The fungal meningitis outbreak caused by contaminated steroid injections that killed 55 people to date and sickened more than 740 is one of the worst public health disasters the nation has seen in recent history. The tainted injections came from a drug manufacturer
The letters clearly show that compounding pharmacies have been exploiting loopholes in the regulatory system for at least a decade. This public health crisis starkly highlights the difference in how compounding pharmacies are regulated compared to pharmaceutical companies, and the need for reform.
Prescriptions are regularly compounded at pharmacies, after a doctor writes a prescription for a compounded drug. However, compounding pharmacies are increasingly behaving like pharmaceutical companies by producing drugs in bulk, despite the fact that they are not inspected or regulated like the pharmaceutical industry. Due to this lack of oversight, many compounding pharmacies have not adhered to safe manufacturing practices, and shown little regard for consumer safety. In the FDA warning letters, the most frequent violations cited included misbranding drugs; producing unapproved new drugs; producing drugs under unsanitary conditions; repackaging sterile drugs; and using unapproved, potentially unsafe ingredients. Some of the most egregious violations by compounding pharmacies included:
The FDA must be given the power to regulate compounding pharmacies that produce drugs in high volume. These pharmacies are acting as pharmaceutical manufacturers and should play by the same rules as pharmaceutical companies. Consumers must be able to rely on the safety of their drugs, regardless of where they are produced.
Before any clinical or surgical treatment, talk to your doctor about the drugs that are going to be used and if they are compounded. If they are compounded drugs ask your doctor if an FDA-approved drug is available and appropriate for your treatment instead. If that is not possible ask where the compounded drug is made and check for safety alerts and warnings on the FDA