As a member of the Pharmacy Compounding Accreditation Board (PCAB), NASPA is committed to uniform accreditation standards for the compounding profession. PCAB will set tough, national standards that pharmacies will have to meet to obtain accreditation. The process will ensure that pharmacies from coast to coast have in place sound practices, processes, facilities, equipment and personnel to prepare compounded medications for their patients.
Voluntary Pharmacy Compounding Accreditation Program
Compounding pharmacists play a vital role in their patients' lives, providing customized medications ordered by prescribers, sometimes when all other options will not work. Compounded medications are prepared by pharmacists for individual patients, often with special needs.
With an estimated 30 million to 40 million prescriptions compounded each year, the pharmacy profession saw a need for an enhanced, profession-wide system of standards by which each compounding pharmacy can test its quality processes. Compounding pharmacists also wanted a mechanism to allow them to know that their quality is high and that their patients are as safe as possible. PCAB Accreditation gives patients and prescribers a way to select a pharmacy that meets high quality standards.
Founding of Pharmacy Compounding Accreditation Board (PCAB™)
Eight of the nation's leading pharmacy organizations joined together, contributing their time, money and leadership to make PCAB, a voluntary system of standards for compounding pharmacies, a reality. PCAB has created stringent standards and the accreditation process is underway. This is an important step for the profession of pharmacy and the practice of compounding. PCAB is exempt from Federal income tax under section 501 (C) 3 of the Internal Revenue Code. Contributions to PCAB may be deductible under section 170 of the Code.
The mission of PCAB is to serve the public good by serving pharmacy, patients and prescribers.
Pharmacy Compounding Accreditation Board (PCAB)
2215 Constitution Ave., NW.
Washington, D.C. 20037
PCAB brings together the expertise of the leading pharmacy organizations in the United States in the field of compounding pharmacy. Through these organizations, PCAB is able to assemble THE experts in the field. For example, PCAB’s Standards Committee includes some of the nation’s leading compounding pharmacists, as well as some who literally “wrote the book” on compounding. No one is more dedicated to protecting patients and the profession than the pharmacists represented by these organizations. They know what to look for, what can be done and what should not be done – and are determined to accept into their ranks only the best.
In addition, the National Association of Boards of Pharmacy (a PCAB member organization) represents all 50 state pharmacy regulatory boards, as well as those from the U.S. territories and most Canadian provinces. These boards of pharmacy represent not the pharmacies in their states, but the citizens (patients) of the state.
Finally, PCAB member the United States Pharmacopeia, formed in 1817, is the premier drug and chemical standards organization in the world (and sets standards for the pharmaceutical industry). The U.S. government recognizes USP standards as official.
No, PCAB Accreditation is voluntary.
Accreditation is necessary to:
Accreditation will provide assurance to patients and prescribers that your pharmacy is among the best. It will allow you to differentiate your pharmacy and your compounding practice from others that have not earned the PCAB Accreditation Seal
No pharmacy “fails,” but some may not pass on the first review. The pharmacy will be provided with comments and information about its deficient areas, and encouraged to correct them.
The question is not whether the quality of compounding will improve. The question is does your pharmacy meet the highest standards for quality in the pharmacy profession? Pharmacies that already meet those standards may not improve, but you will know that your practice has been tested against tough standards. In that way, your pharmacy has a plan designed to assure that high quality. All other pharmacies will be encouraged by competition to be just as good as you.
A pharmacy that compounds a prescription to the highest standards will have fewer errors. Fewer errors equals a reduced risk of harm to the patient – and in turn, lowers your risk of liability.
Also, remember why you went into a healthcare profession: to help people. You should insist that your patients receive the highest-quality service available. Accreditation gives you a way to provide it.
The risk of any professional service is minimized by a quality process. PCAB Accreditation provides the testing against quality standards that allows all to judge where the risks are most minimized.
PCAB standards have been written by a Standards Committee of compounding pharmacists, academics and experts. The complete standards can be seen on our Web site at www.pcab.info .
Examples of specific quality and safety standards include:
The PCAB has contracted with the National Association of Boards of Pharmacy to perform the surveys. NABP possesses the skills and knowledge for this important task.
How often must a pharmacy undergo a quality survey to maintain accreditation?
Each pharmacy is reviewed annually, and every three years, the review includes a physical inspection.
The FDA wants the public to be protected, and this goal is shared by the profession of pharmacy. We believe the FDA wants PCAB to succeed. Like all governmental agencies, FDA has limited resources and very important duties regarding the 99% of the prescriptions that are manufactured under its authority and control. While there remains a disagreement concerning regulatory authority, PCAB believes the FDA wants to leave the regulation of the vast majority of compounding in the hands of state boards of pharmacy.
Unfortunately, every pharmacist is tainted by reports of errors and injuries that result from preventable causes. Bad reports tar the reputation of every member of the profession.
Even if that were not the case, every pharmacist has an obligation to provide his or her patients with the highest-quality level of practice. Patients have the right to know that the pharmacy they have chosen is among the best. And every pharmacist has the obligation to assist in elevating the quality of all pharmacy practice to the highest level possible.
We can do this through identifying the pharmacies that practice according to the highest standards, which in turn pressures others to ensure they are meeting high-quality standards.
NASPA believes that compounding is a core foundation of the profession of pharmacy. A primary role of the state associations is to protect the right of compounding for all of its members. NASPA supports the self regulation of compounding through PCAB so pharmacists can continue to provide quality compounded products for their patients.