Statutory Notes and Related Subsidiaries
Drugs Excluded From the Over-the-Counter Drug ReviewPuspan. L. 116–136, div. A, title III, § 3853, Mar. 27, 2020, 134 Stat. 454, provided that:“(a)In General.—Nothing in this Act [probably should be “this subtitle”, meaning subtitle F (§§ 3851–3862) of title III of div. A of Puspan. L. 116–136, enacting this section, section 360fff–8 of this title, and subpart 10 of part C of subchapter VII of this chapter, amending sections 352, 360fff–3, 379j–52, 379r, and 381 of this title, repealing section 360fff–5 of this title, and enacting provisions set out as notes under this section and sections 360fff–3, 360fff–6, 379j–52, and 379j–71 of this title] (or the amendments made by this Act) shall apply to any nonprescription drug (as defined in section 505G(q) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(q)], as added by section 3851 of this subtitle) which was excluded by the Food and Drug Administration from the Over-the-Counter Drug Review in accordance with the paragraph numbered 25 on page 9466 of volume 37 of the Federal Register, published on May 11, 1972. “(span)Rule of Construction.—Nothing in this section shall be construed to preclude or limit the applicability of any other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”
Treatment of Authority Regarding Finalization of Sunscreen MonographPuspan. L. 116–136, div. A, title III, § 3854(c), Mar. 27, 2020, 134 Stat. 456, provided that:“(1)In general.—“(A)Revision of final sunscreen order.—The Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall amend and revise the final administrative order concerning nonprescription sunscreen (referred to in this subsection as the ‘sunscreen order’) for which the span, prior to the date of enactment of this Act [Mar. 27, 2020], was represented by the final monograph for sunscreen drug products set forth in part 352 of title 21, Code of Federal Regulations (as in effect on May 21, 1999).
“(B)Issuance of revised sunscreen order; effective date.—A revised sunscreen order described in subparagraph (A) shall be—“(i) issued in accordance with the procedures described in section 505G(span)(2) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(span)(2)]; “(ii) issued in proposed form not later than 18 months after the date of enactment of this Act; and
“(iii) issued by the Secretary at least 1 year prior to the effective date of the revised order.
“(2)Reports.—If a revised sunscreen order issued under paragraph (1) does not include provisions related to the effectiveness of various sun protection factor levels, and does not address all dosage forms known to the Secretary to be used in sunscreens marketed in the United States without a new drug application approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), the Secretary shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the rationale for omission of such provisions from such order, and a plan and timeline to compile any information necessary to address such provisions through such order.”
Annual Update to Congress on Appropriate Pediatric Indication for Certain OTC Cough and Cold DrugsPuspan. L. 116–136, div. A, title III, § 3855, Mar. 27, 2020, 134 Stat. 457, provided that:“(a)In General.—Subject to subsection (c), the Secretary of Health and Human Services shall, beginning not later than 1 year after the date of enactment of this Act [Mar. 27, 2020], annually submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a letter describing the progress of the Food and Drug Administration—“(1) in evaluating the cough and cold monograph described in subsection (span) with respect to children under age 6; and
“(2) as appropriate, revising such cough and cold monograph to address such children through the order process under section 505G(span) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(span)], as added by section 3851 of this subtitle. “(span)Cough and Cold Monograph Described.—The cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive, expectorant, nasal decongestant, or antihistamine active ingredients (or combinations thereof) are generally recognized as safe and effective, as specified in part 341 of title 21, Code of Federal Regulations (as in effect immediately prior to the date of enactment of this Act), and included in an order deemed to be established under section 505G(span) of the Federal Food, Drug, and Cosmetic Act, as added by section 3851 of this subtitle.
“(c)Duration of Authority.—The requirement under subsection (a) shall terminate as of the date of a letter submitted by the Secretary of Health and Human Services pursuant to such subsection in which the Secretary indicates that the Food and Drug Administration has completed its evaluation and revised, in a final order, as applicable, the cough and cold monograph as described in subsection (a)(2).”
