Thirty high risk Pharmacies to be inspected in next two months

Northern, WI 03/04/2013 (avauncer) - U.S pharmaceutical regulators are targeting 30 high risk pharmacies for inspection within next two months as a part of rule enforcement after previous year’s deadly meningitis outbreak.

Erica Jefferson of food and drug administration in an interview stated that these companies primarily manufacture sterile drugs and distributes nationwide. Initial visits were made on Feb.19 and this will continue for next two months to inspect all these compounding pharmacies.

As per FDA’s reports on its website, many facilities are found in Florida, Chicago, Arkansas and Mississippi which are under high risk because of microbiological contamination of drugs; FDA has released 4 inspection reports till now. These drug compounders are brought under search light when New England Compounding Pharmacy Inc killed 48 people with its fungal contaminated steroid shots.

These compounding pharmacies manufacture drugs in traditional ways and are under control of state health department. Meningitis outbreak is the mirror to those companies which go over the capacity by ignoring the rules of FDA.

Initially FDA does not do this kind of inspection until they receive a complaint.

FDA has chosen these target companies based on the risk potential, adverse effect reports submitted to FDA, previous inspection reports, quality problems and public in formations etc. the FDA is collaborated with state authorities to conduct the inspections.

Lawmakers of House Energy and Commerce Committee said that the FDA should have terminated the Framingham, Massachusetts-based New England Compounding when the first complaint of contamination was recorded. FDA commissioner Margaret Hamburg defended the agency.

Now the FDA is planning to commit an inspection to stop the disasters of contamination in early stages.

FDA cannot touch the compounding firms that are acting under traditional compounding law.