On January 24, 2006, the U.S. Food and Drug Administration (FDA) issued final regulations governing the content and format of prescribing information (PI) for human drug and biological products. The rule is commonly referred to as the “Physician Labeling Rule” (PLR) because it addresses prescription drug labeling that is used by prescribers and other health care providers.
The goal of the PLR content and format requirements as described at 21 CFR 201.56 and 201.57 is to enhance the safe and effective use of prescription drug products by providing health care providers with clear and concise PI that is easier to access, read, and use. The PLR format also makes PI more accessible for use with electronic prescribing tools and other electronic information resources.
PI submitted with new drug applications (NDAs), biologic license applications (BLAs), and efficacy supplements must conform to the content and format regulations found at 21 CFR 201.56 and 201.57. The Labeling Development Team works with review divisions to ensure PI conforms with the PLR. This page includes links to the Final Rule, regulations, related guidance documents, and additional labeling resources.
On December 3, 2014, the FDA published the Pregnancy and Lactation Labeling Rule (PLLR). The goal of the PLLR is to enhance the safe and effective use of prescription drug products in pregnant women, lactating women, and females and males of reproductive potential.
PLR Final Rule and Labeling Requirements
- Physician Labeling Rule
Requirements on content and format of labeling for human prescription drug and biological products, January 24, 2006 (Federal Register Notice)
- 21 CFR 201.56
Requirements on content and format of labeling for human prescription drug and biological products
- 21 CFR 201.57
PLR Labeling: Specific requirements on content and format of PLR labeling for human prescription drug and biological products described in § 201.56(b)(1)
- 21 CFR 201.80
Older drugs: Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1)
- Implementing the PLR Content and Format Requirements (PDF - 527KB)
- Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway (draft) (PDF - 169KB)
- Dosage and Administration Section of Labeling (PDF - 163KB)
- Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling (PDF - 102KB)
- Adverse Reactions Section of Labeling (PDF - 52KB)
- Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (draft) (PDF - 827KB)
- Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format (draft) (PDF - 208KB)
- Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling (draft) (PDF - 115KB)
- Clinical Pharmacology Section of Labeling (draft) (PDF - 144KB)
- Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling (draft) (PDF - 319KB)
- Clinical Studies Section of Labeling (PDF - 127KB)
- Patient Counseling Information Section of Labeling (PDF - 91KB)
- Labeling for Biosimilar Products (draft) (PDF - 143KB)
- Updating ANDA Labeling After the Marketing Application for the RLD Has Been Withdrawn (draft) (PDF - 94KB)
- CDER Guidances (Drugs)
Refer to this page for other guidances that contain labeling recommendations and product-specific guidances.
- Professional Labeling: The Prescribing Information
Prescribing Information – Resources and Review Process(PDF - 1.5MB)
- Highlights of Prescribing Information (PDF - 2.7MB)
- Indications and Usage Section (PDF - 1.7MB)
- Dosage and Administration Section (PDF - 2.3MB)
- Safety-Related Information in the Prescribing Information (PDF - 3.7MB)
Clinical Pharmacology Information in Labeling - Enhancing Quality, Utility, and Clarity(PDF - 4MB)
- Distributing Specific Population Information in Labeling (PDF - 809KB)
- Clinical Studies Section (PDF - 1.2MB)
- Patient Counseling Information Section (PDF - 1.2MB)
- Prescribing Information Potpourri (PDF - 1.7MB)
Sample Templates and Format Labeling Tools
- Sample PLR Template – Highlights, Contents, and Full Prescribing Information (DOCX - 80KB)
Sample tool for developing the Highlights, Contents, and the Full Prescribing Information that includes sections, subsections, headings, and subheadings.
Selected Requirements of Prescribing Information (SRPI)(PDF - 754KB)
The SRPI is a checklist review of 41 important format items from labeling regulations and guidances. The following two video presentations provide SRPI examples for items in the (1) Highlights, and (2) Table of Contents and Full Prescribing Information:
SRPI Review of Highlights(PDF - 10.9MB) SRPI Review of Table of Contents and Full Prescribing Information(PDF - 9.8MB)
Established Pharmacologic Class (EPC) Resources
- Determining the EPC for Use in Highlights MAPP (PDF - 147KB)
- Determining the EPC for Use in Highlights Guidance (PDF - 65KB)
FDA EPC Text Phrases for Indications and Usage heading in Highlights (updated August 2016)(PDF - 204KB)
Search for EPC of approved drugs (EPCs are terms or phrases associated with an approved indication of an active moiety, which FDA has determined to be scientifically valid and clinically meaningful).
Additional Labeling Resources
- Pregnancy and Lactation Labeling Final Rule
FDA published the final rule on providing information for the use of prescription drugs and biological products during pregnancy, during lactation, and in females and males of reproductive potential.
Structured Product Labeling Resources
SPL is the standard format for electronic submission of the content of labeling.