Questions and Answers
| Why is PCAB uniquely qualified to accredit compounding pharmacies? |
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.
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| Which organizations are members of the PCAB Board of Directors? |
- American College of Apothecaries
- National Community Pharmacists Association
- American Pharmacists Association
- National Council of State Pharmacy Association Executives
- International Academy of Compounding Pharmacists
- National Home Infusion Association
- National Association of Boards of Pharmacy
- United States Pharmacopeia
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| Is PCAB Accreditation mandatory for every compounding pharmacy? |
No, PCAB Accreditation is voluntary.
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| What are the necessary steps to obtain PCAB Accreditation? |
- Agree to the rules and terms of accreditation set by PCAB
- Agree to abide by the PCAB Principles of Compounding
- Submit documented proof that it meets the PCAB standards of quality
- Agree to a review of that proof
- Open the pharmacy to a physical inspection by experts who must verify that the pharmacy meets all of PCAB's stringent standards
- Pay an annual fee
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| How can we be sure that accreditation will improve the quality of compounding pharmacies? |
The question is not whether the quality of compounding will improve; the question is, "Does the pharmacy compounding your prescription meet the highest standards for quality in the pharmacy compounding profession?" Pharmacies that already meet those standards may stay the same; the difference is that you will know they have been tested against standards designed to assure that high quality. In time, other pharmacies will be encouraged by market forces to become one of those whose quality is accredited.
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| Are compounded medications safe? |
Yes. Patients and prescribers should keep in mind, however, that all prescription and non-prescription drugs carry a risk, as does every decision not to take medication for a particular condition. Every time a medication is prescribed, the prescriber makes a risk assessment to weigh the potential benefits against the potential risks. The same is true with each compounded medication.
The risk of using customized medication must be weighed against the benefits it potentially can provide. Several factors must be weighed, including what manufactured drugs could provide equal benefits. Of course, no prescription medication is without risk.
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| Are compounded medications as effective as manufactured medications? |
For many patients, the answer is a resounding "Yes" - the prescription customized by their physician, dentist or other prescriber and compounded by their pharmacist is the most effective for them.
In general, the medication that is the most effective for a particular patient with a particular need is a question that can be answered only by the prescribing professional in consultation with the patient, each of whom have weighed the potential risks against the benefits.
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| How will PCAB Accreditation minimize the risks associated with compounding? |
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.
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| What quality standards does PCAB use for accreditation? |
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:
- Accredited pharmacies can use only high-quality chemicals and equipment
- Compounding pharmacists and their technicians must receive regular, specialized training.
- Compounding pharmacy facilities must meet certain design standards to help ensure quality.
- Pharmacies must employ a system of continuous quality improvement
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| Who performs the PCAB Accreditation quality surveys? |
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.
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| 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.
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