95-7802. Antibiotic Drugs; Bleomycin Sulfate; Withdrawal of Regulation  

  • [Federal Register Volume 60, Number 61 (Thursday, March 30, 1995)]
    [Rules and Regulations]
    [Pages 16376-16377]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-7802]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    
    21 CFR Part 450
    
    [Docket No. 94N-0302]
    
    
    Antibiotic Drugs; Bleomycin Sulfate; Withdrawal of Regulation
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Final rule; withdrawal of regulation.
    
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    SUMMARY: The Food and Drug Administration (FDA) is withdrawing a 
    regulation that established standards for an antibiotic drug, 
    nonsterile bleomycin sulfate bulk drug substance. This action is taken 
    to allow interested persons an opportunity to comment on the standards 
    for nonsterile bleomycin sulfate bulk drug substance. In a future issue 
    of the Federal Register, the agency will issue a proposed rule setting 
    forth standards for bulk nonsterile bleomycin sulfate.
    
    EFFECTIVE DATE: March 30, 1995.
    
    FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug 
    Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
    Standish Pl., Rockville, MD 20855, 301-594-2041.
    
    SUPPLEMENTARY INFORMATION: In the Federal Register of October 4, 1994 
    (59 FR 50484), FDA published a new antibiotic regulation setting forth 
    standards for a nonsterile bleomycin sulfate bulk drug substance (21 
    CFR 450.10). This was published as a final rule to become effective on 
    November 3, 1994. This new regulation differed from [[Page 16377]] the 
    monograph standards for sterile bleomycin sulfate bulk drug, set forth 
    in 21 CFR 450.10a, in two respects: The new regulation did not require 
    sterility at the bulk stage, and the new regulation did not require 
    testing for pyrogens at the bulk stage.
        Bristol-Myers Squibb Co., the sponsor of the innovator product, 
    filed a petition for stay pursuant to 21 CFR 10.35, objecting to FDA's 
    decision to promulgate the new regulation without notice and a prior 
    opportunity for public comment. On November 9, 1994, FDA agreed to stay 
    the effective date of the monograph for nonsterile bleomycin sulfate 
    bulk drug substance to reconsider the manner in which the agency 
    promulgated the new monograph. A copy of FDA's letter notifying 
    Bristol-Myers Squibb Co. of the stay is on file in the Dockets 
    Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
    12420 Parklawn Dr., Rockville, MD 20857. In the Federal Register of 
    March 1, 1995 (60 FR 11026), FDA published a stay of the monograph for 
    nonsterile bleomycin sulfate bulk drug substance.
        Because of the issues that may arise based on the coexistence of 
    alternative standards for nonsterile bleomycin sulfate bulk drug and 
    sterile bleomycin sulfate bulk drug, and because several manufacturers 
    have demonstrated an interest in manufacturing bulk bleomycin sulfate 
    and finished dosage forms for the drug, FDA finds that it is 
    appropriate to provide an opportunity for public comment on the 
    standards. Therefore, FDA is withdrawing the regulation for nonsterile 
    bleomycin sulfate bulk drug substance, and will propose a new 
    regulation setting forth standards for nonsterile bleomycin sulfate 
    bulk drug substance in a future issue of the Federal Register.
        Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
    authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
    450 is amended as follows:
    
    List of Subjects in 21 CFR Part 450
    
        Antibiotics.
    
    PART 450--ANTITUMOR ANTIBIOTIC DRUGS
    
        1. The authority citation for 21 CFR part 450 continues to read as 
    follows:
    
        -Authority: Sec. 507 of the Federal Food, Drug, and Cosmetic Act 
    (21 U.S.C. 357).
    
    
    Sec. 450.10  [Removed]
    
        2. Section 450.10 Bleomycin sulfate is removed.
    
        Dated: March 18, 1995.
     Murray M. Lumpkin,
     Deputy Director, Center for Drug Evaluation and Research.
    [FR Doc. 95-7802 Filed 3-29-95; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Effective Date:
3/30/1995
Published:
03/30/1995
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule; withdrawal of regulation.
Document Number:
95-7802
Dates:
March 30, 1995.
Pages:
16376-16377 (2 pages)
Docket Numbers:
Docket No. 94N-0302
PDF File:
95-7802.pdf
CFR: (1)
21 CFR 450.10