FDA proposed to alter rules on compounding pharmacies

The fungal meningitis outbreak that started in September last year had obvious impact upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and given to numerous persons. As a result, more than 400 patients were contaminated with fungal meningitis in over 20 states. 39 individuals sickened with this disease died. 14 deaths occurred in Tennessee.
It became obvious that it needed to do anything in order to prevent such cases. Contamination must not occur in future. The FDA had to meet with representatives of all states for discussion of this problem. Thus, recently a meeting took place in order to prevent occurring contamination in the future.
It was affirmed during the conference that new rules on compounding pharmacies should be established.
Representatives of certain states affirmed that they did proper job in their states and no any person experienced troubles connected with contamination. Furthermore, they noted with criticism that they didn’t know what occurred in other states.
As for the FDA, its authority over such cases is not established well. Federal court cases which were during past years exhausted the authority of the FDA obviously. In addition to these problems, some laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, proposed to improve the situation through the following modifications:
- to manage training of state regulators;
- to promote sharing information between the FDA and states;
- to remove ambiguity from laws.

These points seem to be justifiable. Such modifications will probably help to induce improving public health of Americans. Of course, if rules contain ambiguity, no any agreement will be achieved. That’s why new rules should be elaborated and existing rules should be modified.
The FDA hopes that state regulators will collaborate with it in order to prevent producing and shipping contaminated medications.