Questions and Answers
| Why is PCAB uniquely qualified to accredit compounding pharmacies? |
Compounded medications are prescriptions that are written by physicians and prepared by pharmacists – often specially trained pharmacists – for individual patients. They are not commercially available; rather, they are prescribed by a physician, dentist, veterinarian or other legally authorized prescriber and prepared by a pharmacist to meet an individual's unique needs. Compounded medications are necessary for a variety of reasons. Examples include:
- The patient is a child who cannot take a pill and needs a liquid version of a medication, or a smaller dose than is available through mass manufacturing.
- The patient cannot tolerate one or more of the components of a manufactured drug (such as preservatives, sugar or gluten)
- A manufacturer decides to stop making a medication for economic reasons. However, a physician believes that medication is best for his or her patient. In this case, the prescriber may write a prescription for the discontinued drug, and the compounding pharmacist can prepare it by mixing the ingredients into a form of the medication the patient can use.
Commonly compounded medicines include hormone-replacement therapy; pain medication for hospice patients and pediatric formulations of a variety of drugs.
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| Which organizations are members of the PCAB Board of Directors? |
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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 for a compounding pharmacy to be designated a PCAB Accredited compounding pharmacy? |
- 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
- Pass a review of that documented proof
- Pass a physical inspection of the pharmacy 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. [back to top]
| 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. [back to top] |
