Regulations for Pharmacy Compounding

Pharmacy compounding is the process of mixing drugs for individual patients. The philosophy behind compounding is that every individual's body is different and may require medications that are prepared specifically for his or her needs.



However, this practice faces controversy in the medical community. A common use of compounding--the preparation of bioidentical hormones--has both advocates and opponents. According to the Mayo Clinic's Dr. Mary Gallenberg, there is no scientific evidence that such hormone therapy is safer than traditional treatment. Regardless of the debate, compounding practitioners must meet the regulations of the FDA's Modernization Act. (Reference 4)

Who Can Compound

• According to the Food and Drug Administration (FDA), licensed medical doctors and licensed pharmacists are permitted to prescribe and prepare compounding drugs. Physicians can prescribe such medications if they determine it is an appropriate treatment option for their patients. Pharmacists must only fill compounding orders for those patients who have valid prescriptions. The FDA regulations also state that compounding pharmacists or physicians need to have a professional relationship with each other or the patients they serve. (Reference 1 [353a])

Drug Manufacturing

• Compounding drugs must meet the manufacturing regulations outlined in the Food and Drug Administration Modernization Act; it is illegal for pharmacists or doctors to distribute medications to patients that do not meet these guidelines. According to the act, drug manufacturers must register with the FDA annually between October 1 and December 31. They must also provide the agency with a list of all drugs they manufacture or prepare. In addition, all drug manufacturers and processors must participate in onsite inspections at least once every two years. They must also report to the FDA at least 90 days in advance any plans to distribute drugs out of their facilities' state. (Reference 2 [353(b)], Reference 3)

Advertising

• The FDA's pharmacy-compounding regulations state that both pharmacists and doctors are allowed to advertise or promote the drug-compounding services they offer. However, physician offices and pharmacies must not advertise a specific drug, type of drug or drug class. In fact, these medical professionals are permitted to compound any drug that meets the manufacturing requirements as long as they do not promote it to patients or the public. (Reference 1 [3(c)])