[Federal Register Volume 64, Number 230 (Wednesday, December 1, 1999)]
[Notices]
[Page 67291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-5013]


Draft Guidance for Industry on Labeling of Over-the-Counter Human 
Drug Products Using a Column Format; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Labeling of 
Over-the-Counter Human Drug Products Using a Column Format.'' This 
draft guidance is intended to provide information on the use of columns 
as part of the standardized format and standardized content 
requirements for the labeling of over-the-counter (OTC) drug and drug-
cosmetic products.

DATES: Submit written comments on the draft guidance for industry by 
January 31, 2000.

ADDRESSES: Copies of the draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance entitled 
``Labeling of Over-the-Counter Human Drug Products Using a Column 
Format'' 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 request. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 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 
draft guidance for industry entitled ``Labeling of Over-the-Counter 
Human Drug Products Using Column Format.'' This is the first of a 
series of guidances the agency plans to issue to help manufacturers, 
packers, and distributors implement the recently issued final rule 
establishing standardized format and content requirements for the 
labeling of all OTC drug products.
    In the Federal Register of March 17, 1999 (64 FR 13254), FDA 
published a final rule establishing a standardized format and 
standardized content 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 regulatory requirements for this new standardized labeling 
require manufacturers to present OTC drug and drug-cosmetic labeling 
information in a certain prescribed order and format. This new format 
will require the revision of all existing labeling.
    The final rule did not include examples where Drug Facts 
information (presented in a defined box or similar enclosure) appeared 
in column format on the same side of the outside container of a retail 
package, or side-by-side on the immediate container label. This draft 
guidance is intended to explain how Drug Facts information can be 
presented using a column format that is consistent with the final rule. 
This draft guidance includes examples of such labeling in columns.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). This draft 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.
    Interested persons may, on or before January 31, 2000, submit 
written comments on the draft guidance to the Dockets Management Branch 
(address above). 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 draft 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: November 22, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-31124 Filed 11-30-99; 8:45 am]
BILLING CODE 4160-01-F