[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Notices]
[Pages 79371-79372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32196]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-5013]
Guidance for Industry on Labeling Over-the-Counter Human Drug
Products Using a Column Format; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 79372]]
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Labeling OTC Human
Drug Products Using a Column Format.'' This guidance is intended to
provide information on the use of columns as part of the standardized
content and format requirements for the labeling of over-the-counter
(OTC) drug and drug-cosmetic products.
DATES: The guidance for industry is effective December 19, 2000. Submit
written comments on agency guidances at any time.
ADDRESSES: Copies of this guidance for industry are available on the
Internet at http://www.fda.gov/cder/guidance/index.htm. Submit written
requests for single copies of this guidance to the Drug Information
Branch (HFD-210), Center for Drug Evaluation and Research, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit written comments on the guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow or Cazemiro R.
Martin, Center for Drug Evaluation and Research (HFD-560), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance for industry entitled ``Labeling OTC Human Drug Products Using
a Column Format.'' This is one of several guidances the agency is
developing to help manufacturers, packers, and distributors implement
the recently issued final rule establishing standardized content and
format requirements for the labeling of all OTC drug products. Once
finalized, these guidances will supersede all other statements,
feedback, and correspondence provided by the agency on these matters
since the issuance of the final rule.
In the Federal Register of March 17, 1999 (64 FR 13254), FDA
published a final rule establishing standardized content and format
requirements for the labeling of all OTC drug products, including drug-
cosmetic products (products that consist of both drug and cosmetic
components or a single component marketed for both drug and cosmetic
uses). This rule is intended to standardize labeling for all OTC drug
products so consumers can easily read and understand OTC drug product
labeling and use these products safely and effectively.
The regulation for this new standardized labeling requires
manufacturers to present OTC drug and drug-cosmetic labeling
information in a prescribed order and format.
The agency received a number of inquiries about the use of columns
in OTC drug product labeling under the new regulation. To address those
inquiries, in the Federal Register of December 1, 1999 (64 FR 67291),
FDA published a notice announcing the availability of a draft guidance
entitled ``Labeling Over-the-Counter Human Drug Products Using a Column
Format,'' which would make recommendations about how to use columns in
OTC drug product labeling in a way that is consistent with the
regulation. The notice invited interested persons to submit comments on
the draft guidance by January 31, 2000. In response, the agency
received four comments from national trade associations representing
manufacturers and distributors of OTC drug and drug-cosmetic products
and from manufacturers of OTC drug products.
In addition to allowing two or more Drug Facts boxes on the same
side of a package (as stated in the draft guidance), the comments
requested that FDA: (1) Allow the use of columns within a single Drug
Facts box or, at a minimum, within headings (e.g., the ``Warnings''
section of the labeling); (2) eliminate the ``Drug Facts (continued)''
requirement from the top of the second (and additional, if present)
Drug Facts boxes on the same side of a package and eliminate the use of
an arrow leading to the next panel; (3) if columns are allowed within a
single Drug Facts box, eliminate the requirement that subsequent
columns begin with a heading or subheading; (4) replace ``Drug Facts
(continued)'' at the top of a second (or subsequent) column with the
previous heading or subheading that appears in the labeling and add
``(continued)'' when information continues from one column to another;
(5) eliminate the recommendation in the draft guidance that multiple
columns should be approximately the same size; and (6) provide an
alternate way to present active ingredient and purpose information on
narrow panels e.g., active ingredient information on one line and the
purpose directly below it).
As a general matter, the requests go beyond what the final rule
provides for in labeling OTC drug products. In particular, the proposed
use of ``columns within columns'' would represent a significant
departure from the overall look and format of the final rule. The
agency also believes it is important to maintain the current
requirements regarding the use of ``signals'' to show the continuation
of the required labeling from one column or panel to the next. The use
of such signals is important for the continuous flow of information on
the ``Drug Facts'' label. These signals provide a valuable visual cue
for introducing the next column of information, without unnecessarily
distracting or confusing the reader.
The agency also will continue to recommend that multiple columns on
the same side of a package be uniform in size to make it easier for
consumers to follow and read the labeling information. The agency
believes that the use of different size columns could be distracting
and cause consumers to miss important labeling information. Finally,
although the final rule requires that the active ingredient and purpose
be stated on the same line, this final guidance clarifies that the
final rule permits the dosage unit information to be stated directly
underneath the active ingredient.
This guidance is being issued consistent with FDA's good guidance
practices (65 FR 56468, September 19, 2000). The guidance represents
the agency's current thinking on using a column format in the labeling
of OTC human drug products (21 CFR part 201). 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 an approach
satisfies the requirements of the applicable statutes and regulations.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guidance. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. The guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: December 4, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32196 Filed 12-18-00; 8:45 am]
BILLING CODE 4160-01-F