[Federal Register: May 19, 2005 (Volume 70, Number 96)]
[Notices]
[Page 28946-28947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my05-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0389] (formerly 02D-0389)
Guidance for Industry on Nonclinical Studies for the Safety
Evaluation of Pharmaceutical Excipients; 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 for industry entitled ``Nonclinical Studies
for the Safety Evaluation of Pharmaceutical Excipients.'' This document
is intended to provide guidance on the types of toxicity information
that FDA recommends be provided to the agency to support the use of new
excipients in drug products. Previously, such information was not
available to drug sponsors in a written document. This information
should allow drug sponsors to determine if a potential new excipient is
safe to use in drug products.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug
[[Page 28947]]
Administration, 5600 Fishers Lane, Rockville, MD 20857, or the Office
of Communications, Training, and Manufacturers Assistance (HFM-40),
Center for Biologics Evaluation and Research, 1401 Rockville Pike, Food
and Drug Administration, Rockville, MD 20852-1448. Send one self-
addressed adhesive label to assist that office in processing your
requests. The guidance may also be obtained by mail by calling the
Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-
827-1800. Submit written comments on the guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
For the Center for Drug Evaluation and Research: Robert E.
Osterberg, Center for Drug Evaluation and Research (HFD-520), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2120, or
For the Center for Biologics Evaluation and Research: Mercedes A.
Serabian, Center for Biologics Evaluation and Research (HFM-760), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-
827-6536.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Nonclinical Studies for the Safety Evaluation of
Pharmaceutical Excipients.'' This guidance addresses the safety testing
of potential excipients to be used in pharmaceutical products. Not all
excipients are inert substances; some have been shown to be potential
toxicants. The Federal Food, Drug, and Cosmetic Act of 1938 (the act)
was enacted after the tragedy of the elixir of sulfanilamide in 1937 in
which an untested excipient was responsible for the death of many
children who consumed the pharmaceutical. The act required
manufacturers to perform safety testing of pharmaceuticals and submit
new drug applications (NDAs) demonstrating safety before marketing.
Since that time, the agency has become aware that certain other
excipients used in commerce can cause serious toxicities in consumers
of prescription and over-the-counter (OTC) drug products in the United
States and other countries.
Some of the information used in developing this guidance was
obtained during meetings involving the International Pharmaceutical
Excipients Council, the United States Pharmacopeia, and the
International Conference on Harmonisation. On October 2, 2002 (67 FR
61910), FDA announced the availability of a draft version of this
guidance entitled ``Nonclinical Studies for Development of
Pharmaceutical Excipients.'' A number of comments were received, and
the agency considered them carefully as it finalized the guidance.
This guidance describes the types of toxicity data that the agency
uses in determining whether a potential new excipient is safe for use
in human pharmaceuticals. It discusses recommended safety evaluations
for excipients proposed for use in OTC and generic drug products, and
describes testing strategies for pharmaceuticals proposed for short-
term, intermediate, and long-term use. It also describes recommended
excipient toxicity testing for pulmonary, injectable, and topical
pharmaceuticals.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on nonclinical studies for the safety
evaluation of pharmaceutical excipients. 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 requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Submit a single copy of electronic comments or two paper copies
of mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. The guidance and received comments are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.
Dated: May 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9957 Filed 5-18-05; 8:45 am]
BILLING CODE 4160-01-S