform to the sterility standards for manufactured drugs.” And this is very true. The problem is that they’re not legally required to conform to any sterility standard.
In its lobbying efforts to fend off stricter federally-imposed regulation, the IACP says that the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and state boards of pharmacy “now routinely use standards based on USP 797 during accreditation and licensing of compounding pharmacies.” I’m sorry, but I read this to say they also routinely don’t use them.
The IACP also points to the tough accreditation standards that will be set by the Pharmacy Compounding Accreditation Board (PCAB). The PCAB, however, is actually just another arm of the IACP together with a few other likeminded industry associations. One thing I can pretty much guarantee is that, come the day of reckoning, it will not be anyone from the PCAB or IACP who will be stepping forward to accept responsibility.
The FDA can justifiably cite the many legal, political and bureaucratic obstacles placed before them, not to mention its completely inadequate manpower resources to conduct the required monitoring and inspection. They can certainly point to the many challenges made to aspects of the agency’s jurisdictional authority over compounding pharmacies as provided through the 1938 Food Drug & Cosmetics (FD&C) and the later FDA Modernization Act (FDAMA) of 1997. And, they have a case that Congress has indeed failed to deliver the unambiguous addendum to the original legislation that is apparently needed. But, it doesn’t change reality.
If we’ve learned nothing else from the circus following hurricane Katrina, it is that-rightly or wrongly-the public holds the Federal government ultimately responsible for its safety and security. Therefore, it is irrelevant what level of state or federal agency is ultimately tasked with the responsibility of inspection and enforcement, the Federal government (i.e., the FDA) has the obligation to define, establish and mandate the specific regulatory requirements for CSPs.
Now is the time for the FDA to demand attention to and action on this issue. The FDA is the only logical choice to be given the lead on this-if only to strictly define the requirements of the regulation (in other words, to mandate USP 797 adherence). We cannot reasonably expect 50 different state boards of pharmacy to come up with a uniform standard or enforcement policy. And, if we really believe that self-regulation is all that is needed, then we have to ask why the FDA was created in the first place.