Ohio Admin. Code 4729:5-16-03 - Record keeping
(A)
A laboratory
shall keep a record of all dangerous drugs and controlled substances received,
administered, personally furnished, used (i.e. chemical analysis or research),
disposed, destroyed or transferred.
(B)
The acts of
administering, using (i.e. chemical analysis or research), and destroying or
disposing controlled substances shall be documented with positive
identification.
(C)
Records of receipt shall contain a description of the
drug or substance and all the following if obtained from a person licensed in
accordance with section
4729.52 or
4729.54 of the Revised
Code:
(1)
The
name, strength, dosage form, quantity of the drug;
(2)
The name and
address of the seller;
(3)
The name and address of the recipient;
and
(4)
The date of receipt.
(D)
Except as
provided in paragraph (E) of this rule, records of personally furnishing shall
contain the name, strength, dosage form, and quantity of the dangerous drugs
personally furnished, the identification of the person personally furnishing
the drug, the name, address and date of birth of the person to whom or for
whose use the dangerous drug were personally furnished, the date the drug is
personally furnished and, if applicable, the date the drug is received by the
patient or patient's caregiver.
(E)
Records of
personally furnishing for animal use shall contain the name, strength, dosage
form, and quantity of the dangerous drugs personally furnished, the
identification of the person personally furnishing the drug, the name of the
animal, the name and address of the animal's owner, the date the drug is
personally furnished and, if applicable, the date the drug is received by the
patient or patient's caregiver.
(F)
Except as
provided in paragraphs (G) and (H) of this rule, records of administration
shall contain the name, strength, dosage form, and quantity of the drugs
administered, the name and date of birth of the person to whom or for whose use
the drugs were administered, the identification of the person administering the
drug, and the date of administration.
(1)
Records of
non-controlled substances administered which become a permanent part of the
patient's medical record shall be deemed to meet the requirements of this
paragraph.
(2)
Records of controlled substances administered which
become a permanent part of the patient's medical record shall be deemed to meet
the requirements of this paragraph if documented using positive
identification.
(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 or protocol issued by
a prescriber 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.
(G)
Except as provided in paragraph (H) of this rule, records of administration for
animal use shall contain the name, strength, dosage form, and quantity of the
drugs administered, the name or identification number of the animal to whom or
for whose use the drugs were administered, the identification of the person
administering the drug, and the date of administration.
(1)
Records of
non-controlled substances administered which become a permanent part of the
patient's medical record shall be deemed to meet the requirements of this
paragraph
(2)
Records of controlled substances administered which
become a permanent part of the patient's medical record shall be deemed to meet
the requirements of this paragraph if documented using positive
identification.
(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 or protocol issued by
a prescriber 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.
(H)
Records of administration for non-human research purposes shall contain the
name of the drugs administered, the name or identifier of the animal, group of
animals, or group of cells for whose use the drugs were administered, and the
date the research protocol began. Administration to an animal or group of
animals shall be pursuant to an institutional animal care and use committee
(IACUC) protocol which outlines the name, strength, dosage form, and quantity
of the drug to be administered, and a timeline for subsequent
administration(s). Documentation within a lab notebook or research record of
shall be deemed to meet the requirements of this paragraph.
(I)
A laboratory
conducting chemical analysis or research with dangerous drugs or controlled
substances shall maintain records with the following information for each
dangerous drug or controlled substance:
(1)
The name of the
drug or controlled substance.
(2)
The form (e.g.,
powder, granulation, tablet, capsule, or solution) and the concentration in
such form (e.g., "C.P.," "U.S.P.," "N.F.," ten-milligram tablet, or
ten-milligram concentration per milliliter).
(3)
The quantity
utilized in any manner by the laboratory including the date and manner of
utilization.
(4)
The identification of the person or persons conducting
the chemical analysis or research. If a controlled substance, the positive
identification of the person or persons conducting the chemical analysis or
research.
(5)
This paragraph does not apply to records relating to
known or suspected controlled substances or dangerous drugs received as
evidentiary material.
(J)
A laboratory
conducting chemical analysis of anonymous samples of suspected controlled
substances or dangerous drugs shall maintain records, to the extent known and
reasonably ascertainable by the person conducting the analysis, containing the
following information:
(1)
Date the sample is received;
(2)
Purported
contents and actual identification;
(3)
Quantity
received;
(4)
Form of sample (i.e., powder, liquid, tablets,
etc.);
(5)
Description of sample;
(6)
Quantity utilized
in analysis; and
(7)
The identification of the person or persons conducting
the analysis.
(K)
Records of dangerous drug disposal, other than
controlled substances, shall contain the name, strength, dosage form, and
quantity of the dangerous drug destroyed, the date destroyed, the method of
disposal, and the identification of the person that performed the
disposal.
(L)
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 dangerous drug
inventory is performed on-site, records shall also include the positive
identification of two laboratory employees 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 dangerous drug, records shall also include the positive
identification of two laboratory employees conducting and witnessing the
disposal.
(M)
Records of the disposal of controlled substances that
are not dangerous drugs or any unused portion of a submitted anonymous sample
shall be maintained in accordance with paragraph (Q) of rule
4729:5-16-02 of the
Administrative Code.
(N)
Controlled substance inventory records shall be
maintained in accordance with rule
4729:5-3-07 of the
Administrative Code.
(O)
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.
(P)
Records of
temperature control monitoring described in paragraph (K)(1) of rule
4729:5-16-02 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.
(Q)
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.
(R)
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.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.07, 4729.55, 4729.57
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.