Day 1Tuesday, 9 June 2026 - ET (Eastern Time, GMT-05:00)

As regulatory scrutiny continues to evolve across the compounding landscape, pharmacies must stay ahead of shifting enforcement priorities and operational expectations. Join Susan Alverson of the Alabama State Board of Pharmacy for a regulator’s perspective on the compliance risks, inspection trends, and oversight challenges shaping today’s environment.

• Gain insight into how State Boards are approaching inspections, enforcement actions, and pharmacy oversight in the current regulatory climate
• Understand the most common compliance gaps and operational issues identified during inspections
• Explore how regulatory expectations are evolving around quality systems, documentation, and patient safety safeguards
• Learn practical strategies for strengthening inspection readiness and maintaining proactive engagement with regulators

Explore how compounders are adapting to evolving USP standards, including the expanded requirements under USP 800, and what “inspection ready” looks like in practice across people, process, facilities, and documentation.

• Identify common gaps in operational readiness, training and quality documentation that create compliance risk.

• Review inspection findings and enforcement trends since the latest revisions, including recurring observations tied to environmental controls and quality systems.

• Discuss best practices for integrating safety protocols and facility design updates, and aligning SOPs to day to day workflow.

• Clarify when USP monograph methods do and do not meet stability indicating expectations, and what that means for compounded preparations with variable compositions.

• Share a practical, repeatable approach to demonstrating stability indicating assays across formulations and clients, including a brief primer on chromatographic separation concepts that support method selection and defensibility.

Join Dr. Thomas Kupiec, owner of ARL Bio and Managing Editor of the International Journal of Pharmaceutical Compounding, as he unpacks the hottest topic in compounding: GLP-1s. From breakthroughs to challenges, this session delivers the answers you need to stay ahead in this rapidly evolving field.

A deep dive into the most frequent FDA 483 observations—from aseptic technique breakdowns to documentation gaps.

• Learn how to analyze audit results to drive continuous improvement.
• Understand current FDA focus areas including environmental monitoring and beyond-use dating.
• Outline actionable remediation frameworks to avoid repeat violations.

• Essential copy disputes
• How recent litigation is influencing FDA enforcement
• Risk exposure for pharmacies and outsourcing facilities
• Key areas operators should prepare for

A state-by-state look at how evolving legislation, board enforcement trends, and inconsistent regulatory expectations are reshaping compounding pharmacy operations for both 503A and 503B facilities.

• Explore emerging legislative activity targeting compounding pharmacies in states like California, Florida, Indiana, Colorado, and beyond.
• Compare how boards of pharmacy and inspectors are interpreting and enforcing USP and compounding requirements differently across jurisdictions.
• Discuss growing tension between state initiatives, federal oversight, and evolving FDA policy positions.
• Hear practical perspectives on how pharmacies and outsourcing facilities are adapting compliance, advocacy, and operational strategies in an increasingly fragmented environment.

Clear, compliant communication is increasingly critical as regulators, payers, and patients scrutinize claims across compounded therapies. This session will explore how pharmacies can navigate evolving expectations while maintaining credibility and reducing enforcement risk:

• Key legal and regulatory boundaries for describing compounded drugs across advertising, patient communications, and provider outreach
• Common compliance pitfalls, including misleading efficacy claims, inappropriate comparisons to FDA-approved products, and off-label promotional language
• Practical strategies for aligning marketing with pharmacy operations, clinical decision-making, and documentation standards to ensure defensible messaging
• Lessons from recent enforcement trends, including high-profile categories such as GLP-1s, and what they signal for broader oversight

As regulatory scrutiny intensifies, pharmacies face complex challenges around ingredient validation, labeling accuracy, and sterility designation. This session will highlight key compliance risks and offer practical guidance for ensuring regulatory alignment.

• Clarifying Ingredient Standards: Understand the importance of NDC numbers, differentiate between excipients and APIs, and recognize that USP designation and API status are not synonymous.
• Buying with Confidence: Emphasize the need for purchasers to understand chemical grades, labeling nuances, and how to select the right ingredients for sterile compounding.
• Navigating Dual Monographs: Review cases where active ingredients carry both sterile and non-sterile USP monographs, and understand the implications for compounding practices.
• Ensuring Sterile Suitability: Learn labeling requirements and risk mitigation strategies to confirm ingredient suitability for sterile use.

Move beyond basic compliance toward building a true culture of quality.

Drawing on extensive experience in pharmaceutical manufacturing and quality systems, this session explores how proven industry frameworks can be thoughtfully adapted for 503A and 503B compounding operations.

• Discover how 503A and 503B facilities can implement cGMP and Human Error Prevention concepts commonly used in commercial pharmaceutical settings to:
  • Reduce risk to product quality and patient safety
  • Enable successful inspections
  • Reduce deviations, errors, rework, and firefighting
  • Drive a strong quality culture
• Design and document CAPAs that not only meet state and federal requirements, but also drive continuous quality improvement and safeguard patient safety in alignment with ICH Q10 Pharmaceutical Quality System principles.
• Explore best practices for writing concise, visual, user-friendly procedures that serve as practical performance improvement tools rather than a compliance burden.

*Edwards Deming, the famous pioneering leader of Toyota in the 1950’s, widely regarded as the Father of Modern Quality, said: “85% of the reasons for failure are deficiencies in the systems and process rather than the employee.” Many studies place that number at 95%. HEP is a well-researched, well documented field adopted by many industries (e.g. aerospace, nuclear) decades ago.

• Financial realities of cGMP, QA, and infrastructure investment 
• Long‑term defensibility 
• Scaling quality systems 
• Avoiding overbuilding or underbuilding 

As virtual care reshapes how patients access personalized therapies, compounders are navigating new territory where innovation meets regulation.

• Examine how telehealth and home-delivery models are redefining patient access and the pharmacist’s role.
• Clarify state-to-state prescribing and shipping rules—and the gray zones emerging around telepharmacy operations.
• Explore direct-to-consumer models to understand their impact on traditional compounding channels.
• Discuss strategies for safeguarding compliance and clinical integrity while embracing new opportunities for reach and patient engagement.