[Federal Register Volume 70, Number 96 (Thursday, May 19, 2005)]
[Notices]
[Pages 28946-28947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9957]


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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://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://www.fda.gov/cder/guidance/index.htm, 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