Excerpt of the Guidance for Industry
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