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Status of certain additional over-the-counter drug category II and III active ingredients. Final rule.
Fed Regist. 2002 May 09; 67(90):31123-5.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule stating that a certain ingredient in over-the-counter (OTC) drug products is not generally recognized as safe and effective or is 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. This final rule addresses the ingredient octoxynol 9, considered in the rulemaking for OTC vaginal contraceptive drug products. Based on the failure of interested parties to submit new data or information to FDA under the proposed regulation, the agency has determined that the presence of this active ingredient in an OTC drug product would result in that drug product not being generally recognized as safe and effective for its intended use or would result in misbranding. This final rule is part of FDA's ongoing OTC drug product review.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12001971

Citation

Food and Drug Administration, HHS. "Status of Certain Additional Over-the-counter Drug Category II and III Active Ingredients. Final Rule." Federal Register, vol. 67, no. 90, 2002, pp. 31123-5.
Food and Drug Administration, HHS. Status of certain additional over-the-counter drug category II and III active ingredients. Final rule. Fed Regist. 2002;67(90):31123-5.
Food and Drug Administration, HHS. (2002). Status of certain additional over-the-counter drug category II and III active ingredients. Final rule. Federal Register, 67(90), 31123-5.
Food and Drug Administration, HHS. Status of Certain Additional Over-the-counter Drug Category II and III Active Ingredients. Final Rule. Fed Regist. 2002 May 9;67(90):31123-5. PubMed PMID: 12001971.
* 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. Final rule. A1 - ,, PY - 2002/5/11/pubmed PY - 2002/5/17/medline PY - 2002/5/11/entrez SP - 31123 EP - 5 JF - Federal register JO - Fed Regist VL - 67 IS - 90 N2 - The Food and Drug Administration (FDA) is issuing a final rule stating that a certain ingredient in over-the-counter (OTC) drug products is not generally recognized as safe and effective or is 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. This final rule addresses the ingredient octoxynol 9, considered in the rulemaking for OTC vaginal contraceptive drug products. Based on the failure of interested parties to submit new data or information to FDA under the proposed regulation, the agency has determined that the presence of this active ingredient in an OTC drug product would result in that drug product not being generally recognized as safe and effective for its intended use or would result in misbranding. This final rule is part of FDA's ongoing OTC drug product review. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12001971/Status_of_certain_additional_over_the_counter_drug_category_II_and_III_active_ingredients__Final_rule_ L2 - http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-11511-filed.pdf DB - PRIME DP - Unbound Medicine ER -