[Federal Register: May 2, 2007 (Volume 72, Number 84)]
[Notices]
[Page 24316-24317]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02my07-81]
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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://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: 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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