What laws require prescription drugs to come with an explanation of the medication?


Quick Answer

Federal law regarding the explanatory materials that must accompany prescription drugs is found in the Code of Federal Regulations, Title 21, Sections 201.56, 201.57 and 201.80, according to the U.S. Food and Drug Administration. These regulations are commonly known as the Physician Labeling Rule.

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Full Answer

The Physician Labeling Rule specifies the content that must be provided about each human prescription drug, explains the FDA. The laws also require the use of a specific format, which includes certain headings and subheadings.

The Pregnancy and Lactation Labeling Rule provides guidelines for the proper labeling of prescription materials with information specific to pregnant and lactating women as well as both men and women of reproductive age, notes the FDA.

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