[Federal Register Volume 59, Number 225 (Wednesday, November 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28857]


[[Page Unknown]]

[Federal Register: November 23, 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; 
Amendment of the Final Monograph

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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 final rule is part of the 
ongoing review of OTC drug products conducted by FDA.

EFFECTIVE DATE: November 23, 1995.

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, 55 FR 33246 at 33253).
    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. Because of 
concerns that this situation could lead to consumer confusion, in the 
Federal Register of January 28, 1994 (59 FR 4015), the agency proposed 
to amend the final monograph for OTC wart remover drug products to 
revise the directions for products containing 15 percent salicylic acid 
in a karaya gum, glycol plaster vehicle. The agency proposed that the 
directions in Sec. 358.150(d)(3) be revised to read as follows:

    ``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 Vol. 16CFMA, 
Docket No. 80N-0238, Dockets Management Branch.

    Interested persons were invited to submit written comments by March 
29, 1994. One manufacturer of OTC wart remover drug products submitted 
a comment in response to the agency's proposal. Copies of the comment 
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 between 9 a.m. and 4 p.m., Monday through Friday.
    The manufacturer stated that it marketed a 15 percent salicylic 
acid in karaya gum product in a glycol plaster vehicle. The comment 
agreed with the agency's proposal and commended the agency's efforts in 
updating the product directions to be consistent with the original 
clinical methods used during its development. The comment stated that 
this revision to include use of an emery file and a drop of water is in 
keeping with the long marketing history of this product.
    The comment pointed out that some mild abrasion is unavoidable 
while preparing the treatment site with the emery file and that the 
karaya gum vehicle minimizes the potential for irritation associated 
with any such abrasion. The comment added that the drop of water helps 
facilitate the initiation of the keratolytic action when the salicylic 
acid is applied.
    The agency appreciates the comment's support. Accordingly, the 
agency is finalizing the proposed revised directions in 
Sec. 358.150(d)(3) for 15 percent salicylic acid in a karaya gum, 
glycol plaster vehicle identified in Sec. 358.110(c).
    No comments were received in response to the agency's request for 
specific comment on the economic impact of this rulemaking (59 FR 4015 
at 4016). FDA has examined the impacts of this final 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 final rule is consistent with the regulatory 
philosophy and principles identified in the Executive Order. In 
addition, this rulemaking 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. This final rule will impose direct one-time costs 
associated with changing product labels for OTC wart remover drug 
products containing 15 percent salicylic acid in a karaya gum, glycol 
plaster vehicle. There are only a few such products in the marketplace. 
Relabeling should be a nominal cost, and manufacturers will have 1 year 
after publication of this final rule to implement this labeling. Thus, 
this rulemaking for OTC wart remover drug products is not expected to 
have an impact on small businesses. Accordingly, the agency certifies 
that this amendment to the final 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 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.
    As discussed in the proposal (59 FR 4015 at 4016), the agency 
advised that any final rule resulting from the proposed rule would be 
effective 12 months after its date of publication in the Federal 
Register. Therefore, on or after November 23, 1995, any OTC wart 
remover drug product that is not in compliance with this final rule may 
not be initially introduced or initially delivered for introduction 
into interstate commerce unless it is the subject of an approved 
application or abbreviated application. Further, any OTC drug product 
subject to this final rule that is repackaged or relabeled after the 
effective date of the rule must be in compliance with the rule 
regardless of the date that the product was initially introduced or 
initially delivered for introduction into interstate commerce. 
Manufacturers are encouraged to comply voluntarily with the final rule 
at the earliest possible date.

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, 21 CFR part 
358 is 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 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.''
* * * * *
    Dated: November 8, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-28857 Filed 11-22-94; 8:45 am]
BILLING CODE 4160-01-P