Section 4729:5-5-02 - Minimum standards for the operation of an outpatient pharmacy(A) As used in this rule, "pharmacy personnel" means any of the following licensed or registered in accordance with Chapter 4729. of the Revised Code:(3) Certified pharmacy technician;(4) Registered pharmacy technician;(5) Pharmacy technician trainee.(B) In accordance with division (D) of section 4729.55 of the Revised Code, an outpatient pharmacy licensed as a terminal distributor of dangerous drugs shall:(1) Ensure sufficient personnel are scheduled to work at all times in order to minimize fatigue, distraction, or other conditions which interfere with a pharmacist's ability to practice with reasonable competence and safety. Staffing levels shall not be solely based on prescription volume but shall consider any other requirements of the practice of pharmacy by pharmacy personnel during working hours.(2) Provide sufficient tools and equipment in updated and good repair. All tools and equipment shall be housed in a suitable, well-lit, and well-ventilated room or department and maintained in a clean, sanitary, and orderly condition.(3) Provide pharmacy personnel with access to the following:(a) All current federal and state laws, regulations, and rules governing the practice of pharmacy and legal distribution of drugs in Ohio, including internet access to:(iii) The code of laws of the United States of America (variously abbreviated to Code of Laws of the United States, United States Code, U.S. Code, U.S.C., or USC); and(iv) The code of federal regulations.(b) References necessary to conduct a pharmacy in a manner that is in the best interest of the patients served and to comply with all state and federal laws, this shall include hard copy or internet access to appropriate pharmacy reference materials.(c) The telephone number of a poison control center.(4) Ensure pharmacy personnel are sufficiently trained to safely and adequately perform their assigned duties.(5) Maintain a stock of drugs sufficient to compound and prepare the types of prescriptions offered by the pharmacy.(6) Maintain a stock of prescription containers necessary to dispense drugs in accordance with federal and state laws, including the provisions of the federal Poison Prevention Act of 1970 and compendial standards, or as recommended by the manufacturer or distributor for non-compendial drug products.(7) Ensure all areas where drugs and devices are stored and prepared are dry, well-lit, well-ventilated, and maintained in a clean, sanitary, and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to their dispensing or administering as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.(8) For outpatient pharmacies open to the public, publicly post the operating hours of the pharmacy department.(9) Ensure all employees of the pharmacy are identified by a name tag that includes the employee's job title and, if a pharmacy technician, the technician's registration type pursuant to Chapter 4729:3-3 of the Administrative Code.(10) Provide adequate security for all dangerous drugs in accordance with the requirements of agency 4729 of the Administrative Code. A pharmacy shall maintain the current contact information for the pharmacy's security system vendor and shall immediately provide this information upon the request of an agent, inspector, or employee of the board.(11) Provide sufficient time for pharmacists to complete professional duties and responsibilities, including:(a) Drug utilization review;(d) Dispensing of prescriptions;(f) All other duties of a pharmacist as authorized by Chapter 4729. of the Revised Code. Replaces: 4729:5-5-02
Ohio Admin. Code 4729:5-5-02
Effective: 5/1/2024
Five Year Review (FYR) Dates: 05/01/2029
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54, 4729.55
Prior Effective Dates: 09/10/1976, 09/01/1985, 03/21/1988, 07/01/1990, 07/01/1992, 07/01/1994, 03/01/1999, 01/01/2006, 01/01/2009, 05/22/2014, 12/01/2020