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Compounding Pharmacy Compliance
June 2-3, 2025
Aloft Boston Seaport DistrictBoston, MA
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Day 2 - ET (Eastern Time, GMT-05:00)

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Day 2 - ET (Eastern Time, GMT-05:00)
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Showing 2 of 2 Streams
8:45am - 9:00am
Track Chair Kick-Off
9:00am - 9:45am
Navigating USP Regulatory Adherence & 503A-Specific Strategies to Operationalize
  • Gain insights into how 503As can navigate interpretation of USP updates as requirements become more stringent
  • Discover practical strategies to implement USP standards into compounding processes
  • Viral Jani - Director of Operations, Town & Country Compounding
9:45am - 10:30am
Managing Drug Shortages –Compliance Strategies for 503A Pharmacies
  • Explore the current legal and regulatory environment around drug shortages for 503As, including what is permissible or prohibited
  • Analyze the impact of drug shortages on the industry and specific challenges faced by 503As when drugs are added to or removed from the shortage list
  • Discuss proactive measures 503As can implement to minimize the impact of drug shortages, including alternative sourcing options and risk management strategies
  • Jo Ah Lee, PharmD, BCSCP, MBA - Director of Compounding, SandsRX Pharmacy
8:45am - 9:00am
Track Chair Kick-Off
9:00am - 9:45am
Examining the 503B Regulatory Landscape – Recent Updates and Industry Impact
  • Explore the latest regulatory updates and trends impacting 503B facilities
  • Examine direct implications for 503B operations and downstream impact for 503As
  • Learn to identify and mitigate common compliance pitfalls and implement proactive strategies to avoid costly errors
  • Barbara Knightly - Chief Quality Officer, Leiters Health
9:45am - 10:30am
Legal Spotlight – FDA’s Removal of Tirzepatide from the Drug Shortage List
  • Hear directly from the Outsourcing Facilities Association on their current lawsuit against the FDA regarding the removal of tirzepatide from the drug shortage list, including the case’s present status and expected timeline
  • Explore possible outcomes and analyze how this lawsuit could reshape the 503B regulatory landscape and the broader compounding industry
  • Lee Rosebush - Partner, BakerHostetler; Chairman and General Counsel, Outsourcing Facilities Association
  • David Flynn, J.D. - Senior Director of Legal and Regulatory Affairs, Olympia Pharmaceuticals
10:30am - 11:00am
Networking & Refreshment Break
Showing 2 of 2 Streams
11:00am - 11:45am
Navigating Drug Shortages for Health Systems – Collaborative Strategies with 503A Pharmacies
  • Learn how 503A pharmacies can provide critical support to health systems during drug shortages
  • Discover strategies for collaborating with 503A pharmacies to ensure patient access to essential medications while maintaining regulatory compliance
  • Kathleen Kane, Pharm.D., BCSCP - Assistant Director of Pharmacy, Compounding Integrity and Compounding Regulatory Compliance, UChicago Medicine
  • Payal Patel, PharmD - Compounding Pharmacist, Mark Drugs Northshore Inc.
11:45am - 12:30pm
Mastering State Board 503A Requirements and Enhancing Inspection Readiness
  • Discuss evolving State Board inspection practices for 503A pharmacies and specific areas of focus that are drawing increased scrutiny
  • Examine emerging trends in state pharmacy regulations
  • Explore common deficiencies in 503A inspection readiness, how to identify areas of potential concern and real-world examples of compliance strategies to mitigate risk
  • Shixian Wang - Director of Operations, Red Rock Pharmacy
  • Tenille Davis - Chief Advocacy Officer, Alliance for Pharmacy Compounding
11:00am - 11:45am
Mastering Drug Shortages – Regulatory and Operational Strategies for 503Bs
  • Deep dive into the current regulatory environment and legal implications of changes to the drug shortage list for 503B compounders
  • Discuss strategies to effectively manage drug shortages while maintaining compliance and patient care
  • Melissa Stefko - Senior Vice President, Regulatory Affairs, Wells Pharmacy Network
11:45am - 12:30pm
Best Practices in 503B Quality Assurance to Ensure cGMP Compliance
  • Develop a deeper understanding of cGMP requirements and hear practical perspectives on how to implement these requirements
  • Explore key considerations in building a robust quality assurance program, including core processes to implement, setting metrics to prioritize, and performing advanced management review programs
  • Dive into real-world examples from compounders on common challenges in building and adapting quality assurance processes to adhere to cGMP standards
  • Anthony Sinconis, PharmD - Director of Quality/Supervising Pharmacist, Nubratori Rx
12:30pm - 1:30pm
Networking Luncheon
Showing 1 of 1 Streams
1:30pm - 2:15pm
AI in Compounding–Navigating Regulatory Considerations
  • Learn about specific ways AI is being leveraged to enhance compounding processes
  • Discuss key compliance considerations to prioritize when implementing AI
  • Explore the future of AI in compounding, including outlook on the regulatory landscape and operational strategies to optimize AI usage
  • Viral Jani - Director of Operations, Town & Country Compounding
2:15pm - 3:00pm
Future-Proof Your Compounding Operations to Meet Future GMP Requirements
  • Examine advanced strategies that compounding facilities can leverage to prepare for evolving regulations
  • Implement proactive measures and adapt your operations to address increasingly stringent GMP requirements
3:00pm - 3:15pm
Chair’s Closing Remarks and Close of Conference
Day 1
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