[Federal Register Volume 62, Number 131 (Wednesday, July 9, 1997)]
[Notices]
[Pages 36836-36837]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0267]


Guidance for Industry on Expiration Dating and Stability Testing 
of Solid Oral Dosage Form Drugs Containing Iron; 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: 
Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs 
Containing Iron.'' The guidance document provides information to 
manufacturers of iron-containing drug products who are affected by a 
final rule that requires label warning statements and unit-dose 
packaging for solid oral drug products that contain 30 milligrams (mg) 
or more of iron per dosage unit. The guidance document describes the 
circumstances under which the agency does not intend to object, for a 
limited period of time, to modified expiration dating by drug 
manufacturers and packagers who are required to package their products 
into unit-dose containers under the final rule.

DATES: Written comments may be submitted at any time. The agency does 
not expect to be guided by the recommendations in this guidance 
document after July 15, 1999.

ADDRESSES: Submit written requests for single copies of ``Guidance for 
Industry: Expiration Dating and Stability Testing of Solid Oral Dosage 
Form Drugs Containing Iron'' 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.

FOR FURTHER INFORMATION CONTACT: Barry Rothman, Center for Drug 
Evaluation and Research (HFD-325), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-0098.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance document entitled ``Guidance for Industry: Expiration Dating 
and Stability Testing of Solid Oral Dosage Form Drugs Containing 
Iron.'' The purpose of this guidance document is to describe an 
approach to stability testing and expiration dating for a limited class 
of iron-containing products for certain manufacturers and packagers of 
drug products containing iron. In the Federal Register of January 15, 
1997 (62 FR 2218), FDA issued a final rule entitled ``Iron-Containing 
Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging 
Requirements'' (hereinafter called the iron regulations). The iron 
regulations, effective July 15, 1997, require label warning statements 
and unit-dose packaging for solid oral drug products that contain 30 mg 
or more of iron per dosage unit.
    FDA requires that drug products bear an expiration date determined 
by appropriate stability testing Secs. 211.137 and 211.166 (21 CFR 
211.137 and 211.166). Drug product stability needs to be evaluated over 
time in the same container-closure system that will be used in the 
marketing of the product, and accelerated stability studies can be used 
to support tentative expiration dates in the event that full shelf life 
studies are not available. When a firm changes the packaging of a drug 
product, stability testing must be performed on the product in its new 
packaging, and expiration dating must reflect the results of the new 
stability testing.
    To meet the requirements of the iron regulations, all manufacturers 
of solid oral drug products that contain 30 mg or more of iron per 
dosage unit must package their products in unit-dose packaging. As a 
result, these manufacturers must determine an appropriate expiration 
date for that packaging. Because the final iron regulations were 
published only 6 months before they were to take effect, accelerated 
stability testing may be necessary to justify an expiration date of 
more than 6 months. However, accelerated stability studies are 
impractical for some drug products containing iron, especially 
multivitamin products, because such products often do not perform well 
under the artificially stressful conditions of accelerated studies. For 
these drug products, real-time stability testing may be the only method 
to determine an appropriate expiration date. To minimize the burden 
faced by those manufacturers and packagers who have made good faith 
efforts to comply with the stability testing requirements but were 
unable to do so, FDA advises that, for a limited period of time, it 
does not intend to object if such a firm fails to comply with 
Secs. 211.137 and 211.166, so long as it establishes expiration dates 
and stability testing protocols under the specific approach described 
in the guidance document. FDA expects that sufficient stability testing 
will be performed in a timely fashion; therefore, the agency does not 
expect to be guided by the recommendations in this guidance document 
after July 15, 1999.
    This guidance document represents the agency's current thinking on 
expiration dating for solid oral drug products containing 30 mg or more 
of iron. 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 to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Requests and comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance 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 using the World Wide Web at http://www.fda.gov/cder/
guidance.htm.


[[Page 36837]]


    Dated: June 30, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-17796 Filed 7-8-97; 8:45 am]
BILLING CODE 4160-01-F