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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):31125-7.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule stating that the stimulant laxative ingredients aloe (including aloe extract and aloe flower extract) and cascara sagrada (including casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, and cascara sagrada fluidextract) in over-the- counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. 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

12001972

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. 31125-7.
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):31125-7.
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), 31125-7.
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):31125-7. PubMed PMID: 12001972.
* 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 - 31125 EP - 7 JF - Federal register JO - Fed Regist VL - 67 IS - 90 N2 - The Food and Drug Administration (FDA) is issuing a final rule stating that the stimulant laxative ingredients aloe (including aloe extract and aloe flower extract) and cascara sagrada (including casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, and cascara sagrada fluidextract) in over-the- counter (OTC) drug products are not generally recognized as safe and effective or are misbranded. This final rule is part of FDA's ongoing OTC drug product review. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12001972/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=02-11510-filed.pdf DB - PRIME DP - Unbound Medicine ER -