[Federal Register Volume 68, Number 216 (Friday, November 7, 2003)]
[Notices]
[Pages 63109-63110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28045]


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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Draft Guidance for Industry on Powder Blends and Finished Dosage 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availability of a draft guidance for industry entitled ``Powder Blends 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 The draft guidance is intended to provide 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DATES: Submit written or electronic comments on the draft guidance by 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 General comments on agency draft guidance documents are 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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://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access to the draft guidance document.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    FDA is announcing the availability of a draft guidance for industry 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 The draft guidance is 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://www.fda.gov/cder/guidance/index.htm or 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