4729-9-10 Occasional sale.

 

 

 

State of Ohio

STATE BOARD OF PHARMACY

77 S. High Street, Room 1702

Columbus, Ohio  43215-6126

 

Acting under the authority of the Ohio Revised Code Sections 119.03 to 119.13, 3715.69, 3719.28, and 4729.26, the State Board of Pharmacy hereby announces a public hearing will be held on Monday, September 12, 2011, at 1:00 p.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 consider adopting proposed new and amended rules as follows:

 

      (Notice of meetings.) To remove language regarding an unused procedure that notice of meetings may be received by regular mail for an annual fee of twenty-five dollars.

 

(Public records.) To amend language to be in compliance with current state law regarding public record requests.

 

4729-3-01 (Definitions.) To update a paragraph reference to the Administrative Code.

 

4729-3-05 (Internship credit.) To remove the reference to the Test of Spoken English since it is no longer provided and add language that the only acceptable test is the Test of Spoken English as a Foreign Language Internet-based test (TOEFL iBT).

 

4729-3-09 (Expiration of pharmacy intern certificate.) To clarify the employer notification and license return procedures required when a pharmacy intern is no longer enrolled in a school of pharmacy.

 

4729-4-03 (Qualified pharmacy technician training program.) To update a paragraph reference to the Administrative Code.

 

4729-5-01 (Definitions.) To create new definitions for "personally furnish", "OARRS report", and "reported drugs" that relate to rule changes pursuant to the passage of House Bill 93 of the 129th General Assembly.

 

4729-5-07 (Recognized and approved colleges of pharmacy.) To remove the reference to the Test of Spoken English since it is no longer provided and add language that the only acceptable test is the Test of Spoken English as a Foreign Language Internet-based test (TOEFL iBT).

 

4729-5-20 (Prospective drug utilization review.) To add new language pursuant to the passage of House Bill 93 of the 129th General Assembly regarding when a pharmacist must request and review an OARRS report.

 

      (Dispensing and compounding of drugs.) To update language regarding qualified pharmacy technicians pursuant to section 4729.42 of the Revised Code.

 

      (Partial dispensing of schedule II controlled substances.) To cite the specific references made to the Code of Federal Regulations in the proper form.

 

4729-5-30 (Manner of issuance of a prescription.) To clarify that an electronic prescription transmission system meeting the requirements of 21 C.F.R. 1311 for both controlled and non- controlled substance prescriptions shall be considered approved.

 

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4729-5-33 (Examination application for registration as a pharmacist.) To add a clarifying reference to an Administrative Code rule regarding approved schools of pharmacy; and, to remove the reference to the Test of Spoken English since it is no longer provided and add language that the only acceptable test is the Test of Spoken English as a Foreign Language Internet-based test (TOEFL iBT).

4729-9-06 (Disposal of dangerous drugs which are controlled substances.) To clarify that the executive director may appoint a designee to authorize the disposal of controlled substances.

4729-9-10 (Occasional sale.) To cite the specific references made to the Code of Federal Regulations in the proper form.

4729-9-16 (Minimum requirements for wholesalers.) To add language requiring when Wholesale Distributors of Dangerous Drugs are required to notify the Board of Pharmacy of changes, which mimics the notification requirements for pharmacies in rule 4729-9-05 of the Administrative Code.

4729-9-26 (Criminal records check for pain management clinics.) To create a new rule pursuant to the passage of House Bill 93 of the 129th General Assembly regarding criminal records checks for owners and employees of pain management clinics.

      (Entities required to submit information.) To change language pursuant to the passage of House Bill 93 of the 129th General Assembly requiring prescribers to submit personally furnishing reportable drug data to the drug database (a.k.a. OARRS).

(Information required for submission.) To change language pursuant to the passage of House Bill 93 of the 129th General Assembly regarding the personally furnishing information by prescribers that is required to be submitted to the drug database; and, to allow pharmacies, wholesalers, and prescribers to use mutually acceptable identifiers when submitting information to the drug database.

      (Electronic format required for the transmission of dispensing information.) To change language pursuant to the passage of House Bill 93 of the 129th General Assembly regarding the electronic format required for prescribers to submit personally furnishing reportable drug data to the drug database.

(Electronic format required for the transmission of wholesale drug sales.) To change language regarding the formats that wholesalers must submit data to the drug database.

      (Frequency requirements for submitting drug database information.) To change language pursuant to the passage of House Bill 93 of the 129th General Assembly regarding the frequency requirements for prescribers submitting personally furnishing information to the drug database.

4729-37-11 (Corrections to the drug database.) To change language pursuant to the passage of House Bill 93 of the 129th General Assembly regarding the correction procedures to the drug database required by prescribers.

The full text of the proposed rule is available 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 www.pharmacy.ohio.gov 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.

William T. Winsley, M.S., R.Ph.

Executive Director