Federal Government Cracks Down on High-Risk Compounding Pharmacies

New Law Gives FDA Greater Authority to Regulate Drug Compounders

After contaminated injections from a Massachusetts compounding pharmacy caused a deadly fungal meningitis outbreak in 2012, the federal government passed a new law to more effectively regulate these types of pharmacies.

In the past, state authorities primarily oversaw and inspected drug compounding pharmacies; however, they were often ill-equipped for the job. The pharmacies could alter, manufacture, and distribute prescriptions on a massive scale, without the fear of strict government regulation. Without regulation, drugs can become contaminated.

This new legislation seeks to have compounding pharmacies register on a federal level, with the Food and Drug Administration (FDA). Registered pharmacies would then be subject to FDA regulations. Federal health officials would inspect their facilities and their products would be required to follow FDA-approved manufacturing practices.

Drug compounding pharmacies can remain unregistered and largely free from federal scrutiny; however, the FDA will entice drug compounders to sign up by encouraging hospitals and other healthcare providers to mainly purchase products from officially registered facilities. The agency plans to post a list of all registered drug compounding companies on its website as well.

The FDA hopes that as more establishments embrace regulations from U.S. health officials, compounded drugs become less dangerous for consumers.