Rules on compounding pharmacies will be modified

The fungal meningitis outbreak that began in September last year had great impact on America. Contaminated injectable steroids were manufactured by the New England Compounding Center (based in Massachusetts) and given to many persons. As a result, over 400 individuals were contaminated with fungal meningitis in over 20 states. 39 individuals contaminated with this disease died. 14 deaths happened in Tennessee.
It became evident that it was necessary to do anything in order to prevent 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 meeting took place in order to discuss ways related to prevention of contamination in the future.
It was noted during the meeting that new laws on compounding centers should be established.
Representatives of some states claimed that they did proper job in their states and no any person suffered from problems 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 situations is limited. Federal court cases which were during past years depressed the authority of the FDA essentially. Furthermore, certain rules seem to be unclear.
Margaret Hamburg, the FDA Commissioner, offered to improve the situation through the following changes:
- to manage training of state regulators;
- to induce sharing information between the FDA and states;
- to dispose of ambiguity in laws.

These points seem to be rational. 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 rules should be implemented and existing rules should be altered.
The FDA believes that state regulators will work together with it in order to prevent manufacturing and shipping contaminated medications.