[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Notices]
[Pages 24316-24317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0135]


Guidance for Industry on Testing of Glycerin for Diethylene 
Glycol; 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 ``Testing of Glycerin 
for Diethylene Glycol.'' This guidance provides recommendations on 
testing that will help pharmaceutical manufacturers, repackers, and 
other suppliers of glycerin, and pharmacists who engage in drug 
compounding, avoid the use of glycerin that is contaminated with 
diethylene glycol (DEG) and prevent incidents of DEG poisoning.

DATES:  Submit written or electronic comments on the guidance by July 
31, 2007. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES:  Submit written requests for single copies of the guidance 
to the Division of Drug Information (HFD-240), 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. 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: Monica Caphart, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-827-9047.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Testing of Glycerin for Diethylene Glycol.'' This guidance 
explains that the agency recommends that certain analytical testing 
procedures be performed on glycerin to avoid the use of DEG-
contaminated product. Specifically, the agency is recommending that all 
lots of glycerin received by a pharmaceutical manufacturing facility 
undergo identity testing that includes a test for DEG content. DEG 
contamination of glycerin can be detected by using specific analytical 
test procedures described in the United States Pharmacopeia monograph 
for glycerin, which quantifies the amount of DEG present at a detection 
level of 0.1 percent, as recommended by the interagency Diethylene 
Glycol Contamination Prevention Workshop of 1997. Repackers, pharmacy 
compounders, and others who distribute and prepare glycerin for use in 
drug products should test glycerin that is used, sold for use, or 
intended for use in drug products. This recommendation also applies to 
bulk or repackaged glycerin intended as an excipient or other component 
for a drug. In addition, pharmacies that purchase glycerin for use in 
compounding drug products should either test the glycerin or ensure 
that such testing was properly done by a reliable supplier.

[[Page 24317]]

    As explained in detail in the guidance, there have been repeated 
instances of DEG poisoning that have led to the development of this 
guidance. Between 1990 and 1998, DEG poisoning has been reported in 
Haiti, Argentina, Bangladesh, India, and Nigeria. More recently, in 
October 2006, there were cases of illness and death in Panama due to 
DEG poisoning.
    The cases involving DEG contamination reveal the following 
similarities:
     The pharmaceutical manufacturers did not perform full 
identity testing on the glycerin raw material, including tests to 
quantify the amount of DEG present and to verify the purity of the 
glycerin received.
     The pharmaceutical manufacturers of the contaminated 
products relied on the certificate of analysis (COA) provided by the 
supplier.
     The origin of the product was not easily apparent from the 
COA.
    FDA has no reason to believe that the U.S. supply of glycerin is 
affected at the present time. However, because of the serious nature of 
this potentially fatal problem and the global nature of the 
pharmaceutical supply chain, FDA is emphasizing in this guidance the 
importance of testing glycerin for DEG.
    We are issuing this level 1 guidance for immediate implementation, 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The agency is not seeking comment prior to implementing this 
guidance because of the potential for a serious public health impact if 
DEG-contaminated glycerin were to enter the domestic market. The 
guidance represents the agency's current thinking on this issue. 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. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, 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. Received comments may be seen 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 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-8389 Filed 5-1-07; 8:45 am]
BILLING CODE 4160-01-S