Regulatory Roundup: FDA holds meeting to discuss dosing information for OTC drugs containing acetaminophen

May 25, 2011
By PharmTech Editors

Last week, FDA held a joint meeting of its Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee to discuss whether new dosing information for oral over-the-counter (OTC) drug products containing acetaminophen should be added to the label for children under age 2. The full meeting agenda is here. Johnson & Johnson’s McNeil Consumer Healthcare, which recalled several children’s OTC products during the past year, provided briefing materials for the meeting, which can be accessed online. At press time, minutes of the meeting had not been posted. Reportedly, the committee recommended adding dosing guidelines to products containing acetaminophen for children under age 2, including Children’s Tylenol. The panel also recommended that dosage labels be revised according to weight, not age, for these products. FDA does not have to accept the panel’s recommendations, but typically does.

Excipact, Rx-360, and IPEA are collaborating on the use of a self-regulated and voluntary audit scheme based on the widely accepted IPEC-PQG GMP and GDP Guides according to a May 24 press release. The goal is to help improve patient safety and global supply chain security. IPEA is the arm of the International Pharmaceutical Excipients Council (IPEC) that focuses on auditing. Excipact is an international group of excipients manufactures, suppliers, and distributors, including the IPEC regional organizations. The audit scheme is based upon the new Excipact standard, launching this year, and the pending equivalent ANSI NSF363 standard, says the release. The Excipact standard includes additional requirements for GMP and GDP certification and is based on the ISO 9001 Quality Management System Standard.