[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