§360fff Definitions

Summary

Gives plain meanings for key words used in this part about sunscreens. Advisory Committee — the Nonprescription Drug Advisory Committee at the FDA or any group that replaces it. Final sunscreen order — a notice the Secretary publishes in the Federal Register saying a nonprescription sunscreen ingredient (or mix) either is GRASE and correctly labeled if sold under that notice, or is not GRASE and is misbranded. GRASE — short for “generally recognized as safe and effective” by experts trained to judge drug safety and effectiveness, for the uses shown on the drug’s label (see section 321(p)). GRASE determination — a decision about whether a nonprescription ingredient or mix is GRASE. Nonprescription — means not covered by section 353(b)(1) of this title. Pending request — a request under 21 C.F.R. 330.14 (as in effect on November 26, 2014) that was found eligible by a Federal Register notice before November 26, 2014 and for which safety and effectiveness data were submitted before that date. Proposed sunscreen order — a Federal Register notice from the Secretary with a tentative finding that an ingredient or mix either is GRASE and not misbranded, is not GRASE and is misbranded, or is not GRASE and misbranded because the data are incomplete and more information is needed. Sponsor — the person who submitted a request under section 360fff–1, a pending request, or any other application covered by this part. Sunscreen — a drug that contains one or more sunscreen active ingredients. Sunscreen active ingredient — an ingredient meant to be put on human skin to absorb, reflect, or scatter ultraviolet (UV) radiation.