96-11640. Over-the-Counter Drug Products Intended for Oral Ingestion that Contain Alcohol; Proposed Amendment of Final Rule  

  • [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]
    
    
    
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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; Proposed Amendment of Final Rule
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice of proposed rulemaking.
    
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    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
    
    

Document Information

Published:
05/10/1996
Department:
Health and Human Services Department
Entry Type:
Proposed Rule
Action:
Notice of proposed rulemaking.
Document Number:
96-11640
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.
Pages:
21392-21394 (3 pages)
Docket Numbers:
Docket No. 95N-0341
PDF File:
96-11640.pdf
CFR: (1)
21 CFR 328.10