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PLR Requirements for Prescribing Information

PLR Requirements for Prescribing Information

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2019 CDER Prescription Drug Labeling Conference
The Center for Drug Evaluation and Research (CDER) at the FDA is having the third biennial CDER Prescription Drug Labeling Conference on December 4th and 5th, 2019.  This conference is part of Small Business & Industry Assistance’s Regulatory Education for Industry (REdI).  Topics will include updates regarding the Prescribing Information, FDA-approved patient labeling, and carton/container labeling. See the agenda and videos from the last CDER Prescription Drug Labeling Conference.   

Participation is free.  You can attend in person at the “The HOTEL” at the University of Maryland in College Park, Maryland or online.  Check the SBIA website for future registration. 

Overview of Website  
FDA’s PLR Requirements for Prescribing Information website provides resources for the development of human prescription drug and biological product labeling regulated under New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications. 

  • Labeling for such products includes but is not limited to:  
    • Prescribing Information (PI)
    • FDA-approved patient labeling [Medication Guides, Instructions for Use, and Patient Information (also called Patient Package Inserts)], and
    • Carton and container labeling. 
  • The PI has two formats: “Physician Labeling Rule” (PLR) format and “old” (non-PLR) format). Given that all new human prescription drug and biological products approved since June 2001 and certain new human prescription drug and biological products approved before June 2001 (e.g., those approved for new uses after June 2001) must have PI in PLR format, this website focuses on providing resources for the development of PI with PLR format labeling.
  • We strongly encourage application holders to voluntarily convert PI approved in “old” format to PLR format because we believe that PLR format labeling enhances the safe and effective use of human prescription drug and biological products and reduces the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information. 

This website includes the following PI resources:  labeling regulations, guidances, presentations, templates, format tools, databases, and additional labeling resources.  This website also includes resources for FDA-approved patient labeling (Instructions for Use and Medication Guides) and carton and container labeling.  For general questions about the PI or this website see the Labeling Development Team webpage and for specific questions about labeling under an NDA, BLA, or ANDA please contact the regulatory project manager assigned to the application.    

This website does not include labeling resources for other FDA-regulated products such as nonprescription drug products, devices, homeopathic products, dietary supplements, foods, tobacco, or animal drugs.

Prescribing Information and Application Holder Responsibilities
The Prescribing Information is written for the healthcare practitioner and must:

  • Contain a summary of essential scientific information needed for safe and effective use of the human prescription drug or biological product.
  • Be informative and accurate and neither promotional in tone nor false or misleading
  • Be updated when new information becomes available that causes labeling to become inaccurate, false, or misleading

Application holders should review PI at least annually for outdated information and must update PI when new information becomes available that causes the PI to become inaccurate, false, or misleading.

Labeling Requirements and Rules

  • Physician Labeling Rule: This January 2006 final rule revised the content and format of PI for human prescription drug and biological products.
  • 21 CFR 201.56: General requirements on the content and format of PLR format labeling and “old” format (non-PLR) labeling
  • 21 CFR 201.57: Specific requirements on content and format of PLR format labeling for human prescription drug and biological products
  • Pregnancy and Lactation Labeling Rule: This December 2014 final rule revised the content and format of pregnancy, lactation, and females and males of reproductive potential information in labeling
  • 21 CFR 201.80: Specific requirements on content and format of “old” format (non-PLR) labeling for human prescription drug and biological products

Prescribing Information Guidances

Presentations – Labeling Sections

Presentations – Broad Labeling Content

Sample Templates and Format Labeling Tools

Product Quality-Related Labeling Resources and Carton/Container Labeling Resources

Established Pharmacologic Class (EPC) Resources

ANDA Labeling Resources

Biological Product Labeling Resources

Patient Labeling Resources

Labeling Databases

Additional Labeling Resources

Articles with Labeling Content

  • Gassman, A. L, Nguyen, C. P., and Joffe, H. V. (2017). FDA Regulation of Prescription Drugs. The New England Journal of Medicine, 376: 674-82. doi: 10.1056/NEJMra1602972