[Federal Register Volume 60, Number 192 (Wednesday, October 4, 1995)]
[Proposed Rules]
[Page 52058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24642]




[[Page 52057]]

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Part III





Department of Health and Human Services





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Food and Drug Administration



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21 CFR Part 330



Labeling of Drug Products for Over-the-Counter Human Use; Proposed Rule

  Federal Register / Vol. 60, No. 192 / Wednesday, October 4, 1995 / 
Proposed Rules  
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[[Page 52058]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 330

[Docket No. 92N-0454]
RIN 0905-AA06


Labeling of Drug Products for Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is modifying a proposed 
rule that proposed to amend the general labeling policy for over-the-
counter (OTC) drug products to allow for interchangeable use of the 
terms ``Drug interaction precaution,'' ``Avoid mixing drugs,'' or ``Do 
not mix drugs'' in labeling required by an OTC drug monograph. This 
modification provides for one additional alternative term, ``Do not use 
with * * *.''

DATES: Written comments by January 2, 1996; written comments on the 
agency's economic impact determination by January 2, 1996. The agency 
is proposing that any final rule that may issue based on this proposal 
become effective 30 days after the date of its publication in the 
Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-810), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 3, 1994 (59 FR 39499), the agency 
proposed to amend its general labeling policy for OTC drug products to 
allow for the interchangeable use of the terms ``Drug interaction 
precaution'' or ``Avoid mixing drugs'' or ``Do not mix drugs.'' The 
agency stated its belief that the phrase ``Avoid mixing drugs'' or ``Do 
not mix drugs'' may be better understood by consumers than ``Drug 
interaction precaution.'' The agency specifically invited comments on 
whether the terms ``Avoid mixing drugs'' or ``Do not mix drugs'' could 
be used interchangeably with the term ``Drug interaction precaution.'' 
Further, the agency requested comments on whether it would be desirable 
to change negatively worded warnings to more positive phraseology 
(e.g., ``Do not use more than 7 days'' to ``Use only 7 days''). The 
agency also asked for comment concerning the desirability of identical 
warning language for similar OTC drug products.
    The agency received a number of comments in response to the 
proposed rule. Those comments are being evaluated. The agency is 
modifying the proposal to include another alternative term and 
reopening the administrative record to allow for comments on this 
alternative term.

II. The Additional Term

    The agency believes that there may be a simpler way to alert 
consumers to this type of information. The agency is proposing an 
additional term, ``Do not use with * * *,'' as an alternative to the 
proposed interchangeable terms. For example, the current drug 
interaction precaution in Sec. 341.76(c)(4) (21 CFR 341.76(c)(4)) 
begins with the words ``Do not use this product * * * '' following the 
words ``Drug interaction precaution.'' If this new approach were used, 
the words ``Drug interaction precaution'' would no longer be needed and 
the precaution would begin with ``Do not use with'' and could be 
followed by ``a prescription drug for * * *.'' This approach would 
shorten the required labeling without changing the meaning. The agency 
would like comment on this approach and whether this term would be 
desirable for all OTC drug product labeling. -

III. Analysis of Impacts

    The economic impact and the environmental impact statements remain 
the same as stated in the proposed rule (59 FR 39499 at 39500).
    Interested persons may, on or before January 2, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this amended proposal. Written comments on the agency's economic impact 
determination may be submitted on or before January 2, 1996. Three 
copies of all 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 and may be 
accompanied by a supporting memorandum or brief. Received comments may 
be seen in the office above between 9 a.m. and 4 p.m., Monday through 
Friday.

List of Subjects in 21 CFR Part 330

    Over-the-counter drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 330 be amended as follows:

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY -
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

    1. The authority citation for 21 CFR part 330 continues to read as 
follows:

    Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
355, 360, 371).
    2. Section 330.1 is amended by redesignating paragraphs (i)(7), 
(i)(8), and (i)(9) as paragraphs (i)(8), (i)(9), and (i)(10), 
respectively, and by adding new paragraph (i)(7) to read as follows:


Sec. 330.1  General conditions for general recognition as safe, -
effective and not misbranded.

-* * * * *
    (i) * * *-
    (7) ``Drug interaction precaution'' or ``Avoid mixing drugs'' or 
``Do not mix drugs'' or ``Do not use with * * *''.
 -* * * * *

    Dated: September 25, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-24642 Filed 10-3-95; 8:45 am]
BILLING CODE 4160-01-F