21 U.S.C. § 360fff — Definitions

submitted 88 years ago by Pub. L. 113-195 to r/title-21-FOOD-AND-DRUGS · 442 words · no verdicts yet

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This section defines terms used in the sunscreen review law, like "GRASE" and "sunscreen active ingredient." It explains a nonprescription sunscreen order, a sponsor, and a pending request already filed with the FDA. These definitions apply throughout this part of the law.

(1) "Advisory Committee" means the FDA's Nonprescription Drug Advisory Committee, or whatever committee replaces it. (2) A "final sunscreen order" is an order the FDA publishes in the Federal Register. It says whether a nonprescription sunscreen ingredient (or combination of ingredients) is GRASE and can be sold under the order's terms, or is not GRASE and counts as misbranded. (3) "GRASE" means "generally recognized... as safe and effective" — qualified experts agree the ingredient is safe and works when used the way its label says, as described in section 321(p). (4) A "GRASE determination" is the FDA's decision about whether a nonprescription active ingredient, or combination of ingredients, is GRASE. (5) "Nonprescription" means a drug that doesn't require a prescription under section 353(b)(1). (6) A "pending request" is a request about a sunscreen ingredient that was filed under the old FDA regulation (21 C.F.R. § 330.14) for possible inclusion in the over-the-counter drug list. To count, the request must have been declared eligible for review, by a Federal Register notice, before November 26, 2014, and its safety and effectiveness data must have been submitted before that date too. (7) A "proposed sunscreen order" is a draft order the FDA publishes proposing that an ingredient (or combination) 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. (8) A "sponsor" is whoever submitted a request under section 360fff–1, a pending request, or any other application covered by this part. (9) "Sunscreen" means a drug that has one or more sunscreen active ingredients. (10) A "sunscreen active ingredient" is an active ingredient meant to go on human skin to absorb, reflect, or scatter ultraviolet light.

the actual law source: uscode.house.gov ↗public domain

In this part—

(1)

the term “Advisory Committee” means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee;

(2)

the term “final sunscreen order” means an order published by the Secretary in the Federal Register containing information stating that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A)

is GRASE and is not misbranded if marketed in accordance with such order; or

(B)

is not GRASE and is misbranded;

(3)

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;

(4)

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;

(5)

the term “nonprescription” means not subject to section 353(b)(1) of this title;

(6)

the term “pending request” means each request with respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on November 26, 2014) for consideration for inclusion in the over-the-counter drug monograph system—

(A)

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

(B)

for which safety and effectiveness data have been submitted to the Secretary prior to November 26, 2014;

(7)

the term “proposed sunscreen order” means an order containing a tentative determination published by the Secretary in the Federal Register containing information proposing that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients—

(A)

is GRASE and is not misbranded if marketed in accordance with such order;

(B)

is not GRASE and is misbranded; or

(C)

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;

(8)

the term “sponsor” means the person that submitted—

(A)

a request under section 360fff–1 of this title;

(B)

a pending request; or

(C)

any other application subject to this part;

(9)

the term “sunscreen” means a drug containing one or more sunscreen active ingredients; and

(10)

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.

Source credit: (June 25, 1938, ch. 675, § 586, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2035.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 113-195 · 128 Stat. 2035

A history note hasn’t been published yet. The record shows enactment by Pub. L. 113-195 on 1938-06-25.

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