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  1. FDA’s Labeling Resources for Human Prescription Drugs

Prescribing Information Resources

For Industry

Who is the Audience for This Webpage?

FDA’s Prescribing Information (PI) resources on this webpage are primarily directed to industry staff who develop PI. For assistance on how to navigate this webpage and the associated FDA labeling resource webpages for human prescription drugs see video. For other prescription drug labeling resources for industry such as those for FDA-approved patient labeling, carton and container labeling, generic drug labeling, biological product labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs. If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines.

FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA’s finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.  The PI is written for the healthcare professional and must:

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

Biologics License Application (BLA) and New Drug Application (NDA) holders should review their Prescribing Information (PI) at least annually for outdated information.  When new information becomes available that causes the PI to become inaccurate, false, or misleading, the BLA and NDA holder must update the PI.  Additionally, when new data or information becomes available that could affect prescribing decisions or the clinical management of patients receiving the drug, BLA and NDA holders submit proposed revised PI (containing the updated data or information) to FDA.  

The Prescribing Information (PI) has two formats: “Physician Labeling Rule” (PLR) format and “old” (non-PLR) format. Given that all new human prescription drugs approved since June 2001 and certain human prescription drugs approved before June 2001 (e.g., those approved for new uses after June 2001) must have PI in PLR format, this webpage focuses on providing resources for the development of PI with PLR format labeling.

We strongly encourage BLA and NDA holders, if applicable, to voluntarily convert Prescribing Information (PI) approved in “old” format to Physician Labeling Rule (PLR) format because we believe that PLR format labeling:

  1. Represents a more useful and modern approach for communicating accurate and up-to-date information on the safe and effective use of drugs,
  2. Reduces the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information, and
  3. Makes PI more accessible for use with electronic prescribing tools and other electronic information resources.  

Key features of PLR-formatted labeling include having a concise summary of critical information (Highlights of Prescribing Information), including a Table of Contents, ordering information according to clinical importance, and including standardized numbered sections and subsections in the Full Prescribing Information.  For recommendations and considerations for converting “old” format PI to PLR format see the 2013 PLR implementation guidance, and a 2017 presentation and video

  • 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
  • 21 CFR 201.80: Specific requirements on content and format of “old” format (non-PLR) labeling for human prescription drugs
  • Geriatric Labeling Rule: Specific requirements on content and format of labeling for human prescription drugs; addition of ‘Geriatric Use’ subsection in the labeling (August 1997).
  • Pediatric Labeling Rule: Specific requirements on content and format of labeling for human prescription drugs; revision of Pediatric Use subsection in the labeling (December 1994).
  • Physician Labeling Rule (PLR): Final rule revised the content and format of Prescribing Information (PI) for human prescription drugs (January 2006)
  • Pregnancy and Lactation Labeling Rule (PLLR): Final rule revised the content and format of pregnancy, lactation, and females and males of reproductive potential information in labeling (December 2014).

FDA Guidances and MAPPs

  • Guidances: FDA guidances that contain recommendations for the Prescribing Information are listed by Prescribing Information section below. For example, guidances that have dosage- and/or administration-related content are included under the heading: “2 Dosage and Administration”. Alternatively, to find these FDA guidances, refer to this page.
  • Manual of Policies and Procedures (MAPPs): Center for Drug Evaluation and Research (CDER) MAPPs that contain directives to CDER staff to document and disseminate Prescribing Information-related policies and procedures are listed by Prescribing Information section below. Alternatively, to find these CDER MAPPs, refer to this page.

Other FDA Guidances with Prescribing Information Content

  • Best Practices in Development Proprietary Names for Human Prescription Drug Products (final guidance)
  • Cross Labeling Oncology Drugs in Combination Regimens (final guidance)
  • Implementing the PLR Content and Format Requirements (final guidance)
  • Medical Product Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers (final guidance)

  • Consider using the enclosed Sample Prescribing Information Template when developing PLR formatted labeling (e.g., PLR-converting “old” format labeling or revising approved PLR format labeling). This sample template does not contain all PLR format and content regulatory requirements or guidance recommendations. Ensure that the PLR formatted labeling meets all regulatory requirements (e.g., 201.56(a) and (d) and 201.57). Refer to the Prescribing Information menu on this webpage for additional resources for development of PLR formatted labeling.
  • Final Labeling Check of Labeling Format and Appearance (2019 presentation and video)
  • Final Labeling Format Check Prior to End-of-Cycle Labeling Submission (2017 presentation)
  • Selected Requirements of Prescribing Information (SRPI): A 41-item, drop-down checklist of important format elements of the Prescribing Information (PI) based on regulations (21 CFR 201.56 and 201.57) and guidances

