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

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.

• Unpack how varying state requirements are reshaping compliance strategies for both 503A and 503B facilities.
  • Contrast interpretations of USP standards across top markets like California, Texas & Florida.
  • Discuss emerging calls for regulatory harmonization and accreditation models.
  • Learn how multi-state operators build inspection-ready systems that adapt to patchwork requirements.

• As regulatory scrutiny intensifies, pharmacies transitioning from non-sterile to sterile compounding 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.
  • 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.
  • Collaborating for Compliance: Explore how pharmacies and testing labs work together to verify sterility and reduce the risk of FDA Form 483 observations.
  • 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.

• Move beyond basic compliance to a culture of quality.
  • Discover how 503A and 503B facilities are implementing GMP-like concepts to strengthen patient safety.
  • Design and document CAPAs that meet state and federal requirements, driving continuous quality improvement and safeguarding patient safety.
  • Hear emerging models for accreditation and standardized inspection criteria.
  • Understand the differences between sterile and non-sterile compounding hoods and their impact on contamination control.
  • Explore best practices for proper third-party testing, including adherence to ICH Q10 principles for pharmaceutical quality systems.

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 like Hims, Hers and Roe 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.