Articles

As many know, there are several challenges faced by 503A and 503B compounding pharmacies due to the FDA's drug shortage list. This article highlights the issues of underreporting, delays, and inaccuracies in the list, which hinder the pharmacies' ability to respond to shortages effectively. It also dives into presenting potential solutions to improve the accuracy and effectiveness of the shortage list, ensuring better support for compounding pharmacies, and continued patient access to essential medications.

In the ever-evolving landscape of pharmaceutical compounding, staying compliant is crucial. This article delves into the best practices for 503A state-licensed compounding pharmacies when creating copies of FDA-approved drugs listed as "currently in shortage" on the FDA Drug Shortage List. It underscores the significance of seeking legal counsel, regularly reviewing the FDA Drug Shortage List, and maintaining meticulous documentation to ensure compliance. Furthermore, it highlights the necessity for pharmacies to source APIs from FDA-registered manufacturers and adhere to USP Chapter <797> testing requirements to guarantee patient safety.

Discover how transitioning from traditional vials to prefilled syringes revolutionizes sterile drug compounding, offering enhanced safety, dosing accuracy, and workflow efficiency. This guide navigates the critical steps of formulation compatibility, sterility assurance, and regulatory compliance to unlock the full potential of prefilled syringe technology.

Explore the intricate world of sterile compounding with this insightful article, uncovering how stringent USP <797> standards, stability testing, and advanced terminal sterilization ensure compounded pharmaceutical safety and efficacy. Learn how extending Beyond-Use Dates through validated processes not only enhances patient safety but also optimizes sterile drug compounding reliability.