Compounding Pharmacy Regulations

Compounding Pharmacy Regulations

Posted By The Maher Law Firm || 20-Dec-2012

Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) commissioner, Margaret Hamburg, met yesterday with representatives of all 50 states to discuss new regulations for compounding pharmacies.

The FDA regulates drug manufacturers but it has no regulation over compounding pharmacies. Compounding facilities custom make medications for people who cannot take normal forms of drugs. This is usually done on a per patient basis, although mass produced medications have been made by compounding pharmacies. The New England Compounding Center (NECC) recently produced a steroid injection that was tainted with fungal meningitis and led to 620 outbreak cases and the death of 39 people in 19 states.

Pharmacies fall primarily under state law, however, Hamburg aims to increase state and federal communications in order to bring stricter national regulations for compounding pharmacies. North Carolina Board of Pharmacy director, Jay Campbell, said, "We feel great about what we are doing in our state, but, gosh, we don't what those other guys are doing."

The FDA is recommending dividing these pharmacies into separate categories; Typical Compounding Pharmacies, which produce medicines based on an individual prescription, and High Output Pharmacies, which mass produce medicines. Each category would have it's own set of regulations. The FDA states they will focus on, "clearly defining traditional pharmacy compounding that should be primarily overseen by the states and higher risk non-traditional pharmacy compounding that would require compliance with federal standards."

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