这 Bolivian Agency for Medicines and Health Technologies (AGEMED) announced on November 25, 2024, the launch of a public consultation on its proposed guidelines titled “Good Pharmacy Practices for Compounding Pharmacies.” This initiative seeks to establish comprehensive standards to ensure the quality and safety of compounded medications.
The draft guidelines are designed to regulate operational procedures in compounding pharmacies, with a focus on quality control, storage, and prescription handling. The objective is to safeguard patient safety and ensure the efficacy of personalized medications created to meet specific patient needs that are not addressed by commercially available products.
Key areas of focus include stringent hygiene practices, accurate record-keeping, and adherence to prescribed formulations to minimize contamination risks and ensure dosing accuracy. While the guidelines do not specify particular product categories or therapeutic areas, they are expected to have broad applicability across various compounded medications, including dermatological and pediatric formulations.
This initiative represents a significant step in enhancing the regulatory framework governing compounding pharmacies in Bolivia, aiming to align practices with international standards and improve patient outcomes through better oversight.