Contamination with meningitis leads to modification of rules on pharmacies

The fungal meningitis outbreak which began in September 2012 had great impact upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and administered by many persons. As a result, over 400 individuals sickened with fungal meningitis in over 20 states. 39 persons contaminated with this illness died. 14 deaths happened in Tennessee.
It became obvious that it was necessary to do something for prevention of such situations. Contamination must not occur in future. The FDA had to meet with representatives of all states in order to discuss this situation. So, recently a conference took place in order to prevent occurring contamination in the future.
It was stated during the meeting that new laws on compounding pharmacies should be implemented.
Representatives of some states specified that they did good job in their states and no any individual experienced problems related to contamination. Moreover, they noted with criticism that they were not aware of what happened in other states.
As for the FDA, its authority over such situations is not established properly. Federal court cases that were during past years reduced the authority of the FDA significantly. Furthermore, several laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, proposed to improve the situation through the following changes:
- to manage training of state regulators;
- to induce sharing information between the FDA and states;
- to eliminate ambiguity from laws.

These points seem to be justifiable. Such changes will probably help to induce improving public health of Americans. Of course, if laws contain ambiguity, no any agreement will be reached. That’s why new rules should be elaborated and existing laws should be altered.
The FDA hopes that state regulators will coact with it in order to prevent manufacturing and shipping contaminated drugs.