[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