Packaging Systems: Compendial Requirements

Authored by: Claudia C. Okeke , Desmond G. Hunt , Nicholas Mohr , Thomas Medwick , Eric B. Sheinin , Roger L. Williams

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v4-1

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Abstract

Since 1820, the US Pharmacopeial Convention established compendial standards for drugs sold and marketed in the U.S.A. Currently these standards are published in the US Pharmacopeia (USP) and the National Formulary (NF). These publications are currently recognized as official compendia in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §321) (1). Furthermore, it became apparent to the Pharmacopeial Convention that to assure pharmaceuticals meet compendial standards when administered, standards must be created for the drug, its packaging, and its storage conditions. For this reason, monographs listed in the USP contain specifications for how the drugs should be packaged and stored in addition to the test procedures designed to evaluate the quality of a pharmaceutical preparation. The US Pharmacopeial Convention XII in 1940 first recognized Packaging, Labeling, and Preservation as an official Executive Committee and beginning in 1942, the USP included specific guidance on pharmacopeial requirements for containers and pharmaceutical packages (13).

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