Current through all regulations passed and filed through September 16, 2024
(A)
The responsible person of a facility where a prescriber
is engaged in the compounding of immediate-use, sterile non-hazardous dangerous
drug preparations in accordance with paragraph (B) of this rule shall be
responsible for all the following:
(1)
Developing and implementing appropriate compounding
procedures;
(2)
Overseeing facility compliance with this
rule;
(3)
Compliance with Title 21 U.S.C. section 353a (11/27/2013) and all other applicable federal and state laws, regulations and
rules;
(4)
Ensuring training and competency of compounding
personnel;
(5)
Ensuring that compounded drug preparations maintain
quality and sterility until administered;
(6)
Maintaining drug
compounding records pursuant to rule
4729:7-3-06 of the
Administrative Code;
(7)
The proper maintenance, cleanliness, and use of all
equipment used in compounding; and
(8)
Ensuring aseptic
technique for the preparation of all sterile compounded drugs.
(B)
Immediate-use, sterile compounded drug preparations are
exempt from the requirements in rule
4729:7-3-03
of the Administrative Code if all the following criteria are met:
(1)
The compounding
process involves the simple transfer of not more than three commercially
manufactured packages of sterile, non-hazardous drugs from the manufacturers'
original containers and not more than two entries into any one container or
package (e.g., bag, vial) of sterile infusion solution or administration
container/device.
(2)
Personnel shall adhere to appropriate aseptic
technique, including all the following:
(a)
Before beginning
compounding activities, personnel shall perform a thorough hand-hygiene
procedure; and
(b)
Compounding personnel shall don gloves prior to
engaging in compounding activities.
(3)
If not
immediately administered, the finished compounded drug preparation shall be
regularly monitored by compounding personnel to minimize the potential for
contact with non-sterile surfaces, introduction of particulate matter or
biological fluids, mix-ups with other compounded drug preparations, and direct
contact of outside surfaces.
(4)
The beyond-use
date for an immediate-use compounded drug preparation is as follows:
(a)
Except as
provided in paragraph (B)(4)(b) of this rule, no later than six-hours following
preparation of the drug.
(b)
For preparations of buffered lidocaine containing
antimicrobial preservatives, no later than twelve-hours following preparation
of the drug.
(5)
If administration has not begun within the beyond-use
dating described in paragraph (B)(4) of this rule, the drug shall be promptly,
properly, and safely disposed. Records of disposal shall be maintained in
accordance with rule
4729:7-3-06 of the
Administrative Code.
(6)
Unless administered immediately, the compounded drug
preparation shall bear a label listing all the following:
(a)
Except for
preparations compounded in accordance with paragraph (G)(2) of this rule,
patient identification information, including the patient's first and last
name;
(b)
The name and quantity of each
ingredient;
(c)
The beyond-use date and time prepared;
and
(d)
The name or initials of the person who prepared the
compounded drug preparation.
(7)
Immediate-use
compounded drug preparations are for administration only and shall not be
personally furnished by a prescriber.
(8)
For an
immediate-use compounded drug preparation administered via injection, a new
sterile needle shall be used to administer the compounded drug preparations to
the patient.
(C)
Unless administered within one-hour of preparation,
sterile compounded drug preparations for immediate-use shall be prepared in a
designated clean medication area that is not adjacent to areas where
potentially contaminated or hazardous items are placed. Such an area shall be
limited to compounding personnel and shall not be in a location that has
unsealed windows or doors that connect to the outdoors or high traffic flow, or
that is adjacent to construction sites, warehouses, or food preparation.
Cleaning and disinfection agents must be selected and used with careful
consideration of compatibility, effectiveness, and inappropriate or toxic
residues. Cleaning and disinfecting shall occur before compounding is
performed. This shall be followed by wiping with a residue-free disinfecting
agent, such as sterile seventy per cent isopropyl alcohol, which is allowed to
dry before compounding begins.
(D)
Preparations that
are deemed category two, medium-risk level, or high-risk level compounded drug
preparations as defined in United States pharmacopeia chapter <797> shall
not be prepared as immediate-use.
(E)
Preparations that
do not meet all the requirements listed in paragraph (B) of this rule shall
comply with the requirements in rule
4729:7-3-03
of the Administrative Code.
(F)
Immediate-use
compounded drug preparations shall be prepared in accordance with this rule
except in an emergency, as documented in the medical record, when the product
is required to treat the immediate needs of a patient whose health would
otherwise be jeopardized.
(G)
(1)
Except as
provided in paragraph (G)(2) of this rule, compounding for anticipated needs or
engaging in compounding practices where multiple non-patient specific doses are
produced in a single activity is prohibited.
(2)
A prescriber may
compound preparations of buffered lidocaine containing antimicrobial
preservatives for anticipated needs where multiple non-patient specific doses
are produced in a single activity.
(H)
Records of drug
compounding shall be maintained pursuant to rule
4729:7-3-06 of the
Administrative Code.
(I)
(1)
Except as
provided for in paragraph (I)(2) of this rule, this rule does not apply to a
prescriber who is a veterinarian licensed under Chapter 4741. of the Revised
Code. If preparing or handling hazardous drug preparations, 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 immediate-use 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; and
(iv)
The name or initials of the person who prepared the
compounded drug preparation.
(J)
For hazardous
compounded drugs, the prescriber shall comply with rule
4729:7-3-05
of the Administrative Code.
(K)
A prescriber may
designate an appropriately trained agent to prepare compounded drug
preparations.
(L)
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 (M) of this rule,
perform medication validation ("final check") prior to the medication being
administered.
(M)
The requirements of paragraph (M)(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 (N) 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 (N) of this rule.
(N)
All the following
are required to administer a compounded drug preparation in accordance with
paragraphs (M)(1) and (M)(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.
Replaces: 4729-16-13
