Tags

Type your tag names separated by a space and hit enter

Antidiarrheal drug products for over-the-counter human use; final monograph. Final rule.
Fed Regist. 2003 Apr 17; 68(74):18869-82.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) antidiarrheal drug products (to control the symptoms of diarrhea) are generally recognized as safe and effective and not misbranded. This final rule is part of FDA's ongoing review of OTC drug products. 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 (TFM), and all new data and information on OTC antidiarrheal drug products that have come to the agency's attention. Also, this final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC antidiarrheal active ingredients that have been found to be not generally recognized as safe and effective.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

AntidiarrhealsHumansLegislation, DrugNonprescription DrugsProduct LabelingReye SyndromeUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12701600

Citation

Food and Drug Administration, HHS. "Antidiarrheal Drug Products for Over-the-counter Human Use; Final Monograph. Final Rule." Federal Register, vol. 68, no. 74, 2003, pp. 18869-82.
Food and Drug Administration, HHS. Antidiarrheal drug products for over-the-counter human use; final monograph. Final rule. Fed Regist. 2003;68(74):18869-82.
Food and Drug Administration, HHS. (2003). Antidiarrheal drug products for over-the-counter human use; final monograph. Final rule. Federal Register, 68(74), 18869-82.
Food and Drug Administration, HHS. Antidiarrheal Drug Products for Over-the-counter Human Use; Final Monograph. Final Rule. Fed Regist. 2003 Apr 17;68(74):18869-82. PubMed PMID: 12701600.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Antidiarrheal drug products for over-the-counter human use; final monograph. Final rule. A1 - ,, PY - 2003/4/19/pubmed PY - 2003/5/6/medline PY - 2003/4/19/entrez SP - 18869 EP - 82 JF - Federal register JO - Fed Regist VL - 68 IS - 74 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) antidiarrheal drug products (to control the symptoms of diarrhea) are generally recognized as safe and effective and not misbranded. This final rule is part of FDA's ongoing review of OTC drug products. 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 (TFM), and all new data and information on OTC antidiarrheal drug products that have come to the agency's attention. Also, this final rule amends the regulation that lists nonmonograph active ingredients by adding those OTC antidiarrheal active ingredients that have been found to be not generally recognized as safe and effective. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12701600/Antidiarrheal_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -