July 28, 2013
MASSACHUSETTS CAN’T make federal officials take responsibility for improving the safety of compounding pharmacies. And until they do, it’s the state’s job to prevent a repeat of the meningitis outbreak that killed dozens of people and sickened hundreds of others and was linked to tainted steroids sold by New England Compounding Center in Framingham. New legislation approved by the Joint Committee on Public Health takes some important steps in protecting consumers and the pharmaceutical supply chain. It’s a good start, but more can be done.
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.
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