Some rules on pharmacies contain ambiguity

The fungal meningitis outbreak that started in September last year had substantial impact upon America. Contaminated injectable steroids were manufactured by the New England Compounding Center (located in Massachusetts) and applied by a lot of persons. As a result, over 400 individuals were contaminated with fungal meningitis in more than 20 states. 39 individuals sickened with this disease died. 14 deaths happened in Tennessee.
It became evident that it needed to do something for prevention of such cases. Contamination must not take place in future. The FDA had to meet with representatives of all states for discussion of this situation. So, recently a conference took place in order to find ways linked with prevention of contamination in the future.
It was underlined during the conference that new rules on compounding pharmacies should be introduced.
Representatives of certain states claimed that they did suitable job in their states and no any person experienced troubles related to contamination. Moreover, they underlined critically that they were not aware of what occurred in other states.
When it comes to the FDA, its authority over such cases is limited. Federal court cases which were during past years depressed the authority of the FDA evidentially. In addition to these problems, several laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, proposed to improve the situation through the following changes:
- to control training of state regulators;
- to induce sharing information between the FDA and states;
- to get rid of ambiguity in rules.

These proposals seem to be fair. Such changes must help to promote improving public health of Americans. Of course, if rules contain ambiguity, no any agreement will be reached. That’s why new laws should be elaborated and existing rules should be altered.
The FDA believes that state regulators will cooperate with it in order to prevent producing and shipping contaminated drugs.