21 U.S.C. § 360fff: Definitions

the term “Advisory Committee” means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee; is GRASE and is not misbranded if marketed in accordance with such order; or is not GRASE and is misbranded; the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title ; the term “GRASE determination” means, with respect to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such ingredient or combination of ingredients is GRASE; the term “nonprescription” means not subject to section 353(b)(1) of this title ; that was determined to be eligible for such review by publication of a notice of eligibility in the Federal Register prior to November 26, 2014 ; and for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014 ; is GRASE and is not misbranded if marketed in accordance with such order; is not GRASE and is misbranded; or is not GRASE and is misbranded because the data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and additional information is necessary to allow the Secretary to determine otherwise; a request under section 360fff–1 of this title ; a pending request; or any other application subject to this part; the term “sunscreen” means a drug containing one or more sunscreen active ingredients; and the term “sunscreen active ingredient” means an active ingredient that is intended for application to the skin of humans for purposes of absorbing, reflecting, or scattering ultraviolet radiation. limit the right of a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 360fff(8) ], as added by subsection (a)) to request that the Secretary of Health and Human Services convene an advisory committee; or limit the authority of the Secretary of Health and Human Services to meet with a sponsor (as defined in section 586(8) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).”