[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