News

The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document. Both documents entered into force on 01 February 2023.

A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

The German Federal Court of Justice (BGH) has submitted questions to the Court of Justice of the European Union (ECJ) on the permissibility of selling pharmaceuticals via Amazon. Specifically, the issue is whether a pharmacist who sells pharmaceuticals on an Internet sales platform is in breach of the data protection provisions applicable to health data. In addition to the data protection aspects (DSGVO), the two underlying legal disputes also concern provisions of the German Medicines Act (AMG), the German Drug Advertising Act (HWG), the Pharmacy Operations Regulation (ApBetrO) and the Professional Code of Conduct for Pharmacists.