ICCR Ushers Forth Updated Cosmetic GMP Guidelines From FDA
This article was originally published in The Rose Sheet
FDA’s draft revision of Cosmetic Good Manufacturing Practices takes into account international consensus formed through harmonization efforts under the International Cooperation on Cosmetics Regulations, says the agency. The recommendations update guidelines created in 1997 and revised in 2008.
You may also be interested in...
From the Personal Care Products Council’s standpoint, FDA’s planned survey of current manufacturing practices in the cosmetics sector isn’t necessary, but the group provided input to contractor RTI to help develop the instrument for optimal utility. Pending OMB approval, FDA aims to launch the survey in spring 2019.
Keystone Labs agrees to cease manufacturing OTC drugs following a 2013 FDA warning letter and repeated GMP violations noted during inspections, including failure to investigate sources of contamination. Firm suggests it will continue making cosmetic hair- and skin-care formulas while outsourcing OTC product manufacturing.
Proposed regulatory reform legislation in the Senate would require FDA to review the safety of cosmetics ingredients, taking into account evaluations conducted by accredited third parties. In August, FDA requested quotes from the contractor community for developing a cosmetic hazard and risk assessment protocol and optional certification program “to show compliance with the protocol.”