Already in April 2007 the Office of New Drugs within the FDA Center for Drug
Evaluation and Research (CDER) published the document MAPP 6020.2 entitled
Applications for Parenteral Products in Plastic Immediate Containers.
Although this document is of high relevance, it is relatively unknown in the
The CDER Manuals of Policies and Procedures (MAPP) describe processes and
regulations for the CDER employees. These MAPPs are a sort of internal SOP
system for the information of FDA employees. They are supposed to ensure that
all personnel follow the same processes in their daily work, especially in
regard to reviewing applications for approval. Via the FDA website these MAPPs
are available to everyone.
With regard to plastic immediate containers the document MAPP 6020.2 was issued
some time ago. This document defines the FDA requirements relative to the
approval of parenteral products that are supposed to be packaged in plastic
immediate containers. In detail, this document deals with the implementation of
the requirement in 21 CFR 310.509(a). According to this regulation, for every
parenteral product to be packaged in plastic immediate containers an approved
NDA (new drug application) has to be generally available for large volume
parenterals as well as for small volume products.