Good Distribution Practices News

At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled "Inspektion der Eignung von Transportprozessen" focuses on transport verification and its inspections by the competent authorities.

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.

Swissmedic plans to bring a SwissGMDP database into operation, which will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The database will make it possible to view the GMP/GDP status of a company easily and free of charge.

The USP revised the general chapter <1079.1> Storage and Transportation of Investigational Drug Products. With the revision reference is made to the new USP Chapter <1079.3> Monitoring Devices - Time, Temperature, and Humidity which will become official on 1 December 2023.

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The U.S. Food and Drug Administration (FDA) has published a Draft Guidance for Industry entitled "Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act". Comments can be submitted until 28 August 2023.