CHPA comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.
FDA issued a proposed rule on labeling requirements for OTC human drugs. The announcement proposed a definition for “convenience-size” OTC drug packages as well as the option of alternative labeling requirements for these products. CHPA welcomes the opportunity to comment on the proposed rule changes.
CHPA appreciates the comments of FDA in the February 2006, feedback letter and understands that these comments are FDA’s best advice on designing a protocol to address the safety and efficacy of benzocaine. We have included a revised final protocol for your final review.
CHPA has supported and continues to support the timely provision of complete and accurate product information to healthcare professionals and patients in an easily accessible format, and commends the Agency for considering new approaches to disseminating emerging drug safety-related data.
CHPA appreciates the opportunity to provide comments concerning U.S. Government positions in preparation for the 33rd session of the Codex Committee on Food Labelling of the Codex Alimentarius Commission.
In considering the safety of NSAIDs, the use of OTC NSAIDs should be clearly distinguished from long-term prescription NSAID use. OTC medicines have a different overall benefit-to-risk equation and a wider margin of safety than prescription NSAIDs.
