[Acrobat Version]
U.S. Department of Health and Human
Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
December 2000
OTC
Additional copies of this Guidance are available from:
Office of Training and Communication
Division of Communications Management
Drug Information Branch, HFD-210,
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
(Phone 301-827-4573)
Internet: http://www.fda.gov/cder/guidance/index.htm
TABLE OF CONTENTS
I. INTRODUCTION
II. BACKGROUND
III. USING COLUMNS AS PART OF THE
STANDARD LABELING FORMAT
IV. COLUMNS
UNDER THE MODIFIED LABELING FORMAT
Guidance for Industry
Labeling OTC Human Drug Products
Using a Column Format
This guidance represents the Food and Drug Administration_s current thinking on this topic.
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.
I. INTRODUCTION
This guidance is intended to assist manufacturers, packers, and
distributors who wish to present labeling information for their over-the-counter (OTC)
human drug products using a column format.
II. BACKGROUND
In the Federal Register of March 17, 1999 (64 FR 13254), the
Food and Drug Administration (FDA) published a final regulation establishing standardized
content and format requirements for the labeling of OTC human drug products. Standardized
labeling for OTC drug products is intended to make it easier for consumers to read and
understand OTC drug product labeling and use OTC drug products safely and effectively.
The new Drug Facts labeling regulation in 21 CFR 201.66 covers all
OTC drug and drug-cosmetic products, whether marketed under a new drug marketing
application (NDA), abbreviated new drug application (ANDA), or OTC drug monograph (or
product not yet the subject of a final OTC drug monograph).
Section 201.66(d)(5) of the labeling regulation provides that the
Drug Facts labeling information may appear on more than one panel on the outside container
of the retail package, or on the immediate container label if there is no outside
container or wrapper. When continuing the required content and format information onto
multiple panels, the required order and flow of headings, subheadings, and information
must be maintained as well. The regulation also requires the use of a visual graphic
(e.g., an arrow) to signal the continuation of the Drug Facts labeling to the next
adjacent panel.
The Agency received a number of inquiries as to whether the required
labeling information may be presented using a column format. One question is whether the
required headings, subheadings, and text can be divided into columns within a
single, defined Drug Facts box or similar enclosure (hereafter referred to together as the
Drug Facts box), or whether such an approach would be inconsistent with the final
rule. The final format for the Drug Facts box generally favors a vertical, linear
presentation, to enhance readability and facilitate product comparisons. Except for the
presentation of active ingredient and purpose information (see _ 201.66(d)(6)) and the use of a
table to present complex dosing information (see _ 201.66(d)(9)), the final format does not allow required information to be
separated into columns within a given Drug Facts box. However, the rule does allow
for the use of an alternative column format that can help to maximize available labeling
space and, in some instances, improve readability. Specifically, this guidance describes
how more than one Drug Facts box can appear on each side of a package or a container to
allow for the use of columns.
III. USING COLUMNS AS PART OF THE
STANDARD LABELING FORMAT
The format established by the regulation requires most headings,
subheadings, and text to be left justified (see _ 201.66(d) and (d)(4)). The regulation also requires the use of horizontal
barlines and hairlines - extending to each side of the Drug Facts box - to provide
separation between headings and subheadings (see _ 201.66(d)(8)). These requirements contribute to the overall organization of
the information, provide the user with easy and consistent access to required information,
and help maximize the amount of open space within the Drug Facts box. More open
space (i.e., space not occupied by text) generally contributes to greater readability.
The regulation, however, can accommodate the use of more than one
Drug Facts box on each side of a package container (see Fig. 1), or the use of
side-by-side Drug Facts boxes on a wrap-around label (e.g., the label of a bottle of cough
syrup). Such a presentation generally is consistent with the rule, provided it is done in
a manner that allows for the clear and legible presentation of all required labeling
information. In the case of elongated packages (such as toothpaste and topical ointment
packages), the column format may noticeably improve
readability.
The following recommendations should be helpful if you are
considering the use of columns in OTC drug product labeling.
A. Vertical
Barline/Hairline
If you are using two or more Drug Facts boxes on the same side of a
package, the right side of the first column and the left side of the second column can
share a common vertical barline extending to each end of the Drug Facts box (see Fig. 1).
This also applies to the right side of the second column and the left side of the third
column, if a third column is used.
B. Number
of Boxes Per Side
· Different sides of a package do not have to contain the same
number of Drug Facts boxes.
· Two or more Drug Facts boxes can appear on one or more sides of a
package, and a single Drug Facts box can appear on one or more sides of a package.
· If you are using two or more Drug Facts boxes on the same side of
a package, the first Drug Facts box or column should be to the left of each successive box
(see Fig. 1).
C. Box or
Column Size
When multiple Drug Fact boxes appear on the same side of a package,
the boxes, enclosures, or columns should be approximately the same size (see Figs. 1 and
2).
D. Titles2
· The first Drug Facts box must bear the title Drug Facts
(see Figs. 1 and 2)
· Subsequent boxes on the same side of the package must bear the
title Drug Facts (continued) at the top of the box (see Figs. 1 and 2).
· If the Drug Facts information appears on more than one side of
the package, each box on each subsequent side of the package must bear the title Drug
Facts (continued) (see Fig. 3).
E. Visual Graphics
If Drug Facts information appears in two or more columns on one side
of a package (see Figs. 1 and 2) or on more than one side of a package (see Fig. 3), a
visual graphic (e.g., an arrow) should be used at the bottom of the first column and/or
side of the package (and at the bottom of subsequent columns and/or sides of the package,
where needed) to signal continuation of the Drug Facts labeling to the next appropriate
Drug Facts box on the package.
F. Order and Flow of
Information
The continuation of the required labeling onto multiple Drug Facts
boxes or columns must be done in a manner that retains the order and flow of headings,
subheadings, and information, meeting all the requirements of _ 201.66.
G. Active Ingredients/Purpose Information
· Section 201.66(d)(6) requires Active Ingredients
information to be left justified and the corresponding Purpose information
to be right justified. The regulation requires that this information be presented in a
manner that readily associates each active ingredient with its purpose.
· When multiple Drug Facts boxes are used, it is important that the
boxes be wide enough to allow the Active Ingredients and Purpose
information to appear on the same horizontal line.
· Where the Drug Facts box is too narrow to accommodate the Active
Ingredient(s) (in each dosage unit) and Purpose headings on the same
line, the dosage unit information (in each dosage unit) required under
_ 201.66(c)(2) may appear on the
same line as the heading Active Ingredient(s) or immediately under the
heading Active Ingredient(s) on the next line using left justification (see
Fig. 3).
IV. COLUMNS UNDER THE MODIFIED LABELING
FORMAT
When the Drug Facts labeling requires more than 60 percent of the
total surface area available to bear labeling, the regulation provides that the box
required
in _ 201.66(d)(8) may
be omitted if the Drug Facts labeling is set off from the rest of the labeling by use of
color contrast
(_ 201.66(d)(10)(v)). In such a case, if more than one Drug Facts box or column
is used on the same side of a package, or side-by-side on a wrap-around label, the columns
should be separated by adequate vertical common space of a contrasting color (see Fig. 2).
Horizontal barlines and hairlines should begin and end where the text begins and ends and
should not extend into the common space between the columns.
