[Federal Register Volume 61, Number 223 (Monday, November 18, 1996)]
[Rules and Regulations]
[Pages 58629-58630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29387]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 328
[Docket No. 95N-0341]
Over-the-Counter Drug Products Intended for Oral Ingestion that
Contain Alcohol; Amendment of Final Rule
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 regulations for over-the-counter (OTC) drug products
intended for oral ingestion that contain alcohol as an inactive
ingredient by exempting ipecac syrup from the maximum concentration
limits of 0.5 percent alcohol or less when used by children under 6
years of age. This final rule is part of the ongoing review of OTC drug
products conducted by FDA.
EFFECTIVE DATE: December 18, 1996.
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 March 13, 1995 (60 FR 13590), the agency
issued a final rule establishing in Sec. 328.10 (21 CFR 328.10) maximum
concentration limits for alcohol (ethyl alcohol) as an inactive
ingredient in OTC drug products intended for oral ingestion. The
maximum concentration limit was set at 0.5 percent for any OTC drug
product labeled for use by children under 6 years of age, and 5 percent
for any OTC drug product labeled for use by children 6 to under 12
years of age. The final rule did not discuss ipecac syrup, an OTC drug
product used to cause vomiting when poisoning occurs.
The United States Pharmacopeia (USP) 23d Revision states that
alcohol is contained in ipecac syrup in concentrations between 1.0 and
2.5 percent (Ref. 1). Alcohol is used in the preparation of the syrup
to ensure the complete extraction of alkaloids as their amine salts
from ipecac powder and to reject extraneous material when ipecac syrup
is prepared by percolation (Ref. 2).
Under Sec. 201.308(c) (21 CFR 201.308(c)), OTC marketing of ipecac
syrup is limited to a 1-fluid-ounce (30 milliliters (mL)) package. The
product's labeling must contain a statement conspicuously boxed and in
red letters that states: ``For emergency use to cause vomiting in
poisoning. Before using, call physician, the Poison Control Center, or
hospital emergency room immediately for advice.'' The labeling also
must state: ``Usual dosage: 1 tablespoon (15 milliliters) in persons
over 1 year of age.''
As part of the rulemaking for OTC poison treatment drug products
(50 FR 2244, January 15, 1985), the agency proposed a dose of 1
tablespoonful (15 mL or 1/2 bottle) of ipecac syrup for children 1 to
under 12 years of age. The agency also proposed a dose of 1 teaspoonful
(5 mL) for children 6 months to under 1 year of age, and that ipecac
syrup not be given to children under 6 months of age unless directed by
a health professional. The agency will finalize these directions for
use in a future issue of the Federal Register.
In the Federal Register of May 10, 1996 (61 FR 21392), the agency
published a proposed amendment of Sec. 328.10 to exempt ipecac syrup
from the requirements of Sec. 328.10(d), which
[[Page 58630]]
limit alcohol content to 0.5 percent or less in OTC drug products
intended for oral ingestion for use by children 6 years of age or less.
The agency noted that the maximum amount of ipecac syrup per
packaged container does not exceed 30 mL, and the maximum quantity of
alcohol at a 2.5 percent concentration contained in 30 mL of ipecac
syrup is 0.75 mL. If a child under 6 years old swallowed the entire
contents of a 30 mL container of ipecac syrup, the ingested amount of
alcohol (0.75 mL) is insignificant. The labeled dose of ipecac syrup is
a one-time treatment of 15 mL (0.375 mL alcohol) for children 1 to
under 12 years of age. In addition, the alcohol and the ipecac syrup
are generally vomited together with other stomach contents. Thus, the
benefit of ipecac syrup as an emetic outweighs any risk of adverse
effects from ingestion of 0.375 to 0.75 mL of alcohol.
Interested persons were invited to submit comments by June 10,
1996, and comments on the agency's economic impact determination by
June 10, 1996. No comments were submitted in response to the proposed
rule.
II. References
(1) United States Pharmacopeia 23/National Formulary 18, United
States Pharmacopeial Convention, Inc., Rockville, MD, pp. 834-835,
1994.
(2) ``Solutions Using Mixed Solvent Systems: Spirits, Elixirs,
and Extracted Products,'' in Sprowls' American Pharmacy, 7th ed., J.
B. Lipincott Co., Philadelphia, pp. 100-101, 1974.
III. The Agency's Final Conclusions
The agency is adding new Sec. 328.10(f) to state: ``Ipecac syrup is
exempt from the provisions of paragraph (d) of this section.'' This
means that ipecac syrup may contain more than 0.5 percent alcohol even
though labeled for use by children under 6 years of age. Also, the
agency is redesignating current Sec. 328.10(f) as Sec. 328.10(g).
IV. Analysis of Impacts
No comments regarding the economic impact of the proposed
rulemaking were received.
FDA has examined the impacts of this 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. Because this final rule has no effect on
the OTC marketing of ipecac syrup drug products, it 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. 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 328
Drugs, Labeling, Alcohol.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
328 is amended as follows:
PART 328--OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL
INGESTION THAT CONTAIN ALCOHOL
1. The authority citation for 21 CFR part 328 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 505, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 355, 371).
2. Section 328.10 is amended by redesignating paragraph (f) as
paragraph (g) and by adding new paragraph (f) to read as follows:
Sec. 328.10 Alcohol.
* * * * *
(f) Ipecac syrup is exempt from the provisions of paragraph (d) of
this section.
* * * * *
Dated: November 5, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-29387 Filed 11-15-96; 8:45 am]
BILLING CODE 4160-01-F