Exclusive: FDA plans new compounding pharmacy policy, agency head says

BOSTON (Reuters) – The head of the U.S. Food and Drug Administration said on Friday the agency is working on a new policy that would encourage more compounding pharmacies to register under a law enacted in the wake of a deadly 2012 meningitis outbreak linked to one such company.

FDA Commissioner Scott Gottlieb made the comments in an interview with Reuters as federal prosecutors in Boston prepare for the second criminal trial over contaminated steroids manufactured by the now-defunct New England Compounding Center (NECC).

That meningitis outbreak sickened 778 patients nationwide, including 76 who died, after receiving contaminated steroids, prosecutors said.

After the outbreak, Congress in 2013 passed the Drug Quality and Security Act, which aimed to bring more compounding pharmacies, which make custom medications, under the authority of the FDA rather than state pharmacy boards.

The law created a category of “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk to hospitals and physician practices without prescriptions for individual patients.

In exchange, those compounders would have to follow federal manufacturing standards and subject themselves to routine inspections. Today, around 70 firms have registered as outsourcing facilities.

According to the American Pharmacists Association, there are about 7,500 pharmacies that specialize in compounding services.

Under the 2013 law, compounders that did not register with the FDA would remain under state oversight, and according to the agency, could only compound drugs based on prescriptions for specific patients.

Gottlieb said that in order to encourage more compounders to register, the FDA would release draft guidance in the next two months reflecting its intention to adjust its enforcement priorities based on the size of registered compounders and the riskiness of their products.

“We’re looking at ways we can provide more of a gradation in our regulatory architecture so we don’t have a one-size-fits-all approach,” Gottlieb said.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. To match Special Report CHINA-PHARMACEUTICALS/ REUTERS/Jason Reed

Pharmacists have long mixed tailored medications for patients based on individual prescriptions. By 2013, the practice had mushroomed, with some pharmacies selling thousands of doses of regularly…

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