Drug package definition

RtiK R and de kruhe n. Active and Intelligent packaging development. Part I. Definitions, efficacy tests and migration experiments. Food, Cosmetics and Drug Packaging 2003, 8, 152-159. 

The definition of a food additive in Section 201(s) of the Federal Food, Drug, and Cosmetic Act, as amended ( the Act ) refers to substances whose intended use results directly or indirectly in the substance becoming a component of food. The FDA refers to direct food additives as those added to a food to accomplish an intended effect. Indirect additives are those that unintentionally, though predictably, become components of food. Components of plastic packaging materials that can migrate to food are indirect additives. 

The fact that many products (e.g., liquids, sprays, powders, gels, some drug products, and cosmetics) cannot exist or be transported without a pack, however, means that for these types of products a broader definition is needed to cover the functions of the pack and the packaging operation. 

United States Pharmacopeia (USP) and National Formulary (NF) standards and specifications relate to the quality, purity and strength, packaging, and labeling of medicines and related articles. The standards are public standards, and new and revised standards are published regularly. Official drug names and definitions are established, as well as tests or assay procedures that allow determination of compliance with the standards. But do the compendia reflect the state of pharmaceutical technology ... 

The scope of the project includes not only the definition of the final product deliverable but the level of work effort required to complete this project. For example, a new pharmaceutical drug will be used to reduce long-term intractable pain, will be in an injectable form, and will use existing packaging configurations in defined concentrations and formulations. This is an initial, general definition of the product scope. The project scope, however, is much more time consuming and complex to develop and would include ... 

The secondary packaging is that outside the primary pack, and by definition is not in direct contact with the drug product. Secondary packaging is often a carton or a blister, which may also function to protect the product from light or moisture. For example, it may be... 

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