USP Proposes to Add Flexibility in the Selection of Parenteral Packaging

Recommendation

5/6 June 2024

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To help address concerns about the supply of glass vials, the USP intends to revise the packaging and storage statements in several USP monographs for parenteral products which currently prescribe a specific type of glass. In addition, it is envisaged to update General Chapter <660> Container—Glass. To address the challenges posed by shortages of packaging materials, the USP reviewed the Packaging and Storage requirements in all USP monographs for parenteral drug products. According to the announcement, the review indicated that the majority of the about 330 monographs provide a certain level of flexibility for the type of packaging by including a reference to a preferable type of glass for packaging, rather than prescribing a specific type of packaging material (like, for example: "Preserve in single-dose or in multiple-dose containers, preferably of Type I or Type II glass"). While the term “preferably” is not explicitly defined in USP´s General Notices, the language indicates an existing flexibility for selecting a suitable type of packaging system for the specified parenteral products. As part of the review, the USP also identified 14 monographs for parenteral products that use prescriptive language to specify the type of glass that must be used, such as “containers of Type I glass.”  

To introduce additional flexibility for manufacturers and regulators, the USP is therefore proposing the addition of the word “preferably” to the Packaging and Storage statements in the monographs that currently use prescriptive language. However, additional changes to a large number of monographs may be needed to fully address the paradigm shift in defining suitable packaging materials for parenteral products.

For more information please see USP´s Notice of Intent to Revise: Proposal to Add Flexibility in the Selection of Suitable Packaging and Storage for Parenteral Drugs.