[Federal Register Volume 59, Number 19 (Friday, January 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1791]


[Federal Register: January 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its general 
labeling policy for over-the-counter (OTC) drug products to allow for 
the interchangeable use of certain words in labeling required by an OTC 
drug monograph. Examples of these words include: ``doctor'' and 
``physician,'' ``consult'' and ``ask,'' and ``indications'' and 
``uses.'' This final rule provides alternate terminology in the 
labeling of OTC drug products for words that have the same meaning.

EFFECTIVE DATE: February 28, 1994.

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: In the Federal Register of April 5, 1993 (58 
FR 17553), the agency proposed to amend its general labeling policy for 
over-the-counter (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. (See, e.g., Secs. 333.150(e), 
333.350(e), and 336.50(e) (21 CFR 333.150(e), 333.350(e), and 
336.50(e)).) 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. (See, e.g., Secs. 333.150(c)(1), 333.350(c)(2), 
and 340.50(c)(2) (21 CFR 340.50(c)(2)).) 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.
    One trade association, representing OTC drug manufacturers, and one 
drug manufacturer submitted comments in response to the agency's 
proposal. Copies of the comments are on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.

I. Summary of the Comments Received

    The comment from the trade association agreed with the agency's 
proposal to allow for the interchangeable use of the words ``doctor'' 
and ``physician,'' and the words ``consult'' and ``ask.'' The comment 
suggested the following additional sets of alternative terms and gave 
the following citations, showing inclusion in several OTC drug 
monographs, as support: (1) ``Clean'' or ``cleanse'' (Secs. 333.150(d), 
333.350(d)(1), and 346.50(d)(1) (21 CFR 346.50(d)(1))); (2) ``persist'' 
or ``continue'' (Secs. 341.76(c)(5)(ii), 346.50(c)(7)(iii), 
357.150(c)(1), and 357.850(c)(1)(i) (21 CFR 341.76(c)(5)(ii), 
346.50(c)(7)(iii), 357.150(c)(1), and 357.850(c)(1)(i))); (3) 
``chronic'' or ``persistent'' (Secs. 336.50(c)(1), 338.50(c)(3), 
341.74(c)(2), (c)(3), and (c)(4)(ii) through (c)(4)(iv), and 
341.78(c)(1) (21 CFR 338.50(c)(3), 341.74(c)(2), (c)(3), and (c)(4)(ii) 
through (c)(4)(iv), and 341.78(c)(1))); (4) ``assistance'' or ``help'' 
(Secs. 331.30(g), 332.30(c), 341.74(f), and 342.76(c)(5)(i) and 
(c)(6)(ii) (21 CFR 331.30(g), 332.30(c), 341.74(f), and 342.76(c)(5)(i) 
and (c)(6)(ii))); and (5) ``pulmonary'' or ``lung'' (Secs. 336.50(c)(1) 
and 338.50(c)(3)). The comment stated that, in some instances, the 
paired terms already appear in the cited regulations and, in other 
cases, the alternative terms may be better understood by consumers. The 
comment mentioned the following examples: ``Lung'' disease may be 
better understood than the more technical ``pulmonary'' disease, and 
``persistent'' may be better understood than ``chronic.'' The comment 
stated its understanding that the rule is intended only to provide a 
glossary of comparable terms that may be used interchangeably, not to 
make substantive changes in the underlying required label statements. 
For example, the comment mentioned that the rule would not permit the 
term ``health professional'' as an alternative to the terms ``doctor'' 
or ``physician,'' because a ``health professional'' may include 
pharmacists, nurses, midwives, and others who are not licensed to 
practice medicine. The comment requested that the agency clarify that 
this rule applies only to OTC drug monograph language otherwise 
required to be declared verbatim in OTC drug product labeling. The 
comment added that the rule would not apply to or otherwise affect the 
use of truthful and nonmisleading alternative terms that can be used 
for monograph indications.
    The other comment also proposed that the terms ``assistance'' and 
``help'' be allowed interchangeably in the general overdose warning, 
which states: ``In case of accidental ingestion, seek professional 
assistance or contact a Poison Control Center immediately.''

II. The Agency's Final Conclusions

    The agency has carefully evaluated the comments' proposals for the 
interchangeable use of certain terms and concludes that the 
interchangeable terms suggested by the comments (``clean'' or 
``cleanse,'' ``persist(s)'' or ``continue(s),'' ``assistance'' or 
``help,'' and ``pulmonary'' or ``lung'') are acceptable and will help 
promote better label readability.
    In addition, the agency has determined that the terms 
``indication(s)'' or ``use(s)'' should be allowed to be used 
interchangeably. The agency considers the term ``use(s)'' to be simpler 
and better understood by consumers than the term ``indication(s).'' The 
agency is including this option in Sec. 330.1(i).
    The agency disagrees with the interchangeable use of the words 
``chronic'' and ``persistent.'' ``Chronic,'' by definition, is of long 
duration, or may be subject to habit or disease for a lengthy period 
(Ref. 1). On the other hand, ``persistent,'' by definition, is refusing 
to let go, insistently repetitive or continuous, or enduring (Ref. 2). 
While ``chronic'' is also ``persistent,'' ``persistent'' is not 
necessarily ``chronic.'' For instance, a chronic cough denotes one that 
has gone on for a lengthy period of time, while a persistent cough 
could be one of recent onset that does not respond to treatment. Thus, 
a chronic cough and a persistent cough may be the same, or they could 
be two separate entities. Therefore, interchangeable use of the terms 
``chronic'' and ``persistent'' is not included in the final rule.

References

    (1) ``Webster's II New Riverside University Dictionary,'' 
Houghton Mifflin Co., Boston, 1984, s.v. ``chronic.''
    (2) ``Webster's II New Riverside University Dictionary,'' 
Houghton Mifflin Co., Boston, 1984, s.v. ``persistent.''
    This final rule does not make substantive changes in the language 
required in OTC drug monographs. The rule allows for alternative 
terminology for certain terms that are sufficiently comparable to be 
used interchangeably. The rule does not affect the use of truthful and 
nonmisleading terminology as an alternative to monograph indications in 
accord with Sec. 330.1(c)(2)(ii) and (c)(2)(iii).
    The agency has examined the economic consequences of this final 
rule and determined that it does not require either a regulatory impact 
analysis, as specified in Executive Order 12866, or a regulatory 
flexibility analysis, as defined in the Regulatory Flexibility Act 
(Pub. L. 96-354). This final rule provides alternative labeling options 
that can 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. Thus, the rule will have no significant 
economic impact. The agency concludes that the final rule is not a 
major rule as defined in Executive Order 12866. Further, the agency 
certifies that the rule will not have a significant economic impact on 
a substantial number of small entities as defined in the Regulatory 
Flexibility Act.
    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.

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, 21 CFR part 
330 is 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) to read as 
follows:


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

* * * * *
    (i) The following terms may be used interchangeably in any of the 
labeling established in parts 331 through 358 of this chapter:
    (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''.
    (9) ``Lung'' or ``pulmonary''.
* * * * *

    Dated: October 15, 1993.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1791 Filed 1-27-94; 8:45 am]
BILLING CODE 4160-01-F