[Federal Register Volume 61, Number 92 (Friday, May 10, 1996)]
[Proposed Rules]
[Pages 21392-21394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11640]



-----------------------------------------------------------------------


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; Proposed Amendment of Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a notice of 
proposed rulemaking that would amend 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 proposal is part of the ongoing 
review of OTC drug products conducted by FDA.

DATES: Submit written comments by June 10, 1996; written comments on 
the agency's economic impact determination by June 10, 1996. The agency 
is proposing that any final rule based on this proposal become 
effective on the date of its publication in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch

[[Page 21393]]

(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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.

References

    (1) United States Pharmacopeia 23d Revision 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.

II. The Agency's Proposed Amendment

    The agency is proposing to exempt ipecac syrup from the 
requirements of Sec. 328.10(d), which 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.
    Ipecac syrup is indicated for use in potential life-threatening 
emergencies with directions for use calling for a one-time treatment 
dose of 15 mL for children 1 to under 12 years of age. Ipecac syrup is 
usually used under the advice of a health professional, and it is not 
indicated for repeated or routine use. Because the maximum amount of 
ipecac syrup per packaged container does not exceed 30 mL, 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. In addition, the alcohol 
and the ipecac syrup are generally vomited together with other stomach 
contents. The agency concludes that the benefit of ipecac syrup as an 
emetic outweighs any risk of adverse effects from ingestion of 0.75 mL 
of alcohol. Accordingly, the agency is proposing to add a new paragraph 
to Sec. 328.10 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. The agency is designating this new 
paragraph as paragraph (f) and redesignating current paragraph (f) as 
paragraph (g).

III. Analysis of Impacts

    The agency has examined the economic consequences of this proposed 
rulemaking in conjunction with other rules resulting from the OTC drug 
review. In a notice published in the Federal Register of February 8, 
1983 (48 FR 5806), the agency announced the availability of an 
assessment of these economic impacts. The assessment determined that 
the combined impacts of all the rules resulting from the OTC drug 
review do not constitute a major rule according to the criteria 
established by Executive Order 12291. Executive Order 12291 has been 
superseded by Executive Order 12866. FDA has examined the impacts of 
the proposed rule under Executive Order 12866 and the Regulatory 
Flexibility Act (Pub. L. 96-354). 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 
proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and, thus, is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This proposal has no effect on the OTC marketing of 
ipecac syrup drug products. Therefore, the agency certifies that this 
proposal, if implemented, will not have a significant economic impact 
on a substantial number of small entities.
    The agency invites public comment regarding any substantial or 
significant economic impact that this rulemaking would have on OTC drug 
products intended for oral ingestion that contain alcohol as an 
inactive ingredient. Comments regarding the impact of this rulemaking 
on OTC drug products intended for oral ingestion that contain alcohol 
as an inactive ingredient should be accompanied by appropriate 
documentation.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(c)(6) that this action 
is not 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.

V. Request for Comments

    Interested persons may, on or before June 10, 1996, submit to the 
Dockets Management Branch (address above) written comments or 
objections on the proposed regulation. Written comments on the agency's 
economic impact determination may be submitted on or before June 10, 
1996. Three copies of all comments or objections are to be submitted, 
except that individuals may submit one copy. Comments or

[[Page 21394]]

objections are to be identified with the docket number found in 
brackets in the heading of this document and may be accompanied by a 
supporting memorandum or brief. The agency has determined that comments 
or objections should be submitted within 30 days because this proposal 
has no effect on currently marketed products.-

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, it is 
proposed that 21 CFR part 328 be 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: May 1, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-11640 Filed 5-9-96; 8:45 am]
BILLING CODE 4160-01-F