Drugs made by compounders — who mix, combine, or alter ingredients to customize medicine for specific patients — aren’t bound by the same Food and Drug Administration rules that larger drug manufacturers must follow. Ed Markey, then a US representative, introduced federal legislation last year to close this loophole, and Congress should pass it.
In the meantime, Massachusetts needs to address the holes in state regulation of the industry. The bill now before the Legislature, sponsored by Representative Jeffrey Sánchez, should help. It increases ongoing education for pharmacists, establishes a public database of compounders’ track records, and provides funding to continue the unannounced inspections the state has done since the meningitis crisis. The state pharmacy board would also be able to impose fines of up to $25,000 for violations. All are important upgrades. Surprise inspections in February gave clean bills of health to only four of the state’s 40 or so compounders; 11 others were shut down.
Another pragmatic measure in the bill is to start labeling compounded drugs as such. Labels needn’t be seen as a scare tactic — compounded drugs aren’t inherently dangerous. But patients should be aware that the compounding process does introduce some opportunities for error. And if warning labels prompt patients to have more detailed discussions with doctors and pharmacists, safety should improve.
Still, the bill could do more. The state should also require regular sampling of manufacturers’ products. Although expensive, such analysis is the most thorough way to know drugs are being made correctly. In Texas, random tests by the state’s pharmacy board found as many as one in four compounded drugs was either too weak or too strong. More testing would also give officials the chance to scrutinize raw ingredients, which, critics say, often come from gray markets in China and India that skirt FDA rules.
Finally, the bill should go farther in overhauling the state pharmacy board. Appointed members should be required to disclose potential conflicts of interest and undergo background checks. Harder to solve is the board’s current identity crisis. Without federal oversight of compounding drugs, the state agency must act as both a professional licensing board and safety regulator . Yet its politically appointed members haven’t had the interest or expertise to sustain the latter role.
It would more ideally fall to the Department of Public Health, which can hire inspectors with technical expertise on drug manufacturing. This is not a subject even pharmacy schools teach routinely anymore, so board members can’t be assumed to have the detailed knowledge to be effective — even if a majority are pharmacists, as Sánchez’s bill proposes. A competing proposal by Governor Patrick to have a majority of board members come from outside the industry should provide more independence, but a better setup might not leave this crucial oversight function to the board to begin with.
Sánchez’s bill will certainly strengthen the regulatory framework for compounding pharmacies, but if Massachusetts wants to be national leader on this front, lawmakers must be bolder.