By Bruce Flickinger
Compounding pharmacies, particularly those compounding sterile products, are increasingly under the regulatory eye. Once governed by a hodgepodge of state regulations, the industry has seen USP Chapter <797>: Pharmaceutical Compounding-Sterile Preparations emerge from an amorphous effort to standardize practices to the de facto industry standard in just a few years. Now there is the specter, albeit distant, of the Safe Drug Compounding Act, a draft Senate bill that would place the federal government (namely FDA) firmly in both the compounding pharmacy and the physician’s office. At press time, the bill had not been introduced and written comments were being received from numerous industry and special interest groups.
Preferring the carrot over the regulatory stick, the compounding pharmacy industry, and the healthcare community as a whole, is moving aggressively to police itself. While USP <797> is somewhat in flux, many of those affected by it are already girding for its impact instead of watching it develop and waiting for a clear mandate to comply. One manifestation of industry initiative is the Pharmacy Compounding Accreditation Board (PCAB), a group formed in 2004 to provide a profession-wide system of standards by which individual compounding pharmacies can test their quality processes.
Formed by six national pharmacy organizations, along with the National Association of Boards of Pharmacy and United States Pharmacopeia (USP), the PCAB tests and accredits pharmacies against standards, and notifies the public about which pharmacies have achieved accreditation. Thirteen pharmacies have been accredited to date, and about another 100 are currently undergoing the process. “We’re seeing a lot of enthusiasm,” says Ken Baker, executive director of the PCAB, based in Washington, DC. “Pharmacies want a set of national standards that they can meet voluntarily.”
Clearly, the intentions behind such efforts are good, but realistically, 13 accredited pharmacies nationwide is not a substantive number. And while many more quality-focused compounding pharmacies abound, the call has gone out from all invested parties for a tangible, nationally recognized mechanism that details the way sterile and high-risk pharmaceutical products should be compounded to optimally protect the safety and health of both patients and workers. USP <797> is the critical cog in this mechanism.
It’s easy to say that there’s much grumbling about the standard, but Baker is not seeing much consternation about USP <797> among the pharmacies pursuing accreditation. “Most of them already considered it to be a nationally recognized standard and were in the process of meeting the requirements,” he says. “There was some confusion when the standard first came out, but it’s been a long time since I’ve heard any complaints about USP <797>.” He is not alone in this observation.
“National standards like USP <797> will always be moving targets,” Baker adds. “There will always be revisions and changes, and pharmacies will have to meet them.”
Doing so is not a simple matter. As for PCAB accreditation, which requires compliance to USP <797> for pharmacies doing sterile compounding, Baker minces no words in saying it is “not an easy process. There are 10 standards to be accredited to and the pharmacy has to meet all 10 of them.” Following accreditation, there is a yearly application renewal and an on-site visit every three years. The revisit can take place before the three-year period if the application renewal reveals significant change in a pharmacy’s operations.
The pharmacy visit, called a survey, looks at two elements: what the pharmacy says it is doing and whether it is actually doing what it says it is. “We’ll follow back a filled prescription to see the process it went through to get there,” Baker says. “What a pharmacy is doing on a given day is just that: a snapshot of their operations. We need to see the policies and procedures that say they’ll be doing the same thing six months from now, or when new technicians are hired and trained.”
