503A Compounding for Shortages – What Can (and Can't) You Do?
One of the primary reasons for a 503A compounding pharmacy to compound is to provide solutions during product unavailability, notably shortages. Although seemingly apparent, many compounders are unclear on the extent and capacity of the involvement they can have during these periods. This was particularly evident during the COVID-19 pandemic where pharmacies were challenged to navigate through the patchwork of federal and state laws and regulations.
Facilitated by three distinguished experts spanning compounding practices, regulatory compliance, and all matters FDA, this activity aims to provide clarity on how 503A compounding pharmacies can successfully meet drug shortage needs, such as those occurring in major healthcare systems (e.g. large hospital systems).
This program will focus on recent involvement with Federal, State, County, and 503B stakeholders, as well as with drug shortage lists and the impact of the FDA’s temporary guidance during the COVID-19 pandemic to illustrate the extent to which 503A pharmacies can help patients receive the medications they need.
- Pharmacists & Pharmacy Technicians
Google Chrome (most recent 2 versions)
Mozilla Firefox (most recent 2 versions)
Internet Explorer v11
Apple Safari (most recent 2 versions)
Microsoft Edge (most recent 2 versions)
Computer: 1 Mbps or better (broadband recommended)
Mobile device: 3G or better (WiFi recommended)
No additional software needed
|2GB of RAM (minimum), 4GB or more of RAM (recommended)|
This webinar is Copyright © Alliance for Pharmacy Compounding 2022.
|Shawn Hodges, PharmD|
Dr. Shawn Hodges holds a PharmD degree from Texas Tech University Health Sciences Center, and is currently a pharmacist and owner of Innovation Compounding in Atlanta while also operating as Chief Business Development Officer at Revelation Pharma Corporation. As an owner, Dr. Hodges has built a compounding pharmacy offering allergy immunotherapy, women's health, pain management, men's health, and strategic planning.
Consulting both practitioners and their patients on men’s health, women’s health, and pain management, Dr. Hodges has and continues to practice pharmacy in a community setting, and has also worked as a Regional Director for the nation’s largest hospice pharmacy provider. Specifically, he supported health care practitioners in the hospice market by delivering countless hospice medication management consultations and clinical presentations through various state conferences.
Dr. Hodges served as the President and Board Chairman for the APC, helping to protect, promote, and advance the art and science of pharmacy compounding, primarily by networking with state and federal legislators who have a direct impact on patient access to compounded medications.
|Kathleen Kane, PharmD, BCSCP, DPLA|
Dr. Kathleen Kane graduated from Chicago State University-College of Pharmacy with a PharmD degree in 2014. Over the past 13 years, Dr. Kane has focused her professional career on compounding pharmacy and has worked closely with the changing USP standards for sterile and non-sterile, as well as other standards set forth by pharmacy regulating bodies.
Prior to commencing pharmacy school, Dr. Kane was a laboratory manager for an independent community compounding pharmacy managing both sterile and non-sterile compounding and operations. Once completing pharmacy school, Dr. Kane continued her management position and was contracted and involved in compounding for Phase 1 and Phase 2 clinical trials at a drug manufacturer. She has since furthered her career by moving to hospital pharmacy management, and now is the Assistant Director of Pharmacy; Compounding integrity and Compounding Regulatory compliance at University of Chicago Medical Center in Chicago, IL.
Dr. Kane was part of the inaugural certification testing for pharmacists provided by Board of Pharmacy Specialities, and now sits as an elected member of the board overseeing future exam development. Dr. Kane is also involved in Committees and task forces within APC.
Karla Palmer, a law graduate from the University of Richmond School of Law, is currently Director at Hyman, Phelps & McNamara, the largest dedicated FDA law firm in the U.S. With 25 years’ experience as a litigator, Karla Palmer’s present focus is on DEA and FDA enforcement and litigation matters, where she advises clients throughout the supply chain – from manufacturers and distributors to outsourcing facilities, pharmacies and doctors – on a range of issues including DEA and FDA regulations and guidance, government inspections (including Form 483s) and investigations, warning letters, consent decrees, and administrative and federal proceedings.
Ms. Palmer has also written about and addressed industry audiences across the country on all aspects of the passage and implementation of the 2013 Drug Quality and Security Act including both compounding and supply chain issues, its guidance documents, and implementing regulations. She is well-versed in compounding laws, regulations and guidance, and regularly counsels clients on these topics.
Ms. Palmer is an immediate past member of the Board of Directors of the Law School Alumni Association at the University of Richmond, and is a former board member of Chattering Children, a nonprofit that provides speech and language education, therapy, and services to hearing impaired children throughout the Washington, D.C. area.