Prescribing Information

Regulations

Guidance

Presentation


Product Title and Initial U.S. Approval

Guidance

  • Product Title and Initial U.S. Approval in the Highlights of Prescribing Information (draft guidance)

Related Guidance

Examples and Presentations


Established Pharmacologic Class (EPC)

EPC MAPP and Guidance

EPCs for Indications and Usage Heading in Highlights

Regulations

Guidance

  • Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling (final guidance)

Related Guidance and MAPP

  • Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act (final guidance) and (MAPP)

Presentation

Regulations

Guidance

Related Guidances

  • Labeling for Human Prescription Drugs and Biological Products Under the Accelerated Approval Regulatory Pathway (final guidance)
  • Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations (draft guidance)

Presentations

Regulations

Guidance

Related Guidances

  • Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (final guidance)
  • Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” (draft guidance)
  • Liposome Drug Products: CMC; Human PK and Bioavailability; and Labeling Documentation (final guidance)
  • Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations (draft guidance) 
  • Quality Attribute Considerations for Chewable Tablets (final guidance)
  • Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments (draft guidance)

Presentations

  • Dosage and Administration Section (2023 videos part 1 and part 2).
  • Improving Consistency of Information Between Carton-Container Labeling and Prescribing Information (2019 presentation and video)

Regulations

Related Guidances

  • Metered Dose Inhaler and Dry Powder Inhaler Drug Products - Quality Considerations (draft guidance)
  • Naming of Drug Products Containing Salt Drug Substances (final guidance and MAPP)
  • Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (final guidance)
  • Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (final guidance)
  • Transdermal and Topical Delivery Systems - Product Development and Quality Considerations (draft guidance)

Presentations

  • Considerations for Product Quality Information in the Prescribing Information (2017 presentation)
  • Drug Product Nomenclature (2019 presentation and video)
  • Improving Consistency of Information Between Carton-Container Labeling and Prescribing Information (2019 presentation and video)

Regulations

Guidance

  • Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling (final guidance)

Related Guidance and MAPP

  • Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act (final guidance) and (MAPP)

Presentation

Regulations

Guidance

  • Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling (final guidance)

Related Guidances and MAPP

  • Assessment of Pressor Effects of Drugs (draft guidance)
  • Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials (draft guidance).
  • QTc Information in Human Prescription Drug and Biological Product Labeling (draft guidance)
  • Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act (final guidance) and (MAPP)
  • Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations (draft guidance)

Presentations

Regulations

Guidance

Related Guidances and MAPP

  • Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling (draft guidance)
  • Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act (final guidance) and (MAPP)

Presentations

FDA Medical Queries

  • FDA Medical Queries (FMQs) is a standardized approach to group preferred terms.  Grouping related terms in labeling (e.g., common adverse reactions (AR) table in the ADVERSE REACTIONS section) can be useful to include an AR that was not initially apparent when reporting was spread across multiple related individual preferred terms; provide a better estimate of the true magnitude of the AR; and/or exclude adverse events that are unrelated or unlikely related to the drug when analysis of grouped terms does not support determination that the adverse event is an AR (e.g., after grouping terms, there is no difference in the frequency or severity of an AR in the drug and placebo groups).
  • For the FDA Medical Queries (FMQs) and their component terms download the Excel document in the docket.
  • Duke Margolis-FDA September 2022 workshop on advancing premarket safety analytics included a detailed discussion of FMQs and other safety analytic topics. See presentation and video.

Regulations

Guidance

  • Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (draft guidance)

Related Guidances and MAPP

  • M12 Drug Interaction Studies (final guidance):  designing, conducting and interpreting drug interactions studies
  • QTc Information in Human Prescription Drug and Biological Product Labeling (draft guidance)
  • Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act (final guidance) and (MAPP)

Presentations and Additional Resources

See 21 CFR 201.57(c)(9). For information about the Pregnancy, Lactation, Females and Males of Reproductive Potential, Pediatric Use, and Geriatric Use subsections see below.

