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 listed on the drug addendum and only at locations licensed by the board of pharmacy.

(1) A medical director may add dangerous drugs to the drug list by submitting revised, signed and notarized protocols and list of medications, and the addendum update fee.

(2) A medical director may delete dangerous drugs from the drug list by submitting a letter listing the drugs to be deleted.

(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. These changes may be made during the annual renewal period with no additional fee other than the renewal fee.

(F) The responsible person shall provide supervision and control of all locations where dangerous drugs are stored. The responsible person must be a physician licensed pursuant to Chapter 4731. of the Revised Code or a pharmacist licensed pursuant to Chapter 4729. of the Revised Code.

(1) To change the responsible person, the new responsible person must complete and return a notification of change of responsible person form within thirty days by regular mail or verified facsimile transmission.

(2) To change the medical director, the new medical director must submit a signed and notarized letter stating that he/she is accepting responsibility for the EMS organization.

(a) If the new medical director approves of the current protocol and drug list, a signed and notarized letter must be submitted stating the current protocols and drug list on file have been reviewed and are approved by the medical director for use by this EMS organization, or

(b) If the new medical director desires to change the protocols or drug list, the medical director must submit the revised, signed, and notarized protocols and drug list, and the addendum update fee.

(G) Any changes in protocols that involve dangerous drugs must be submitted to the state board of pharmacy prior to the implementation of the protocols involved. The state board of pharmacy may discuss such protocols with the state board of emergency medical, fire and transportation services, state medical board, or other governmental agencies as needed to assure their validity.

(H) Any change of personnel requires a letter from the organization within 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.

Effective: 08/22/2014
R.C. 119.032 review dates: 06/06/2014 and 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