FDA to issue proposed rule for certain OTC shampoos
The FDA is issuing a proposed rule to amend the final monograph (FM) for OTC dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8% coal tar solution and 1.5% menthol in a shampoo drug product to control dandruff. The agency is issuing this proposed rule after considering information submitted in a citizen petition. In 1993, FDA received a petition to amend the FM for OTC dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 9% coal tar solution and 1.5% menthol in a shampoo drug product to relieve scalp itching associated with dandruff. To submit electronic comments by March 9, 2006, visit http://www.regulations.gov/.
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.
