Questions continue to arise about the future of the compounding industry after 50 people were killed starting last fall by tainted steroid injections distributed by the New England Compounding Center.
Because most of the 2,700 pharmacists in the International Academy of Compounding Pharmacists (IACP) are much smaller than drug manufacturers, they have answered primarily to state pharmacy boards rather than the U.S. Food and Drug Administration.
While FDA inspections have been met with unease and confusion, they have proven necessary as 14 recent risk-based inspections at compounding pharmacies known to mix large quantities of sterile drugs have yielded deficiency findings so far. These FDA findings, including how pharmacies had been deficient in practices to maintain sterility, which included keeping skin covered and maintaining proper air flow, have been published online.
In order to close perceived loopholes, laws in 17 states have begun to make their way through state legislatures, some examining whether accreditation should be mandatory for compounding pharmacies, and others clarifying what constitutes a proper prescription.
"The FDA's authority over compounding companies is limited but not nonexistent," said Sarah Clark-Lynn, FDA spokeswoman. "While the current FDA oversight over compounding pharmacies is limited, the agency continues to use its existing authorities to protect consumers." Read the full details here:
The FDA had been cut out of the regulatory loop for compounding pharmacies, a law which only recently took effect and was clearly misguided. The recent fungal infection which led to numerous injuries and wrongful death, will spotlight the need for change.
If you or a loved one have been injured by a manufactured product, drug, medical device or medical malpractice leading to wrongful death or other injury, you should consult a qualified attorney to protect your rights. The lawyers of Crandall & Pera Law are available to help answer your questions and guide you in determining your next steps.