Unbelievable in the 21st Century: "compounding pharmacies do not have to demonstrate the safety and efficacy of their products or adhere to manufacturing and labeling standards"

http://www.ncbi.nlm.nih.gov/pubmed/23104261

JAMA. 2012 Oct 26:1-2. doi: 10.1001/jama.2012.47932. [Epub ahead of print]

Fungal Meningitis From Injection of Contaminated Steroids: A Compounding Problem.

Wilson LE, Blythe D, Sharfstein JM.

"And everyone wants to know: Why did this happen?

According to the International Association for Compounding Pharmacists, there are an estimated 7500 compounding pharmacies in the United States, and 1% to 3% of all prescriptions are compounded.⁶ Unlike pharmaceutical manufacturers, compounding pharmacies do not have to demonstrate the safety and efficacy of their products or adhere to manufacturing and labeling standards. Only about 2% participate in the industry's voluntary accreditation program.⁷

State pharmacy boards provide inconsistent oversight, with few having the resources to address complex manufacturing issues or to police improper behavior. Efforts by the FDA to oversee compounding pharmacies have been thwarted by court action and political opposition; nonetheless, the agency has issued consumer advisories and sought to retain authority over pharmacies that function as large-scale manufacturers by, for example, selling compounded drugs to clinics without requiring patient-specific prescriptions. In the case of the New England Compounding Center, however, oversight efforts failed to prevent harm."