Compounding pharmacists who would like to put their practices to the test can now apply to earn the seal of approval offered by the Pharmacy Compounding Accreditation Board (PCAB).
About 60 compounding pharmacies volunteered last year to be the guinea pigs put through the PCAB wringer, including a recently completed in-store survey. The accreditation candidates should learn this month whether they pass muster with the 10 tough quality standards approved by the PCAB board last December.
Now that the first class has helped tweak its application process, PCAB is urging all pharmacies to step up and strut their compounding stuff. Applying for accreditation is as simple as going to the PCAB Web site, clicking on the "apply" button, and filling out the application. The hard part is doing a self-assessment to see if the operation measures up to the quality standards yardstick. The final hurdle to accreditation is the in-store visit from surveyors trained by the National Association of Boards of Pharmacy under contract with PCAB.
The cost to earn accreditation depends on a pharmacy's volume of compounded scripts. Pharmacies that compound one to 15 Rxs per day will be charged $1,250; those with a compounded Rx count between 16 and 100 daily will pay $2,500; and operations that turn out more than 100 Rxs each day will be assessed $5,000. The fees will eventually help run PCAB's operations.
The decision of eight pharmacy organizations to create PCAB in 2004 was pushed, in part, by the Food & Drug Administration's increasingly aggressive stance on regulating compounding. Baker sees PCAB as the profession's best chance to forestall the FDA. Accreditation will eventually tell the FDA and state boards of pharmacy which compounders are quality providers.
"Pharmacists know what is at stake," Baker told Drug Topics. "We think it's important for pharmacies to make a real statement by showing their support for PCAB and quality standards by signing up for accreditation. And we think it's important to do that now."
For more information or to apply for accreditation, go to http://www.pcab.info.