Ohio Admin. Code 4729:7-3-06 - Record keeping
(A)
The responsible
person shall maintain the following records relating to the compounding of
dangerous drugs:
(1)
All drug orders and records, including logs, relating
to the compounding of drugs. Such drug orders and records may be retained by
any process providing an exact duplicate of the original order or
prescription.
(2)
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:
(a)
Complies with the requirements of this rule;
(b)
All paper records
shall be scanned in full color via technology designed to capture information
and reproduce it in an electronic medium presentable and usable to an end
user;
(c)
Contains security features, such as unique user names
and passwords, to prevent unauthorized access; and
(d)
Contains daily
back-up functionality to protect against record loss.
(3)
Records of each
drug compounded shall, at a minimum, include all the following:
(a)
The full name of
the patient, unless compounded in accordance with paragraph (G)(2) of rule
4729:7-3-04 of the Administrative Code;
(b)
Name, strength,
and dosage form of the compounded drug;
(c)
Name and quantity
of each ingredient;
(d)
If a controlled substance, the disposition of unused
drug(s) and amount;
(e)
Date and time of preparation;
(f)
Beyond-use date
of the compounded drug;
(g)
The positive identification of the personnel
responsible for compounding the drug;
(h)
The positive
identification of either of the following:
(i)
Person or persons
performing medication validation prior to the compounded drug being
administered; or
(ii)
The prescriber personally furnishing the compounded
drug.
(B)
Records of
disposal of compounded drugs, 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, the identification of the
licensed health care professional that performed the disposal.
(C)
Records of the
disposal of compounded drugs containing controlled substances shall comply with
the requirements of rule
4729:5-3-01
of the Administrative Code.
(1)
If the disposal of a compounded drug containing a
controlled substance is performed on-site, records shall also include the
positive identification of two licensed or registered 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 compounded drug containing a controlled
substance resulting from administration to a patient, records shall also
include the positive identification of two licensed or registered healthcare
professionals conducting and witnessing the disposal.
(3)
A veterinarian
may use an animal aide, as defined in section
4741.01 of the Revised Code, in
lieu of one of the licensed or registered healthcare professionals required to
witness and conduct the disposal of controlled substances pursuant to
paragraphs (C)(1) and (C)(2) of this rule. Records kept in accordance with
paragraphs (C)(1) and (C)(2) of this rule shall include the positive
identification of the animal aide witnessing the
disposal.
(D)
Drug compounding records which become a permanent part
of the patient's medical record shall be deemed to meet the requirements of
this rule.
(E)
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.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.01, 4729.51, 4729.53, 4729.54, 4729.541 and 4729.55
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