4729-5-35 Automated drug delivery systems.

                                                                                                                                             

NOTICE OF PUBLIC HEARING

Acting under the authority of the Ohio Revised Code Sections 119.03 to 119.13, 3715.69, 3719.28, 3719.44 and 4729.26, the State Board of Pharmacy hereby announces a public hearing will be held on Tuesday, July 8, 2014 at 11:00 a.m. in Room South A, 31st Floor, Vern Riffe Center for Government and the Arts, 77 South High Street, Columbus, Ohio.

This is a statement of the agency's intention to amend the following rule:

·          4729-3-01: Authorizes the Board of Pharmacy to waive the 2:1 ratio for the operation of immunization clinics or other specific circumstances.

·          4729-5-10: Requires electronic submission of the pick-up station waiver to avoid the unnecessary paperwork. Also, removes the requirement of pre-approval but does allow for Board inspectors to review the waiver upon inspection of the facility acting as a pick-up station and/or the pharmacy shipping to that location.

·          4729-5-11: Requires the responsible person for a pain management clinic to be a physician that meets certain requirements (i.e. board certification). This rule ensures that there is proper oversight at each location. The requirements for the responsible person are taken from the Medical Board pain management clinic rules.

·          4729-5-17: Clarifies that prescriber dispensing limits to not apply in the following instances, as indicated in law: (a) methadone provided to patients for the purpose of treating drug addiction, (b) buprenorphine provided to patients for the purpose of treating drug addiction, (c) controlled substances provided to research subjects by a facility conducting clinical research, (d) and a prescriber who is a veterinarian.

·          4729-5-35: Removes the 100% accuracy requirement for automated drug delivery systems and also provides an appeal process by which a terminal distributor of dangerous drugs can appeal a decision by a Board of Pharmacy inspector.

·          4729-5-38: Authorizes a licensed pharmacist to administer the measles, mumps, and rubella (MMR) vaccine to individuals 18 years and older.

·          4729-6-01: Changes references from the Ohio Department of Alcohol and Drug Addiction Services to the Ohio Department of Mental Health and Addiction Services.

·          4729-6-03: Changes references from the Ohio Department of Alcohol and Drug Addiction Services to the Ohio Department of Mental Health and Addiction Services.

·          4729-7-06: Changes the requirement that in-state continuing education providers submit their participant lists to the Board. Instead, providers will be required to maintain those records. In addition, in-state providers will no longer have to send notification to the Board before or within fourteen days after a program has been presented.

·          4729-9-21: Requires drugs compounded in a pharmacy to meet national standards as well as meet all requirements of federal law.

·          4729-9-26: Corrects a typo in the criminal records check for pain management clinics section of the OAC.

·          4729-9-14: Updates references to measurement standards. In addition, requires all prescribers or terminal distributor of dangerous drugs who store controlled substances to conduct an inventory of these drugs annually to detect for theft or diversion.

·          4729-33-01: Updates definitions section to reflect change in EMS terminology and to reference the correct cross references to sections of the OAC and ORC.

·          4729-33-02: Updates the EMS licensure section to reference to the official name of the state board of emergency medical, fire and transportation services and clarifies that volunteer personnel should also be listed on the terminal distributor of dangerous drugs license application.

·          4729-33-05: Defines "posting up" as a temporary, short-term location of the EMS unit for less than twenty-four hours where the EMS unit is under constant supervision of the EMS personnel on duty. Exempts emergency situations from this requirement.

The full text of the proposed rule is at the office of the State Board of Pharmacy in printed form without charge to any person affected by such proposals. The proposed rule is also on the Board's website at  http://pharmacy.ohio.gov/LawsRules/ProposedRules.aspx and on the Register of Ohio website at  www.registerofohio.state.oh.us.

On the date and at the time and place designated in this notice, any person affected by the proposed action of the State Board of Pharmacy may appear and be heard in person, by his/her attorney, or both; may present his/her position, arguments, or contentions orally or in writing; offer witnesses; and, present evidence tending to show that any proposal, if adopted or effectuated, will be unreasonable or unlawful.

Kyle W. Parker, M.B.A., R.Ph., Executive Director