Medical Mega

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

On September 6, 2017, FDA issued a final rule establishing that certain ingredients for OTC topical consumer antiseptic wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (81 FR 61106). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(iii). On December 20, 2018, FDA issued a final rule establishing that certain ingredients for OTC health care antiseptic hand wash nonprescription drug products, including triclosan, are not generally recognized as safe and effective (82 FR 60474). FDA’s final determination was codified in regulations at 21 CFR 310.545(a)(27)(vi). Under section 505G(k)(2)(A) of the FD&C Act, the non-monograph conditions in 21 CFR 310.545 in effect on the day before the date of enactment of the CARES Act (i.e., March 26, 2020) were deemed to be a final administrative order. The final administrative order is entitled “Non-Monograph Conditions NM900: Drug Products Containing Certain Active Ingredients Offered Over-the-Counter for Certain Uses” (See Order ID OTC 000007, available at OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/).