Executive Briefing Series (formerly The Food & Drug Letter)

In early October, the FDA became aware that some batches of injectable drugs compounded by New England Compounding Center may be associated with an outbreak of fungal meningitis. The Agency advised medical professionals should cease use of all products produced by NECC and the company voluntarily recalled all products currently in circulation compounded and distributed from its Framingham, Mass., facility. FDA later asked providers to follow-up with patients administered any NECC injectable product on or after May 21, including an injectable ophthalmic drug used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by the company. That was the date of release of three batches of NECC’s compounded preservative-free methylprednisolone acetate (80 mg/ml). This situation brings to the forefront the FDA’s authority over compounding pharmacies, which is murky, at best. The 1997 FDA Modernization Act required compounding pharmacies to be licensed by states and exempted them from most pharmaceutical regulations, if they limited compounding services to individual patients with valid prescriptions. Those authorities have been further eroded over time by court challenges to the FDA’s authority. This issue of The Food & Drug Letter takes a look at what’s happened so far in the NECC situation and what regulatory and legislative actions lawmakers may take to prevent such a situation in the future.

U.S. lawmakers want the FDA to explain who regulates the 28,000 compounding pharmacies operating in the country and how the agency can better control them.

FDA investigators and local police Oct. 16 raided the Framingham, Mass., facilities of the compounding pharmacy whose steroid injections are linked to a recent fungal meningitis outbreak.

The Senate Committee on Health, Education, Labor, & Pensions (HELP) is launching a probe of the compounding crisis, asking the Massachusetts pharmacy registrar to explain why New England Compounding Center (NECC) was allowed to operate as a large-scale drug manufacturer.

The New England Compounding Center (NECC), at the heart of a nationwide fungal meningitis outbreak, dropped the ball after seeing early signs of unacceptable levels of microbial contamination, the FDA says.

In the wake of a meningitis outbreak linked to contaminated compounded injectables from the New England Compounding Center (NECC) and Ameridose in Massachusetts, the state’s Department of Public Health (DPH) has launched a series of immediate, on-site inspections of other compounding pharmacies that prepare sterile injectable medications within its purview.

New England Compounding Center (NECC), the compounder blamed for an outbreak of fungal meningitis, violated state pharmacy law by acting as a bulk manufacturer and distributor of sterile drug products without proper registration, a preliminary investigation report states.

Two House Democrats have asked the Government Accountability Office (GAO) to investigate the compounding pharmacy industry to look for gaps in federal and state oversight.

Rep. Edward Markey (D-Mass.) continues to push the FDA for answers about how it will respond to a compounding pharmacy linked to several deaths.

The FDA has released two lists of customers that received products shipped on or after May 21 from New England Compounding Center’s (NECC) Framingham, Mass., facility.