Joanne Neizer

Technical Customer Support Specialist

January 14, 2014

Industry Concerns Over Natural Rubber Latex Still Linger

Natural Rubber Latex (NRL) has been a topic of concern in the pharmaceutical industry since the early 1990s. Concerns with allergens prompted labeling guidelines to ensure safe patient treatment. West Pharmaceutical Services’ elastomeric formulations for injectable packaging components for vials and syringes may contain Dry Natural Rubber (DNR) in the form of crepe, but the formulations do not incorporate NRL.

The United States Food and Drug Administration issued a draft guidance in March 2013: “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.”

According to the draft guidance,

… there are no regulations requiring a manufacturer to state that natural rubber latex was not used as a material in their medical product or medical product container. If a manufacturer elects to include a statement in medical product labeling indicating that natural rubber latex or synthetic derivatives of natural rubber latex were not used as materials in the manufacture of their medical product and container, FDA recommends the use of the statement “Not made with natural rubber latex.”

Additionally the terms “natural rubber-free” and “latex-free” should be eliminated from use for package labeling.

Because of the concern of patient and caregiver allergic reactions to the proteins found in natural rubber, West’s modern synthetic rubber formulations are widely used for packaging pharmaceutical injectable dosages. By using a synthetic formulation, pharmaceutical manufacturers can reduce concerns regarding risk from allergic reactions to the drug product packaging.

Contact West’s Technical Customer Support to discuss injectable packaging options that are not made with dry natural rubber or natural rubber latex.