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                FDA’s Labeling Resources for Human Prescription Drugs

FDA’s Labeling Resources for Human Prescription Drugs

                        Prescribing Information Resources
          Patient Labeling Resources
          Carton and Container Labeling Resources
          Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
          Generic Drugs - Specific Labeling Resources
          Biological Products - Specific Labeling Resources
          Frequently Asked Questions about Labeling for Prescription Medicines
          Prescription Drug Labeling Contact Information Home
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          FDA’s Labeling Resources for Human Prescription Drugs
          Prescribing Information ResourcesFDA’s Labeling Resources for Human Prescription Drugs Prescribing Information Resources
  
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    PrintWho 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.

What is the Prescribing Information?
	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:

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

When Should Prescribing Information Be Updated?
	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.

What Are the Formats for the Prescribing Information?
	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.

What Are the Advantages of PLR Format?
	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:

Represents a more useful and modern approach for communicating accurate and up-to-date information on the safe and effective use of drugs,
	Reduces the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information, and
	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.

Prescribing Information Regulations
	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
	Physician Labeling Rule (PLR): Final rule revised the content and format of Prescribing Information (PI) for human prescription drugs (January 2006)

Prescribing Information Guidances and MAPPs
	**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 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)

Format Tools and Sample Templates
	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

General Labeling Presentations
	CDER’s Review of Prescribing Information (PI) (2017 presentation) and (2019 presentation)
	Consistency and Methods to Optimize Communication in Labeling (2017 presentation)
	Improving Consistency of Information Between Carton-Container Labeling and PI (2019 presentation and video)
	PLR Implementation and CDER Staff for Labeling Review (2017 presentation and video)
	PI Potpourri (2015 presentation)
	PI Topics Including Labeling Review Process (2016 presentation)
	Prescription Drug Labeling (April 2022 presentation)
	Prescription Drug Labeling Updates (June 2022 presentation)
	Voluntary PLR Conversions and Updating PI (2019 presentation and video)

Publications
	Ashraf, Adrita; Brodsky, Eric; Burkhart, Keith. Use of Natural Language Processing Text-Mining to Identify Differences in the OVERDOSAGE Section of Drug Labeling. https://www.fda.gov/media/148926/download
	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. https://theoncologist.onlinelibrary.wiley.com/doi/10.1634/theoncologist.2019-0698
	Borders-Hemphill V, et al.  Use of Proprietary Names by Prescribers for Generic Products, Ther Innov Regul Sci. 2018;52(2):256-260.  Available at https://pubmed.ncbi.nlm.nih.gov/29714516/.
	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. https://www.nejm.org/doi/10.1056/NEJMra1602972
	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
	Kluetz PG, Keegan P, Demetri GD, Thornton K, Sul J, Kim J, Katzen H, Burke LB, Harvey RD, Alebachew E, Agrawal S, Nair A, Donoghue M, Pierce WF, Shord SS, Gao JJ, Pazdur R. FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs. Clin Cancer Res. 2021 Feb 15;27(4):916-921. doi: 10.1158/1078-0432.CCR-20-3213. Epub 2020 Nov 30. PMID: 33257426. https://clincancerres.aacrjournals.org/content/clincanres/27/4/916.full.pdf
	Harrison, N. R., Sheehan, S M., Tran, M. T., Herndon, J, Brodsky, E. and Grillo, J.A. Enhancing the Accessibility and Utility of Drug Interaction Information in Prescription Drug Labeling.  Duke Margolis Workshop Summary, December 2021. Available at https://healthpolicy.duke.edu/publications/enhancing-accessibility-and-utility-drug-interaction-information-prescription-drug
	Merchant L, Lutter R, Chang S, Identical or similar brand names used in different countries for medications with different active ingredients: a descriptive analysis. BMJ Qual Saf, April 2020. Available at https://pubmed.ncbi.nlm.nih.gov/32341076/.
	Sullivan, H.W., Squire, C., Aikin, K.J., Tzeng, J., Ferriola-Bruckenstein, K., Brodsky, E., Trentacosti, A.M., & Johnson, M. (in press). Physicians' use of and preferences for FDA-approved prescribing information. Research in Social and Administrative Pharmacy. Available at https://www.sciencedirect.com/science/article/pii/S1551741121002862?via%3Dihub
	Tran, MT, Grillo JA. Translation of drug interaction knowledge to actionable labeling. Clin. Pharmacol. Ther. 105, 1292– 1295 (2019) https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.1427?af=R

Prescribing Information

Highlights of Prescribing Information
	Guidance

Implementing the PLR Content and Format Requirements (final guidance)Presentation

Highlights of Prescribing Information (2015 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

Naming of Drug Products Containing Salt Drug Substances (final guidance and MAPP)Examples and Presentations

Considerations for Product Quality Information in the Prescribing Information (2017 presentation)
	Example Product Titles in Highlights
	Product Title and Initial U.S. Approval in the Highlights (2019 presentation and video)Established Pharmacologic Class (EPC)

EPC MAPP and Guidance

Determining the EPC for Use in Highlights MAPP and GuidanceEPCs for Indications and Usage Heading in Highlights

FDA EPC Text Phrases for Indications and Usage Heading in Highlights (December 2023)

Boxed Warning
	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

Safety-Related Information in the Prescribing Information (2015 presentation)

1 Indications and Usage
	Guidance

Indications and Usage Section of Labeling (draft 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

