§355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application — Inbound Citations
21 U.S.C. § 355h
Cited by 13 provisions in release 119-102.
Citations to 21 U.S.C. § 355h as a whole
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(ee) If it is a nonprescription drug that is subject to section 355h of this title, is not the subject of an application approved under section 355 of this title, and does not comply with the requirements under section 355h of this title.
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(i) supersede or modify the authority of the Secretary under section 355h of this title with respect to the regulation of OTC monograph drugs; or
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(3) A final sunscreen order shall be deemed to be a final order under section 355h of this title.
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(5) The term “OTC monograph drug” means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title.
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(E) Other activities necessary for implementation of section 355h of this title.
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(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 355h of this title.
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(13) The terms “requestor” and “sponsor” have the meanings given such terms in section 355h of this title.
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(1) In the case of a drug described in subsection (a)(1) that is not the subject of an application approved under section 355 of this title or section 357 of this title (as in effect on the day before November 21, 1997) or a final order under section 355h of this title by the Secretary establishing conditions under which the drug is generally recognized as safe and effective, subsection (a) shall apply only with respect to a requirement of a State or political subdivision of a State that relates to the same subject as, but is different from or in addition to, or that is otherwise not identical with—(A) a regulation or order in effect with respect to the drug pursuant to a statute described in subsection (a)(2); or(B) any other requirement in effect with respect to the drug pursuant to an amendment to such a statute made on or after November 21, 1997.
Citations to §355h(b)
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(ii) the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section 355h(b) of this title; and
Citations to §355h(b)(5)
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(7) The term “OTC monograph order request” means a request for an order submitted under section 355h(b)(5) of this title.
Citations to §355h(c)(3)(A)
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(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 355h(c)(3)(A) of this title;
Citations to §355h(i)
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(vi) meetings referred to in section 355h(i) of this title;
Citations to §355h(r)
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(C) the status of implementation of evidence and testing standards under section 355h(r) of this title for nonprescription drugs intended for topical administration, including—(i) the application of evidence or testing standards; and(ii) the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section 355h(b) of this title; and