§360fff Definitions

Summary

Defines key words used in FDA rules about over-the-counter sunscreens. Advisory Committee means the FDA’s Nonprescription Drug Advisory Committee or its successor. Final sunscreen order means a notice the Secretary publishes in the Federal Register saying a nonprescription sunscreen ingredient (or combination) is either GRASE and not misbranded when marketed under that order, or is not GRASE and is misbranded. GRASE means generally recognized by qualified experts as safe and effective for the uses listed in the drug’s label, as described in section 321(p) of this title. GRASE determination means a decision about whether an ingredient or combination is GRASE. Nonprescription means not subject to section 353(b)(1) of this title. Pending request means a request under 21 C.F.R. 330.14 (as in effect on November 26, 2014) that had an eligibility notice published before November 26, 2014 and had safety and effectiveness data submitted before that date. Proposed sunscreen order means a Federal Register notice tentatively saying an ingredient is either GRASE and not misbranded, not GRASE and misbranded, or not GRASE and misbranded because more data are needed. Sponsor means the person who submitted a request under section 360fff–1 of this title, a pending request, or any other application under this part. Sunscreen means a drug with one or more sunscreen active ingredients. Sunscreen active ingredient means an ingredient meant to be put on human skin to absorb, reflect, or scatter ultraviolet radiation.