Safety considerations for container labels and carton labeling design to minimize medication errors
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body. Center for Biologics Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, May 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Labeling -- legislation & jurisprudence Medication Errors -- prevention & control Patient Safety United States United States. Department of Health and Human Services United States. Food and Drug Administration
- Genre(s):
- Technical Report
- Abstract:
- 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. This guidance applies to human prescription drug and biological products, including the following: (1) Prescription drug products marketed under an approved new drug application or abbreviated new drug application (2) Prescription drugs marketed without an approved application (3) Biological products marketed under an approved biologics license application In this guidance, all such products are jointly referred to as products, drugs, or drug products unless otherwise specified, and persons responsible for designing product container labels and carton labeling are referred to as sponsors. References to end users include, but are not limited to, the patient; the patient’s caregiver; and the physician, nurse, pharmacist, pharmacy technician, and other individuals who are involved in the routine procurement, stocking, storage, selection, dispensing, preparation, and/or administration of prescription medications (e.g., medication technicians). Although this guidance does not apply to over-the-counter drug products, compounded products, marketed prescription products used in clinical or bioequivalence studies, or investigational products, the principles outlined in this guidance may still be useful for such products. The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 37 pages)).
- NLM Unique ID:
- 9918470189006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918470189006676