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Compounding Pharmacy Compliance
August 17-18, 2023
The Westin Copley PlaceBoston, MA
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Day Two - EST/EDT (Eastern Daylight, GMT-4)

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Day Two - EST/EDT (Eastern Daylight, GMT-4)

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7:30am - 8:30am
Continental Breakfast and Coffee
8:30am - 8:45am
Co-Chair Opening Remarks
Showing 2 of 2 Streams
8:45am - 9:35am
Key Vendor Qualifications When Contracting with 503Bs
  • Necessary vendor qualifications and certifications.
  • Issues with relying on the FDA for qualified vendor lists
  • What to do when your vendor is shut down
  • Kathleen Kane, PharmaD, BCSCP - Assistant Director of Pharmacy, Compounding Integrity and Compounding Regulatory Compliance, UChicago Medicine
  • Alexandar Pytlarz - President of Operations, Infuserve America
9:40am - 10:30am
Hospital Perspective for Compounding Pharmacists
  • Developing clean rooms in a hospital compounding setting. Initial costs vs long term benefits?
  • Creating business cases that encourage hospitals to implement technology management systems.
  • Khang Pham, Pharm.D. - Director, Clinical Oncology Pharmacy, Memorial Cancer Institute
  • Matt Martin, PharmD BCSCP - Director of Clinical Services, PCCA
8:45am - 9:35am
The Definition of Insanity: 503B Pitfalls that Just Keep Happening and How to Break the Cycle

The definition of insanity is doing the same thing over and over and expecting the same result. In the 10 years since DQSA was passed, the 503B industry has grown and evolved, but several pitfalls that have ultimately led to business & compliance failures remain present. This presentation will identify the mishaps commonly seen across the first decade of the 503b industry and provide successfully tested ways to overcome them.

  • Kristopher Le, PharmD - CEO and Principal Consultant, Amicus cGMP Consulting
9:40am - 10:30am
Regulatory Implementations Surrounding 503B Compounding

Considering current CGMP guidelines, there are many questions surrounding 503b compounding such as

  • What are the specifics regarding the implementation of 503b compounding in a healthcare setting?
  • What should we base these guidelines on?
  • Varsha Gaitonde, PharmD, PhD, BCPS, BCSCP, FACHE - Vice President, Pharmacy Services, QuVa Pharma
10:30am - 11:00am
Networking and Refreshment Break
Showing 1 of 1 Streams
11:00am - 11:45am
State Board Perspectives on Compounding Regulations
  • Interstate Commerce – harmonization of state boards for more streamlined compounding commerce
  • Inspections process – how pharmacies can be better prepared
11:45am - 12:30pm
FDA Current Landscape – Priorities and Policies for Drug Compounding
  • Addressing current compliance concerns
  • New and updated regulatory standards and guidance for industry compounders
  • Keeping up to date with information on qualified vendors.
  • Hidee Molina, MS - Division Director, Division of Compounding 1, Office of Compounding Quality and Compliance, FDA
  • Lori G. Cantin, PharmD, MS - Branch Chief, Division of Compounding 2, Office of Compounding and Quality Compliance, FDA
  • Dominic Markwordt, JD - Regulatory Counsel, Division of Compounding Policy and Outreach, Office of Compounding Quality and Compliance, FDA
12:30pm - 1:30pm
Networking Luncheon
Showing 1 of 1 Streams
1:30pm - 2:10pm
503B Quality Control Solutions to Meet Patient Needs
2:10pm - 2:50pm
Management Systems
  • Compounding: Different process perspectives from manual, semi-automatic, and fully automatic. What are the benefits and challenges of each?
    • More discussion about robotics in this space on large and small scales
  • IV Workflow: Discussing the pros and cons of IV workflow systems and better utilizing information that is collected.
  • Task Management: Implementations and benefits of task management systems.
  • Thomas Karakosta, PharmD - Vice President, Strategic Marketing, Consortiex
  • Paul Baker, MpH - Compounding Compliance Co-ordinator, Massachusetts General Hospital
2:55pm - 3:35pm
Discussing Strategic Solutions for Challenges Faced by Smaller Compounding Pharmacies
  • Navigating challenges surrounding needing smaller quantities at a faster rate.
  • Finding suppliers with the right volumes and timeliness
  • Regulatory scrutiny requiring more resources
  • Production capacity
3:35pm - 4:15pm
Personnel Compliance and Training
  • How are different organizations tackling training requirements?
  • Discussing the best resources in procuring the adequately trained personnel to run operations
  • Pallavi Badkar, Rph, M.S, BCSCP - Director Of Operations / Pharmacist in Charge, Medisource Rx
  • Deborah McHugh - Senior Director Quality, Fagron Sterile Services
4:15pm - 4:30pm
Co-Chair Closing Remarks and Close of Conference
Day One
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