USP <659> - Packaging and Storage Requirements

What it says

Packaging and storage requirements establish standard definitions for container classifications, such as tight, well-closed and light-resistant containers, and standard terminology for storage conditions, such as controlled room temperature and refrigerated, that apply throughout USP-NF monographs unless a specific monograph states otherwise.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• These definitions function as a shared vocabulary across the entire USP-NF, so correctly interpreting a monograph's packaging and storage instructions depends on understanding what terms like tight container or controlled room temperature actually mean under this chapter.
• Selecting packaging based on marketing or cost considerations without verifying it meets the specific container classification required by the monograph is a frequent source of stability and packaging-related deviations.
• Storage condition terminology defined here also underpins how labeling, shipping and distribution instructions are written, connecting packaging and storage decisions to broader supply chain and distribution practices.

What inspectors look for

• Whether the packaging actually used for a product meets the specific container classification, tight, well-closed, light-resistant, specified for that product.
• Whether storage conditions maintained in warehouses and during distribution match the defined storage condition terminology applicable to the product.
• Whether packaging or storage condition changes were evaluated against the definitions in this chapter before being implemented.

Related regulations