Description
The purpose of this guidance is to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products. This guidance focuses on safety aspects of the application holder’s container label and carton labeling design. It provides a set of principles and recommendations for ensuring that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration, and use of the product.
Scope & Applicability
Product Classes
10guidance applies to drugs regulated under section 505
Products that are converted to the active moiety after administration.
The container closure system of a sterile preparation for parenteral use that contains many single doses
Transdermal and topical systems should include an identifying label on the backing membrane
For injectable drugs for parenteral administration, the inclusion of the package type term is important
Must bear labels denoting status as a drug sample.
Sterile preparations for dispensing single doses to many patients in a pharmacy admixture program.
Parenteral drug products intended for intravenous infusion; Container labels should be devoid of clutter to mitigate confusion and errors.
Drugs subject to the Controlled Substances Act requiring schedule display
requires specific cautionary statements and red bold font
Stakeholders
3Entity responsible for submitting applications under section 524B
Entity responsible for the approved NDA or ANDA; entity responsible for risk assessment
Target audience for recommendations on assessment of overall survival
Regulatory Context
Attributes
10Special consideration for product names to minimize errors
Content recommendation for patient labeling
indicating the package is not child-resistant
inclusion of the package type term on container labels and carton labeling
Recommended against on large-volume injection labels unless required by USP.
Required information on unit dose blister cell labels
BUD is restricted to the last time point at which the data remained within specifications
Required element on the principal display panel
established name for drug products should be displayed with the finished dosage form
Visual branding used to distinguish products which must not compromise legibility.
Identified Hazards
Hazards
7Design risk that can lead to medication errors
reuse of insulin pens on multiple patients can result in exposure to bloodborne pathogens
risk associated with NMBAs
wrong strength can be selected or the wrong dose administered
wrong strength can be selected or the wrong dose administered
Risks resulting from misinterpreted abbreviations, poor legibility, or look-alike packaging.
safety considerations to minimize medication errors; minimize medication errors through label design
Related CFR Sections (16)
- 21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
- 21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
- 21CFR314.3§ 314.3 Definitions.
(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .Read full regulation →
- 21CFR203.38§ 203.38 Sample lot or control numbers; labeling of sample units.
(a) Lot or control number required on drug sample labeling and sample unit label. The manufacturer or authorized distributor of record of a drug sample shall include on the label of the sample unit and on the outside container or packaging of the sample unit, if any, an identifying lot or control nuRead full regulation →
- 21CFR201.17§ 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration dating of drug products required by § 211.137 of this chapter , it shall appear on the immediate container and also the outer package, if any, unless it is easily legible through such outer package. However, when single-dose containers Read full regulation →
- 21CFR201.18§ 201.18 Drugs; significance of control numbers.
The lot number on the label of a drug should be capable of yielding the complete manufacturing history of the package. An incorrect lot number may be regarded as causing the article to be misbranded.Read full regulation →
- 21CFR201.25§ 201.25 Bar code label requirements.
(a) Who is subject to these bar code requirements? Manufacturers, repackers, relabelers, and private label distributors of a human prescription drug product or an over-the-counter (OTC) drug product that is regulated under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act areRead full regulation →
- 21CFR1302.04§ 1302.04 Location and size of symbol on label and labeling.
The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall be clear and large enough to afford easy identification of the scheduRead full regulation →
- 21CFR1302.03§ 1302.03 Symbol required; exceptions.
(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to § 1308.31 of this chapter ) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial contRead full regulation →
- 21CFR207.37§ 207.37 What restrictions pertain to the use of the NDC?
(a) A product may be deemed to be misbranded if an NDC is used:Read full regulation →
- 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.
(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →
- 21CFR610.61§ 610.61 Package label.
The following items shall appear on the label affixed to each package containing a product:Read full regulation →
- 21CFR610.60§ 610.60 Container label.
(a) Full label. The following items shall appear on the label affixed to each container of a product capable of bearing a full label:Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR206.10§ 206.10 Code imprint required.
(a) Unless exempted under § 206.7 , no drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identRead full regulation →
- 21CFR201.15§ 201.15 Drugs; prominence of required label statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →
Related Warning Letters (10)
- 2025-12-23
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded
Darmerica, LLC
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Supergoop!
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
K & Care Organics
- 2025-08-12
OTC/Unapproved New Drug/Misbranded
Fallien Cosmeceuticals Ltd. dba Fallene Ltd.
- 2025-05-27
Failure to List/Misbranded
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
- 2025-04-29
Electronic Drug Registration and Listing System (eDRLS)/Violations
Prodose, Inc. formerly known as Spirit Pharmaceuticals LLC
- 2025-02-18
CGMP/Finished Pharmaceutical/Adulterated
Jagsonpal Pharmaceuticals Limited
- 2024-10-22
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
Omni Lens Pvt. Ltd.
- 2024-08-20
Failure to Register and List
Media Networks Sydney Pty Limited
- 2024-04-23
Failure to Register and List
Zen Enterprises LLC
See Also (8)
- CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms (Status: Final)
- Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation: Guidance for Industry (Status: Final)
- Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (Status: Draft)
- Nonproprietary Naming of Biological Products Guidance for Industry (Status: Final)
- Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling-Final (Status: Final)
- Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry (Status: Draft)
- Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry (Status: Draft)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)