[Federal Register: August 7, 2009 (Volume 74, Number 151)]
[Notices]
[Page 39704-39705]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au09-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0354]
Guidance for Industry on Pharmaceutical Components at Risk for
Melamine Contamination; 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 ``Pharmaceutical
Components at Risk for Melamine Contamination.'' This guidance provides
recommendations that will help pharmaceutical manufacturers of finished
products, repackers, other suppliers, and pharmacists who engage in
drug compounding avoid the use of components that are at risk for
melamine contamination. As of the date of this announcement, FDA is not
aware of any pharmaceutical components that are contaminated with
melamine.
DATES: Submit written or electronic comments on the guidance by
October 6, 2009. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002; or the Communications Staff
(HFV-12), Center for Veterinary Medicine, Food and Drug Administration,
7519 Standish Pl., Rockville, MD 20855. 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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Frank W. Perrella, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,
rm. 4337, Silver Spring, MD 20993-0002, 301-796-3265; or
Brian Hasselbalch, Center for Drug Evaluation and Research (HFD-
320), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51,
rm. 4364, Silver Spring, MD 20993-0002, 301-796-3279; or
Diane Heinz, Center for Veterinary Medicine (HFV-6), Food and Drug
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9031.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Pharmaceutical Components at Risk for Melamine
Contamination.'' This guidance provides recommendations that will help
pharmaceutical manufacturers of finished products, repackers, other
suppliers, and pharmacists who engage in drug compounding to better
control their use of at-risk components that might be contaminated with
melamine. The guidance explains that the agency is recommending that
at-risk components be properly tested for melamine contamination before
they are used in the manufacture or preparation of drugs or drug
products. This recommendation applies to nitrogen-based components.
As discussed in the guidance, FDA has posted on its Web site
methods for measuring melamine contamination in foods using liquid
chromatography triple quadrupole tandem mass spectrometry (LC-
MS[sol]MS) and gas chromatography/mass spectrometry (GC-MS). Although
these methods have been evaluated using dry protein materials, they can
also be applicable to other material, including at-risk components.
Manufacturers are encouraged to validate test methods that
[[Page 39705]]
are suitable for detecting melamine contamination in at-risk components
down to 2.5 parts per million (ppm) to give a high degree of assurance
that they are not contaminated. At this time, FDA has not established
an appropriate level of melamine in drug products.
As explained in detail in the guidance, there have been repeated
instances of melamine contamination in food articles, including in the
U.S. market. In 2007, FDA learned that certain pet foods were sickening
and killing cats and dogs. In September 2008, FDA received reports of
melamine-contaminated infant formula in China. These two incidents
share the following similarities:
Melamine, a nitrogen-based compound, was apparently added
to bolster the apparent protein content in foods or in ingredients used
in processed food products intended to contain protein.
The recipients of the ingredients using a test for
nitrogen content would not have been able to distinguish between
melamine and the desired protein.
Melamine contamination became public only after numerous
adverse health events, including deaths, were reported and associated
with the use of contaminated products.
These incidents illustrate the potential for drug components to be
contaminated with melamine; therefore, it is important for drug
manufacturers to be diligent in assuring that no component used in the
manufacture of any drug is contaminated with melamine. As of the date
of this guidance, FDA is not aware of any pharmaceuticals that are
contaminated with melamine. However, because of the potential risk of
drug contamination, it is important that manufacturers take steps to
ensure that susceptible components are not contaminated with melamine.
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 before implementing this
guidance because of the potential for a serious public health impact if
melamine-contaminated pharmaceuticals 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 regarding this document.
Submit a single copy of electronic comments or two paper copies of any
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. 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
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm, http://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
http://www.regulations.gov.
Dated: July 31, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-18952 Filed 8-6-09; 8:45 am]
BILLING CODE 4160-01-S