NABP action plan created to help enforce compounding regulations

Last month NABP Executive Director Carmen Catizone, MS, RPh, unveiled an action plan to inspect nonresident compounding pharmacies and create a database to share regulatory information about these pharmacies with the state boards of pharmacy nationwide. This was in response to the fungal meningitis outbreak that took the lives of 39 individuals and injured more than 600.

Catizone spoke to attendees of the American Society of Health-System Pharmacists (ASHP) Midyear meeting in Las Vegas.

These patients had received contaminated compounded steroid injections that were produced and distributed by the New England Compounding Center, Framingham, Mass.

“This is a tragedy like no other that NABP has faced,” said Catizone who has served the association for 27 years. “This issue has totally consumed NABP and the state boards of pharmacy. This will change pharmacy regulation like no one has anticipated.”

NABP’s action plan began in November during the meeting of the board of pharmacy executive directors. The Iowa Board of Pharmacy had already requested that NABP develop an inspection plan for all of its nonresident pharmacies dispensing compounded drugs that were licensed by Iowa.

“Based upon that agreement, we will be acting as an agent of the state of Iowa and going into all the other states where these pharmacies are located and physically inspecting those pharmacies. We will do so with the cooperation of the resident states,” Catizone said. The state boards have been supportive and cooperative in providing a list of pharmacies for inspection, the first part of NABP’s action plan, he said.

The week of December 10, NABP started implementing the second part of its action plan to inspect these facilities that are compounding and to determine whether the pharmacies are compounding pursuant to a prescription in compliance with state regulations, or are engaged in manufacturing.

The third part of the action plan involves the creation of a database with information pertaining to compounding pharmacies identified by the Iowa Board as well as those indicated by other state boards.

“Initial data collected from the boards and the inspection reports will be stored in an NABP Pharmacy e-Profile, allowing the NABP to disseminate pertinent public information among state boards,” NABP reported on its website. “Ultimately, states will be able to submit inspection reports and other related information to NABP for inclusion in pharmacies’ e-Profiles.”

NABP also plans to provide training and education of board of pharmacy inspectors via Web seminars and field training, according to its website. State boards are supportive of these efforts. “They have said, ‘We can’t sit back and we can’t argue this for 20 more years-what is the definition of compounding versus manufacturing. Too many patients have been killed or injured. We have to act. And we will do so in the best interest of the patient,’ ”
Catizone said.

–Julia Talsma, Content Channel Director