ABSTRACT
Pharmaceutical products are among the most regulated products on the planet.
Pharmaceutical packaging, particularly the labeling of pharmaceuticals, must
meet a myriad of regulations and approvals from government agencies all over
the world. The regulations essentially make the package a part of the product and
place it under evaluation and review in much the same way the drug receives
evaluation and review. Each product and package must face and pass rigorous
approval requirements mandated in the United States by the United States Food
and Drug Administration (FDA)-administered statute and by similar agencies in
almost every country of the world. Typically, the countries require multiple
stages of testing with multiple submissions of data with voluminous documen-
tation to prove that the product and its packaging are safe, efficacious, and
perform as the manufacturer claims. This scrutiny is for the public protection,
and it places a considerable burden on the manufacturer to prove and document
that a product works and meets all claims related to its performance. Regulations
vary around the world, but for the most part, the varying processes require and
use much the same information as required by the FDA. In this chapter, we will
discuss and highlight what the FDA requires.
