What is Pharmacy Compounding?

Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For them, customized medicines — prescribed or ordered by licensed prescribers and mixed safely by trained, licensed compounding pharmacists — are the only way to better health.

The Food and Drug Administration, the U.S. Supreme Court, Congress, and virtually every major association of health care professionals recognize the value of compounding pharmacists.

By definition, compounded medicines are different from commercial pharmaceuticals; they are prepared at the direction of licensed prescribers to meet patients' individual needs that are not met by manufactured pharmaceuticals. As a result, federal requirements designed for large-scale manufacture of uniformly dosed drugs do not apply to compounding pharmacies.

Who Needs Compounded Medicines?

Many patients depend on compounded medicines, including infants and children, those with allergies, cancer patients, children with autism, senior citizens, menopausal women, hospice patients and those who rely on discontinued drugs.

For patients who are unable to take medications orally or as injections — the traditional dosage forms for manufactured drugs — compounding pharmacists can create alternate methods of delivery, like ointments, solutions or suppositories, to fit their unique health needs.

Many, if not most, of the lifesaving intravenous drugs given in hospitals and clinics are compounded. Because hospital patients are often on multiple medications, compounding them into one treatment saves the hospital personnel time and the patient multiple injections or administrations.

Compounded medicines not only help human patients, they are also vital for the veterinary patient population. Animals come in all shapes and sizes, so one-size-fits-all pharmaceuticals do not always meet their needs. In many cases, a compounded medication may be necessary for a non-food animal to be satisfactorily treated.

How Safe Are Compounded Medicines?

State boards of pharmacy, state medical boards, the Food and Drug Administration, the Federal Trade Commission, the Drug Enforcement Agency, and other federal and state agencies each have some degree of oversight over pharmacy compounding practice. The U.S. Pharmacopeia and the Pharmacy Compounding Accreditation Board also play critical roles. Together, they have constructed a web of regulations and standards that protect patients.

State Boards of Pharmacy

States boards of pharmacy license pharmacists and pharmacies. State pharmacy laws, enforced by these boards, govern the processes and equipment pharmacists use to prepare those medications. States also have requirements that mandate record keeping, labeling, and proper procedures for sterile compounding, among other aspects of pharmacy practice.

Federal Agencies

The FDA, which primarily regulates manufacturers, still has an important role to play in regulating compounding. FDA is responsible for ensuring purity and quality of ingredients used in compounding. Compounded medications are prepared using ingredients that must come from FDA-registered facilities — ultimately, the same facilities that supply drug manufacturers. The FDA also has authority to inspect any pharmacy's facilities, equipment and ingredients. In addition, the FDA and the Federal Trade Commission have authority over any false and misleading marketing practices by pharmacies and manufacturers alike.

U.S. Pharmacopeia

Since 1820, U.S. Pharmacopeia (USP) has been the official national standards-setter for pharmaceutical ingredients, recognized by Congress as such. USP is constantly strengthening pharmacy practice, and has revised chapters related to compounding, both nonsterile and sterile in recent years. USP Chapter Nonsterile Compounding and USP Chapter Sterile Compounding both have many new and rigorous standards.

Since 1995, most state boards of pharmacy have developed comprehensive regulations for pharmacy compounding and now many are beginning to adopt the USP standards as well. In fact at their annual meeting in May 2007, the National Association of Boards of Pharmacy conducted special training for state board inspectors with regards to the USP standards for pharmacy compounding.

Pharmacy Compounding Accreditation Board

In 2004, leading pharmacy associations joined with the U.S. Pharmacopeia to form the Pharmacy Compounding Accreditation Board (PCAB), a voluntary accreditation body whose mission is to assure the quality of compounded medications that patients are prescribed.

To become PCAB-accredited, compounding pharmacies are tested against 10 stringent standards. These standards encompass regulatory compliance; personnel; facilities and equipment for both sterile and non-sterile compounding; chemicals and the compounding process; beyond-use dating and stability; packaging, labeling, delivery for administration and dispensing; practitioner and patient education; quality assurance and self-assessment.

With 50 pharmacies already accredited, and over 100 additional applications pending, PCAB is already giving patients and prescribers a way to select a pharmacy that meets high quality standards.

Self-Regulation

The International Academy of Compounding Pharmacists (IACP) has issued guidelines for the labeling of compounded medications, which PCAB has also adopted. These are designed to help pharmacists communicate to their patients that the compounded medications they've been prescribed are customized to meet the individual patient's unique needs.

Pharmacists and physicians communicate much of this information to patients already, but the labeling guidelines provide an extra measure to ensure patients understand (1) that their medicine was compounded in a pharmacy, (2) how to use and care for the medication, and (3) that their doctor or pharmacist can provide additional information.

The IACP and PCAB guidelines are meant to encourage pharmacists to go beyond what the laws require to ensure patients understand the unique value of compounded medicines. The guidelines will provide a standardized labeling model for compounded medicines across all 50 states.

Courtesy of International Academy of Compounding Pharmacists (IACP)- http://www.iacprx.org/site/PageServer?pagename=home_page

To locate a compounding pharmacy near you, click here or call IACP's toll-free referral line at 1-800-927-4227.

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