[Federal Register Volume 61, Number 222 (Friday, November 15, 1996)]
[Rules and Regulations]
[Pages 58471-58472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 333

[Docket No. 95N-0062]
RIN 0910-AA01


Topical Antimicrobial Drug Products for Over-the-Counter Human 
Use; Amendment of Final Monograph for OTC First Aid Antibiotic Drug 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
amending the monograph for over-the-counter (OTC) first aid antibiotic 
drug products (the regulation that establishes conditions under which 
these drug products are generally recognized as safe and effective and 
not misbranded). The amendment adds a warning statement concerning 
allergic reactions resulting from topical antibiotic drug products 
containing bacitracin, bacitracin zinc, neomycin, neomycin sulfate, 
polymyxin B, or polymyxin B sulfate. This final rule is part of the 
ongoing review of OTC drug products conducted by FDA.

EFFECTIVE DATE: November 17, 1997.

FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug 
Evaluation and Research (HFD-105), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2304.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 11, 1987 (52 FR 47312), FDA 
issued a final monograph for OTC first aid antibiotic drug products in 
part 333 (21 CFR part 333) subpart B. The monograph provides for single 
ingredient products containing bacitracin, bacitracin zinc, neomycin, 
or neomycin sulfate and various combinations containing bacitracin, 
neomycin sulfate, and polymyxin B sulfate. The monograph did not 
include an allergy warning for products containing bacitracin (zinc), 
neomycin (sulfate), and polymyxin B (sulfate).
    In the Federal Register of February 14, 1996 (61 FR 5918), the 
agency published a proposed amendment of the monograph for OTC first 
aid antibiotic drug products to add a new warning for products 
containing bacitracin (zinc), neomycin (sulfate), and polymyxin B 
(sulfate). The warning adds the words ``or if a rash or other allergic 
reaction develops. Do not use this product if you are allergic to any 
of the ingredients.'' in the middle of the existing warning in 
Sec. 333.150(c)(2) that has been used for all OTC first aid antibiotic 
drug products for years. The new warning would read:
    Stop use and consult a doctor if the condition persists or gets 
worse, or if a rash or other allergic reaction develops. Do not use 
this product if you are allergic to any of the ingredients. Do not 
use longer than 1 week unless directed by a doctor.
    The agency included this new warning in proposed Sec. 333.150(c)(3) 
under the heading For any product containing bacitracin, bacitracin 
zinc, neomycin, neomycin sulfate, polymyxin B and/or polymyxin B 
sulfate. The agency retained the current warning in Sec. 333.150(c)(2) 
for products containing chlortetracycline hydrochloride and 
tetracycline hydrochloride and added the heading For any products 
containing chlortetracycline hydrochloride or tetracycline 
hydrochloride to Sec. 333.150(c)(2). Combinations containing 
oxytetracycline hydrochloride and polymyxin B sulfate in 
Sec. 333.120(a)(11) and (a)(12) would use the new warning in proposed 
Sec. 333.150(c)(3).

[[Page 58472]]

    Interested persons were invited to submit comments on the proposal 
by May 14, 1996, and comments on the agency's economic impact 
determination by May 14, 1996.
    In response to the proposed monograph amendment, one trade 
association of OTC drug manufacturers submitted a comment. Copies of 
the comment received are on public display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857, and may be seen between 9 a.m. and 4 p.m., 
Monday through Friday. Any additional information that has come to the 
agency's attention since publication of the proposed rule is also on 
public display in the Dockets Management Branch.
    The agency has considered the comment in proceeding with this final 
rule. A summary of the comment with FDA's response follows.

II. Summary of the Comment Received

    The comment supported the warning language proposed by the agency 
and requested a technical clarification of part of one sentence of the 
warning. The comment noted that in the preamble to the monograph 
amendment (61 FR 5918), the agency had stated a new sentence as ``Do 
not use if you are allergic to any of the ingredients,'' while in 
proposed Sec. 333.150(c)(3) (61 FR 5918 at 5920), the agency had 
included the words ``this product'' after the word ``use'' in this 
sentence. The comment stated that the words ``this product'' were 
implicitly understood in product labeling and that deletion of these 
words would conserve label space. The comment supported deletion of 
these two words and asked the agency to clarify this issue as soon as 
possible.
    The agency concurs with the comment that the words ``this product'' 
are implicitly understood in product labeling. While the agency 
proposed to include these two words for completeness, the agency agrees 
that the words can be deleted without affecting the meaning of the 
sentence. Accordingly, Sec. 333.150(c)(3) in this final rule does not 
include the words ``this product.''

III. The Agency's Final Conclusions

    The agency concludes that addition of a warning statement about the 
possibility of allergic reactions to the labeling of topical antibiotic 
drug products containing bacitracin (zinc), neomycin (sulfate), and 
polymyxin B (sulfate) would benefit consumers who use these OTC drug 
products. The new warning is supportable based on the adverse event 
reports discussed in the proposal (61 FR 5918).

 IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
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, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    Under the Regulatory Flexibility Act, if a rule has a significant 
impact on a substantial number of small entities, an agency must 
analyze regulatory options that would minimize any significant impact 
of a rule on small entities. The final rule will generate a one-time 
label modification, which can be implemented at very little cost by 
manufacturers at the next printing of labels. The agency is providing 
12 months for this revision to be made. Thus, this final rule will not 
impose a significant economic burden on affected entities. Therefore, 
under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the 
Commissioner of Food and Drugs certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities. No further analysis is required.

V. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirement in this document is not 
subject to review by the Office of Management and Budget because it 
does not constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the warning 
statement is a ``public disclosure of information originally supplied 
by the Federal government to the recipient for the purpose of 
disclosure to the public'' (5 CFR 1320.3(c)(2)).

 VI. Environmental Impact

    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 333

    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 
333 is amended as follows:

PART 333--TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER 
HUMAN USE

    1. The authority citation for 21 CFR part 333 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), unless otherwise noted.

    2. Section 333.150 is amended by adding a heading to paragraph 
(c)(2) and by adding new paragraph (c)(3) to read as follows:


Sec. 333.150  Labeling of first aid antibiotic drug products.

 *   *   *   *  *
    (c) *   *   *
    (2) For products containing chlortetracycline hydrochloride or 
tetracycline hydrochloride. * * *
    (3) For any product containing bacitracin, bacitracin zinc, 
neomycin, neomycin sulfate, polymyxin B, and/or polymyxin B sulfate. 
``Stop use and consult a doctor if the condition persists or gets 
worse, or if a rash or other allergic reaction develops. Do not use if 
you are allergic to any of the ingredients. Do not use longer than 1 
week unless directed by a doctor.''
 *   *   *   *   *

    Dated: November 5, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-29302 Filed 11-14-96; 8:45 am]
BILLING CODE 4160-01-F