Current through all regulations passed and filed through September 16, 2024
(A)
Except as
provided in paragraph (L) of this rule, all non-hazardous, non-sterile
compounded drug preparations shall be prepared in accordance with United States
pharmacopeia chapter <795>.
(B)
Except as
provided in paragraph (C) of this rule, all non-hazardous, sterile compounded
drug preparations, shall be prepared in accordance with United States
pharmacopeia chapter <797>.
(C)
For all
immediate-use, non-hazardous sterile compounded drug preparations, a prescriber
shall comply with either:
(1)
Rule 4729:7-3-04 of the Administrative Code;
or
(2)
United States pharmacopeia chapter
<797>.
(D)
For all hazardous non-sterile and sterile compounded
drug preparations, a prescriber shall comply with rule 4729:7-3-05 of the
Administrative Code.
(E)
The responsible person of a facility where a prescriber
is engaged in the compounding of dangerous drugs shall be responsible for all
of the following:
(1)
Developing and implementing appropriate compounding
procedures;
(2)
Overseeing facility compliance with this
rule;
(3)
Compliance with Title 21 U.S. Code section 353a
(November 27, /2013) and all other applicable federal and state laws,
regulations and rules;
(4)
Ensuring documented training and competency of
compounding personnel;
(5)
Ensuring environmental control of the compounding
areas;
(6)
Ensuring compounded drug preparations maintain quality
and sterility until administered or personally furnished;
(7)
Maintaining drug
compounding records pursuant to rule 4729:7-3-06 of the
Administrative Code.
(8)
The
proper maintenance, cleanliness, and use of all equipment used in compounding;
and
(9)
Ensuring aseptic technique for the preparation of all
sterile compounded drugs.
(F)
A prescriber may
designate an appropriately trained agent to prepare compounded drug
preparations.
(G)
For all compounded drugs prepared pursuant to this
rule, a prescriber shall:
(1)
Inspect and approve the compounding process;
and
(2)
Except as provided in paragraph (H) of this rule,
perform medication validation ("final check") prior to the medication being
administered.
(H)
The requirements of paragraph (G)(2) of this rule do
not apply to either of the following:
(1)
A compounded drug
preparation is being administered to a patient in the facility by a nurse
licensed under Chapter 4723. of the Revised Code pursuant to a prescriber's
order and, prior to administration, at least two nurses that are approved by
the responsible person to prepare or administer compounded drugs comply with
the requirements in paragraph (I) of this rule; or
(2)
A compounded drug
preparation is prepared and administered to a patient in the facility by a
nurse licensed under Chapter 4723. of the Revised Code pursuant to a
prescriber's order and, prior to administration, the same nurse complies with
paragraph (I) of this rule.
(I)
All the following
are required to administer a compounded drug preparation in accordance with
paragraphs (H)(1) and (H)(2) of this rule:
(1)
Verify patient
identification using at least two identifiers (e.g., last name, medical record
number, DOB, etc.).
(2)
Confirm with the patient the patient's planned
treatment, drug route, and symptom management.
(3)
Verify the
accuracy of:
(a)
Drug name;
(b)
Drug strength and
dosage form;
(c)
Drug volume;
(d)
Rate of
administration;
(e)
Route of administration;
(f)
Expiration
dates/times;
(g)
Appearance and physical integrity of the
drugs.
(4)
Indicate in the compounding record verification was
completed;
(5)
A licensed prescriber is on-site and immediately
available.
(J)
A prescriber shall not compound drug preparations
unless a specific patient need exists. Compounding for anticipated needs or
engaging in compounding practices where multiple non-patient specific doses are
produced in a single activity is prohibited.
(K)
A prescriber
shall comply with the drug database reporting requirements for personally
furnishing drugs pursuant to section
4729.79 of the Revised
Code.
(L)
(1)
Except as
provided for in paragraph (L)(2) of this rule, the requirements of this rule do
not apply to a prescriber who is a veterinarian licensed under Chapter 4741. of
the Revised Code.
If preparing or handling compounded
hazardous drugs, a prescriber who is a veterinarian shall comply with rule
4729:7-3-05 of the Administrative Code.
(2)
A veterinarian
engaged in the compounding of sterile and non-sterile drug preparations shall
comply with the following:
(a)
Unless administered immediately, the compounded drug
preparation shall bear a label listing all of the following:
(i)
Patient
identification information, including the full name of the owner, if
applicable, and the name or identification of the animal;
(ii)
The name and
quantity of each ingredient;
(iii)
The date and
time prepared;
(iv)
The name or initials of the person who prepared the
compounded drug preparation.
Replaces: 4729-16-04
