[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: 94-1790]
[Federal Register: January 28, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 358
[Docket No. 80N-0238]
RIN 0905-AA06
Wart Remover Drug Products for Over-the-Counter Human use;
Proposed Amendment of the Final Monograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the final monograph for over-the-counter (OTC) wart remover drug
products to revise the directions for products containing 15 percent
salicylic acid in a karaya gum, glycol plaster vehicle. This proposal
is part of the ongoing review of OTC drug products conducted by FDA.
DATES: Written comments by March 29, 1994. Written comments on the
agency's economic impact determination by March 29, 1994. FDA is
proposing that any final rule that may issue based on this proposal
become effective 12 months after the date of publication in the Federal
Register.
ADDRESSES: 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: In the Federal Register of August 14, 1990
(55 FR 33246), FDA issued a final monograph for OTC wart remover drug
products (21 CFR part 358). The final monograph included in
Sec. 358.110(c) (21 CFR 358.110(c)) products containing 15 percent
salicylic acid in a karaya gum, glycol plaster vehicle. Such products
were included in the monograph based on the agency's evaluation of data
from three clinical studies (Ref. 1) (see comment 13, 55 FR 33246 at
33253). The directions for such products were included in
Sec. 358.150(d)(3) (21 CFR 358.150(d)(3)), as follows:
``Wash affected area.'' (Optional: ``May soak wart in warm water
for 5 minutes.'') ``Dry area thoroughly.'' (If appropriate: ``Cut
plaster to fit wart.'') ``Apply medicated plaster at bedtime, leave
in place for at least 8 hours; in the morning, remove plaster and
discard. Repeat procedure every 24 hours as needed (until wart is
removed) for up to 12 weeks.''
In discussing the labeling for these products (also in comment 13), the
agency stated:
If there are any special directions that relate to using a
particular product, then such information should appear as part of
the manufacturer's additional directions for the product. The
monograph provides the minimum directions necessary for use of the
product. Manufacturers may supplement these directions with
additional information necessary to use their specific product. For
example, the agency notes that the manufacturer's directions for its
specific product include statements to ``keep plastic film on the
top of pad facing up and to apply sticky bottom side to the wart.''
The agency finds no need to include such directions in this final
monograph; however, manufacturers may add such information, as
appropriate, to the labeling of their products.
Subsequently, the agency became aware that a manufacturer of this
product had the following additional statements in its product's
labeling (Ref. 2): (1) ``Smooth wart surface with emery file
supplied,'' and (2) ``Apply a drop of warm water to the wart, keeping
the surrounding skin dry.'' The agency has rereviewed the clinical
studies (Ref. 1) for this product and determined that this additional
labeling information is based on the manner in which the clinical
studies were performed. The agency notes that use of an emery file and
application of a drop of warm water to the wart site as part of the
directions for this type of product were not included in the labeling
suggestions made by the manufacturer when the final monograph was being
prepared (see comment 13).
The agency is concerned that similar products in the marketplace
may have different directions--some recommending use of an emery file
and a drop of warm water to prepare the wart site and others not
mentioning use of an emery file and a drop of warm water. The agency
believes this situation could lead to consumer confusion. (Although the
agency is aware of only one such marketed product, this does not rule
out small volume operations and private label products.)
The clinical studies (Ref. 1) did not show that using an emery file
and a drop of warm water were necessary to prepare the wart site before
application of the medicated plaster. However, these studies also did
not show that these procedures were not necessary, that any adverse
effects occurred, or that any interference with the product's safety
and effectiveness occurred when an emery file and a drop of warm water
were used. Because the procedure used in the studies included the use
of an emery file and a drop of warm water, the agency has determined
that these items should be part of the directions for this product. The
agency is also making a minor format revision in one sentence of the
directions. Accordingly, the agency is proposing to amend the
directions in Sec. 358.150(d)(3) for 15 percent salicylic acid in a
karaya gum, glycol plaster vehicle, to read as follows:
For products containing salicylic acid identified in
Sec. 358.110(c). ``Wash affected area.'' (Optional: ``May soak wart
in warm water for 5 minutes.'') ``Dry area thoroughly. Gently smooth
wart surface with emery file supplied.'' (If appropriate: ``Cut
plaster to fit wart.'') ``Apply a drop of warm water to the wart,
keeping the surrounding skin dry. Apply medicated plaster at bedtime
and leave in place for at least 8 hours. In the morning, remove
plaster and discard. Repeat procedure every 24 hours as needed
(until wart is removed) for up to 12 weeks.''
References
(1) Comment No. RPT2, Docket No. 80N-0238, Dockets Management
Branch.
(2) Labeling for Trans-Ver-Sal, included in OTC Volume 16CFMA,
Docket No. 80N-0238, Dockets Management Branch.
The agency has examined the economic consequences of this proposed
rulemaking in conjunction with other rules resulting from the OTC drug
review. In a notice published in the Federal Register of February 8,
1983 (48 FR 5806), the agency announced the availability of an
assessment of these economic impacts. The assessment determined that
the combined impacts of all the rules resulting from the OTC drug
review do not constitute a major rule according to the criteria
established by Executive Order 12866. The agency therefore concludes
that no one of these rules, including this proposed rule amending the
final monograph for OTC wart remover drug products, is a major rule.
The economic assessment also concluded that the overall OTC drug
review was not likely to have a significant economic impact on a
substantial number of small entities as defined in the Regulatory
Flexibility Act (Pub. L. 96-354). That assessment included a
discretionary regulatory flexibility analysis in the event that an
individual rule might impose an unusual or disproportionate impact on
small entities. However, this particular rulemaking for OTC wart
remover drug products is not expected to pose such an impact on small
business. The final rule may require some very minor relabeling;
however, such relabeling should be a one time nominal cost. The agency
is currently aware of only one such product in the marketplace, and it
already has this labeling. Other manufacturers who may market this
product will have 1 year after publication of the final rule to
implement this labeling. The cost to do so will be minimal. Therefore,
the agency certifies that this proposed rule, if implemented, will not
have a significant economic impact on a substantial number of small
entities.
The agency invites public comment regarding any substantial or
significant economic impact that this rulemaking would have on OTC wart
remover drug products. Types of impact may include, but are not limited
to, costs associated with relabeling or repackaging. Comments regarding
the impact of this rulemaking on OTC wart remover 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.
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 March 29, 1994, submit written
comments on the proposed regulation to the Dockets Management Branch
(address above). Written comments on the agency's economic impact
determination may be submitted on or before March 29, 1994. Three
copies of all comments are to be submitted, except that individuals may
submit one copy. Comments and objections 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 358
Labeling, 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 358 be amended as follows:
PART 358--MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
1. The authority citation for 21 CFR part 358 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 358.150 is amended by revising paragraph (d)(3) to read
as follows:
Sec. 358.150 Labeling of wart remover drug products.
* * * * *
(d) * * *
(3) For products containing salicylic acid identified
inSec. 358.110(c). ``Wash affected area.'' (Optional: ``May soak wart
in warm water for 5 minutes.'') ``Dry area thoroughly. Gently smooth
wart surface with emery file supplied.'' (If appropriate: ``Cut plaster
to fit wart.'') ``Apply a drop of warm water to the wart, keeping the
surrounding skin dry. Apply medicated plaster at bedtime and leave in
place for at least 8 hours. In the morning, remove plaster and discard.
Repeat procedure every 24 hours as needed (until wart is removed) for
up to 12 weeks.''
* * * * *
Dated: September 13, 1993.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-1790 Filed 1-27-94; 8:45 am]
BILLING CODE 4160-01-F