(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 patients
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
professionals 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.
