[Federal Register Volume 63, Number 109 (Monday, June 8, 1998)]
[Notices]
[Pages 31224-31225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0362]


Draft Guidance for Industry on Stability Testing of Drug 
Substances and Drug Products; 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availability of a draft guidance for industry entitled ``Stability 
Testing of Drug Substances and Drug Products.'' The draft guidance 
provides recommendations regarding the stability studies that should be 
performed to support new drug applications, abbreviated new drug 
applications, investigational new drug applications, biologics license 
applications, product license applications, and supplements to these 
applications.

DATES: Written comments on the draft guidance may be submitted by 
September 9, 1998. General comments on agency guidance documents are 
welcome at any time.
ADDRESSES: Copies of this draft guidance are available on the Internet 
at http://www.fda.gov/cder/guidance/index.htm or <a href="http://www.fda.gov/
cber/guidelines.htm">http://www.fda.gov/
cber/guidelines.htm</a>. Submit written requests for single copies of the 
draft guidance entitled ``Stability Testing of Drug Substances and Drug 
Products'' to the Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or to the Office of Communication, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research, Food and Drug Administration, 1401 Rockville Pike, 
Rockville MD 20852-1448. Send one self-addressed adhesive label to 
assist the office in processing your request. Submit written comments 
on the draft guidance to the Dockets Management Branch (HFA-305), Food 
and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 
20857. Requests and comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
    Kenneth J. Furnkranz, Center for Drug Evaluation and Research (HFD-
625), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855-2737, 301-827-5848, or
    Rebecca A. Devine, Center for Biologics Evaluation and Research 
(HFM-10), 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Stability Testing of Drug 
Substances and Drug Products.'' The draft guidance provides 
recommendations regarding the stability studies that should be 
performed by pharmaceutical applicants to support applications 
submitted to the Center for

[[Page 31225]]

Drug Evaluation and Research (CDER) and the Center for Biologics 
Evaluation and Research (CBER).
    The draft guidance for industry entitled ``Stability Testing of 
Drug Substances and Drug Products'' revises, updates, and is intended 
to supersede the guidance entitled ``Submitting Documentation for the 
Stability of Human Drugs and Biologics'' (February 1987). This draft 
guidance relies on and incorporates the ICH Q1A guidance ``Stability 
Testing of New Drug Substances and Products'' (59 FR 48754, September 
22, 1994) and its annexes.
    This draft guidance represents the agency's current thinking on 
stability testing of human drugs and biologics regulated by CDER and 
CBER. 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, on or before September 9, 1998, submit 
written comments on the draft guidance 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 draft guidance and received comments may be seen in the 
office above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 2, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15148 Filed 6-5-98; 8:45 am]
BILLING CODE 4160-01-F