99-6447. Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use; Required Alcohol Warning; Final Rule; Compliance Date  

  • [Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
    [Rules and Regulations]
    [Pages 13066-13067]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 99-6447]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 201
    
    [Docket No. 77N-094W]
    
    
    Over-the-Counter Drug Products Containing Analgesic/Antipyretic 
    Active Ingredients for Internal Use; Required Alcohol Warning; Final 
    Rule; Compliance Date
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule; compliance date.
    
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    SUMMARY: The Food and Drug Administration (FDA) is establishing a 
    compliance date of October 22, 1999, for the regulation that published 
    in the Federal Register of October 23, 1998 (63 FR 56789). The 
    regulation established warning statements that advise consumers with a 
    history of heavy alcohol use to consult a physician for advice about 
    the use of OTC internal analgesic/antipyretic drug products. The 
    compliance date applies to all affected OTC drug products, whether 
    marketed with or without an approved application. FDA is taking this 
    action in response to correspondence and a citizen petition requesting 
    more time to relabel these products.
    
    DATES: 21 CFR 201.322, published on October 23, 1998 (63 FR 56789), is 
    effective April 23, 1999; but compliance is not required until October 
    22, 1999.
    
    FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug 
    Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
    Fishers Lane, Rockville, MD 20857, 301-827-2307.
    
    SUPPLEMENTARY INFORMATION: 
    
    I. Background
    
        In the Federal Register of November 14, 1997 (62 FR 61041), FDA 
    published a proposed amendment of part 201 (21 CFR part 201) to 
    establish alcohol warnings for all OTC drug products labeled for adult 
    use containing internal analgesic/antipyretic active ingredients. The 
    agency stated that it may change the wording of the proposed warnings 
    or not require them as a result of comments filed in response to the 
    proposal. Because it wished to encourage the voluntary use of the 
    proposed warning statements, the agency advised that manufacturers 
    would be given ample time after publication of a final rule to use up 
    any labeling printed in conformance with the proposal (62 FR 61041 at 
    61052).
        In the Federal Register of October 23, 1998 (63 FR 56789), FDA 
    issued a final rule amending part 201 and establishing in Sec. 201.322 
    a required alcohol warning for OTC drug products containing internal 
    analgesic/antipyretic active ingredients. The final rule requires 
    manufacturers to add certain new warnings for any OTC drug product, 
    labeled for adult use, containing any internal analgesic/antipyretic 
    active ingredients (including, but not limited to, acetaminophen, 
    aspirin, carbaspirin calcium, choline salicylate, ibuprofen, 
    ketoprofen, magnesium salicylate, naproxen sodium, and sodium 
    salicylate) alone or in combination and marketed with or without an 
    approved application. The wording of the warnings in the final rule was 
    different than the wording in the proposal. The final rule specified an 
    effective date of April 23, 1999, for any OTC drug product subject to 
    this section.
    
    II. Summary of Comments Received
    
        In response to the final rule, the agency received several comments 
    (Ref. 1) and a citizen petition (Ref. 2) requesting more time to 
    implement the new required alcohol warnings and a mechanism by which 
    manufacturers may petition the agency for a variance or extension of 
    time to comply with the regulation's 6-month implementation date. The 
    comments were submitted by several large manufacturers of brand name 
    OTC internal analgesic/antipyretic drug products and a manufacturer of 
    a large number of private label OTC internal analgesic/antipyretic drug 
    products. The comments stated that relabeling procedures generally take 
    longer than the 6 months provided for in the final rule and that the 
    companies simply lack the needed manpower and equipment to comply by 
    April 23, 1999.
        The comments added that the implementation period for the new rule 
    must ensure that label integrity is not compromised or done 
    haphazardly. The comments stated that 6 months is an insufficient 
    period of time for a number of companies to accomplish the relabeling, 
    and the short timeframe does not promote emphasis on labeling integrity 
    and good manufacturing practice compliance. All of the comments 
    expressed concern that numerous products could become unavailable and 
    estimated significant loss of inventory if required to implement the 
    labeling change by April 23, 1999.
        One comment requested permission to use up all existing supplies of 
    labeling that contain the precise alcohol warning contained in an 
    agency letter dated March 14, 1996 (Ref. 3). Another
    
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    comment, submitted by a manufacturer, stated that it would implement 
    the new alcohol warnings by the effective date and that other affected 
    companies should also be required to meet that date (Ref. 4).
        The agency held a public meeting on January 20, 1999 (Ref. 5), to 
    hear the views of interested parties regarding the implementation date 
    of the rule. At this meeting, one large private label manufacturer of 
    internal analgesic/antipyretic drug products stated that it would not 
    be able to meet the April 23, 1999, implementation date, and that if 
    the deadline were not extended a real possibility existed that there 
    would be a national shortage of certain products that it manufactures. 
    Another manufacturer at the meeting stated that it would be able to 
    comply by the implementation date.
    
