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Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule.
Fed Regist. 2003 Jun 13; 68(114):35290-3.FR

Abstract

The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revises some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products (68 FR 33362, June 4, 2003) and adds labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Aluminum CompoundsAstringentsAvenaColloidsConsumer Product SafetyDrug ApprovalDrug LabelingHumansNonprescription DrugsProtective AgentsSodium BicarbonateUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12807133

Citation

Food and Drug Administration, HHS. "Skin Protectant Drug Products for Over-the-counter Human Use; Astringent Drug Products; Final Monograph; Direct Final Rule. Direct Final Rule." Federal Register, vol. 68, no. 114, 2003, pp. 35290-3.
Food and Drug Administration, HHS. Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule. Fed Regist. 2003;68(114):35290-3.
Food and Drug Administration, HHS. (2003). Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule. Federal Register, 68(114), 35290-3.
Food and Drug Administration, HHS. Skin Protectant Drug Products for Over-the-counter Human Use; Astringent Drug Products; Final Monograph; Direct Final Rule. Direct Final Rule. Fed Regist. 2003 Jun 13;68(114):35290-3. PubMed PMID: 12807133.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Skin protectant drug products for over-the-counter human use; astringent drug products; final monograph; direct final rule. Direct final rule. A1 - ,, PY - 2003/6/17/pubmed PY - 2003/6/28/medline PY - 2003/6/17/entrez SP - 35290 EP - 3 JF - Federal register JO - Fed Regist VL - 68 IS - 114 N2 - The Food and Drug Administration (FDA) is amending the regulation that established conditions under which over-the-counter (OTC) skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. This action revises some labeling for astringent drug products to be consistent with the final rule for OTC skin protectant drug products (68 FR 33362, June 4, 2003) and adds labeling for certain small packages (styptic pencils). This action is part of FDA's ongoing review of OTC drug products. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedure for notice-and-comment rulemaking, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12807133/Skin_protectant_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -