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Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

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Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Guidance for Industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov/. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CDER), Office of Surveillance and Epidemiology, Division of Medication Error Prevention and Analysis, Carol Holquist at 301- 796-0171. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) April 2013 Drug Safety Guidance for Industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 [email protected] http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research April 2013 Drug Safety Table of Contents I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 III. GENERAL CONSIDERATIONS ................................................................................... 3 A. Poor Design of Product Container Labels and Carton Labeling Can Obscure Critical Safety Information.............................................................................................. 3 B. Risk Assessment During the Design Stage Can Reduce the Risk of Medication Errors................................................................................................................................. 4 C. Critical Product Information Should Appear on the Principal Display Panel ........... 4 D. Labels Should be Legible, Readable, and Easy to Understand .................................... 4 1. Container Label Size..................................................................................................... 5 2. Text Size and Style ........................................................................................................ 5 3. Contrast of Text and Background Color....................................................................... 6 4. Information Crowding and Visual Clutter.................................................................... 6 5. Dangerous Abbreviations, Acronyms, and Symbols..................................................... 7 E. Avoid Look-alike Container Labels and Carton Labeling ........................................... 7 1. Corporate Trade Dress................................................................................................. 7 2. Use of Color.................................................................................................................. 8 IV. SPECIAL CONSIDERATIONS AND RECOMMENDATIONS ................................ 9 A. Proprietary, Established, and Proper Names................................................................. 9 B. Product Strength............................................................................................................. 10 1. Strength Differentiation .............................................................................................. 10 2. Strength Designation .................................................................................................. 10 3. Small Volume Parenteral Products ............................................................................ 10 4. Expression of Strength for Dry Powder Products ...................................................... 11 5. Salt Nomenclature....................................................................................................... 11 6. Prodrugs ..................................................................................................................... 12 7. Metric Measurements.................................................................................................. 12 8. Location of Net Quantity Statements .......................................................................... 12 9. Leading and Terminal Zeros, Decimals, and Commas .............................................. 12 C. Route(s) of Administration............................................................................................. 13 D. Warnings for Critical Information................................................................................ 13 E. Expiration Dates.............................................................................................................. 13 F. Bar Codes......................................................................................................................... 13 G. National Drug Code Numbers ....................................................................................... 14 i H. Controlled Substance Schedule ..................................................................................... 15 V. OTHER SPECIAL CONTAINER LABEL AND CARTON LABELING CONSIDERATIONS ...................................................................................................... 15 A. Unit Dose Blister Pack Presentations............................................................................ 15 1. Blister Cell Label ........................................................................................................ 15 2. Product Strength ......................................................................................................... 15 3. Blister Cell Label Material and Readability............................................................... 16 4. Blister Pack Label Design .......................................................................................... 16 B. Labeling of Ferrules and Cap Overseals ...................................................................... 17 C. Color Closure System for Concentrated Potassium Chloride .................................... 17 D. Labels for Large Volume Parenterals........................................................................... 17 E. Transferable or Peel-Off Labels for Injectable Medications...................................... 19 F. Double-sided Labels and Labeling ................................................................................ 19 G. Pharmacy Bulk Packages............................................................................................... 19 H. Communication of Important Product Changes ......................................................... 19 I. Dosing Devices................................................................................................................. 19 J. Product Samples.............................................................................................................. 20 K. Package Type................................................................................................................... 20 L. Quick Response Code ..................................................................................................... 20 GLOSSARY................................................................................................................................. 23 ii Contains Nonbinding Recommendations Draft – Not for Implementation 1 1 Guidance for Industry 2 3 Safety Considerations for Container Labels and Carton Labeling 4 Design to Minimize Medication Errors 5 6 7 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current 8 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to 9 bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of 10 the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 11 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 12 the appropriate number listed on the title page of this guidance. 13 14 15 16 I. INTRODUCTION 17 18 The purpose of this guidance is to help prescription drug and biologic product manufacturers 19 minimize medication errors2 associated with their products. This guidance focuses on safety 20 aspects of the container label3 and carton labeling design, and provides a set of principles and 21 recommendations for ensuring that critical elements of a product’s container labels and carton 22 labeling are designed to promote safe dispensing, administration, and use of the product. 23 24 This guidance applies to prescription drug and CDER-regulated biological products, including 25 the following: 26 27 Prescription drug products marketed under an approved new drug application (NDA)
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