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Virtual | Virtual

Event Title
Compounding Quality Center of Excellence Annual Conference
September 6 - 8, 2022

September 6 - 8, 2022

Our 2022 conference highlighted how stakeholders can protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving access to compounded drugs for patients who have a medical need for them. Slide presentations and recorded videos with captions are available on this page.

2022 Conference Agenda

Presentation Title and slides

Watch the recorded session


Pre-conference session, Sept. 6, 2022


Outsourcing Facility Nuts and Bolts: Reporting, Registration, and Other Topics, time 2:20:20

FDA presents an overview of logistical elements, including product reporting, registration, pre-inspection meeting requests, inspections, and posting to the bulk nomination and general compounding dockets.

Compounding Quality Center of Excellence 2022 Conference: Opening Plenary, Sept. 7, 2022

Opening plenary including panel discussion, Aligning on Compounding Excellence: Understanding Its Meaning Across the Sector, time: 1:02

Panel discussion of what compounding ‘excellence’ means to a diverse group of stakeholders.

Characteristics of Pharmaceutical Elastomers in Container Closure Systems, Sept. 7, 2022


Container Closure Systems, time: 58:11

Presentation on qualifying container closure systems for intended use.

Visual Inspection of Injectable Products, Sept. 7, 2022

Visual Inspection, time: 59:04

Presentation on visual inspection practices and related current good manufacturing practice (CGMP) regulations, including examples of FDA Form 483 observations and potential responses.

Areas of Customer Need for Outsourcing Facility Products, Sept. 7, 2022


Areas of Need Roundtable, time: 48:33

Panel discussion with external stakeholders to discuss the areas of need for drug products compounded by outsourcing facilities, including FDA-sponsored research on stakeholder perspectives.

Virtual Breakout Sessions, Sept. 7, 2022

  1. Understanding the Form FDA 483 Process and Timeline
  2. 503B Product Reporting Compounded Products Update NDC Directory
  3. Quality Risk Management Moderated Discussion
  4. Implementation of Emerging Technologies (Automation)


No recording

Moderated breakout rooms:

  1. Understanding FDA Form 483 Process and Timeline
  2. Product Reporting, Registration, and Other Requirements
  3. Quality Risk Management
  4. Automation

FDA Hot Topics Panel Discussion, Sept. 8, 2022

FDA Hot Topics, time: 50:36

Panel discussion on current Agency topics of interest to outsourcing facilities.

Hospital and Health System Compounding Under Section 503A of the FD&C Act, Sept. 8, 2022


Hospital and Health System Guidance, time: 39:17

Presentation on revised draft compounding guidance for health systems.

Roundtable Discussion — 503B Hospital Panel: How are Outsourcing Facilities Evaluated by Prospective Customers?

Sept. 8, 2022


503B Hospital Panel; time: 54:20

Panel discussion on hospital and health system approaches to evaluating and selecting outsourcing facility partners.

Building Connections Co-Presentation, Sept. 8, 2022


Perspectives from the Field, time: 41:24

Case study presentation highlighting stakeholder collaboration to address patient needs

Building Connections: Advancing Our Shared Pursuit of Compounding Quality, Sept. 8, 2022


Closing panel, time: 1:04:26

Moderated panel on building cross-sector connections to advance compounding excellence.


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