4729-33-02 Licensure.

(A) Any emergency medical service (EMS) organization that desires to stock dangerous drugs shall apply for and maintain a license as a terminal distributor of dangerous drugs. The one location that serves as the main station will be deemed the headquarters location. Any other locations associated with this headquarters where dangerous drugs will be stored will be licensed as "satellites." Only the headquarters location will be charged a license fee or renewal license fee.

(B) Each location, headquarters and satellites, must be licensed as a limited terminal distributor of dangerous drugs and must maintain a current terminal distributor of dangerous drugs license and drug addendum.

(C) An application for licensure must include all of the following:

(1) A completed application;

(2) A compilation of all protocols involving dangerous drugs that have been signed by the medical director and notarized;

(3) A list of drugs referenced in the protocols to be stocked by the EMS organization, signed by the medical director and notarized;

(4) A list of personnel employed, including volunteers, by the EMS organization who may access and administer dangerous drugs, which includes the name of the individual, level of certification, their certification number, and expiration date;

(5) A list of any and all formal written mutual aid agreements with other EMS organizations;

(6) The fee for the appropriate category of licensure.

(D) Each location, headquarters and satellite, may only possess those dangerous drugs that are on the drug list submitted to the board pursuant to paragraph (C)(3) of this rule and only at locations licensed by the board of pharmacy.

(1) A medical director may modify the drugs that can be possessed and administered by an emergency medical service organization by submitting a new drug list in a manner prescribed by the board.

(2) A modification to the drug list shall require an update to the EMS organization's protocols. The updated protocols shall be maintained and readily retrievable upon inspection at the location licensed by the board and are not required to be submitted with the updated drug list as described in paragraph (D)(1) of this rule.

(E) A new application and fee is required prior to any change of location, addition of a satellite location, change of category, name change, or change of ownership. The new application and required fee shall be submitted within thirty days of any change in the ownership, business or trade name, category, or address.

(F) The responsible person shall comply with rule 4729-5-11 of the Administrative Code.

(G) To change the medical director of an EMS organization, the new medical director shall submit notification, in a manner prescribed by the board, to the board within five business days of the change. The notification shall indicate whether or not the medical director approves of the current protocol and drug list. If the new medical director makes any changes the drug list, they shall comply with the requirements in paragraph (D) of this rule. If the new medical director makes any changes to the protocols, they shall comply with paragraph (J) of this rule.

(H) Any changes in the list of dangerous drugs referenced in an EMS organization's protocol shall be submitted to the state board of pharmacy prior to the implementation of the protocols involved.

(I) Any change of personnel shall be updatedwithin thirty days of the change listing the type of change (addition, update, or deletion), names of the personnel involved, level of certification, their certification number, and expiration date. Personnel lists shall be maintained by the EMS organization and shall be readily retrievable upon inspection by the board.

(J) An EMS organization shall maintain a current copy of their protocols at their licensed location. Protocols shall be readily retrievable upon inspection by the board.

Effective: 4/10/2016
Five Year Review (FYR) Dates: 05/30/2019
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.51, 4729.54, 4729.55
Prior Effective Dates: 8/15/2000, 1/1/2004, 1/1/09, 8/22/14