2013-09640. Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The draft guidance focuses on safety aspects of the container label and carton labeling design for prescription drug and biological products. The draft guidance provides sponsors of new drug applications (NDAs), biologics licensing applications (BLAs), abbreviated new drug applications (ANDAs), and prescription drugs marketed without an approved NDA or ANDA with a set of principles and recommendations for ensuring that critical elements of product container labels and carton labeling are designed to promote safe dispensing, administration, and use of the product to minimize medication errors.

DATES:

Although you can comment on any guidance at any time (see 21 CFR 10.115(g), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 24, 2013.

ADDRESSES:

Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT:

Carol Holquist, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4416, Silver Spring, MD 20993-0002, 301-796-0171.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” In Title I of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85), Congress reauthorized and expanded the Prescription Drug User Fee Act program for fiscal years (FYs) 2008 through 2012 (PDUFA IV). As part of the performance goals and procedures set forth in an enclosure to the letter from the Secretary of Health and Human Services referred to in section 101(c) of FDAAA, FDA committed to certain performance goals and procedures. (See http://www.fda.gov/​ForIndustry/​UserFees/​PrescriptionDrugUserFee/​ucm119243.htm). In that letter, FDA stated that it would use fees collected under PDUFA to implement various measures to reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose designations, and error-prone label and packaging designs. Among these measures, FDA agreed that by the end of FY 2010, after public consultation with academia, industry, other stakeholders, and the general public, the Agency would publish draft guidance describing practices for naming, labeling, and packaging drugs and biologics to reduce medication errors. On June 24 and 25, 2010, FDA held a public workshop and opened a public docket (Docket No. FDA-2010-N-0168) to receive comments on these measures.

This draft guidance document, which addresses safety achieved through the design of drug product container labels and carton labeling design, is the second in a series of three planned guidance documents to minimize risks contributing to medication errors. The first guidance focuses on minimizing risks with the design of drug product and container closure design (December 13, 2012, 77 FR 74196), and the third guidance will focus on minimizing risks with drug product nomenclature.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the Agency's current thinking on addressing safety achieved through drug product design to minimize medication errors. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

II. Comments

Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), before publication of the final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this draft guidance that are new or that would represent material modifications to previously approved collections of information found in FDA regulations.

IV. Electronic Access

Persons with access to the Internet may obtain the document at http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm,, or http://www.regulations.gov.

Dated: April 18, 2013.

Leslie Kux,

Assistant Commissioner for Policy.