[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52138-52139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0410]


Guidance for Industry on SUPAC-MR, Modified Release Solid Oral 
Dosage Forms; Scale-Up and Postapproval Changes for Chemistry, 
Manufacturing, and Controls; 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 guidance for industry entitled ``SUPAC-MR: Modified 
Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: 
Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing 
and In Vivo Bioequivalence Documentation.'' The purpose of this 
guidance document is to provide insight and recommendations to 
pharmaceutical sponsors of new drug applications (NDA's), abbreviated 
new drug applications (ANDA's), and abbreviated antibiotic applications 
(AADA's) who intend to change the components or composition, the 
manufacturing (process or equipment), the scale-up/scale-down of 
manufacture, and/or the site of manufacture of a modified release solid 
oral formulation during the postapproval period. This guidance document 
represents the agency's current thinking on scale-up and postapproval 
changes (SUPAC) for modified release solid oral dosage forms regulated 
by the Center for Drug Evaluation and Research (CDER).

DATES: Written comments may be submitted at any time.

ADDRESSES: Submit written requests for single copies of ``SUPAC-MR: 
Modified Release Solid Oral Dosage Forms; Scale-Up and Postapproval 
Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution 
Testing and In Vivo Bioequivalence Documentation'' to the Drug 
Information Branch (HFD-210), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 
Send two self-addressed adhesive labels to assist that office in 
processing your requests. Submit written comments on the guidance 
document to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Mehul U. Mehta, Center for Drug 
Evaluation and Research (HFD-860), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-0501.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``SUPAC-MR: Modified Release Solid Oral 
Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, 
Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo 
Bioequivalence Documentation.'' The purpose of this guidance document 
is to provide insight and recommendations to pharmaceutical sponsors of 
NDA's, ANDA's, and AADA's who intend to change: (1) The components or 
composition; (2) the manufacturing (process or equipment); (3) the 
scale-up/scale-down of manufacture; and/or (4) the site of manufacture 
of a modified release solid oral formulation during the postapproval 
period. The guidance document defines the following: (1) Levels of 
change; (2) recommended chemistry, manufacturing, and controls (CMC) 
tests to support each level of change; (3) recommended in vitro 
dissolution release tests and/or in vivo bioequivalence tests to 
support each level of change; and (4) documentation to support the 
change.
    For postapproval changes for modified release dosage forms that 
affect components and composition, manufacturing process or equipment 
changes, scale-up, and site change, this guidance supersedes the 
recommendations in section 4.G of the Office of Generic Drugs Policy 
and Procedure Guide 22-90 (FDA, September 11, 1990). For all other 
dosage forms and changes, this guidance does not affect the 
recommendations in Guide 22-90.
    This guidance document represents the agency's current thinking on 
SUPAC for modified release solid oral dosage forms regulated by CDER. 
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 
statute, regulations, or both.
    Interested persons may, at any time, submit written comments on the 
guidance document to the Dockets Management Branch (address above). Two 
copies of any 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. A copy of the 
guidance

[[Page 52139]]

document and received comments may be seen in the office above between 
9 a.m. and 4 p.m., Monday through Friday.
    An electronic version of this guidance is also available on the 
Internet at http://www.fda.gov/cder/guidance/index.htm.

    Dated: September 29, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26412 Filed 10-3-97; 8:45 am]
BILLING CODE 4160-01-F