[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
