Current through all regulations passed and filed through September 16, 2024
(A) A limited facility shall keep a record of
all dangerous drugs and controlled substances received, administered,
personally furnished, disposed, sold or transferred.
(B) Records of receipt shall contain the
name, strength, dosage form, and quantity of the dangerous drugs or controlled
substances received, the name and address of the seller, the name and address
of the recipient, and the date of receipt. An invoice from a drug distributor
licensed in accordance with division 4729:6 of the Administrative Code
containing the required information may be used to meet this
requirement.
(C) Records of
temperature control monitoring described in paragraph (L) of rule
4729:5-23-02 of the
Administrative Code shall include any of the following:
(1) For temperature logs, either:
(a) The date and time of observation, the
full name or the initials of the individual performing the check, and the
temperature recorded; or
(b) For
systems that provide automated temperature monitoring, maintain a report that
provides, at a minimum, the date and time of observation and the temperature
recorded.
(2) For
temperature monitoring systems capable of detecting and alerting staff of a
temperature excursion, maintain reports that provide information on any
temperature excursion that includes the date, time, temperature recorded, and
length of each excursion.
(D) Records of personally furnishing shall
contain the name, strength, dosage form, and quantity of the dangerous drugs
personally furnished, the name, address and date of birth of the person to whom
or for whose use the dangerous drug were personally furnished, the positive
identification of the prescriber or delegated pharmacist personally furnishing
the drug, the date the drug is personally furnished and, if applicable, the
date the drug is received by the patient or patient's caregiver.
(E)
(1)
Records of administration shall contain the name, strength, dosage form, and
quantity of the dangerous drugs administered, the name and date of birth of the
person to whom or for whose use the dangerous drugs were administered and the
date of administration, and either:
(a) For
non-controlled substance dangerous drugs: the identification of the health care
professional administering the drug.
(b) For controlled substance dangerous drugs:
the positive identification of the health care professional administering the
drug.
(2) Records of
dangerous drugs administered which become a permanent part of the patient's
medical record shall be deemed to meet the requirements of this
paragraph.
(3) Records of dangerous
drugs administered by a health care professional, acting within the
professional's scope of practice, who is not a prescriber shall include
documentation of an order issued by a prescriber or protocol authorizing the
administration of the drug. An order that is a permanent part of the patient's
medical record shall be deemed to meet the requirements of this paragraph.
Orders for the administration of controlled substances shall be documented
using positive identification.
(4)
Paragraph (E)(3) of this rule does not apply to the
administration of dangerous drugs pursuant to paragraph (G) of rule
4729:5-23-03 of the
Administrative Code or non-controlled dangerous drugs for direct administration
to a patient that have been dispensed by a pharmacy or personally furnished by
a prescriber.
(F)
Records of disposal of dangerous drugs from inventory, other than controlled
substances, shall contain the name, strength, dosage form, and quantity of the
dangerous drug disposed, the date of disposal, the method of disposal, and the
identification of the licensed health care professional that performed the
disposal.
(G) Records of disposal
of controlled substances that are not dangerous drugs shall comply with the
requirements of paragraph (P) of rule
4729:5-23-02 of the
Administrative Code.
(H) Records of
controlled substance dangerous drug disposal shall comply with the requirements
of rule
4729:5-3-01 of the
Administrative Code.
(1) If the disposal of
controlled substance drug inventory is performed on-site, records shall also
include the positive identification of two licensed healthcare professionals
conducting and witnessing the disposal, one of whom shall be the responsible
person or the responsible person's designee.
(2) If conducting the disposal of an unused
portion of a controlled substance resulting from administration to a patient,
records shall also include the positive identification of two licensed
healthcare professionals conducting and witnessing the disposal.
(I) Records of transfer or sale
conducted in accordance with rule
4729:5-3-09 of the
Administrative Code shall contain the name, strength, dosage form, national
drug code, expiration date and quantity of the dangerous drug transferred or
sold, the address of the location where the drugs were transferred or sold, and
the date of transfer or sale.
(J)
Controlled substance inventory records shall be maintained in accordance with
rule 4729:5-3-07 of the
Administrative Code.
(K) All
records maintained in accordance with this rule shall be readily retrievable
and shall be kept on-site for a period of three years.
(1) A terminal distributor intending to
maintain records at a location other than the location licensed by the state
board of pharmacy must notify the board in a manner determined by the
board.
(2) Any such alternate
location shall be secured and accessible only to authorized representatives or
contractors of the terminal distributor of dangerous drugs.
(L) All records maintained
pursuant to this rule may be electronically created and maintained, provided
that the system that creates and maintains the electronic record does so in
accordance with the following:
(1) Complies
with the requirements of this rule;
(2) All paper records shall be scanned in
full color via technology designed to capture information in one form and
reproduce it in an electronic medium presentable and usable to an end
user;
(3) Contains security
features, such as unique user names and passwords, to prevent unauthorized
access to the records; and
(4)
Contains daily back-up functionality to protect against record loss.
Effective: 2/4/2021
Five Year Review
(FYR) Dates: 3/1/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26,
3719.28
Rule Amplifies: 4729.54
Prior Effective Dates:
03/01/2020
