The FDA is seeking information to formulate a regulatory position on insect repellent products that contain OTC sunscreen ingredients. The agency is considering amending its monograph for OTC sunscreen drug products to add conditions for marketing insect repellent-sunscreen drug products. The insect repellent ingredients in these products are regulated by the EPA. Currently there are about 20 combination insect repellent-sunscreen drug products available for consumers. Written comments may be submitted by May 23 to
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.