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Prescription Drug Labeling Resources

FDA's Prescription Drug Labeling Resources website provides over 150 labeling resources for the Prescribing Information, FDA-approved patient labeling, and/or carton and container labeling for human prescription drugs, including biological products (including over 50 guidances with labeling content) - see Overview of Website.

Highlights of Prescribing Information: Format Sample

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Table of Contents

Overview of Website

FDA’s Prescription Drug Labeling Resources website [formerly known as the PLR Requirements for Prescribing Information website] provides resources for the development of human prescription drug, including biological product, labeling regulated under New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs).

  • 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 drugs, including biological products, approved since June 2001 and certain new human prescription drugs, including 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 drugs, including 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, Medication Guides, and Patient Information) and carton and container labeling.  Not every resource will be applicable to every prescription drug or biological product.    

This website does not include:

  • Promotional labeling resources for human prescription drugs, including biological products.
  • Labeling resources for other FDA-regulated products such as nonprescription drug products ("over-the-counter" drugs), 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.

Prescribing Information Requirements and Rules

  • Physician Labeling Rule: This January 2006 final rule revised the content and format of PI for human prescription drugs, including 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 drugs, including 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 drugs, including biological products

Prescribing Information Guidances

(this list is not comprehensive - please see additional labeling guidances on this webpage)

Presentations – Sections of the Prescribing Information

Presentations – Broad Labeling Content

Safety-Related Labeling Resources

Pregnancy, Lactation, and Females and Males of Reproductive Potential Labeling Resources

Sample Templates and Format Tools for Prescribing Information

Established Pharmacologic Class (EPC) Resources

Generic Drug Products -Specific Labeling Resources

Biological Product-Specific Labeling Resources

Product Quality-Related Labeling Resources

Carton and Container Labeling Specific Resources

Patient Labeling Specific Resources

Structured Product Labeling Resources

Labeling Databases

  • Drugs@FDA - includes information about drugs, including biological products, approved for human use in the United States (e.g., product information, regulatory history, most recent FDA-approved Prescribing Information and patient labeling, and reviews by FDA staff that evaluate the safety and effectiveness of the product). Drugs@FDA does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research or products not approved by the FDA.
  • DailyMed - NIH’s labeling search tool over 110,000 labeling documents for prescription drugs (including biological products, vaccines, blood products, cellular and gene therapy products), over-the-counter drugs, homeopathic drugs, animal drugs, and other products.
  • FDALabel - FDA’s labeling search tool over 110,000 labeling documents. FDALabel and DailyMed have the same database but have different search functions and different displays of search results.
  • Pediatric Labeling Information Database - highlights important labeling changes related to pediatric use.
  • Drug Safety Labeling Changes Database - provides recent updates on safety information in labeling.
  • National Drug Code (NDC) Directory – search for NDC codes
  • CDER’s Novel Drugs and Biological Products
  • CBER’s Novel Biological Products

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
  • Balogh EP, Bindman AB, Eckhardt SG, Halabi S, Harvey RD, Jaiyesimi I, Miksad R, Moses HL, Nass SJ, Schilsky RL, Sun S, Torrente JM, and Warren KE. (2019). Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs. The Oncologist, 24:1–7. doi: 10.1634/theoncologist.2019-0698.
  • Guinn, D., Madabushi, R., Wang, Y., Brodsky, E., Zineh, I., and Maxfield, K. Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation. Ther Innov Regul Sci (2020). https://doi.org/10.1007/s43441-020-00161-z

Questions
For general questions about the Prescribing Information or this website see the Labeling Policy Team webpage and for specific questions about labeling under an NDA, BLA, or ANDA please contact the regulatory project manager assigned to the application. 

 

 

 

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