Bill gives FDA oversight of compounders

A bill that would give the FDA greater oversight of compounded drugs won bipartisan support from both Senate and House committees. The legislation is designed to prevent outbreaks from contaminated products.

In 2012, the FDA traced contaminated injectable steroids to the New England Compounding Center in Framingham, Mass. One contaminated product, methylprednisolone acetate, was linked to a fungal meningitis outbreak that killed 16 people and sickened many hundreds of others who had been injected with the solution for back pain. The FDA also identified two cases of heart transplant patients who during surgery received a cardioplegic solution produced by the compounder and who later developed Aspergillus fumigatus infections.

“This legislation will help ensure that providers and their patients have access to high-quality compounded drugs,” Sen. Tom Harkin, D-Iowa, chairman of the Committee on Health, Education, Labor and Pensions, said in a statement. He added that it clarified the FDA’s oversight responsibilities of large-volume compounders and provided a system to track prescription drugs from manufacturing to distribution as well as trace counterfeit drugs.

Lawmakers described the current federal regulation as patchwork and unstandardized. The bill, which has the support of the House, will allow compounders to register as outsourcing facilities. The FDA will have oversight of outsourcing facilities. Compounders that want to remain as traditional pharmacies will be regulated through state boards of pharmacy.