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Mar 18 , 2024

(A portion of the Associated Components section of this chapter will become official on May 1, 2019, and a portion of the Packaging section of this chapter will become official on December 1, 2025▲ (USP 1-Aug-2020)as indicated. Early adoption of the requirements in this chapter and Plastic Materials of Construction 〈661.1〉 and Plastic Packaging Systems for Pharmaceutical Use 〈661.2〉 are permitted by USP.)


The purpose of this chapter is to provide packaging definitions, auxiliary packaging information, and storage condition definitions relevant to the storage and distribution of active ingredients, excipients, and medical products, such as pharmaceuticals, devices, combination products (e.g., drug-eluting stents), and dietary supplements.


Packaging materials must not interact physically or chemically with a packaged article in a manner that causes its safety, identity, strength, quality, or purity to fail to conform to established requirements. ▲Any plastic material used to construct a Packaging system must meet the applicable requirements of Plastic Materials of Construction 〈661.1〉.▲All Packaging systems must meet the applicable requirements specified in Containers—Glass 〈660〉, Plastic Packaging Systems and Their Materials of Construction 〈661〉, ▲Plastic Packaging Systems for Pharmaceutical Use 〈661.2〉,▲and Auxiliary Packaging Components 〈670〉. All elastomeric closures must meet the applicable requirements in Elastomeric Closures for Injections 〈381〉.

Every monograph in USP–NF must have packaging and storage requirements. For the packaging portion of the statement, the choice of containers is provided in this chapter. For active pharmaceutical ingredients (APIs), the choice would be a tight, well-closed, or, where needed, light-resistant container. For excipients, given their typical presentation as large-volume commodity items (Packaging systems ranging from drums to tank cars), a well-closed container is an appropriate default requirement. Articles must be protected from moisture, freezing, and excessive heat (see General Definitions) when no specific directions or limitations are provided.

The compendial requirements for the use of specified containers apply also to articles packaged by Dispensers, Repackagers, or other individuals, unless otherwise indicated in the individual drug product monograph.

Source from USP and Please refer to USP for details:

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