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."