Interesting Read FDA NEWS.com Reports on why some compounders have registered as outsourcing facilities

A Higher Standard

The pharmacies that did register told DGR

that they did so to meet the highest quality standards

and free themselves from complex and varied

state laws.

PharMedium, which registered all four of

its sites as outsourcing facilities under the Drug

Quality and Security Act, is attracted to the idea of

syncing its operations to a single federal standard

for quality, President Rich Kruzynski told DGR.

PharMedium’s facilities — located in Texas,

Tennessee, Mississippi and New Jersey — ship

batches of compounded drugs to hospitals across

the country. The sites are not traditional pharmacies

that make drugs per prescription, nor are they largescale

drug manufacturers — falling into the grey

area that prompted FDA calls for further authority.

The company’s state licenses are a good

example of the confusion surrounding mediumsized

compounders. PharMedium is licensed in

20 states as a wholesaler, 14 states as a pharmacy

and 12 as a manufacturer, Kruzynski said.

Now the facilities must meet only the FDA’s

regulations.

New Effort

Meanwhile, state governments are continuing

to push tougher regulations on compounding

pharmacies.

Twenty-seven bills or resolutions have been

filed across 16 states to crack down on compounders

as of October 2013. Of those bills,

nine have become law, according to the National

Conference of State Legislators. The states that

adopted measures are Maryland, Georgia, California,

Minnesota, Utah, Texas, New Hampshire,

Tennessee and Virginia.
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