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Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule.
Fed Regist. 1998 Apr 22; 63(77):19799-802.FR

Abstract

The Food and Drug administration (FDA) is issuing a final rule stating that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this final rule after considering the reports and recommendations of various OTC drug advisory review panels and public comments on proposed agency regulations, which were issued in the form of a tentative final monograph (proposed rule). Based on the absence of substantive comments in opposition to the agency's proposed nonmonograph status for these ingredients, as well as the failure of interested parties to submit new data or information to FDA under the regulation, the agency has determined that the presence of these ingredients in an OTC drug product would result in that drug product not being generally recognized as safe and effective or would result in misbranding. This final rule is part of the ongoing review of OTC drug products conducted by FDA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10179316

Citation

"Status of Certain Additional Over-the-counter Drug Category II and III Active ingredients--FDA. Final Rule." Federal Register, vol. 63, no. 77, 1998, pp. 19799-802.
Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule. Fed Regist. 1998;63(77):19799-802.
(1998). Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule. Federal Register, 63(77), 19799-802.
Status of Certain Additional Over-the-counter Drug Category II and III Active ingredients--FDA. Final Rule. Fed Regist. 1998 Apr 22;63(77):19799-802. PubMed PMID: 10179316.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Status of certain additional over-the-counter drug category II and III active ingredients--FDA. Final rule. PY - 1998/3/29/pubmed PY - 1998/3/29/medline PY - 1998/3/29/entrez SP - 19799 EP - 802 JF - Federal register JO - Fed Regist VL - 63 IS - 77 N2 - The Food and Drug administration (FDA) is issuing a final rule stating that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. FDA is issuing this final rule after considering the reports and recommendations of various OTC drug advisory review panels and public comments on proposed agency regulations, which were issued in the form of a tentative final monograph (proposed rule). Based on the absence of substantive comments in opposition to the agency's proposed nonmonograph status for these ingredients, as well as the failure of interested parties to submit new data or information to FDA under the regulation, the agency has determined that the presence of these ingredients in an OTC drug product would result in that drug product not being generally recognized as safe and effective or would result in misbranding. This final rule is part of the ongoing review of OTC drug products conducted by FDA. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/10179316/Status_of_certain_additional_over_the_counter_drug_category_II_and_III_active_ingredients__FDA__Final_rule_ L2 - https://medlineplus.gov/overthecountermedicines.html DB - PRIME DP - Unbound Medicine ER -
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