[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Proposed Rules]
[Pages 8450-8451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4912]
[[Page 8449]]
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Part VII
Department of Health and Human Services
_______________________________________________________________________
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. 61, No. 43 / Monday, March 4, 1996 / Proposed
Rules
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[[Page 8450]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 330
[Docket No. 92N-454A]
RIN 0910-AA01
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 proposing to amend
its general labeling policy for over-the-counter (OTC) drug products to
allow for the interchangeable use of certain labeling terms required by
an OTC drug monograph. Examples of words already allowed include:
``doctor'' or ``physician,'' ``consult'' or ``ask,'' and
``indications'' or ``uses.'' This proposal provides an additional
phrase (``unless a doctor tells you'') that can be used in place of
several other phrases found in various OTC drug monographs.
DATES: Written comments by May 20, 1996; written comments on the
agency's economic impact determination by May 20, 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-105), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2304.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of April 5, 1993 (58 FR 17553), the agency
proposed to amend its general labeling policy for OTC drug products to
allow for the interchangeable use of certain words in the labeling
required by an OTC drug monograph. The agency had previously proposed
in a number of tentative final monographs and included in a number of
final monographs a provision that the words ``doctor'' and
``physician'' may be used interchangeably in the labeling of OTC drug
products. Instead of including this provision in each OTC drug
monograph, the agency proposed to include such a provision in
Sec. 330.1 (21 CFR 330.1) as part of the general conditions under which
an OTC drug is generally recognized as safe, effective, and not
misbranded. The agency also proposed that, at manufacturers'
discretion, the word ``ask'' could be substituted for the word
``consult,'' which appears in the directions for many OTC drug
monograph ingredients. Thus, the agency proposed that the phrases
``consult a physician,'' ``consult a doctor,'' ``ask a physician,'' and
``ask a doctor'' could be used interchangeably. The agency invited
comments and suggestions as to such other terms that could be used
interchangeably, i.e., terms general in nature that appear in more than
one OTC drug monograph. The comments received in response to the
proposed rulemaking were favorable and suggested a number of additional
terms that could be used interchangeably.
In a final rule published in the Federal Register of January 28,
1994 (59 FR 3998), the agency allowed the following terms to be used
interchangeably in the labeling of OTC drug products: (1) ``Ask'' or
``consult,'' (2) ``assistance'' or ``help,'' (3) ``clean'' or
``cleanse,'' (4) ``continue'' or ``persist,'' (5) ``continues'' or
``persists,'' (6) ``doctor'' or ``physician,'' (7) ``indication'' or
``use,'' (8) ``indications'' or ``uses,'' and (9) ``lung'' or
``pulmonary.'' These terms are included in Sec. 330.1(i).
In the Federal Register of August 3, 1994 (59 FR 39499), the agency
proposed to amend Sec. 330.1(i) so that the phrases ``Drug interaction
precaution,'' ``Avoid mixing drugs,'' or ``Do not mix drugs'' could be
used interchangeably. The agency also requested public comment on
changing the wording of warnings from negative phraseology to a more
positive approach (e.g., ``Do not use more than 7 days'' to ``Use only
7 days,'' ``Do not use in * * *'' to ``Avoid use in * * *,'' ``Do not
use longer than 1 week * * *'' to ``Use only 1 week * * *,'' and ``Do
not use this product except under the advice and supervision of a
physician if * * *,'' to ``Use only with a physician's help if * * *''
or ``Use only with the help of a doctor if * * *'').
The agency has received a number of comments on the proposal, and
they are being evaluated at this time. The agency intends to publish a
final rule in a future issue of the Federal Register.
The agency intends to continue to examine labeling required by OTC
drug monographs to provide consumers more simplified and understandable
information. This includes interchangeable terms, alternative
phraseology, and possibly a new or different labeling format. At this
time, the agency is proposing an additional phrase that could be used
interchangeably.
Labeling information about not using an OTC drug product under
certain circumstances (e.g., ``unless directed by a doctor,'' or
``except under the advice and supervision of a physician'') appears in
different OTC drug monographs in different language. This has occurred
because various OTC advisory review panels recommended different
wording, and OTC drug rulemakings have been completed over a period of
years.
