Though specifically authorized in the federal Food, Drug & Cosmetic Act, some restrictions on compounded drug therapies threaten patient access, and many of the restrictions are not rooted in science. In this session, the Alliance for Pharmacy Compounding’s CEO Scott Brunner, CAE, will brief attendees on the following:

• USP’s restrictions on beyond-use dates and batch sizes for compounded meds
• FDA’s threat to restrict compounded hormone therapy
• As California Goes: Proposed regulations exceed national standards
• The need for 503A compounders to prepare shortage drugs for urgent use
• Proscriptions on Peptides and the reclassification of DTE
• Proposed legislation to eliminate the MOU and implement 503A adverse event reporting

• Nuances in chapter changes and the “why” behind the revisions
• What effects will the new revisions have on 503A and 503B pharmacies?
• Designated Person responsibilities
• New implications for old compounds

• Facility updates considering revisions – initial costs are heavy
  • Impacts for small companies and how to sustain substantial price increases
  • Challenges with supply chain

An FDA inspection can be a very stressful experience and can pose significant risk for pharmacies, compounding pharmacies and outsourcing facilities. That’s why it is important to be prepared. This session will cover the nuts and bolts of an FDA inspection of a compounding facility and provide useful tips and tricks on navigating FDA’s visit. The session will also cover what happens after the inspection, including FDA’s process and potential outcomes. Finally, the session will discuss ways to remain proactive as opposed to reactive when it comes to FDA audits and inspections, in order to put your facility in the best position possible for a future FDA inspection.

• How to build facilities – What to consider if starting a facility If you were to start from scratch, what should you consider?
• Process workflows
• Clean rooms – Importance of HVAC systems, airflow, and pressure requirements.

From a raw powder to a final product, testing and quality assurance is continuously addresses the following topics

• Most suitable testing methods
• Process of sterility testing
• Multi-incubations
• environmental monitoring requirements from state boards and FDA

• Differences in working with sterile vs nonsterile drugs
• Process and patient safety

Upcoming changes to USP compendial chapters will shorten the shelf life of many compounded products. However, the updates clarify expectations for validating alternative microbial methods. These methods can significantly shorten the time for product release, allowing you to make the most of the product shelf life and batch size planning. This presentation outlines steps you can take to implement a rapid microbial method in your laboratory.