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U.S. Department of Health and Human Services

Drugs

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PLR Requirements for Prescribing Information

 

On January 24, 2006, the U.S. Food and Drug Administration (FDA) issued final regulations governing the content and format of prescribing information (PI) for human drug and biological products. The rule is commonly referred to as the “Physician Labeling Rule” (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care providers.  

The goal of the PLR content and format requirements as described at 21 CFR 201.56 and 201.57 is to enhance the safe and effective use of prescription drug products by providing health care providers with clear and concise PI that is easier to access, read, and use. The PLR format also makes PI more accessible for use with electronic prescribing tools and other electronic information resources. 

PI submitted with new drug applications (NDAs), biologic license applications (BLAs), and efficacy supplements must conform to the content and format regulations found at 21 CFR 201.56 and 201.57. The Labeling Team works with review divisions to ensure PI conforms with the PLR. This page includes links to the Final Rule, regulations, related guidance documents, and additional labeling resources.  
 

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PLR Final Rule and Labeling Requirements

  • Physican Labeling Rule
    Requirements on content and format of labeling for human prescription drug and biological products, January 24, 2006 (Federal Register Notice)
  • 21 CFR 201.56
    Requirements on content and format of labeling for human prescription drug and biological products
  • 21 CFR 201.57
    PLR Labeling: Specific requirements on content and format of PLR labeling for human prescription drug and biological products described in § 201.56(b)(1)
  • 21 CFR 201.80
    Older drugs: Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1)
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Additional Labeling Resources

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