Senate passes stricter compounding rules

November 14, 2013

The U.S. Senate has voted overwhelmingly to adopt tighter regulations for compounding pharmacies and to create a national system that tracks prescription drugs from manufacturers to pharmacies.

The U.S. Senate this week voted to adopt tighter regulations for compounding pharmacies and to create a national system that tracks prescription drugs from manufacturers to pharmacies.

The bill passed by a voice vote on Monday and it will be forwarded to President Barack Obama for his signature.

The new regulations were spurred by last year’s fungal meningitis outbreak that killed 64 people and sickened more than 750 others across the U.S. The outbreak was traced to contaminated steroids from the now closed the New England Compounding Center in Massachusetts, where investigators found mold and other unsterile conditions.

 “Americans deserve to know that their medications are safe, and by enacting this legislation, we can help make that a reality,” said Sen. Tom Harkin (D-Iowa).

Under the regulations, state pharmacy boards would continue to regulate compounders that produce small amounts of medications to fill doctors’ prescriptions.  Pharmacies that ship drugs without prescriptions can voluntarily register with the FDA and submit to federal inspections and quality standards. However, the bill does not require these large compounders to register with the FDA, which some safety advocates believe will continue to leave consumers vulnerable.

The bill also creates a track-and-trace system. Within four years, manufacturers will be required to add serial numbers to all drug containers. After 10 years, drug manufacturers would be required to upgrade to electronic tracking codes that can be used to trace medicines from factory to pharmacy.