Drafts of revised USP plastic packaging chapters <661.1> and <661.2>: removal of the biological reactivity test for oral and topical dosage forms

Recommendation

7/8 May 2024

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Challenges and Solutions for Packaging and Single Use Systems

In Pharmacopeial Forum 42(4) [Jun-Jul 2016] drafts of two revised USP general chapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use have been published for comment. Deadline for comments is September 30, 2016. With these drafts, the USP General Chapters - Packaging and Distribution Expert Committee is removing the requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms.

The Expert Committee is removing the requirement for <87> testing at this time, while the effort to revise the general chapters <87> and Biological Reactivity Tests, In Vivo <88> proceeds. Depending on the revisions of <87> and <88> the two packaging chapters may be revised to align with those chapters.

The new requirement (since May 2016) for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms has been highly discussed, since this testing is not required for the mentioned dosage forms according to EMA guideline on plastic immediate packaging materials (December 2005) and US FDA container closure guidance (May 1999). In case of oral and topical dosage forms both guidances require "only" compliance to food regulations (EU: regulation 10/2011, US: indirect food additives guidelines) or, if applicable, (preferably) to pharmacopoeial monographs (if the material or system is described in a pharmacopoeial chapter).

The principle of these two guidances is that materials considered safe for food contact are also safe for topical and oral dosage form packaging systems.

The new requirement (Biological Reactivity Tests, In Vitro) could have led to delays in releasing new oral or topical products on the market. Additionally, one might have had to re-evaluate already existing oral and topical products packaging systems on the market. Therefore, the present decision to revise the two packaging chapters regarding the requirement for <87> Biological Reactivity Tests, In Vitro seems to be justified.

Furthermore, the Expert Committee is proposing the addition of four new polymers [polyamide 6, polycarbonate, poly(ethylene-vinyl acetate), and polyvinyl chloride, plasticized] with test methods and specifications to general chapter <661.1>. To support the addition of these new polymers, polymer descriptions have been added to Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact <1661>, which appeared in PF 42(3) [May–June 2016].

In addition, the test for Spectral Transmission in Containers—Performance Testing <671> is being moved into general chapter <661.2> as requirement for light resistant containers.

On the basis of comments received, the scope of both chapters was revised for clarification.

After registration on the USP Pharmacopeial Forum website you can read the complete drafts of the two general chapters <661.1> and <661.2>.