More than six months after they were first approved, new rules governing the operation of compounding pharmacies in Tennessee have passed legal muster and gone into effect.
The rules, issued by the state Board of Pharmacy, were drawn up in reaction to a nationwide outbreak of fungal meningitis that hit particularly hard in Tennessee. Sixteen Tennessee patients died after being injected with fungus-tainted spinal steroids shipped from a Massachusetts drug compounding firm.
Reginald Dillard, executive director of the pharmacy board, said the final version of the rules won approval from the state attorney general and went into effect late last month.
The panel was forced to drop from the lengthy package provisions that would have empowered the board or the state health commissioner to order the immediate shutdown of a pharmacy without first holding a hearing.
“There is no provision for an immediate cease-and-desist order,” Dillard said. “We can’t just shut someone down.”
The rules do, however, set in place new requirements for pharmacies that compound drugs.
Drug compounders are now required to disclose to state regulators what sterile drugs they are compounding and maintain records of the patients or health facilities to which those drugs were shipped.
The rules also require that compounding pharmacies submit quarterly reports to the state board and establish quality assurance programs. Training programs for those compounding the drugs are also mandatory.
Other requirements include special labeling, including specific warnings of possible adverse effects.
Dillard said the rules do allow the board to issue a summary suspension order, but an actual shutdown cannot be ordered until a hearing is held.
The rules also require that drug compounders comply with federal sterility standards, Dillard said.
The board and its staff are still reviewing a new federal law on drug compounders to see whether it will require any changes at the state level. The panel must also come up with a permanent version of the compounding regulations.
“We hope to have that done by May,” Dillard said.
The fungal meningitis outbreak has been blamed on the now-defunct New England Compounding Center, which shipped thousands of vials of fungus-tainted methylprednisolone acetate to Tennessee and 19 other states.
Overall, 64 patients died and 751 were sickened, 153 of them in Tennessee.