4729-19-04 Minimum standards for compounding parenteral or sterile product prescriptions.

 

 

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, December 2, 2014 at 9:00 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 promulgate the following rules:

 

New Rules

·          4729-7-10: Outlines Board of Pharmacy provisions relating to the licensure of veterans and military families. Includes all Board policies regarding fee waivers, continuing education and license renewal extensions for veterans and military families.

·          4729-16-03: Provides the requirements for drugs compounded in a pharmacy.

·          4729-16-04: Provides the requirements drugs compounded by a physician.

·          4729-16-05: Provides the requirements for drugs compounded in a fluid therapy pharmacy.

·          4729-16-06: Provides the recordkeeping requirements for pharmacies and prescribers when compounding drugs.

·          4729-16-07: Permits an in-state pharmacy to provide non-patient specific compounded drugs to a prescriber in limited quantities and in specific circumstances.

·          4729-16-08: Provides the requirement for drugs compounded by a nonresident (i.e. out-of-state) pharmacy.

·          4729-16-09: Requires all prescribers that are ordering compounded drugs and compounding drugs on site to have a terminal distributor license. This is to reflect a recent law change in HB 483 (130th General Assembly).

·          4729-16-10: Permits an in-state pharmacy to provide non-patient specific compounded drugs to a health care facility in the event of drug shortage. The health care facility and in-state pharmacy are required to notify the Board's Executive Director.

 

 

Amended Rules

·          4729-5-12: Provides the criminal records checks for pharmacists and pharmacy interns. Requires a pharmacist who lets their license lapse for more than three years to submit to a criminal background check if requesting a pharmacist or pharmacy intern license.

·          4729-5-21: Provides the manner with which a prescription must be processed by a pharmacy. Allows a pharmacy to document the administration of an immunization on a prescription form in order to allow a pharmacy to bill an individual's health insurance.

·          4729-16-01: Provides definitions for a new rule chapter on compounding of dangerous drugs.

 

 

Amended Rules (5 Year Review)

·          4729-21-06: Provides the approved courses that divers must complete before they are allowed to purchase and utilize medical oxygen. Authorizes individuals who have completed courses from the National Association of Underwater Instructors to purchase and possess medical oxygen for the purpose of emergency care or treatment at the scene of a diving emergency.

 

·          4729-15-03: Sets the minimum standards for a nuclear pharmacy. Updates a cross reference to a new compounding chapter (Chapter 16). This chapter will be in effect prior to the effective date of this rule.

·          4729-5-27: Provides the record keeping for the practice of pharmacy in an outpatient setting. Updates the rule to reflect current technology.

·          4729-5-30: Provides the manner in which a valid prescription must be issued by a prescriber in order to be dispensed by a pharmacy. Updates a cross reference to a new compounding chapter (Chapter 16). This chapter will be in effect prior to the effective date of this rule.

·          4729-21-03: Requires sellers of compressed medical gas to keep records for three years. Updates current terminology for a Board of Pharmacy agent to match other record keeping sections of the Administrative Code.

·          4729-22-04: Prior to selling medical oxygen to a patient, the retail seller must have an order issued by a prescriber. Allows for the electronic transmission of an order for medical oxygen

·          4729-13-01: Provides the definitional section for the OAC chapter for laboratory licensure. This rule is amended to update an incorrect cross reference to the ORC.

·          4729-13-02: Provides the procedure for Board approval as a laboratory, including licensure as a terminal distributor of dangerous drugs.

·          4729-14-01: Provides the definitional section for the OAC chapter for animal shelter licensure. This rule is amended to update an incorrect cross reference to the ORC.

·          4729-14-02: Provides the procedure for obtaining a terminal distributor of dangerous drugs from the Board.

Rescinded Rules

·          Chapter 4729-19

·          Chapter 4729-31

·      4729-9-25

·      4729-5-25

The full text of the rules is available at the office of the State Board of Pharmacy in printed form without charge to any person affected by such proposals. The rules are also available on the Register of Ohio web site 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.

Eric Griffin

Interim Executive Director