The phrase ``* * * unless directed by a doctor'' appears in the
warning statements of many recent OTC drug monographs. (See, for
example, Sec. 341.76(c)(2) (21 CFR 341.76(c)(2)) which states: ``Do not
use this product if you have * * * unless directed by a doctor.'') In a
number of other monographs, terms with the same (or similar) meaning
have been used. For example, the OTC antacid drug products monograph in
Sec. 331.30(c)(1) and (c)(4) through (c)(7) (21 CFR 331.30(c)(1) and
(c)(4) through (c)(7)) uses the phrase ``except under the advice and
supervision of a physician,'' and the OTC ophthalmic drug products
monograph in Sec. 349.75(c)(2) (21 CFR 349.75(c)(2)) uses the phrase
``except under the advice and supervision of a doctor.'' That
terminology has not been used in more recent OTC drug monographs.
For OTC antihistamine drug products in Sec. 341.72(c)(3) and (c)(4)
(21 CFR 341.72(c)(3) and (c)(4)), and for OTC anorectal drug products
in Sec. 346.50(c)(7)(ii) (21 CFR 346.50(c)(7)(ii)), the phrase ``* * *
without first consulting your doctor'' is used. In Sec. 341.72(c)(6)(i)
through (c)(6)(iii), the phrase ``* * * without first consulting the
child's doctor'' is used. The warning statements for OTC dandruff,
seborrheic dermatitis, and psoriasis drug products in
Sec. 358.750(c)(2)(ii), (c)(3), and (c)(4) (21 CFR 358.750(c)(2)(ii),
(c)(3), and (c)(4)) include the phrases ``* * * without consulting a
doctor,'' ``* * * except on the advice of a doctor,'' and ``* * *
unless directed to do so by a doctor.'' Thus, a number of different
phrases have been used to convey the same message. The phrase ``unless
directed by a doctor'' has been used more recently and most frequently.
The agency believes that all of these phrases can be interpreted in
the same way (e.g., ``* * * unless a doctor tells you''). The agency
believes this simpler phrase may be better understood by consumers than
some of the other phrases. Accordingly, the agency is proposing to
amend Sec. 330.1(i) to include the phrase ``unless a doctor tells you''
as an alternative for these other phrases
[[Page 8451]]
where they appear in the labeling of OTC drug products. In a few
instances, the words ``or your child's doctor'' would be used as part
of this phrase. The agency is asking whether it would be preferable to
say ``your'' child's doctor or ``the'' child's doctor, or whether it
does not make any difference which wording is used. The agency is
requesting comment from manufacturers, health professionals, and
consumers on whether it would be desirable to use this alternative
phrase interchangeably with the other phrases and/or whether a single
uniform phrase should appear in all of the cited regulations. The
agency also seeks comment whether there are additional, simpler,
informative ways in which this information may be stated.
II. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and, thus, is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. If this proposed rule becomes a final rule, the
labeling options could be implemented at very little cost by
manufacturers at the next printing of labels, for those products for
which the manufacturer chooses to make a change. Accordingly, the
agency certifies that the proposed rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
The agency invites public comment regarding any substantial or
significant economic impact that this rulemaking would have on the
labeling of OTC drug products. Types of impact may include, but are not
limited to, costs associated with relabeling. Comments regarding the
impact of this rulemaking on OTC drug products should be accompanied by
appropriate documentation. The agency will evaluate any comments and
supporting data that are received and will reassess the economic impact
of this rulemaking in the preamble to the final rule.
III. Paperwork Reduction Act of 1995
FDA tentatively concludes that the labeling requirements proposed
in this document are not subject to review by the Office of Management
and Budget because they do not constitute a ``collection of
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.). Rather, the proposed labeling statements are a ``public
disclosure of information originally supplied by the Federal government
to the recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(c)(6) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
Interested persons may, on or before May 20, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Written comments on the agency's economic impact
determination may be submitted on or before May 20, 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 adding new paragraph (i)(11), to
read as follows:
Sec. 330.1 General conditions for general recognition as safe, -
effective and not misbranded.
* * * * *
(i) * * *-
(11) ``Unless a doctor'' (or ``your child's doctor,'' where
applicable) ``tells you'' may be used in place of any of the following
phrases:
(i) ``Except on the advice of a doctor''.
(ii) ``Except under the advice and supervision of a''
[``physician'' or ``doctor''].
(iii) ``Unless directed by a doctor''.
(iv) ``Unless directed to do so by a doctor''.
(v) ``Without consulting a doctor''.
(vi) ``Without first consulting your'' (or ``your child's'' or
``the child's'') ``doctor''.
* * * * *
Dated: February 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4912 Filed 3-1-96; 8:45 am]
BILLING CODE 4160-01-F
