[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