Regulatory Roundup for the Week of March 11, 2013

Mar 12, 2013
By PharmTech Editors

FDA has issued a draft guidance document for the manufacture of products that are not made with natural rubber latex (NRL). FDA is recommending that manufacturers use the statement “not made with natural rubber latex” instead of “latex free” or “does not contain natural rubber latex” because these statements are not scientifically accurate.  FDA says the terms “latex free” and “does not contain natural rubber latex” suggest that the medical product is completely without NRL when there is a chance that products can become contaminated with NRL allergens during manufacturing or packaging processes. “Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions,” said William Maisel, MD, MPH, deputy director for science in the FDA’s Center for Devices and Radiological Health, in a press release. “Our recommendations regarding natural rubber latex provide consistent, scientifically accurate language for health care providers, patients and consumers who want to avoid this material due to possible sensitivity or allergy.”

FDA’s Center for Drug Evaluation and Research released its publishing agenda for guidance documents for the rest of the year. Included on the agenda are guidance documents on quality systems for CGMPs; contract manufacturing arrangements for drugs; and pharmacy compounding of human drugs.