News

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.

Is it acceptable that storage conditions are not monitored for medicinal products which do not have any predefined storage conditions on the outer packaging? This is one of three new questions answered by the European Medicines Agency (EMA) on its website. The other two questions relate to the activities of brokers with parties outside the EEA.

The U.S. Food and Drug Administration (FDA) has published a Warning Letter to a drug repackaging and relabeling facility located in Pennsylvania. The document summarizes significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). It also addresses Good Distribution Practice (GDP) aspects.