Legal Administration of American Drug Labels and Package Inserts
- VernacularTitle:美国药品标签和说明书的法规管理
- Author:
Yang HU
;
Qi LAI
;
Xuehua JIANG
;
Ming HU
- Publication Type:Journal Article
- Keywords:
Drug label;
Drug package insert;
Administration;
The USA;
Acts;
Federal regulations;
Guidances
- From:
China Pharmacy
2001;0(07):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To provide references for the evolvement of the administration of drug labels and package inserts in China. METHODS: By content analysis in non-contact research, 23 law documents relevant to American drug labels and package inserts were collected from FDA website, of which, 7 were acts, 1 federal regulation and 15 guiding principles RESULTS: The drug labels and package inserts of the prescription drugs and the over-the-counter drugs in US were administrated in classification with an emphasis on the contents and formats. CONCLUSIONS: A set of comprehensive lawful system for drug labels and package inserts has been established in American, from which China should draw experience to ensure the comprehensiveness, objectiveness and accuracy of drug information and guarantee safety and efficacy of drugs.
