When a patient needs a medication that is not ordinarily found on the market, a physician may send a prescription to a compounding pharmacy to have a customized medication created. Most of these businesses are small operations, but some have expanded in scope, leading them to supply bulk quantities to hospitals and physicians across the country.
Unlike pharmaceutical companies, compounding pharmacies do not have to register with the FDA and undergo regular inspections. They are licensed and overseen by state pharmacy boards. The FDA has the power to step in only when major safety problems arise.
Despite Limited Power, FDA Finds Major Safety Issues
- In April of 2013, the FDA reported the results of a crackdown on compounding pharmacies. Out of 31 pharmacies that were targeted, the FDA found that 30 of them were guilty of unsanitary conditions and quality control problems.
- On August 9, 2013, a compounding pharmacy in Texas issued a recall of an intravenous medication called calcium gluconate after at least 15 people developed bacterial infections. The medication had been sold to every state except for North Carolina. An FDA investigation revealed inadequate testing practices and a lack of procedures to insure drug sterility.
- A Tennessee drug compounding pharmacy was linked to steroid injections contaminated with fungus in June of 2013. At least seven patients in North Carolina and Illinois reported skin abscesses. A 2011 inspection revealed the Tennessee pharmacy using out-of-date medications to fashion orders, and an unregistered technician. Inspectors returned in November of 2012 and found the pharmacy was still using out-of-date medications.
- In October of 2012, FDA investigators linked a Massachusetts compounding pharmacy to steroid injections that were contaminated with mold and fungus. The facilities of the compounding pharmacy itself were found to be contaminated. The injections from the Massachusetts facility resulted in patients developing meningitis, and led to 63 deaths across 20 states.
There has been a movement in Congress to give the FDA direct oversight over compounding pharmacies. The Senate (including members of both parties) has proposed a bill to implement federal safety inspections and manufacturing standards.