[Federal Register: November 7, 2003 (Volume 68, Number 216)]
[Notices]
[Page 63109-63110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no03-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0493]
Draft Guidance for Industry on Powder Blends and Finished Dosage
Units--Stratified In-Process Dosage Unit Sampling and Assessment;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Powder Blends
and Finished Dosage Units--Stratified In-Process Dosage Unit Sampling
and Assessment.'' The draft guidance is intended to provide
recommendations to manufacturers of human drug products on how to
develop a single control procedure to demonstrate the adequacy of mix
to ensure uniformity and homogeneity of in-process powder blends and
finished dosage units.
DATES: Submit written or electronic comments on the draft guidance by
March 8, 2004. General comments on agency draft guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit written comments
on the draft guidance to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Jon Clark, Center for Drug Evaluation
and Research (HFD-003), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-443-5103.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Powder Blends and Finished Dosage Units--Stratified In-
Process Dosage Unit Sampling and Assessment.'' The draft guidance is
intended to respond to industry concerns regarding FDA policies on
demonstrating the adequacy of in-process powder mixing and uniform
content in finished products under 21 CFR 211.110(a)(3).
In the Federal Register of August 27, 1999 (64 FR 46917), FDA
published notice of the availability of a draft guidance for industry
on blend uniformity analysis. Although FDA subsequently withdrew the
draft guidance on May 17, 2002 (67 FR 35120), comments submitted on the
draft guidance led to the formation of the Blend Uniformity Working
Group (BUWG). The BUWG, which includes representatives from the agency,
industry, and academia, conducted a public meeting on September 7 and
8,
[[Page 63110]]
2000, and developed a draft recommendation, ``The Use of Stratified
Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for
Powder Blends,'' which included the consensus reached by participants
in this workshop. The PDA Journal of Pharmaceutical Science and
Technology published the recommendation (March/April 2003, pp. 59-74).
This draft guidance reflects CDER's effort to incorporate the
recommendation into regulatory policy.
Stratified sampling is the selection of in-process dosage unit
samples to specifically target locations in the compression/filling
operation that have the greatest potential to yield extreme highs and
lows in test results. The test results are used to monitor the
manufacturing process output that is most responsible for causing
finished product variability. These test results can be used to develop
a single control procedure to ensure adequate powder mix and uniform
content in finished products.
This draft guidance is being issued consistent with FDAs good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on ``Powder
Blends and Finished Dosage Units--Stratified In-Process Dosage Unit
Sampling and Assessment.'' It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the draft guidance.
Two copies of mailed comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document. The
draft guidance and received comments are available for public
examination in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.
Dated: October 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28045 Filed 11-6-03; 8:45 am]
BILLING CODE 4160-01-S