Guidance for Industry on Pharmaceutical Components at Risk for Melamine Contamination; Availability, 39704-39705 [E9-18952]
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Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Notices
challenging economic times. In
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community resources that need to be
utilized to reach out to those in their
communities most at risk, including
those currently impacted severely by the
economy.
Contact: Shelly Hara, Substance
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Administration, 1 Choke Cherry Road,
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telephone: (240) 276–2321; E-mail:
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DEPARTMENT OF HEALTH AND
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Substance Abuse and Mental Health
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Fiscal Year (FY) 2009 Funding
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VerDate Nov<24>2008
17:09 Aug 06, 2009
Jkt 217001
Toian Vaughn,
Committee Management Officer, Substance
Abuse and Mental Health Services
Administration.
[FR Doc. E9–18873 Filed 8–6–09; 8:45 am]
BILLING CODE 4162–20–P
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.
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.,
PO 00000
Frm 00100
Fmt 4703
Sfmt 4703
Rockville, MD 20855. Send one selfaddressed 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 https://
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/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
E:\FR\FM\07AUN1.SGM
07AUN1
pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Notices
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 melaminecontaminated 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.
VerDate Nov<24>2008
17:09 Aug 06, 2009
Jkt 217001
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 https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm, or
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Environmental Health
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Date: August 25–26, 2009.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
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Place: Sheraton Chapel Hill Hotel, One
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Fmt 4703
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Dated: August 3, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–18993 Filed 8–6–09; 8:45 am]
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Research and Training, Nat’l Institute of
Environmental Health Sciences, P.O. Box
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NC 27709, (919) 541–1307.
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E:\FR\FM\07AUN1.SGM
07AUN1
Agencies
[Federal Register Volume 74, Number 151 (Friday, August 7, 2009)]
[Notices]
[Pages 39704-39705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18952]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, or
https://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