[Federal Register Volume 62, Number 114 (Friday, June 13, 1997)]
[Notices]
[Page 32352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15451]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0211]
Guidance for Industry on Nonsterile Semisolid Dosage Forms
(SUPAC-SS) 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 document entitled ``Guidance for Industry:
Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval Changes:
Chemistry, Manufacturing, and Controls; In Vitro Release 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 drug applications
(AADA's) who intend to change the components or composition, the
manufacturing (process and equipment), the scale-up/scale-down of
manufacture, and/or the site of manufacture of a semisolid formulation
during the postapproval period. This guidance document addresses
nonsterile semisolid preparations (e.g., creams, gels, lotions, and
ointments) intended for topical routes of administration. This guidance
document represents the agency's current thinking on scale-up and
postapproval changes for nonsterile semisolid (SUPAC-SS) 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 ``Guidance for
Industry: Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval
Changes: Chemistry, Manufacturing, and Controls; In Vitro Release
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 one self-addressed adhesive label 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: Vinod P. Shah, Center for Drug
Evaluation and Research (HFD-350), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-5635.
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
guidance document entitled ``Guidance for Industry: Nonsterile
Semisolid Dosage Forms; Scale-Up and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Release 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 and equipment); (3) the
scale-up/scale-down of manufacture; and/or (4) the site of manufacture
of a semisolid formulation during the postapproval period. This
guidance document addresses nonsterile semisolid preparations (e.g.,
creams, gels, lotions, and ointments) intended for topical routes of
administration. 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 release
tests and/or in vivo bioequivalence tests to support each level of
change; and (4) documentation to support the change.
This guidance document represents the agency's current thinking on
scale-up and postapproval changes for nonsterile semisolid 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
requirement 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. The guidance
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 document is also available
on the Internet using the World Wide Web (http://www.fda.gov/cder/
guidance.htm).
Dated: June 5, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-15451 Filed 6-12-97; 8:45 am]
BILLING CODE 4160-01-F