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News about GMP/cGMP

2009-08-07

NEW FDA Guidance for Industry: Pharmaceutical Components at Risk for Melamine Contamination

FDA Center for Drug Evaluation and Research (CDER) and Center for Veterinary Medicine (CVM) published today a new Guidance for Industry: "Pharmaceutical Components at Risk for Melamine Contamination"

 

Excerpt of the Guidance for Industry

I. INTRODUCTION

We, FDA, are issuing this guidance to provide you, manufacturers of plasma-derived products, with recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. Such testing will identify and help to prevent the use of plasma units containing high levels of parvovirus B19. This guidance also recommends how to report to FDA implementation of parvovirus B19 NAT.

We recognize that in the current business practice for parvovirus B19 NAT in-process testing, several weeks can elapse between collection of the units of Source Plasma or recovered plasma and identification of B19 NAT-positive pools or units. We encourage manufacturers of plasma-derived products to employ practices that will reduce the time between product collection and in-process testing to allow for the meaningful notification of blood and plasma collection establishments of positive test results within the dating period of any blood components intended for use in transfusion.

This guidance finalizes the draft guidance of the same title, dated July 2008.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required

I. INTRODUCTION

This guidance is intended to alert pharmaceutical manufacturers of finished products, pharmacy compounders, repackers, and suppliers to the potential risk of melamine 2 contamination in pharmaceutical components. In September 2008, FDA received reports from China about food articles contaminated with melamine, which have resulted in thousands of hospitalizations for kidney problems and at least three deaths. As of the date of this guidance, FDA is not aware of any pharmaceuticals that have been 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.

This guidance provides recommendations that will help pharmaceutical manufacturers of finished products, repackers, other suppliers, and pharmacists who engage in drug compounding better control their use of at-risk components that might be contaminated with melamine. FDA considers the presence of melamine in any drug (unless specifically approved as an impurity) to render that drug adulterated under sections 501(a)(2)(B) and 501(d) of the Act (21 U.S.C. 351(a)(2)(B) and 351(d)).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

 

Source: Guidance for Industry "Pharmaceutical Components at Risk for Melamine Contamination", August 2009

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