95-15923. Antibiotic Drugs; Cefotetan and Cefotetan Disodium Injection; Technical Amendments

[Federal Register Volume 60, Number 125 (Thursday, June 29, 1995)]
[Rules and Regulations]
[Page 33712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15923]




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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 442

[Docket No. 94N-0132]


Antibiotic Drugs; Cefotetan and Cefotetan Disodium Injection; 
Technical Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is technically amending 
a final rule that appeared in the Federal Register of May 25, 1994 (59 
FR 26939). The document amended the antibiotic drug regulations to 
provide for the inclusion of accepted standards for a new bulk form of 
cefotetan. The agency received a comment on the final rule that pointed 
out, among other things, that the correct name of the antibiotic is 
cefotetan disodium. This document corrects those errors.

EFFECTIVE DATE: June 29, 1995.

FOR FURTHER INFORMATION CONTACT: James M. Timper, Center for Drug 
Evaluation and Research (HFD-520), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-6714.

SUPPLEMENTARY INFORMATION: As published, the final regulation contains 
errors that may prove to be misleading and are in need of 
clarification. The name of the antibiotic is ``cefotetan disodium'' not 
``cefotetan sodium.'' The calculation for determining cefotetan 
concentration in the finished dosage form was published incorrectly, 
and an additional sample preparation, potassium bromide discs, can be 
used also. Accordingly the agency is amending 21 CFR 442.52 to correct 
those errors.

List of Subjects in 21 CFR Part 442

    Antibiotics.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
442 is amended as follows:

PART 442--CEPHA ANTIBIOTIC DRUGS

    1. The authority citation for 21 CFR part 442 continues to read as 
follows:

    Authority: Sec. 507 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 357).

    2. Section 442.52 is amended by revising paragraphs (b)(1)(iv) and 
(b)(3) to read as follows:

Sec. 442.52  Cefotetan.

    (b) * * *
    (1) * * *
    (iv) Calculation. Calculate the micrograms of cefotetan per 
milligram of sample as follows:


                                                                        
                                                   AU X PS X Vf X 1,000 
Micrograms of cefotetan             =            -----------------------
     per milligram                                        AS X Vs       
                                                                        

where:
AU = Area of the cefotetan peak in the chromatogram of the 
sample (at a retention time equal to that observed for the 
standard);
AS = Area of the cefotetan peak in the chromatogram of the 
cefotetan working standard;
PS = Cefotetan activity in the cefotetan working standard 
solution in micrograms per milliliter;
Vf = Volume of flask used to dilute standard; and
Vs = Volume of sample diluted.
* * * * *
    (3) Identity. Proceed as directed in Sec. 436.211 of this chapter 
using the potassium bromide discs prepared as described in 
Sec. 436.211(b)(1) of this chapter or the mineral oil mull prepared as 
described in Sec. 436.211(b)(2) of this chapter.
    Dated: May 9, 1995.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 95-15923 Filed 6-28-95; 8:45 am]
BILLING CODE 4160-01-F