Ohio Administrative Code
Title 4729:5 - Dangerous Drugs
Chapter 4729:5-5 - Outpatient Pharmacies
Section 4729:5-5-02 - Minimum standards for the operation of an outpatient pharmacy
Universal Citation: OH Admin Code 4729:5-5-02
Current through all regulations passed and filed through September 16, 2024
(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:
(1)
Pharmacist;
(2)
Pharmacy
intern;
(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:
(i)
The board's website (www.pharmacy.ohio.gov);
(ii)
Ohio laws and administrative rules (https://codes.ohio.gov)
(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;
(b)
Immunization;
(c)
Patient
counseling;
(d)
Dispensing of prescriptions;
(e)
Patient testing;
and
(f)
All other duties of a pharmacist as authorized by
Chapter 4729. of the Revised Code.
Replaces: 4729:5-5-02
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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