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FDA Proposes New Rules for Compounding Pharmacies

July 1, 2014 — In the wake of a deadly fungal meningitis outbreak, the U.S. Food and Drug Administration (FDA) has proposed a new set of regulations for good manufacturing practices at  compounding pharmacies.

The documents include draft guidance for Current Good Manufacturing Practices (CGMP) aimed at ensuring sterility and improving the general safety of compounded medicines.

The FDA issued a proposed rule that would update its list of risky drugs that have been removed from the market or are banned over safety concerns. The agency wants to add 25 new drugs to a list of pharmaceutical ingredients that cannot be compounded. The FDA also wants to re-open the nomination process for new pharmaceutical ingredients that can be compounded.

For pharmacies who violate these rules, the FDA issued final guidance for a non-exhaustive list of enforcement actions.

Meanwhile, lawmakers in Massachusetts have passed a bill expanding regulation of compounding pharmacies in the state. The bill reorganizes the state pharmacy board, creates specialty licenses for different types of compounding pharmacies, and imposes a $25,000 fine for each safety violation, according to CBS News.

Oversight of the compounding industry has increased substantially in the last two years. In 2012, an outbreak of fungal meningitis was linked to one pharmacy in Massachusetts. Over 700 people in 20 states were infected, including 64 who died.

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