Tennessee pharmacy board strengthens compounding rules

Less than a month after FDA warned of an outbreak following steroid injections from a compounding pharmacy there, the Tennessee Board of Pharmacy (TBOP) strengthened its oversight of compounding pharmacies.

Under newly adopted rules, the officer of the TBOP, its executive director, and the TBOP commissioner can now jointly suspend a sterile compounder’s license for cause without a meeting of the full board. 

“The board is working cooperatively to identify solutions to improve safeguards for public health while not placing unnecessary barriers on sterile compounding pharmacies that would hamper production of much-needed drugs already in short supply,” said Charles E. “Buddy” Stephens, DPh, TBOP president. “We believe our actions enhance existing safeguards and offer new steps to ensure safe and effective medications are there when needed.”

On May 24, FDA reported that 7 Tennesseans had fallen ill after receiving compounded steroid injections made by Main Street Family Pharmacy of Newbern, Tenn. The patients suffered adverse reactions after receiving injections of preservative-free methylprednisolone acetate (80 mg/mL).

Same drug implicated

FDA also advised healthcare providers not to use any products from Main Street Family Pharmacy that were labeled sterile, and to quarantine the products until further notice. The same steroid was involved in the 2012 New England Compounding Center (NECC) fungal meningitis outbreak that killed 58 people and sickened more than 700 others.

In the NECC case, investigators found greenish-yellow residue on sterilized equipment, work surfaces coated with mold and bacteria, and an air conditioner that was supposed to be used to control temperatures shut off at night. FDA investigators also found black foreign matter on 83 of the 321 vials linked to the meningitis outbreak.

FDA confirms bacteria

In the Main Street Family Pharmacy case, FDA found bacteria and fungus in drug vials manufactured by the compounder. It also reported that rooms at the pharmacy that were supposed to be sterile were not, and that basic hygiene procedures were not being followed. Additionally, spiders were found in a clean room.

During inspections in 2011 and 2012, Main Street had been cited for violations that included using outdated medications, prescriptions not written on tamper-resistant paper, and for emailing and dispensing prescriptions without signatures.

TBOP’s new rules increase oversight and regulation of Tennessee drug manufacturing operations, with licensed manufacturers now placed into a separate license category. The new regulations require the state’s drug manufacturers to show proof that their operations are registered with FDA.

And TBOP has added a sterile compounding registration to the regular pharmacy license, to the manufacturer license, and to the wholesaler/distributor license.

“It’s a great challenge to strike a thoughtful, protective balance between addressing the daily drug shortages faced by patients and healthcare providers across Tennessee with the absolute need to assure safety and effectiveness in the compounded product,” said John Dreyzehner, MD, MPH, commissioner of the Tennessee Department of Health (TDH). “While we wish the current situation associated with a Tennessee pharmacy had not happened and that patients had not been affected, the actions taken by the board, along with legislation passed recently, are moving us forward in assuring the safety and availability of important medications.”

Proactive inspections

TBOP, along with TDH, is reviewing several other regulation changes. TBOP hopes to create a more proactive inspection posture, with additional emphasis on critical reviews of maintenance and quality control records; interim self-assessment and applicable reporting by facilities; and adoption of applicable U.S. Pharmacopeia Standards.

To facilitate the regulation changes, TBOP will hire 3 licensed pharmacists to serve as additional inspectors, and an administrative staffer to assist with the new self-assessment and reporting responsibilities. 

“The prior regulatory process resulted in the business ceasing sterile compounding of methylprednisolone acetate almost 2 months before cases were identified,” said TDH Chief Medical Officer David Reagan, MD, PhD. “Of course, we never want any patients to be adversely impacted. The actions by the board will strengthen a regulatory system, allowing earlier identification of potential problems."