GMP News - Packaging

The U.S. Food and Drug Administration (FDA) has published a new guidance document entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies". The document focuses on the enforcement of the enhanced drug distribution security requirements that will become effective on 27 November 2023. The authority grants a one-year extension as it does not intend to take action to enforce the requirements until 27 November 2024.

In the context of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."

The USP adopted the revised general chapter <670> Auxiliary Packaging Components. In particular a new category "odor adsorbent" has been added.

Due to numerous GMP deficiencies, a US company in the field of solid dosage form packaging received a Warning Letter from the FDA. The inspection had already taken place in November 2022. Since the FDA found the company's response to the Form 483 as insufficient, the Warning Letter now followed.

The MHRA has announced a "long-term solution" of the Windsor Framework for the supply of medicines into Northern Ireland, effective from January 1, 2025. One key issue concerns the packaging and labelling of medicinal products.

The USP has recently published a revision of its Chapter <87> "Biological Reactivitiy Tests, In Vitro" for comments. One of the objectives is a better alignment with other relevant USP chapters.

The two proposed USP General Chapters <660> and <661.2> have been published for comment in the current issue of Pharmacopeial Forum. The deadline for comments is May 31, 2023.