Editorial: Pharmacy Compounding Accreditation Board Surveyors Trained
On Thursday and Friday of last week, 22 surveyors were trained for the Pharmacy Compounding Accreditation Board (PCAB). These surveyors will work with the pharmacy PCAB applicants, visit the applicant's facility to determine whether or not the PCAB standards are met, and make recommendations to PCAB.
The training sessions began with a presentation on the background of PCAB, its development, organization, implementation, and operation. The application and resource materials that are available online (www.pcab.info) were demonstrated and reviewed. Next, the standards were discussed in detail over several hours. The 10 general standards were developed by a committee named by PCAB almost two years ago and approved by PCAB last year. The standards are accompanied by "compliance indicators" to assist in determining whether or not the standards are met, and these were also discussed.
For the accreditation process, a lot of emphasis is placed on standard operating procedures (SOPs) or policies and procedures that must be in place and operational (over 300 SOPs are available for download at www.CompoundingToday.com). Simply having a file or book of SOPs with the cellophane wrapper on them or sitting undisturbed on the shelf does not meet the standards. They must be implemented, used, and documented.
PCAB provides compounding pharmacists an opportunity of providing evidence of a quality compounding facility. Admittedly, it is not a perfect system, but, currently, it is the best system we have. Accredited pharmacies have opportunities to market and publicize their accreditation status. Many accredited pharmacies have already commented that it is making a difference in their operations and marketing. Additionally, discounted liability insurance rates are available.
Are you ready for accreditation? Perform a GAP analysis (available at www.ijpc.com) and evaluate where you are at this time. Then, visit the PCAB website for information and the application. Most of it is done online and is then followed up by a visit from a PCAB surveyor. The surveyor may be available to also make recommendations and provide some assistance in the process. Actually, there will be two individuals involved (one or two surveyors directly, depending upon the size of the pharmacy, and a second individual as a resource).
The PCAB process is underway with the goal of accrediting several hundred compounding pharmacies in 2007.
Loyd V. Allen, Jr., Ph.D., R.Ph
Editor-in-Chief
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