CHPA submits these comments on the proposal published by the Food and Drug Administration in 64 Fed. Reg. 66822 (November 30, 1999) to revise its citizen petition regulations, 21 C.F.R. § 10.25 and 21 C.F.R. § 10.30.
Request for agency exercise of enforcement discretion regarding the addition of new Warning language to Drug Facts labeling for Over-the-Counter benzocaine liquid/gel products indicated for relieving oral discomfort.
CHPA generally supports prohibitions on animal testing while allowing exemptions in select research areas deemed critical to substantiating human health and safety based on federal or state regulator evaluations.
The success of healthcare vending indicates many consumers welcome the affordability and around-the-clock availability these machines provide. As the trend accelerates, people across socioeconomic backgrounds are empowered to conveniently tend to their healthcare needs.
Current good manufacturing practices establish uniform standards to ensure quality throughout the manufacturing, packaging, labeling, and holding of OTC medicines and dietary supplement products.
CHPA is committed to advancing solutions to illegal sales that penalize criminals and ensure law-abiding consumers continue to have access to a wide range of treatment options, including nonprescription medicines containing PSE.