WASHINGTON – Compounding pharmacies that custom-mix medications in bulk are expected to come under more federal oversight under a bill signed into law Wednesday by President Barack Obama.
Last year a meningitis outbreak from contaminated steroid pain injections killed 64 people and sickened more than 750 across the country.
The sickness was traced to a now-closed pharmacy in Framingham, Mass., the New England Compounding Center, where inspectors found unsterile conditions. The company had shipped more than 17,600 doses of the implicated injection to 23 states.
Jurisdiction over such large-volume compounding pharmacies has long been murky. Pharmacies are typically regulated through state boards, but the Food and Drug Administration regulates manufacturers of medicines.
The law attempts to sort out the legal grey area that allowed the Massachusetts pharmacy and similar operations to skirt both state and federal regulations.
Under the new law, large-volume compounding pharmacies can register with the FDA and submit to federal inspections and quality standards much like drug manufacturers. Smaller businesses that choose to remain traditional pharmacies — generally filling a small number of prescriptions each week — will continue to be regulated by state boards of pharmacy.
Under the new system, the FDA will be able to track what the registered pharmacies are making, receive reports about problems with any of the compounded drugs, and have the authority to conduct safety inspections.
But the law does not require any large compounding pharmacies to register with the FDA — a step that FDA officials previously said was crucial to preventing future outbreaks.
Critics of the law question how the FDA will be able to identify rogue pharmacies if they are not required to register with the federal government. But proponents say the voluntary approach can succeed if doctors and hospitals choose only to do business with FDA-registered pharmacies.
Despite questions about the approach, the law enjoys broad support from medical professionals, in part because it contains separate requirements designed to track all prescription drugs throughout the U.S. supply chain.
The so-called track and trace system, long sought by doctors and patient groups, is designed to help authorities catch counterfeit or stolen drugs that increasingly have been making their way into the U.S.
Drugmakers will be required to add serial numbers to all drug packages within four years. After 10 years the industry must upgrade to electronic codes that can be used to track medicines from the factory to the pharmacy.