PLR Requirements for Prescribing Information
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 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, FDA published the Pregnancy and Lactation Labeling Rule (PLLR or Final Rule). The PLLR completed the changes as set forth by the PLR for the content and format of drug labeling.
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)
- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB)
- 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 - 117KB)
- Clinical Studies Section of Labeling (PDF - 127KB)
- Patient Counseling Information Section of Labeling (PDF - 91KB)
- CDER Guidances (Drugs)
Refer to this page for other guidances that contain labeling recommendations and product-specific guidances.
Format Labeling Tools
Selected Requirements of Prescribing Information (SRPI)(PDF - 183KB)
The SRPI is a checklist review of 42 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)
- Sample Tool Illustrating the Format for Highlights and Contents (DOC - 88KB)
Additional Labeling Resources
- Pregnancy and Lactation Labeling Final Rule
FDA published the final rule on providing pregnancy and lactation information for prescription drugs and biological products.
- Established Pharmacologic Class (EPC)
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).
- FDA EPC Text Phrases for Highlights Indications and Usage heading (updated December 17, 2014) (PDF - 605KB)
- Structured Product Labeling (SPL)
SPL is the standard format for electronic submission of the content of labeling.