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Pharmacy Pilot Projects

The Missouri General Assembly recently enacted § 338.143, RSMo, which gave the Board authority to approve pharmacy pilot or demonstration research projects related to technology assisted verification or remote medication dispensing. Applications to operate a pilot or research project are now being accepted. Learn more about the program below:

Who Can Apply?

To be eligible, applicants for a pilot or research project must hold a current and active license, registration, or permit from the Board that is not under discipline. Unlicensed entities or licensees currently on Board discipline are not eligible to apply.

What Type of Projects Are Eligible for Approval?

Section 338.143 authorizes pilot/research projects that are related to technology assisted verification or remote medication dispensing. To be approved, the proposed project must be designed to:

  • Enhance patient care or services,
  • Improve patient outcomes or
  • Expand access to pharmacy services.

Can Non-Resident Entities Apply?

Yes, however, the non-resident entity must hold a current Board license, registration or permit. Once again, unlicensed entities are not eligible to apply.

How Will the Project Program Work?

Once approved, operators may begin project activities as identified or approved by the Board. Reporting requirements will be specified by the Board based on the individual project. Deviations from approved project operations must be reported to the Board within five (5) business days and may result in Board approval being withdrawn or rescinded.

How Will Participants Be Selected?

As identified in 20 CSR 2220-2.995, the Board will consider:

  1. Patient safety and public protection needs;
  2. Feasibility of the project within proposed project guidelines;
  3. The needs of the state/Missouri patients, and
  4. Potential impact of the proposed project on Missouri pharmacy practice.

How Do I Apply?

Proposed project operators must submit a one (1) page abstract of the project to the Board that includes the project's goals, purpose, scope and proposed timelines. Additionally, a narrative description of the project must be submitted that includes:

  • (1) Activities that will be undertaken as part of the pilot project, including, the intended audience;
  • (2) The goals and objectives of the project. Services and anticipated outcomes must be clearly described and align with section 338.143, RSMo;
  • (3) A description of the capacity and structure the applicant has in place to operate the proposed pilot program, including, staff and personnel who will be monitoring, supervising or participating in the pilot project and their relevant education, experience, or qualifications;
  • (4) Procedures for training staff on project operations;
  • (5) An explanation of how the proposal will enhance patient care or safety, improve patient outcomes, or expand access to pharmacy services for Missouri citizens;
  • (6) A projected timeline for implementation and completion of the proposed pilot project. The proposed pilot project must be eligible for completion within eighteen (18) months of approval, unless otherwise authorized by the board;
  • (7) Evaluation measures for assessing impact and effectiveness; and
  • (8) A plan for terminating the pilot project after completion.
A sample application form is available on the Board's website; there is no application fee.

How Long Can A Pilot/Research Project Operate?

Approved projects must be eligible for completion within eighteen (18) months of approval, unless otherwise approved by the Board. Requests to extend the 18-month timeframe can be included in your application materials.

When Is The Application Deadline?

Applications will be accepted on a rolling basis; No application deadline currently exists.

How Much Does it Cost to Apply?

Applicants can apply at no cost.

Questions?

Emergency rule 20 CSR 2220-2.995 contains detailed information on project operational requirements and the approval process (see copies attached). For additional information, contact the Board office at compliance@pr.mo.gov or (573) 751-0091 (e-mail is preferred)