INTRODUCTION

A packaging system, as defined in Packaging and Storage Requirements 〈659〉, contains or is intended to contain a drug product, including pharmaceuticals and biologics. The packaging system provides the means for storing and distributing drug products, and in some cases the means for administering the drug product. A plastic packaging system is composed wholly or of a substantial portion of plastic materials and/or components and refers to the sum of packaging components that together contain the drug product, including closures (e.g., rubber seals, foil closures, laminated closures).