Compounding board gears up for accreditation

December 12, 2005

The Pharmacy Compounding Accreditation Board (PCAB) is gearing up to graduate the first class of pharmacies able to meet tough quality standards to win its seal of approval.

The Pharmacy Compounding Accreditation Board (PCAB) is gearing up to graduate the first class of pharmacies able to meet tough quality standards to win its seal of approval.

After working out some kinks at a beta test site in Alabama and one in Arizona, PCAB is ready to put the first 100-plus compounding pharmacies through the evaluation wringer. And the first accreditations should be granted in about six months, executive director Kenneth Baker, R.Ph., J.D., told attendees at the recent annual meeting of the National Community Pharmacists Association in Fort Lauderdale, Fla.

The foundation for PCAB accreditation is 10 general standards on various aspects of compounding, such as personnel, facilities and equipment, and the compounding process. Each standard is then broken down further. For example, the personnel category is subdivided to cover the responsible pharmacist, the compounding pharmacist, the dispensing pharmacist, and other compounding personnel.

The bad news for compounders who want to earn the credential is that the accreditation standards set by a panel of leading compounding R.Ph.s are tough. The good news is that no pharmacy that applies for accreditation will fail, said Baker. "The answer that comes back [to the applicant] is either 'Yes, you passed' and you're issued accreditation or 'Not yet,' and we'll tell you what's not yet and you keep working on it," he said. "The answer is never No. PCAB will walk everybody through it, and there are ways we can work with you. Nobody fails."

The annual fees compounding pharmacies will have to pay to maintain their accreditation have also been set, based on Rx volume. Pharmacies that compound one to 15 Rxs per day will be charged $1,250; those with a compounded Rx count between 16 and 100 per day will pay $2,500; and pharmacies that compound more than 100 Rxs daily will be assessed $5,000. "We want to make sure we stay in business," said Baker. "PCAB is supported by pharmacy groups now, but eventually it has to be supported by compounding pharmacists, who must step up and make sure PCAB remains viable."

Although the first applications for accreditation have been on paper, PCAB has set up a Web site at http://www.pcab.info/ that will soon allow candidates to apply on-line. There will also be a Web site at http://www.pcab.org/ for physicians, veterinarians, and patients.

Baker, a former executive with Pharmacists Mutual Insurance Co. who was appointed to head PCAB last spring, has heard a lot of excuses from compounders about why they won't go through the accreditation process. Some say it's just for the big operations; others think it's too hard, takes too much time, is too expensive, he said. All of those excuses are precisely that-excuses, he added.

"If our concern is the patient, our real concern ought to be that everybody who compounds ought to meet a quality standard," Baker said. "If you're not willing to have your quality tested against real standards, just don't compound. If you decide later that you want to compound, come back. We'll still be here."

In addition to the application, candidate pharmacies will be visited by surveyors who will check to see how policies and procedures are used in actual practice. PCAB will pay surveyors an honorarium, but the pharmacy has to pay his or her expenses. "The written policy and procedures are 80% of the job," said Baker. "The other 20% is when we'll actually go out and look to see that you do what is in your policy and procedures."