[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: 94-8533]
[[Page Unknown]]
[Federal Register: April 11, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 338
[Docket No. 92N-0349]
RIN 0905-AA06
Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use;
Amendment of Final Monograph
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to amend the final monograph for over-the-counter (OTC) nighttime
sleep-aid drug products to revise a warning required for products that
contain diphenhydramine citrate or diphenhydramine hydrochloride. This
final rule will ensure that warnings are the same for diphenhydramine
salts whether the ingredient is used in OTC nighttime sleep-aid,
antihistamine, or antitussive drug products. 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 February 14, 1989
(54 FR 6814), FDA issued a final monograph for OTC nighttime sleep-aid
drug products (21 CFR part 338) that included the following warning
statement in Sec. 338.50(c)(3) (21 CFR 338.50(c)(3)) for products
containing diphenhydramine salts: ``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) (21
CFR 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. 38.50(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
antiemetic drug products mentioned above.
In the proposal (58 FR 45217 at 45218), 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 45217
at 45218). 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 nighttime
sleep-aid 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 338
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
338 is amended as follows:
Part 338--NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE
1. The authority citation for 21 CFR part 338 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 338.50 is amended by revising paragraph (c)(3) to read
as follows:
Sec. 338.50 Labeling of nighttime sleep-aid products.
* * * * *
(c) * * *
(3) ``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.''
* * * * *
Dated: March 4, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-8533 Filed 4-8-94; 8:45 am]
BILLING CODE 4160-01-F
