The recent deadly meningitis outbreak in Tennessee and around the country has people asking about compounding pharmacies, since it was a steroid injection from a compounding pharmacy that caused the problem in the first place.
What are compounding pharmacies? What do they do? And are their products unsafe?
Compounding is actually a traditional part of pharmacy. It just refers to pharmacists mixing ingredients for a unique patient or type of patient. It’s used commonly for patients who have allergies to specific ingredients that might be found in the normal commercial brand.
However, lately what was once a relatively boutique pharmacy practice has grown into a large-scale manufacturing stronghold and a thorn in the side of regulators.
In the case of this recent meningitis outbreak, the offending facility – New England Compounding Center (NECC) – was a huge compounding organization working at the same level as a major drug company.
So it may come as a surprise that compounding businesses don’t have to register with the FDA. And since each compound is prepared for a specific patient, it’s nearly impossible to oversee the final products’ safety. Thus the FDA considers every compound an unapproved drug.
Testing standards at these centers are mostly voluntary. Some regulations are determined according to state; but the products being compounded can ship anywhere in the country.
According to the Washington Post:
In 1997, Congress passed legislation establishing state and federal regulation of compounding pharmacies. But the federal role was challenged by some pharmacies in the courts, and it has been caught up in legal wrangling for years. The FDA has attempted to keep watch with “policy guidance” instead of law, and the agency initiated enforcement actions when abuses became apparent. But this lack of clarity has led to serious gaps in oversight.
The recent outbreak doesn’t come as a surprise to the FDA, which for years has released reports of quality problems in products manufactured by compounding centers. In one report, 33% of analyzed compounds failed their safety tests. They mention toxicity and overdose risks that were likely linked to the death of children; and they call the poor quality of some compounded drugs a “serious public health concern.”
So no, a lot of products from compounding facilities are not safe. In fact, many are actually incredibly unsafe. And no, you most likely won’t always know if you’re taking a compounded drug or what that might mean exactly.
It’s unacceptable for drug companies to use patients like lab rats. At the least, we can expect these centers to keep rigid standards of cleanliness and testing procedures. But as a dangerous drug lawyer in Memphis, I know that drug companies rarely take the safe route when the choice is voluntary. They would rather budget in the price of patients getting sick and dying from their medications.
If you’ve been hurt by a pharmaceutical compound or dangerous drug, contact me today to discuss your case. The conversation is free.