Ohio Administrative Code
Title 4729:7
Chapter 4729:7-2
Section 4729:7-2-04 - Record keeping
Universal Citation: OH Admin Code 4729:7-2-04
Current through all regulations passed and filed through March 18, 2024
(A) In addition to the pharmacy record keeping requirements of agency 4729 of the Administrative Code, a pharmacy shall maintain records of all drugs compounded that include, at a minimum, all the following:
(1)
The name of the
patient;
(2)
Name of drug, strength or activity, and dosage
form;
(3)
Assigned internal identification number (e.g.,
prescription, order, lot number);
(4)
Date and time of
preparation;
(5)
Name of each ingredient;
(6)
Vendor, lot
number, and expiration date for each ingredient for compounded drug
preparations prepared for more than one patient and for any sterile compounded
product prepared from nonsterile ingredient(s);
(7)
Weight or volume
of each ingredient;
(8)
Total quantity compounded;
(9)
The disposition
of unused controlled substances drug(s) and amount;
(10)
Assigned
beyond-use date;
(11)
The positive identification of the following:
(a)
The pharmacy
personnel responsible for preparing the compounded drug
preparation;
(b)
The pharmacist conducting the final check of the
compounded drug preparation; and
(c)
The pharmacist
who dispenses the compounded drug preparation.
(12)
All other drug
compounding records as required by USP 795, USP 797, and USP
800.
(B) All records maintained in accordance with this rule shall be readily retrievable and uniformly maintained for at least three years.
(1)
Except as provided in paragraph (B)(2) of this rule, all
records maintained in accordance with this rule shall be kept
on-site.
(2)
A pharmacy located in this state intending to maintain
records pursuant to this rule at an alternate location must first send a
written request to the state board of pharmacy. The request shall contain the
pharmacy's name and license number and the name and address of the alternate
location. The state board of pharmacy will send written notification to the
pharmacy documenting the approval or denial of the request. A copy of the
board's approval shall be maintained with the other records of dangerous drugs.
Any such alternate location shall be secured and accessible only to authorized
personnel or contractors of the pharmacy.
Replaces: 4729-16-06
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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