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