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New compounding pharmacy rules remain on hold in TN

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.

“The statutes do not allow us to do it,” Dillard said of the immediate cease-and-desist rules.
He said the licenses issued to pharmacists are considered a property right and can’t be revoked without due process, which would require prior formal notice and a hearing.

He said the attorney general also concluded that under current law the board cannot delegate its authority to revoke a license to the health commissioner.

Meeting minutes show pharmacy board members learned of the attorney general’s decision at their October meeting.

A board attorney, Stefan Cange, told members that not only would there have to be a hearing before a license suspension, but also the pharmacy board would bear the burden of proving that a suspension was justified.

Cange also told the board that while the health commissioner could recommend the suspension of a compounding pharmacy license, he could not implement a suspension on his own. “The commissioner has been removed from that process,” Cange said, according to the minutes.
Other technical changes were discussed at the October session, including the precise standards that compounding pharmacists will be required to follow when compounding sterile drugs. Dillard said the intent was to make it easier to keep the Tennessee standards in line with any changes in national norms.

As the state efforts to tighten regulations have inched along, Dillard acknowledged that a new federal law affecting compounding pharmacies has passed Congress and been sent to President Barack Obama, who is expected to sign it.

Under that law, Dillard said, compounders producing drugs in bulk can register with the U.S. Food and Drug Administration and become subject to federal scrutiny.

“It does kind of take the oversight from the state boards,” he said. “I hope they give the FDA the manpower to do it.”

He said it was too soon to determine whether the federal legislation would require changes in state laws or regulations.

As for the new state rules, Dillard said the revised package is undergoing a final review by the attorney general.

Baeteena Black, executive director of the Tennessee Pharmacists Association, said that while the exact form of the new rules won’t be known until the final legal review is completed, the association is generally in support of the board’s efforts.