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 In this section:

        Development & Approval Process (CBER)

Labeling for CBER-Regulated Products

                        
                About the Advertising and Promotional Labeling Branch (APLB)
          Submitting Biologics Advertising & Promotional Labeling
          Compliance Actions on Biologics Advertising & Promotional Labeling
          Proprietary Name Review for Biologic Products
          Regulatory Information about Biologics Advertising & Promotional Labeling Home
          Vaccines, Blood & Biologics
          Development & Approval Process (CBER)
          Labeling for CBER-Regulated ProductsDevelopment & Approval Process (CBER) Labeling for CBER-Regulated Products
  	
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    PrintThe 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 InformationStructured 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 & AsPatient 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 IdentifierPromotional 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 DrugsANDA 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 FormatAdditional Resources

FDA’s Labeling Resources for Human Prescription Drugs
	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 RecommendationsSub-Topic Paragraphs
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	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
			Report a Problem to the Center for Biologics Evaluation & Research
			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      06/07/2022
                  
                   
Regulated Product(s)
		 BiologicsLabeling for CBER-Regulated Products                
                          

                        About the Advertising and Promotional Labeling Branch (APLB)
          Submitting Biologics Advertising & Promotional Labeling
          Compliance Actions on Biologics Advertising & Promotional Labeling
          Proprietary Name Review for Biologic Products
          Regulatory Information about Biologics Advertising & Promotional Labeling
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