The short answer is no. USP <661.1> and USP <661.2> becomes official on December 1, 2025 and until such time USP <661> still applies. However, as stated in the USP early adoption of <661.1> and <661.2> is encouraged early and if early adoption is chosen, then USP <661> does not need to be done. It is important to note that all packaging materials must meet USP <661.1> and <661.2> requirements after December 1, 2025 even if they had only met the requirements of USP <661> previously.

USP <661.1> relates to a plastic material of construction used to manufacture a packaging system. It is best to think of this at the resin level. If your container is made of HDPE, the <661.1> testing is designed to test that specific resin. USP <661.2> relates to a packaging system as a whole and includes all components that make up that system. For example, the container, the closure, the dropper, the snap cap, etc. Collectively, USP <661.1> and <661.2> provide a comprehensive data package that will facilitate an appropriate evaluation for the correct selection of materials and protect patients more than would be possible with the current <661> test methods.

USP <661.1< and <661.2> describes the biocompatibility testing requirements that are dependent on the dosage form, therefore knowledge of the end use is required. Oral and topical dosage forms do not require USP <87> Biological Reactivity Test, In Vitro. Testing for compliance to USP <661.1> or USP <661.2> for all other dosage forms require the <87> testing. USP <88> Biological Reactivity Tests, In Vivo is not directly referenced in these chapters. USP <87> does however note that materials that fail USP <87> should be further tested to USP <88> standards.

E&L Testing is not a stated and specific requirement. As directed by the USP, a “Chemical Safety Assessment” is required for packaging systems as described in USP <661.2> that is “risk-based”.  This risk-based assessment is based on the packaging system, its materials of construction, its components of construction, and the actual drug product it will hold. Where testing is needed as part of a chemical safety assessment, it must be based on sound and justifiable scientific principles which are outlined in USP <1663> and USP <1664>.

USP <661.1> and <661.2> can be applied depending on whether the end-user seeks to evaluate an individual plastic material or an entire packaging system. For example, let’s consider a package system that uses a High-Density Polyethylene (HDPE) bottle in conjunction with a Polypropylene (PP) closure. HDPE and PP resin used to develop this packaging system are considered well-characterized if they meet the USP requirements as outlined and required in the <661.1> chapter. The individual bottle (HDPE) would be tested, and the separate and individual closure (PP) would be tested. As a whole package system (bottle and closure combined, the USP <661.2> would be required. As a simple rule, <661.1> applies to INDIVIDUAL COMPONENTS or plastic types and <661.2> applies to entire PACKAGE SYSTEMS.

USP <661.1> and <661.2> can be applied depending on whether the end-user seeks to evaluate an individual plastic material or an entire packaging system. For example, let’s consider a package system that uses a High-Density Polyethylene (HDPE) bottle in conjunction with a Polypropylene (PP) closure. HDPE and PP resin used to develop this packaging system are considered well-characterized if they meet the USP requirements as outlined and required in the <661.1> chapter. The individual bottle (HDPE) would be tested, and the separate and individual closure (PP) would be tested. As a whole package system (bottle and closure combined, the USP661.2 would be required. As a simple rule, 661.1 applies to INDIVIDUAL COMPONENTS or plastic types and <661.2> applies to entire PACKAGE SYSTEMS.