Senate to vote on specialty pharmacy crackdown

(AP) Senate to vote on specialty pharmacy crackdown
WASHINGTON
The Senate on Tuesday considered whether to advance a bill designed to tighten government oversight of pharmacies that custom-mix prescription drugs and ship them in large batches.

The legislation, passed by the House in September, also would create a national system for tracking prescription drugs from manufacturers to retail pharmacies. The bill has virtually unanimous support in the Senate, where a test vote on the measure was expected late Tuesday. If it passes that chamber, perhaps this week, President Barack Obama was expected to sign the bill into law.

The compounding pharmacy bill is intended to prevent a repeat of last year’s fungal meningitis outbreak that killed 64 people and sickened 750 more across the U.S. The sickness was traced to a now-closed pharmacy in Massachusetts, the New England Compounding Center, where inspectors found mold, standing water and other unsterile conditions

Compounded medicines have been tied to contamination problems for decades. But jurisdiction over them has been murky. Pharmacies are typically regulated through state boards, but the federal Food and Drug Administration regulates manufacturers of medicines.

The bill attempts to sort out that legal gray area, which allowed the NECC and other pharmacies to skirt both state and federal regulations. The measure would clarify when the FDA can intervene against compounding pharmacies.

Pharmacies that operate as traditional compounders, producing small batches of medications to fill doctors’ prescriptions, would continue to be regulated by state pharmacy boards, under the legislation. Pharmacies that do large-scale compounding, shipping drugs in bulk without doctors’ prescriptions, could voluntarily register with the FDA and submit to federal inspections and quality standards similar to manufacturers.

But the bill would not require these large-scale compounders to register with the FDA. The agency’s leaders said in congressional hearings earlier this year that mandatory registration was crucial to prevent future outbreaks.

And safety advocates say the voluntary approach leaves consumers vulnerable to more rogue pharmacies like the NECC, which operate like manufacturers without the extra oversight.

The compounding industry’s chief lobbying group also opposes the bill, saying it would further complicate pharmacy regulations.

Despite complaints about the bill’s shortcomings it has garnered broad support, in part because it contains a separate measure for tracking prescription drugs. The so-called track-and-trace system is designed to help authorities catch counterfeit or stolen drugs.

Under that measure, drug makers would be required to add serial numbers to all drug containers within four years. After 10 years the industry would have to upgrade to electronic tracking codes that can be used to trace medicines from factory to pharmacy.