A compounding pharmacy combines, mixes or alters the ingredients in medication in order to customize it for a particular patient pursuant to a prescription by a licensed practitioner. Compounding pharmacies are typically small businesses with a pharmacist on staff who oversees the making of the compounded drugs.
Compounding pharmacies are regulated by the states rather than the federal government. For decades the FDA has sought greater authority to regulate compounding pharmacies. It even commissioned a study of compounding pharmacies in April 2001 by the Eastern Research Group, Inc., which produced a report in August 2001. The conclusions of the FDA were included in its testimony to Congress:
- According to their August 2001 report, over 650 pharmacies fill more than 13 million prescriptions for compounded products per year. Although many more pharmacies compound (some estimates put the number at more than 3,000 compounding pharmacies) this relatively small number of pharmacies that specialize in compounding appear to account for a majority of the drugs compounded nationally. Some estimate that compounding represents one percent of all of the prescriptions filled each year. In 2003, according to one estimate, this would amount to 30 million prescriptions for compounded products. In some cases, these prescriptions may be compounded in pharmacies that dispense only compounded medications or in other pharmacies for which compounding is a large percentage of their business.