[Federal Register Volume 74, Number 151 (Friday, August 7, 2009)]
[Notices]
[Pages 39704-39705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18952]


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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