The U.S. Senate has approved by voice vote a bill (H.R. 3204) that would broaden federal oversight of compounding pharmacies; it now awaits President Barack Obama’s signature. Drafted in response to last year’s fatal outbreak of fungal meningitis reportedly traced to contaminated vials of an injectable painkilling steroid from a New England compounding pharmacy, the bill would bar compounding pharmacies from copying drugs approved by the U.S. Food and Drug Administration (FDA) and marketed by other pharmaceutical companies. It would also create a national system for tracking prescription drugs from manufacturers to retail pharmacies.
The new law would establish a category of "outsourcing facilities," under which pharmacies conducting large-scale drug compounding could opt for federal oversight, and FDA would conduct risk-based inspections of such facilities. The bill would also require detailed compounded drug labeling and fees to pay for the oversight. Traditional compounding pharmacies would continue to be regulated by the states, and the decision to opt into the category and its associated FDA regulations would be voluntary. Entities that do not stay within the limits of a traditional pharmacy and fail to register as an outsourcing facility would be deemed to be selling drugs illegally.
Noting that the bill is not as comprehensive as FDA would have hoped, Commissioner Margaret Hamburg reportedly called it "a step in the right direction." Hamburg also explained that although the agency is concerned with current regulatory oversight of compounding pharmacies in general, its chief concern is with large volume drug compounders shipping high-risk products, such as sterile injectables, across state lines—not with compounding in traditional "mom and pop" pharmacies. See CQ Roll Call, November 12 and 18, 2013; ABC News.com, November 13, 2013; American Pharmacists Association, November 15, 2013; CQ News, November 18, 2013.