PLLR Rule and Guidance

  • Pregnancy and Lactation Labeling Rule (PLLR): This final rule revised the content and format of pregnancy, lactation, and females and males of reproductive potential information in labeling (December 2014).
  • Pregnancy, Lactation, and Reproductive Potential:  Labeling for Human Prescription Drug and Biological Products (draft guidance) 

PLLR Implementation Schedule, Presentations, and Related Guidance

Pediatric Labeling Rule and Guidance

  • Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Revision of Pediatric Use Subsection in the Labeling, (21 CFR 201; 59 FR 64240) published December 13, 1994.  (Pediatric Labeling Rule).
  • Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling (final guidance)

Related Guidance

  • Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations (draft guidance)

Presentations and Additional Resources  

Geriatric Labeling Rule and Guidance

  • “Specific Requirements on Content and Format of Labeling for Human Prescription Drugs; Addition of ‘Geriatric Use’ Subsection in the Labeling,” (21 CFR 201; 62 FR 45313) published August 27, 1997. (Geriatric Labeling Rule).
  • Geriatric Information in Human Prescription Drug and Biological Product Labeling (draft guidance) 

Presentation  

  • Geriatric Patients - Promoting Safe and Effective Prescription Drug Use (2020 presentation and video

Regulations

Guidance  

  • Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing (final guidance)

Regulations

Guidance

Presentation and Other Guidance

Regulations

Presentation

  • Overdosage Information in Prescription Drug Labeling (2024 presentation).

Regulations

USP Recommendations

  • <1091>:  Labeling of Inactive ingredients

Related Guidances

  • Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (draft guidance)
  • Gluten in Drug Products and Associated Labeling Recommendations (draft guidance)
  • Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (final guidance)
  • Metered Dose Inhaler and Dry Powder Inhaler Drug Products - Quality Considerations (draft guidance)
  • Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products (draft guidance)
  • Salt Guidance and MAPP:  Naming of Drug Products Containing Salt Drug Substances (final guidance and MAPP)
  • Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations (draft guidance)

Presentations

  • Considerations for Product Quality Information in the Prescribing Information (2017 presentation)
  • Drug Product Nomenclature (2019 presentation and video)
  • Improving Consistency of Information Between Carton-Container Labeling and Prescribing Information (2019 presentation and video)

  • See 21 CFR 201.57(c)(13). For information about the Mechanism of Action, Pharmacodynamics, Pharmacokinetics, Microbiology, Pharmacogenomics, and Immunogenicity subsections see below.

Guidances

Related Guidances

  • Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations (final guidance)
  • Assessment of Pressor Effects of Drugs (draft guidance)
  • M12 Drug Interaction Studies (final guidance):  designing, conducting and interpreting drug interactions studies
  • Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data, Data Analysis, and Impact on Dosing (draft guidance)
  • QTc Information in Human Prescription Drug and Biological Product Labeling (draft guidance)
  • Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments (draft guidance)

Presentations

Guidances

  • Clinical Pharmacology Section of Labeling (final guidance) 
  • Limited Population Pathway for Antibacterial and Antifungal Drugs (final guidance) 
  • Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation (final guidance)
  • Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs (final guidance)

Guidances

  • Clinical Pharmacology Section of Labeling (final guidance) 
  • Clinical Pharmacogenomics:  Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (final guidance)

Guidance

  • Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling (draft guidance

Presentations and Additional Resources

Regulations

Guidance

Related Guidance

  • Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products (draft guidance)

Presentations

Regulations

Related Guidances

  • Child-Resistant Packaging Statements in Drug Product Labeling (final guidance)
  • Metered Dose Inhaler and Dry Powder Inhaler Drug Products - Quality Considerations (draft guidance)
  • Naming of Drug Products Containing Salt Drug Substances (final guidance) and MAPP
  • Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex (final guidance)
  • Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use (final guidance)
  • Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (final guidance)
  • Transdermal and Topical Delivery Systems - Product Development and Quality Considerations (draft guidance)

Presentations

  • Considerations for Product Quality Information in the Prescribing Information (2017 presentation)
  • Drug Product Nomenclature (2019 presentation and video)
  • Improving Consistency of Information Between Carton-Container Labeling and Prescribing Information (2019 presentation and video)

Regulations

Guidance

Presentation

Contact Information

For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.

 

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