Who Qualifies for the New FDA PreCheck Pilot Program?

FDA is now accepting submissions to its PreCheck Pilot Program, which is the Agency’s latest initiative to increase domestic production of pharmaceuticals.  The two-phase structure of the Program and its benefits to industry, which we previously detailed in connection with the Onshoring Manufacturing of Drugs and Biological Products Public Meeting, have not significantly changed.  However, FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.

Eligibility Criteria

1. New manufacturing facility: neither existing facilities nor extensions of existing facilities are eligible. Eligible new facilities include those that will break ground by the full proposal deadline, as well as those still in “preoperational development.”
2. Located in the United States (including U.S. territories): the most straightforward of the criteria.
3. Facility size: the new facility must produce sufficient volume to meet a specified market need or contribute significantly to addressing U.S. market supply needs. FDA is clear that eligibility is not necessarily tied to production capacity as “a small volume may be acceptable if it fully meets the needs for a rare disease state with a limited patient population.”
4. Submission commitment: companies must to commit to submitting an application for the new facility during the PreCheck Pilot Program and must continue to actively manufacture products in the facility for at least 3 years following FDA approval. The application could be a new NDA/ANDA/BLA, supplement to an existing application for a drug substance/drug product facility, or a Type II DMF for small molecule APIs.

In reviewing the eligibility criteria, it is worth noting that FDA generally considers separate buildings within close proximity to be part of the same “facility,” assuming they are related to the same business and capable of being covered in a single inspection.  21 USC §379j-41(6).  In other words, a new building on an existing campus could be part of the same “facility” under the statutory definition.  The FDA PreCheck Pilot Program repeatedly refers to new facilities—not buildings—meaning that a new building on an existing campus would presumably not be eligible.

Interested companies that meet the PreCheck eligibility criteria can submit a request to participate now through March 1, 2026.  Only one facility can be included in a request, and only one request per company.  However, our reading of Eligibility Criteria 4 in combination with Selection Criteria 6 suggests that the owner of the facility does not necessarily also have to be the sponsor of the future application (e.g., contract manufacturers working in cooperation with an identified sponsor could be eligible).

Selection Criteria

FDA PreCheck submissions for eligible facilities need to meet at least two of the program selection criteria and FDA has specified what they will prioritize within each criterion.

1. Source: FDA will prioritize facilities that will also use domestically sourced key starting materials. This does not come as a surprise given the overall emphasis on U.S. production, which we discussed last week.
2. Products: while all pharmaceutical products are eligible, priority may be given to facilities that will produce essential medicines, drugs on shortage, or address supply chain vulnerability. The specific examples FDA references are sterile drug products and large volume parenterals.
3. Facility development phase: facilities in earlier development phases will be prioritized as this is when the agency-industry engagement will be the most beneficial.
4. Timeline: priority will be given to submissions that quantify how participation in the program will help minimize time-to-market critical products and contribute to domestic manufacturing capacity.
5. Innovation: FDA is interested in novel approaches to facility design and construction, such as modular or prefabricated construction methodologies, advanced automation technologies, and digital integration. Depending on the technology, there may also be engagement with FDA’s other advanced manufacturing technology initiates, which we have previously discussed in 2024 and 2025.
6. Company qualifications: priority will be given to companies (of any size) with past pharmaceutical manufacturing experience. FDA states that this could also include contract manufacturers that “have agreements in place with experienced sponsors and a documented willingness to share information with their proposed partner sponsors about the proposed facility.”

FDA will request additional detailed information from the selected PreCheck Program Finalists by April 1.  Finalists will then have until May 1 to submit the requested information.  Following a review of the final submission packages, FDA will select 7 participants as part of the initial PreCheck cohort, and “pre-operational engagements” will begin by July 1.  The learnings from the initial cohort will be used to “further enhance the program,” meaning that additional cohorts are anticipated, but no timelines have been provided.