Months after voting to implement strict new rules on compounding pharmacies on an emergency basis, a state regulatory board is still waiting for a vastly altered package to emerge and actually go into effect.
It was in June that the Tennessee Pharmacy Board voted to adopt emergency rules to make possible the quick shutdown of compounding pharmacies deemed to be a threat to public health and safety.
The action came as Tennessee found itself in the midst of a nationwide fungal meningitis outbreak caused by a Massachusetts compounding firm that shipped fungus-tainted steroids to health-care providers across the country. Only Michigan had more victims.
Sixteen deaths have been recorded among patients treated in Tennessee, while 154 were sickened from the methylprednisolone acetate shipped from the now-defunct New England Compounding Center.
In what he termed a major change, Reginald Dillard, executive director of the pharmacy board, said the board has been forced to remove provisions to issue an immediate cease-and-desist order to a compounder believed to be endangering the public health.
A companion measure giving the state health commissioner authority to issue such an order also has been eliminated.
Dillard said those provisions were stripped from the new rules after a review by the state attorney general concluded the cease-and-desist provisions would violate the state Administrative Procedures Act.
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