[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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