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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.
As the demand for compounded medications increased, 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.
PCAB Mission
The mission of PCAB is to serve the public good by serving pharmacy, patients and prescribers.
- to organize and carryout a comprehensive program of voluntary accreditation in the practice of pharmacy compounding.
- to promote, develop and maintain principles, policies and standards for the practice of pharmacy compounding in the public interest and to apply these in the accreditation of pharmacies that offer pharmacy compounding to improve the quality and safety of pharmacy compounding provided to the general public.
- to offer to the public and prescribers a way to identify the pharmacies that satisfy accreditation criteria.
- to provide a public forum for information on the practice of pharmacy compounding, and to educate the public on the importance of pharmacy compounding.
PCAB Accredited compounding pharmacies
When choosing a compounding pharmacy, PCAB suggests looking for the designation "PCAB Accredited™ compounding pharmacy" or the PCAB Seal.
For a list of PCAB Accredited compounding pharmacies in your area, including a summary of each pharmacy's PCAB Accreditation Report, click on the PCAB Seal below.
What are compounded medications?
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.
How are they different from manufactured medications?
Compounded prescriptions may differ from manufactured medications in several ways:
- They are customized, meaning they are prescribed to meet the needs of a particular patient, whereas manufactured medications are formulated to meet the needs of a large "average" population. A compounded medication does not exist until it is ordered for a particular patient.
- In the one case, the medication is matched to the patient, whereas in the >other, the patient is matched to the medication that is available.
- Manufactured medications are manufactured under federal law, and thus are subject to FDA regulations. In contrast, the practice of pharmacy (as with the practice of all healthcare professions) is controlled by state. Because compounding is a part of the practice of pharmacy, it is regulated at the state level.
- A compounded medication is not manufacturing, but is the practice of pharmacy. The practice of all health care professions is controlled by the state government. Within each state, the agency usually responsible is the board of pharmacy.
Why do physicians and veterinarians prescribe compounded medications?
There are many reasons for prescribing compounded medicines. These reasons include:
- Standard treatments have failed and an alternative is needed.
- The dosage forms available may be unusable by some patients. (For example, a product that is only available as a tablet may need to be formulated so that it can be absorbed through the skin or taken as a suppository for a patient who cannot swallow.)
- The manufactured version of a medication is discontinued for economic reasons, but the prescriber believes that medicine is still the best solution for the patient.
Who takes/needs compounded medications?
Examples of people who benefit from compounded medications include:
- The young patient who will not take the "bad"-tasting medicine or who needs a child-sized dosage of a medicine that is manufactured in adult doses.
- The patient who is allergic to the dye or other inactive ingredients in manufactured medicines.
- The patient who responds better to bio-identical hormones than the manufactured forms of hormonal drugs.
What are the advantages of compounded medications?
The advantage is the same as every treatment alternative the prescriber has at hand. The prescriber will search for the best way to treat a patient’s healthcare problem. Compounded medication is one possible answer.
There are no perfect medications.The medicine or dosage form that works well on one patient for one particular condition may not work well for another patient or a different condition.This is why the physician, or other prescriber, needs options.With each patient and each treatment, the prescriber must consider and assess the risks and benefits among all alternatives – including the choice of doing nothing.
Do most pharmacies provide compounded medications, or do only specialized pharmacies do this?
Many pharmacies will provide some compounding. Most will perform basic compounding – for example, combining two ointments into one preparation. The more complicated and time-consuming the procedure, the more likely it is to be performed only in specialized pharmacies.
Often, the equipment needed for complicated or sensitive compounding is expensive. For example, if the resulting compounded preparation must be sterile, a special air-filtering system will probably be required. In the case of higher-level sterile products, an entire room designed to meet special requirements as a "clean room" will be necessary.
Are all pharmacists trained to prepare compounded prescriptions?
Pharmacists are trained in pharmacy school to compound; the depth of that training may depend on when a student graduated and from what pharmacy school. As the preparations become more difficult or complicated, the amount of training needed increases, sometimes above that taught in many colleges of pharmacy.
PCAB Accredited compounding pharmacies are required to have specific training in the art and science of compounding on a regular basis.
Accreditation
General questions
What is the Pharmacy Compounding Accreditation Board (PCAB), and what is its mission?
PCAB is a not-for-profit corporation formed by eight national pharmacy organizations that recognized the need for a national standards organization for compounding pharmacy. Each of these organizations has one representative on the board. The member organizations are:
The mission of PCAB is:
a.To organize and carryout a comprehensive program of voluntary accreditation in the practice of pharmacy compounding.
b.To promote, develop and maintain principles, policies and standards for the practice of pharmacy compounding in the public interest and to apply these in the accreditation of pharmacies that offer pharmacy compounding to improve the quality and safety of pharmacy compounding provided to the general public.
c.To offer to the public and prescribers a way to identify the pharmacies that satisfy accreditation criteria.
d.To provide a public forum for information on the practice of pharmacy compounding, and to educate the public on the importance of pharmacy compounding.
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.
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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