FDA notes about ambiguity in rules on pharmacies

The fungal meningitis outbreak that started in September 2012 had serious influence on America. Contaminated injectable steroids were manufactured by the New England Compounding Center (located in Massachusetts) and administered by a lot of persons. As a result, more than 400 patients were contaminated with fungal meningitis in more than 20 states. 39 individuals sickened with this illness died. 14 deaths occurred in Tennessee.
It became evident that it was necessary to do something in order to prevent such cases. Contamination must not occur in future. The FDA had to meet with representatives of all states in order to discuss this problem. Thus, lately a meeting took place in order to find ways linked with prevention of contamination in the future.
It was specified during the meeting that new rules on compounding centers should be introduced.
Representatives of certain states claimed that they did suitable job in their states and no any person experienced troubles connected with contamination. Furthermore, they noted critically that they didn’t know what occurred in other states.
When it comes to the FDA, its authority over such cases is not established properly. Federal court cases which were during past years weakened the authority of the FDA evidentially. In addition to these unpleasant aspects, some laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, expressed the proposal to improve the situation through the following modifications:
- to manage training of state regulators;
- to promote sharing information between the FDA and states;
- to eradicate ambiguity from laws.

These proposals seem to be justifiable. Such modifications will probably help to promote improving public health of Americans. Undoubtedly, if laws contain ambiguity, no any agreement will be reached. That’s why new rules should be introduced and existing laws should be altered.
The FDA hopes that state regulators will cooperate with it in order to prevent producing and shipping contaminated drugs.