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FDA Reviewing Labeling Content and Format Requirements for Drug and Biological Products

Wednesday, January 21, 2015
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is inviting through March 23 comments on the proposed extension of the information collection provisions of its labeling content and format requirements for human prescription drug and biological products.

Currently, FDA regulations require that prescription drug labeling contain certain information in one of two formats, depending on when the drug was approved for marketing. 21 CFR 201.56(a) sets forth general labeling requirements applicable to all prescription drugs, section 201.56(b) specifies the categories of new and more recently approved prescription drugs subject to the revised content and format requirements in 201.56(d) and 201.57, section 201.56(c) sets forth the schedule for implementing these revised content and format requirements, and section 201.56(e) specifies the sections and subsections, required and optional, for the labeling of older prescription drugs not subject to the revised format and content requirements.

Section 201.57(a) requires that prescription drug labeling for new and more recently approved prescription drug products include “Highlights of Prescribing Information,” which provide a concise extract of the most important information required under 201.57(c) (the full prescribing information) as well as certain additional information important to prescribers. Section 201.57(b) requires a table of contents to prescribing information, entitled “Full Prescribing Information: Contents,” consisting of a list of each heading and subheading along with its identifying number to facilitate health care practitioners' use of labeling information. Section 201.57(c) specifies the contents of the FPI. Section 201.57(d) mandates the minimum specifications for the format of prescription drug labeling and establishes minimum requirements for key graphic elements such as bold type, bullet points, type size and spacing.

Older drugs not subject to the revised labeling content and format requirements in section 201.57 are subject to labeling requirements at section 201.80. Section 201.80(f)(2) requires that within one year any FDA-approved patient labeling be referenced in the “Precautions” section of the labeling of older products and either accompany or be reprinted immediately following the labeling.

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