[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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