USP chapter on packaging and storage revised

Recommendation

10-12 October 2023
Barcelona, Spain

Validation of Analytical Test Procedures & Measurement Uncertainty
Qualification and Validation in an uncertain analytical world – a holistic approach

Suggestions by the USP on chapter <659> - Packaging and Storage Requirements have been published in the Pharmacopeial Forum (PF) 44 (4).

It was newly added that all materials used for manufacturing plastic packaging systems must meet the requirements of General Chapter <661.1> - Plastic Materials of Construction.

Also, all packaging systems must comply with the requirements of General Chapter <664.2> - Plastic Packaging Systems for Pharmaceutical use.

The "Poison Prevention Packaging Act" (PPPA) is also discussed in detail. This act demands special packaging for most prescription and non-prescription (OTC) drugs. Thus, the public is to be protected from injuries or illnesses due to the faulty use of medicinal products.

According to PPPA, the primary packaging must comply with the special standards of 16 CFR §1700.15. These apply to all sorts of packaging, like

• reclosable
• non-reclosable
• unit-dose containers.

Manufacturers or packers of PPPA-regulated OTC products may pack up one size in a not child-resistant container. If such a product is not packed in a child-resistant way however, this must be plainly indicated on the outer packaging.

More information on the revision of the General Chapter <659> - Packaging and Storage Requirements can be found on the USP Website of Pharmacopeial Forum PF, 44 (4).

Recently, there had also been recalls from the American market because drug products did not meet the requirements for child-resistant packaging.