    III. The Agency's Response
    
        As stated in the final rule, the agency considers the lack of 
    sufficient alcohol warnings to be a significant public health issue. 
    However, additional information (Refs. 6 through 11) that the agency 
    has obtained since publication of the final rule suggests that the 
    agency may have underestimated the number of individual label changes 
    that some manufacturers will have to make. This information also 
    indicates that there may be a significantly greater disparity in the 
    effect of the required labeling upon manufacturers than originally 
    anticipated. For these reasons, FDA now believes that the original 6-
    month implementation period would not provide adequate time for many 
    manufacturers of affected products to relabel a significant number of 
    their products and that strict adherence to the April 23, 1999, 
    effective date might result in short-term shortages of some of these 
    important OTC drug products, which are widely used by many consumers. 
    Consequently, the agency believes that establishing a compliance date 
    for the regulation, until October 22, 1999, will provide sufficient 
    time for industry to implement the labeling revisions required for 
    these OTC internal analgesic/antipyretic drug products.
        The agency does not believe that there should be an open-ended 
    period, as one comment requested, to use up existing supplies of 
    labeling that contain an alcohol warning that was implemented 
    voluntarily in response to an agency letter dated March 14, 1996 (Ref. 
    3). Rather, FDA believes that there should be a date certain after 
    which all products initially introduced or initially delivered for 
    introduction into interstate commerce contain the new warnings. 
    Further, because of the importance of the alcohol warnings, the agency 
    continues to encourage all affected manufacturers to bring their 
    labeling into compliance with the final rule as promptly as possible.
        Because this document merely establishes a compliance date, FDA 
    finds that notice and comment procedures are unnecessary and not in the 
    public interest (5 U.S.C. 553(b) and (d)). Moreover, because of the 
    need for the agency to publish this document before the original April 
    23, 1999, effective date, notice and comment rulemaking would be 
    impracticable for this document.
    
    IV. Analysis of Impacts
    
        The economic impact of the final regulation was discussed in the 
    final rule (63 FR 56789 at 56798 to 56799). This document will provide 
    additional time for companies to relabel affected products and will 
    reduce label obsolescence, as there will be additional time to use up 
    more existing labeling. Thus, setting a compliance date of October 22, 
    1999, should reduce the economic impact on industry significantly.
        FDA has examined the impacts of this final rule (establishment of 
    the compliance date) 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 set 
    out in the Executive Order. 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.
        The Regulatory Flexibility Act requires agencies to analyze 
    regulatory options that would minimize any significant impact of a rule 
    on small entities. This final rule sets a compliance date, which will 
    provide manufacturers additional time to use up existing product 
    labeling. Accordingly, the agency certifies that the final rule will 
    not have a significant economic impact on a substantial number of small 
    entities. Therefore, under the Regulatory Flexibility Act, no further 
    analysis is required.
    
    V. Paperwork Reduction Act of 1995
    
        FDA concludes that the labeling requirements in this document are 
    not subject to review by the Office of Management and Budget because 
    they do not constitute a ``collection of information'' under the 
    Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the 
    labeling statements are a ``public disclosure of information originally 
    supplied by the Federal government to the recipient for the purpose of 
    disclosure to the public'' (5 CFR 1320.3(c)(2)).
    
    VI. Environmental Impact
    
        The agency has determined under 21 CFR 25.31(c) 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.
    
    VII. References
    
        The following references are on display in the Dockets Management 
    Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
    1061, Rockville, MD 20852, and may be seen by interested parties 
    between 9 a.m. and 4 p.m., Monday through Friday.
        1. Comment Nos. C20, C21, and C22, Docket No. 77N-094W, Dockets 
    Management Branch.
        2. Comment No. CP1, Docket No. 77N-094W, Dockets Management 
    Branch.
        3. Letter from D. Bowen, FDA, to R. Soller, Nonprescription Drug 
    Manufacturers Association, Coded LET2, Docket No. 77N-094W, Dockets 
    Management Branch.
        4. Comment No. C19, Docket No. 77N-094W, Dockets Management 
    Branch.
        5. Comment No. MM, Docket No. 77N-094W, Dockets Management 
    Branch.
        6. Letter from K. Rothschild, FDA, to D. Jespersen, Perrigo, 
    coded LET3, Docket No. 77N-094W, Dockets Management Branch.
        7. Letter from K. Rothschild, FDA, to H. McCain, Whitehall-
    Robins, coded LET4, Docket No. 77N-094W, Dockets Management Branch.
        8. Comment No. C23, Docket No. 77N-094W, Dockets Management 
    Branch.
        9. Comment No. C24, Docket No. 77N-094W, Dockets Management 
    Branch.
        10. Letter from K. Rothschild, FDA, to H. McCain, Whitehall-
    Robins, coded LET5, Docket No. 77N-094W, Dockets Management Branch.
        11. Comment No. C25, Docket No. 77N-094W, Dockets Management 
    Branch.
    
        Dated: March 11, 1999.
    William K. Hubbard,
    Acting Deputy Commissioner for Policy.
    [FR Doc. 99-6447 Filed 3-12-99; 12:40 pm]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
4/23/1999
Published:
03/17/1999
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule; compliance date.
Document Number:
99-6447
Dates:
21 CFR 201.322, published on October 23, 1998 (63 FR 56789), is effective April 23, 1999; but compliance is not required until October 22, 1999.
Pages:
13066-13067 (2 pages)
Docket Numbers:
Docket No. 77N-094W
PDF File:
99-6447.pdf
CFR: (1)
21 CFR 201