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Drug & Medical Device Labeling Requirements

Posted on:2/27/2012
The Food and Drug Administration (FDA) relies on word labeling to regulate both drugs and medical devices.


The FDA's extensive labeling requirements (21 CFR Part 201 [4-1-95]) pertain primarily to the type of drug or device to be labeled, the type of information that must be contained on the label, and general guidance for avoiding misrepresentation or fraud on the label. Adequate directions for use also must be given in a form suitable for a layperson to use the drug safely and for the purposes for which it was intended.

 

Ingredients must be listed accurately, along with an expiration date if required. Graphic requirements typically relate to size and prominence of the wording on the label. Labeling in Spanish is authorized only for medications available by prescription and distributed in the Commonwealth of Puerto Rico.

 

Requirements for supplementary information are given also if the total package and label are too small to accommodate all the required information. The FDA's specific guidance for labeling prescription drugs includes section headings for labels. The FDA defines each of these terms, and specifies the type of information to be included on the label. Although the Code specifies the information that must be included on the label, it does not include any use of symbols or colors.

 

The FDA gives specific guidance for labeling over-the-counter drugs (CFR 201.60). The FDA specifies detailed information to be included on the label, and particular drugs for which warnings must be given.


  
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