On Monday, after a routine investigation by the U.S. Food and Drug Administration (FDA) discovered potential contamination, there was a recall of all compounded drugs manufactured and marked as sterile by the pharmaceutical manufacturer. This is 2018’s second major recall of all sterile compounded drugs manufactured by an “outsourcing facility” – a facility exempted from certain FDA safe manufacturing requirements. While neither company received reports of adverse effects, a contamination in 2012-2013 of a different compounded drug led to 60 people dying of fungal meningitis and others surviving with chronic illness.
“It is unacceptable that patients could be exposed to life threatening illness because of exemptions from FDA safety and manufacturing requirements. With lives on the line, we must close loopholes to help protect everyone who uses these drugs. ” said Tano Toussaint, Consumer Watchdog Associate for U.S. Public Interest Research Group (U.S. PIRG).
Traditionally, compounding pharmacies have engaged in the practice of customizing a medication for a particular patient – often for patients with very serious or specific conditions – that might require an altered dosage or a pill turned into a liquid. Unfortunately, large compounding outsourcing facilities do not adhere to many of the safe manufacturing processes that are required to ensure consumers’ safety.
In response to the 2012 incident, Congress amended the Federal Food, Drug, and Cosmetic Act in 2013 to grant the FDA more authority to regulate and monitor the manufacturing of compounded drugs. While this has significantly reduced the risk around compounded drugs, there are still instances of contamination, due to some compounding facilities gaining exemptions as “outsourcing facilities.” These facilities, according to the FDA, are allowed to “compound and distribute drugs without receiving prescriptions for individually identified patients, and without limitation on the quantity of drugs that they ship interstate.” This has created a hazard for many consumers.
The FDA strengthened guidance around drug compounding in January, which has allowed the agency to more quickly to identify contamination issues. However, it is still vital that the same federal safety and manufacturing standards that are applied to pharmaceutical manufacturers are applied to interstate firms that compound bulk drug products in advance of or without a prescription.