FDA Registered 503B Outsourcing Facility

Join us for a FREE webinar discussing GFI #256:

Do You Know What’s In A Compound? New FDA Guidance Says You Should.

Thursday, January 26, 2023 | 8 pm ET

Speakers: Lauren Forsythe, PharmD, DICVP and Mike Juliano, RPh, J.D.

Total RACE-Approved CE Credit Hours: 1 hour

Presentation approved by AAVSB in jurisdictions that recognize RACE approval

Understanding GFI #256 and the impact on your veterinary practice.

The FDA has released the final version of GFI #256. This guidance document outlines when it is appropriate to prepare compounded medications utilizing bulk chemicals and the additional documentation that is required. While the beginning of enforcement was scheduled for October of 2022, it has been delayed until 2023 to provide additional time for compliance and education.

This 1 hour CE session will review the guidance requirements, the risks it is designed to minimize, and practical considerations for how you can comply in daily practice.

Reserve your spot and join us for an informative and helpful webinar, Do You Know What’s In A Compound? New FDA Guidance Says You Should.

Review the official guidance from the FDA:
Learning Objectives & Takeaways

Meet the Presenters

Lauren Forsythe, PharmD, DICVP

Dr. Forsythe is a Clinical Assistant Professor of Pharmacy and the Pharmacy Service Head at the University of Illinois Veterinary Teaching Hospital. She is also a diplomat of the International College of Veterinary Pharmacists. Dr. Forsythe graduated from the University of Findlay, College of Pharmacy in 2015 and completed her veterinary pharmacy residency at Purdue’s Veterinary Teaching Hospital. Following the completion of her residency, Dr. Forsythe spent three years at the UC Davis Veterinary Medical Teaching Hospital as a Clinical Pharmacist before coming to UIUC in 2019.

Mike Juliano, RPh, J.D.

Mike Juliano is an attorney and licensed pharmacist. He works for Stokes Healthcare Inc. which operates both a 503A traditional compounding pharmacy and a 503B outsourcing facility. Mike assists with ensuring that each facility complies with federal regulations as well as the myriad of state regulations applicable to both facilities, which are licensed in almost every state in the country.