97-24349. Biological Product Standards; Technical Amendment  

  • [Federal Register Volume 62, Number 178 (Monday, September 15, 1997)]
    [Rules and Regulations]
    [Pages 48174-48175]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-24349]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 610
    
    
    Biological Product Standards; Technical Amendment
    
    Agency: Food and Drug Administration, HHS.
    
    Action: Final rule; technical amendment.
    
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    SUMMARY: The Food and Drug Administration (FDA) is amending the 
    regulations for biological products standards to update a reference to 
    the United States Pharmacopeia (USP). The agency has determined that 
    the 1995 edition of the USP should be referenced rather than previous 
    editions. This action is necessary to ensure the consistency and 
    accuracy of the regulations.
    
    DATES: The regulation is effective September 15, 1997. The Director of 
    the Office of the Federal Register approves the incorporation by 
    reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a 
    certain publication in 21 CFR 610.12(f), effective September 15, 1997.
    
    FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics 
    Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
    Rockville Pike, suite 200N, Rockville, MD 20852, 301-594-3074.
    
    SUPPLEMENTARY INFORMATION: Section 610.12(f) (21 CFR 610.12(f)) 
    incorporates by reference the 1985 edition of the USP concerning test 
    procedures for membrane filtration. Since the USP has been revised and 
    the 1995 edition of the USP (23d Revision, 1995) is more readily 
    available to the public, FDA has determined that Sec. 610.12(f) should 
    reference the test standards for the ``Test Procedures Using Membrane 
    Filtration'' in the 1995 edition, in lieu of the test standards in the 
    1985 edition. The test standards for membrane filtration in the 1995 
    edition of the USP are identical to
    
    [[Page 48175]]
    
    those in the 1985 edition with the following exceptions:
        (1) In the second paragraph under ``Apparatus,'' the 1985 edition 
    states ``A membrane generally suitable for sterility testing has a 
    normal porosity of .45 +/-0.02um, * * *,'' while the 1995 edition does 
    not include the ``+/-0.02um''; and
        (2) the 1985 edition did not have a section on ``Filterable 
    Solids,'' because information of filterable solids was not available in 
    1985. The 1995 edition now has this information.
        Because these differences in the two editions of the USP are 
    insignificant, and the 1995 edition is more readily available to the 
    public, the agency believes that the regulation should be amended, as 
    indicated herein, to reflect the more recent version of the test 
    standards. Accordingly Sec. 610.12(f) is being amended to reflect the 
    1995 edition of the USP (23d Revision, 1995).
        Publication of this document constitutes final action on this 
    change under the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)). 
    Notice and public procedure are unnecessary because FDA is merely 
    updating a reference in its regulations.
    
    List of Subjects in 21 CFR Part 610
    
        Biologics, Incorporation by reference, Labeling, Reporting and 
    recordkeeping requirements.
        Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
    authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
    610 is amended as follows:
    
    PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS
    
        1. The authority citation for 21 CFR part 610 continues to read as 
    follows:
    
        Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353, 
    355, 360, 371); secs. 215, 351, 352, 353, 361 of the Public Health 
    Service Act (42 U.S.C. 216, 262, 263, 263a, 264).
    
        2. Section 610.12 is amended by revising paragraph (f) to read as 
    follows:
    
    Sec. 610.12  Sterility.
    
    * * * * *
        (f) Membrane filtration. Bulk and final container material or 
    products containing oil products in water-insoluble ointments may be 
    tested for sterility using the membrane filtration procedure set forth 
    in the United States Pharmacopeia (23d Revision, 1995), section 
    entitled ``Test Procedures Using Membrane Filtration,'' pp. 1689 to 
    1690, which is incorporated by reference in accordance with 5 U.S.C. 
    552(a) and 1 CFR part 51. Copies are available from the United States 
    Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 
    20852, or available for inspection at the Center for Drug Evaluation 
    and Research's Division of Medical Library, 5600 Fishers Lane, rm. 11B-
    40, Rockville, MD, or at the Office of the Federal Register, 800 North 
    Capitol St. NW., suite 700, Washington, DC, except that:
        (1) The test samples shall conform with paragraph (d) of this 
    section; and
        (2) In addition, for products containing a mercurial preservative, 
    the product shall be tested in a second test using Fluid Thioglycollate 
    Medium incubated at 20 to 25  deg.C in lieu of the test in Soybean-
    Casein Digest Medium.
    * * * * *
    
        Dated: September 2, 1997.
    William K. Hubbard,
    Associate Commissioner for Policy Coordination.
    [FR Doc. 97-24349 Filed 9-12-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
9/15/1997
Published:
09/15/1997
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule; technical amendment.
Document Number:
97-24349
Dates:
The regulation is effective September 15, 1997. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication in 21 CFR 610.12(f), effective September 15, 1997.
Pages:
48174-48175 (2 pages)
PDF File:
97-24349.pdf
CFR: (1)
21 CFR 610.12