Considerations for Developing Indications and Usage Section (2017 presentation and video) and (2015 presentation)
	Indications and Usage Section of Labeling (2019 presentation and video)
	Labeling Case Study - Transformation of an Indication (2019 presentation and video)

2 Dosage and Administration
	Guidance

Dosage and Administration Section of Labeling (draft 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)

3 Dosage Forms and Strengths
	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)

4 Contraindictions
	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

Safety-Related Information in the Prescribing Information (2015 presentation)

5 Warnings and Precautions
	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

Describing Clinically Significant Drug Interactions in the Warnings and Precautions Section (2015 presentation)
	Safety-Related Information in the Prescribing Information (2015 presentation)

6 Adverse Reactions
	Guidance

Adverse Reactions Section of Labeling (final 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

Adverse Reaction Information in Labeling (2019 presentation and video)
	Including Grouped Term Information in the Adverse Reactions Section (2022 presentation)
	Safety-Related Information in the Prescribing Information (2015 presentation)FDA Medical Queries

For the FDA Medical Queries (FMQs) and their component terms see the docket.

7 Drug Interactions
	Related Guidances and MAPP

Clinical Drug Interactions Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (final 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)Presentations and Additional Resources

Clinical Pharmacology Information in Labeling (2017 presentation) and (2019 presentation and video)
	Describing Clinically Significant Drug Interactions in the Warnings and Precautions Section (2015 presentation)
	Drug Interactions Information in Labeling  (2020 presentation and video)
	FDA’s examples of drugs that interact with CYP enzymes and transporter systems

8 Use in Specific Populations
	For information about the Pregnancy, Lactation, Females and Males of Reproductive Potential, Pediatric Use, and Geriatric Use subsections see below.

8.1 Pregnancy, 8.2 Lactation, and 8.3 Females and Males Reproductive Potential
	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

Oncology Pharmaceuticals:  Reproductive Toxicology Testing and Labeling Recommendations (final guidance)
	PLLR Implementation Schedule
	PLLR:  Four Years In – What’s Next? (2019 presentation); PLLR:  Two Years In – Incorporating Human Pregnancy Data in the Prescribing Information (2017 presentation); and PLLR (2016 presentation)
	Supplementary PLLR Resources: Additional resources for including pregnancy, lactation, and females and males of reproductive potential information in the Prescribing Information.

8.4 Pediatric Use
	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

Pediatric Information in Labeling (2019 presentation and video)
	Summary of Pediatric Labeling Changes (see webpage).

8.5 Geriatric Use
	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)

9 Drug Abuse and Dependence
	Guidance

Drug Abuse and Dependence Section of Labeling (draft guidance)Presentation and Other Guidance

Abuse-Deterrent Opioids – Evaluation and Labeling (final guidance)
	Drug Abuse and Dependence Section of Labeling (2019 presentation and video)

10 Overdosage
	See 21 CFR 201.57(c)(11) for the OVERDOSAGE section of labeling regulations.

11 Description
	USP Recommendations

<1091>:  Labeling of Inactive ingredientsRelated Guidances

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)

12 Clinical Pharmacology
	For information about the Mechanism of Action, Pharmacodynamics, Pharmacokinetics, Microbiology, Pharmacogenomics, and Immunogenicity subsections see below.

12.1 Mechanism of Action, 12.2 Pharmacodynamics, and 12.3 Pharmacokinetics
	Guidances

Clinical Pharmacology Section of Labeling (final guidance)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)
	Clinical Drug Interactions Studies – Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions (final guidance)
	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

Clinical Pharmacology Information in Labeling (2017 presentation) and (2019 presentation and video)
	Clinical Pharmacology Section of Labeling Guidance Webinar (2017 webinar)
	Clinical Pharmacology Section of Labeling (2017 presentation and video)
	Drug Interaction Information in Labeling (2020 presentation and video)

12.4 Microbiology
	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)

12.5 Pharmacogenomics
	Guidances

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

12.6 Immunogenicity
	Guidance

Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling (draft guidance)Presentations and Additional Resources

Immunogenicity Information in Labeling (presentation and video)
	US Food & Drug Administration Perspective on Immunogenicity (presentation)
	Immunogenicity Analyses

13 Nonclinical Toxicology
	See 21 CFR 201.57(c)(14) for the NONCLINICAL TOXICOLOGY section of labeling regulations.

14 Clinical Studies
	Guidance

Clinical Studies Section of Labeling (final guidance)Presentations

Considerations for the Clinical Studies Section (2017 presentation) and (2015 presentation)

15 References
	See 21 CFR 201.57(c)(16) for the REFERENCES section of labeling regulations.

16 How Supplied/Storage and Handling
	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)

17 Patient Counseling Information
	Patient Counseling Information

Guidance

Patient Counseling Information Section of Labeling (final guidance)Presentation

Patient Counseling Information Section of Labeling (2015 presentation)

Contact Information

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

                                                                                  Content current as of:
      11/30/2023FDA’s Labeling Resources for Human Prescription Drugs

          
                        Prescribing Information Resources
          Patient Labeling Resources
          Carton and Container Labeling Resources
          Selection of Appropriate SPL Codes for Human Prescription Drug Labeling
          Generic Drugs - Specific Labeling Resources
          Biological Products - Specific Labeling Resources
          Frequently Asked Questions about Labeling for Prescription Medicines
          Prescription Drug Labeling Contact Information
 
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