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Skin protectant drug products for over-the-counter human use; final monograph. Final rule.
Fed Regist. 2003 Jun 04; 68(107):33362-81.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of the ongoing review of OTC drug products conducted by FDA. The final monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on skin protectant drug products for these specific uses that have come to the agency's attention. This final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC skin protectant ingredients that have been found to be not generally recognized as safe and effective. This final rule also lifts the stay of 21 CFR part 352 (published at 66 FR 67485, December 31, 2001) to amend the final monograph for OTC sunscreen drug products to include sunscreen-skin protectant combination drug products, and then stays Sec. 347.20(d) (21 CFR 347.20(d)) and part 352 until further notice in the Federal Register.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12785379

Citation

Food and Drug Administration, HHS. "Skin Protectant Drug Products for Over-the-counter Human Use; Final Monograph. Final Rule." Federal Register, vol. 68, no. 107, 2003, pp. 33362-81.
Food and Drug Administration, HHS. Skin protectant drug products for over-the-counter human use; final monograph. Final rule. Fed Regist. 2003;68(107):33362-81.
Food and Drug Administration, HHS. (2003). Skin protectant drug products for over-the-counter human use; final monograph. Final rule. Federal Register, 68(107), 33362-81.
Food and Drug Administration, HHS. Skin Protectant Drug Products for Over-the-counter Human Use; Final Monograph. Final Rule. Fed Regist. 2003 Jun 4;68(107):33362-81. PubMed PMID: 12785379.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Skin protectant drug products for over-the-counter human use; final monograph. Final rule. A1 - ,, PY - 2003/6/6/pubmed PY - 2003/6/14/medline PY - 2003/6/6/entrez SP - 33362 EP - 81 JF - Federal register JO - Fed Regist VL - 68 IS - 107 N2 - The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded as part of the ongoing review of OTC drug products conducted by FDA. The final monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued in the form of a tentative final monograph, and all new data and information on skin protectant drug products for these specific uses that have come to the agency's attention. This final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC skin protectant ingredients that have been found to be not generally recognized as safe and effective. This final rule also lifts the stay of 21 CFR part 352 (published at 66 FR 67485, December 31, 2001) to amend the final monograph for OTC sunscreen drug products to include sunscreen-skin protectant combination drug products, and then stays Sec. 347.20(d) (21 CFR 347.20(d)) and part 352 until further notice in the Federal Register. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12785379/Skin_protectant_drug_products_for_over_the_counter_human_use L2 - https://www.govinfo.gov/content/pkg/FR-2003-06-04/pdf/03-13751.pdf DB - PRIME DP - Unbound Medicine ER -