The Federal Food, Drug, and Cosmetic Act authorizes FDA to require that prescription drug labeling provides healthcare professionals and patients with adequate information to permit safe and effective use of drug products. The Public Health Service Act provides legal authority for the agency to regulate the labeling and shipment of biological products. Labeling is reviewed as part of a Biologics License Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), their respective supplements, annual reports, and promotional material. For the most current guidance, refer to Search for FDA Guidance Documents.

This website does not include labeling resources for Medical Devices.

Prescribing Information

• Physician Labeling Rule – Final Rule (71 FR 3922, January 24, 2006)
• Title 21→ Chapter I → Subchapter C → Part 201 →LABELING
• Pregnancy and Lactation Labeling (Drugs) Final Rule
• Guidance Documents
  • Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling
  • Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
  • Clinical Lactation Studies: Considerations for Study Design
  • Labeling for Human Prescription Drug and Biological Products - Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information Good Review Practice
  • Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements
  • Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
  • Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format
  • Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products - Content and Format
  • Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway
  • Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling
  • FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information

Structured Product Labeling (SPL)

• Structured Product Labeling Resources
• Electronic Drug Registration and Listing Instructions
• Section Headings (LOINC)
• Guidance Documents
  • Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
  • Providing Regulatory Submissions in Electronic Format - Standardized Study Data
  • SPL Standard for Content of Labeling Technical Qs & As

Patient Labeling

•  Medication Guides (MG)
  • Risk Evaluation and Mitigation Strategies (REMS)
    • REMS is a strategy for managing the risks associated with drug use. Medication Guide is an integral component of the REMS.
• Patient Package Inserts (PPI)
  • PPIs are voluntary for prescription drug products except for oral contraceptives and estrogen-containing products
• Guidance Documents
  • Providing Regulatory Submissions in Electronic Format - Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling
  • Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products – Content and Format
  • Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

Package and Carton/Container Labeling

• 21 CFR PART 610 Subpart G - Labeling Standards (21 CFR 610.60-610.67)
• 21 CFR PART 201 Subpart A - 201.25 Bar code label requirements
• 21 CFR PART 207 Subpart C - National Drug Code
• National Drug Code Directory
• Drug Supply Chain Security Act (DSCSA)
• Bar Code Label Requirements
• Guidance Documents
  • Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
  • Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy
  • Product Identifiers Under the Drug Supply Chain Security Act - Questions and Answers
  • Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Promotional Materials

• About the Advertising and Promotional Labeling Branch (APLB)
• Guidance Documents
  • Contents of a Complete Submission for the Evaluation of Proprietary Names
  • Best Practices in Developing Proprietary Names for Human Prescription Drug Products
  • Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers
  • Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs

ANDA Labeling Resources

• Abbreviated New Drug Application (ANDA)
• GDUFA Guidances and MAPPS
• Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
• Guidance Document
  • ANDA Submissions – Content and Format

Additional Resources

• Prescription Drug Labeling Resources
• 21 CFR PART 201 Labeling Subpart A - General Labeling Provisions
• Pediatric Research Equity Act (PREA)
• Purple Book
  The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products.
  The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).
• Drugs@FDA
  Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQs), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (see Biologics Products & Establishments). for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products). For prescription brand-name drugs, Drugs@FDA typically includes the most recent labeling approved by the FDA (for example, Prescribing Information and FDA-approved patient labeling when available), regulatory information, and FDA staff reviews that evaluate the safety and effectiveness of the drug.
• FDALabel
  Web-based application to search labeling documents of FDA-approved drug products.
• DailyMed
  DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.
• FDA Online Label Repository
  The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA).
• Guidance Documents
  • Nonproprietary Naming of Biological Products
  • The "Deemed To Be a License" Provision of the BPCI Act: Questions and Answers
  • Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format
  • 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
  • Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex
  • Child-Resistant Packaging Statements in Drug Product Labeling
  • Gluten in Drug Products and Associated Labeling Recommendations