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  1. Human Drug Compounding

Compounding Outsourcing Facilities Annual Study

Background

Since 2019, the FDA Compounding Quality Center of Excellence has conducted the Compounding Outsourcing Facilities Annual Study to better understand industry perspectives and challenges, as well as dynamics between suppliers and purchasers. A total of two studies (2019–2020 and 2020–2021) have been completed, and the 2021–2022 study is in progress. Select findings from the first two studies are summarized in the presentations State of Outsourcing Facility Sector and Possibilities for the Future and Areas of Customer Need for Outsourcing Facility Products.

Each study includes (1) an annual survey of outsourcing facilities, (2) discussions with outsourcing facilities and their stakeholders, and (3) an analysis of existing publicly available data. The study is conducted by a research partner under the direction of the FDA. The research partner also develops an annual report of the study results and findings. Data gathered through surveys and discussions are deidentified and anonymous to the FDA.

Feedback From Outsourcing Facilities

Based on input from outsourcing facilities, the annual studies have collected information about areas such as:

  • Outsourcing facility perceptions of engagement with the FDA
  • How current FDA policies affect outsourcing facilities
  • Outsourcing facility needs and challenges that can inform FDA’s future policy and programmatic work
  • Topics identified by outsourcing facilities as needs for training or additional clarification
  • Size, scope, and trends in the outsourcing facility sector
  • Outsourcing facility perceptions of quality and implementation of quality practices
  • Interactions between outsourcing facilities and various stakeholders (e.g., suppliers of active pharmaceutical ingredients [APIs] and purchasers of outsourcing facility products)

Annual Reports

2021–2022 (In Progress)

  • Featured topic: Market demand for drug products produced by outsourcing facilities.

2020–2021

  • Executive summary, 2020–2021
  • Overview: Outsourcing facilities are showing some movement toward stabilization in the number of firms in the sector, demand for compounded drugs from customers continues, and outsourcing facilities continue to improve their understanding of current good manufacturing practice (CGMP) regulations. Financial and regulatory realities continue to shape the industry.
  • Featured topic: API suppliers.

2019–2020

  • Executive summary, 2019–2020
  • Overview: Outsourcing facilities are still adjusting and trying to understand how to balance regulation with profitable and sustainable business models. They need consistent, constructive communication with the FDA that is sensitive to their challenges.

Selected Research Findings and Subsequent FDA Actions

Clarifying FDA Quality Practices and Expectations for Outsourcing Facilities

Research Finding

FDA found that registered outsourcing facilities enter the market with varying levels of experience and knowledge of quality practices and CGMP regulations. Newly established outsourcing facilities might not be familiar with the expectations associated with FDA regulations, such as inspections or other general requirements.

FDA Action

The FDA expanded CGMP training topics to include areas identified by outsourcing facilities and added conference topics related to CGMP regulations, inspections, and Form FDA 483 observations.

Specific Actions Taken

Increasing Communication Between Outsourcing Facilities and the FDA

Research Finding

Outsourcing facilities prefer more two-way communication with the Agency. Rather than relying on FDA inspections for communication, which the facilities view as their primary means of interacting with the Agency, they would prefer additional avenues for communication in the future.

FDA Action

Provide informal opportunities for outsourcing facilities to ask the FDA questions and share their perspectives.

Specific Actions Taken

  • In 2022, the FDA initiated a cross-sector stakeholder group with representatives from the FDA, outsourcing facilities, and other stakeholders. The group is designed to promote information sharing across the outsourcing facility ecosystem. The forum includes stakeholder discussions of issues related to production, use, and quality of compounded drug products. Meeting summaries are posted to the FDA website.
  • The FDA is conducting small-group listening sessions for groups of outsourcing facilities with similar operations.
  • The FDA is obtaining input from outsourcing facility representatives on potential topics for the annual Compounding Quality Center of Excellence conference.

Identifying Areas for Additional Research

Research Finding

Based on previous outsourcing facility study findings, the FDA identified several areas that would benefit from additional research. The findings will be used to support more effective interactions between the FDA and outsourcing facilities.

FDA Action

After obtaining baseline information from the first year (2019–2020) of the annual research study, the FDA fine-tuned its approach to developing and addressing research questions. The study now includes items that the FDA tracks from year to year to detect trends, a featured topic each year, and focused research questions on various topics designed to address smaller, more specific knowledge gaps that change each year.

Specific Actions Taken

  • API suppliers was selected as the 2021 featured topic.
  • Market demand for drug products produced by outsourcing facilities was selected as the 2022 featured topic.

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