By JULIE M. DONNELLY
BOSTON — A legislative committee has voted in favor of a bill to reform the compounding pharmacy industry, moving it one step closer to approval. The bill would require all in-state and out-of-state compounding pharmacies to get a specialty license and set up state tracking of all drugs made by the pharmacies. The bill also would mandate unannounced, detailed inspections of all compounding facilities and offer protection to whistleblowers.
Pharmacies and clinicians would have to report serious adverse events to the U.S. Food and Drug Administration and to state agencies. Businesses would have to provide a hotline for patients. The bill, if approved, would also create a database for the public to access safety information about pharmacies that had reported serious adverse events. Compounded drugs, going forward, would have to be clearly labeled as such, and the state and the FDA would have to issue public notices on any pharmacy that may pose a threat to public health.
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