IPEC Coalition/Rx-360 Recommended Letter Template for
Surveying Suppliers on Melamine Controls
September xx, 2009
Supplier contact
Supplier name
And address
RE: FDA Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination
INITIAL INFORMATION REQUEST – MELAMINE CONTROL PROGRAM
Dear XXXX;
The purpose of my letter is two-fold: 1) to inform you of the recently issued FDA Guidance for Industry:
Pharmaceutical Components at Risk for Melamine Contamination, and 2) to request your support in providing
information concerning the controls that your company already has in place or the controls that may be
planned to assure the absence of melamine contamination for each of the following materials supplied to
(insert Your Company Name), no later than October 31, 2009.
Product Name
Product Number
XXXXXX
XXXXXX
XXXXXX
XXXXXX
What is the FDA Guidance for Industry?
The FDA Guidance document outlines the agency’s concern for the potential risk of melamine contamination
in certain pharmaceutical components where economically motivated adulteration could occur.
The August 6, 2009 press release on this Guidance stated that “although the FDA has no reason to believe
that the U.S. pharmaceutical supply is contaminated with melamine, recent events involving pet and livestock
food products in the United States, and milk products for infants in China, underscore the potential problem.
"The FDA urges implementation of appropriate controls to assure consumers that melamine contamination
will not happen in the pharmaceutical supply chain," said Commissioner of Food and Drugs Margaret A.
Hamburg, M.D. "We look forward to working with industry on this serious public health concern."”
Based on the potential risk of drug contamination, the Guidance states the importance of manufacturers
taking steps to ensure that susceptible components are not contaminated with melamine. This Guidance
applies to manufacturers of drug components, finished drug products and Active Pharmaceutical ingredients.
The Guidance document is available on the FDA’s website at the following URL:
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM175984.pdf.
Further background information concerning this guidance can be found at the following URL:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm176088.htm
What materials are in scope?
Pharmaceutical companies need to review their use of materials in drug products which may be at risk for
melamine contamination. Section IV of the Guidance lists examples of “at-risk” pharmaceutical components
that have been identified by FDA. These materials include those where a test for total nitrogen content is
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specified in the USP monograph, ammonium salts, materials that may be animal derived and could be tested
for total nitrogen content to estimate protein content, and materials that can be derived from milk.
What are the requirements for pharmaceutical companies?
Section III of the Guidance outlines FDA’s recommendations. It states: “Manufacturers of finished
pharmaceuticals [should] know and monitor their supply chain for any “at-risk” components, which means
knowing the identity and role of the actual manufacturer of such components and any re-packers and
distributors who handle the components before receipt by the manufacturer.”
Will this Guidance change?
This Guidance represents the FDA’s current thinking on this topic, and FDA is receptive to discussing
alterative approaches that satisfy the requirements of the applicable statues and regulations.
At this time, the International Pharmaceutical Excipients Council (IPEC) and a Coalition of the major
Pharmaceutical Industry Trade Associations are developing a set of recommendations for revisions to the
Guidance and are actively seeking to meet with FDA to discuss the best approach to potentially revise the
guidance or establish a Q&A document to clarify the recommendations in a way that will best accomplish the
objective of minimizing the risk of melamine contamination. The Coalition believes that some modifications in
the current Guidance document would be beneficial to assist in the implementation of an appropriate control
program that protects patient safety and meets the needs of FDA and Industry.
At this time, with the Guidance in place as is, I want to initiate a dialog with you regarding your awareness of
the Guidance and gain an understanding of what your plans may be to control the risk of melamine
contamination in the “at risk” materials that your company supplies to (insert Your Company Name).
Request for information:
Please provide the information requested in the attached form concerning the controls that your company
already has in place or the controls that may be planned to assure the absence of melamine contamination
for each of the listed materials supplied to (insert Your Company Name), no later than October 31, 2009.
If you would like to supply this information in your own format as part of an Excipient Information Package
(EIP)1 or other standardized document rather than fill out the attached information request form, this is
acceptable as well, provided it addresses the relevant points listed in the attached form.
If you have any questions concerning this information request or about the FDA Guidance, please let me
know. My intention with this letter is to initiate a proactive dialog with you on this issue and foster open
discussion on the controls you have or are developing to assure the absence of melamine contamination.
I appreciate your attention to this request for information.
Best Regards,
Title
Company
Mailing address
Email address
Phone no.
Attachment: Initial Information Request Form – Melamine Control Program
1
For further information concerning IPEC’s Excipient Information Protocol Guideline, please download
this guideline from the following website: http://www.ipecamericas.org/
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