SECTION 535:1-17-2. General requirements

(a)   These pilot project rules become effective upon the pilot project statute effective date.

(b)   A petitioner who wishes the Board to consider a pilot project for approval shall submit to the Board a petition that contains all of the following information:

(1)   The name, address, telephone number, electronic mail address and Oklahoma license number of the pharmacist responsible for overseeing the proposed pilot project.

(2)   The specific location where the proposed pilot project will be conducted. The petitioner shall include the Oklahoma license number of the pharmacy and a statement that the Oklahoma license of the pharmacy and any pharmacist involved with the pilot project is current and is not subject to sanction for violation of federal or state statutes or rules.

(3)   A detailed summary of the proposed pilot project that includes all of the following:

(A)   The goals and objectives, as applicable, of the proposed pilot project.

(B)   A full explanation of the proposed pilot project and how the project will be conducted.

(C)   The initial time frame for the pilot project, including the proposed start date and length of the project, which initial time frame shall not exceed twelve (12) months.

(D)   All background information and literature review, as applicable, to support the proposed pilot project.

(E)   If applicable, identification of the rules from which the petitioner is requesting an exception as provided in subsection (c) in order to complete the proposed pilot project and a request for that exception.

(F)   If applicable, procedures the petitioner will use during the proposed pilot project to ensure that the public's health and safety are not compromised as a result of an exception to a rule being granted under subsection (c).

(c)   The Board shall not approve a pilot project that does any of the following:

(1)   Expands the definition of the practice of pharmacy.

(2)   Provides for the therapeutic substitution or substitution of medical devices used in patient care.

(3)   Allows a pharmacy or pharmacist to be involved with a pilot project if the pharmacy's or pharmacist's license is not current or is subject to a sanction for a violation of the Pharmacy Act and/or federal or state laws.

(d)   The Board may grant to a petitioner conducting an approved pilot project under this section an exception to a rule promulgated by the Board. The Board may grant an exception under this section for a specified period of time, which period shall not exceed twelve (12) months, unless the pilot project is extended under subsection (h) and/or (i).

(e)   Upon approval of a petition for a pilot project, the Board shall specify a time period for the operation of that pilot project, which period shall not exceed twelve (12) months. This time period may later be extended under subsections (h) and/or (i). The Board may include appropriate conditions or qualifications on approval of a pilot project. The Board may suspend the operation of a pilot project if it determines that the petitioner or any person involved with the pilot project has deviated the operation of the pilot project from the plan of operation that was approved. The Board may terminate a pilot project at any time if it determines that the health and safety of the public have become endangered by the pilot project.

(f)   If determined appropriate for the pilot project approved under this section, the Board may require the petitioner to notify patients that pharmacy services are being provided as part of a pilot project. If required under this subsection, the petitioner shall notify patients in the manner required by the Board.

(g)   The petitioner shall allow the Board to inspect and review pilot project documentation and the pilot project site at any time during the review process and after the pilot project is approved.

(h)   The pharmacist responsible for overseeing an approved pilot project shall forward all of the following to the Board:

(1)   Progress reports at intervals specified by the Board.

(2)   A summary of the results of the project and conclusions drawn from the results of the project within three (3) months after completion of the pilot project.

(3)   Documentation required by these rules shall be maintained by the petitioner and be available for review for a minimum of two (2) years.

(i)   If determined appropriate by the Board, the specified period of time for conducting a pilot project may be extended for an additional two periods of up to twelve (12) months each. The Board shall not grant an extension that would result in the specified period of time for conducting a pilot project under this section to exceed thirty-six (36) months.

(j)   If the Board determines that a pilot project for which an exception to a rule has been granted under subsection (c) should be extended so that rules may be promulgated in order to allow the pilot project to be conducted on a permanent basis, the Board may extend the thirty-six (36) months period of time for conducting a pilot project under subsection (i) for an additional period of up to twelve (12) months in order to promulgate such rules.

[Source: Added at 34 Ok Reg 1880, eff 9-11-17]