[Federal Register Volume 59, Number 69 (Monday, April 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8511]
[[Page Unknown]]
[Federal Register: April 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 336
[Docket No. 92N-0346]
RIN 0905-AA06
Antiemetic Drug Products for Over-The-Counter Human Use;
Amendment of Final Monograph
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 final monograph for over-the-counter (OTC) antiemetic drug
products to revise a required warning and to add a similar warning for
antiemetic drug products labeled for use only for children under 12
years of age. This final rule will ensure that warnings for ingredients
contained in OTC antiemetic drug products are the same as those
required for related ingredients used in other OTC drug products (e.g.,
antihistamines, antitussives, and nighttime sleep-aids). This final
rule is part of the ongoing review of OTC drug products conducted by
FDA.
EFFECTIVE DATE: April 11, 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 April 30, 1987
(52 FR 15886), FDA issued a final monograph for OTC antiemetic drug
products (21 CFR part 336) that included the following warning
statement in Sec. 336.50(c)(1) (21 CFR 336.50(c)(1)) for all
antiemetics: ``Do not take this product if you have asthma, glaucoma,
emphysema, chronic pulmonary disease, shortness of breath, difficulty
in breathing, or difficulty in urination due to enlargement of the
prostate gland unless directed by a doctor.''
In Sec. 341.72 of the tentative final monograph for OTC
antihistamine drug products, published in the Federal Register of
January 15, 1985 (50 FR 2200 at 2215), the agency proposed this same
warning for all OTC antihistamines. Antihistamines should not be used
by people who have any obstructive pulmonary disease in which clearance
of secretions is a problem. The agency stated that respiratory distress
symptoms, such as difficulty in breathing and shortness of breath, are
characteristic of chronic obstructive pulmonary disease. The agency
concluded that such descriptive terms should be included in the warning
in addition to the names of the diseases, in order to provide more
information to the consumer.
In the final monograph for OTC antihistamine drug products,
published in the Federal Register of December 9, 1992 (57 FR 58356 at
58374), the agency revised this warning to include the broader phrase
``breathing problem'' to describe symptoms such as shortness of breath
and difficulty in breathing related to obstructive pulmonary disease.
The change in wording will allow consumers to recognize respiratory
distress symptoms more readily. The agency also removed the descriptive
term ``asthma'' from the warning and replaced the term ``chronic
pulmonary disease'' with the term ``chronic bronchitis.'' The revised
warning, which appears in Sec. 341.72(c)(2) of the final monograph (21
CFR 341.72(c)(2)), reads as follows: ``Do not take this product, unless
directed by a doctor, if you have a breathing problem such as emphysema
or chronic bronchitis, or if you have glaucoma or difficulty in
urination due to enlargement of the prostate gland.''
In the Federal Register of August 26, 1993 (58 FR 45216 and 45217),
the agency proposed to revise the same warning in Sec. 336.50(c)(1) for
diphenhydramine and the other antiemetic ingredients listed in
Sec. 336.10 (21 CFR 336.10) (58 FR 45216 at 45217) and the same warning
in Sec. 338.50(c)(3) (21 CFR 338.50(c)(3)) for diphenhydramine used as
an OTC nighttime sleep-aid (58 FR 45217 at 45218) to be consistent with
the warning in Sec. 341.72(c)(2) for OTC antihistamine drug products.
No comments were received in response to the proposed monograph
amendment. Therefore, the agency is finalizing the amendment as
proposed. Elsewhere in this issue of the Federal Register, the agency
is also finalizing the amendment to the final monograph for OTC
nighttime sleep-aid drug products mentioned above.
In the proposal (58 FR 45216 at 45217), the agency advised that any
final rule resulting from the proposal would be effective 12 months
after its date of publication in the Federal Register. Therefore, on or
after April 11, 1995, any OTC drug product that is not in compliance
with the final rule may not be initially introduced or initially
delivered for introduction into interstate commerce unless it is the
subject of an approved application. Further, any OTC drug product
subject to the rule that is repackaged or relabeled after the effective
date of the rule must be in compliance with the rule regardless of the
date the product was initially introduced or initially delivered for
introduction into interstate commerce. Manufacturers are encouraged to
comply voluntarily with the rule at the earliest possible date.
No comments were received in response to the agency's request for
specific comment on the economic impact of this rulemaking (58 FR 45216
at 45217). The agency has examined the economic consequences of this
final rule and has determined that it does not require either a
regulatory impact analysis, as specified in Executive Order 12866, or a
regulatory flexibility analysis, as defined in the Regulatory
Flexibility Act (Pub. L. 96-354). This rulemaking for OTC antiemetic
drug products is not expected to have an impact on small businesses.
This final rule will require a minor, one-time labeling revision, which
manufacturers will have 1 year to implement. The impact of this final
rule appears to be minimal. Therefore, the agency concludes that this
final rule is not a major rule as defined in Executive Order 12866.
Further, the agency certifies that this final rule will not have a
significant economic impact on a substantial number of small entities
as defined in the Regulatory Flexibility Act.
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 336
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
336 is amended as follows:
PART 336--ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
1. The authority citation for 21 CFR part 336 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 336.50 is amended by revising paragraph (c)(1) to read
as follows:
Sec. 336.50 Labeling of antiemetic drug products.
* * * * *
(c) * * *
(1) For products containing any ingredient identified in
Sec. 336.10--(i) When labeled for use in adults and for those products
that can be and are labeled for use in children under 12 years of age.
``Do not take this product, unless directed by a doctor, if you have a
breathing problem such as emphysema or chronic bronchitis, or if you
have glaucoma or difficulty in urination due to enlargement of the
prostate gland.''
(ii) For those products that can be and are labeled only for
children under 12 years of age. ``Do not give this product to children
who have a breathing problem such as chronic bronchitis or who have
glaucoma, without first consulting the child's doctor.''
* * * * *
Dated: March 4, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-8511 Filed 4-8-94; 8:45 am]
BILLING CODE 4160-01-F