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 or
handling of hazardous dangerous drugs shall be responsible for all of the
following:
(1)
Developing and implementing appropriate compounding policies
and 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 training and competency of compounding
personnel;
(5)
Ensuring environmental control of the compounding
areas;
(6)
Ensuring that compounded drug preparations maintain
quality and sterility until administered or personally
furnished;
(7)
Ensuring appropriate equipment cleaning and disposal of
all hazardous drug waste;
(8)
All drug compounding records pursuant to rule
4729:7-3-06 of the Administrative Code;
(9)
The proper
maintenance, cleanliness, and use of all equipment used in compounding;
and
(10)
Ensuring aseptic technique for the preparation of all
sterile compounded drugs.
(B)
A prescriber who
compounds or handles hazardous drugs as defined in rule 4729:7-3-01 of the
Administrative Code shall meet all of the following requirements:
(1)
Policy and
procedures
(a)
A policy and procedure manual shall be prepared, maintained,
and reviewed regularly by the responsible person regarding the compounding,
safe handling, personally furnishing, and administration of hazardous drugs.
The policy and procedure manual shall include a quality assurance program for
the purpose of monitoring personnel qualifications, training and performance,
product integrity, equipment, facilities, and guidelines regarding patient
education. The policy and procedure manual shall be current and available for
inspection and copying by an agent of the state board of
pharmacy.
(2)
Physical requirements
(a)
Sterile
compounded hazardous drug preparations shall be compounded within a containment
primary engineering control (C-PEC) that meets all of the following
requirements:
(i)
Provides an ISO class 5 or better air quality, such as
a class II or III biological safety cabinet (BSC) or compounding aseptic
containment isolator (CACI). Class II BSC types A2, B1 or B2 are
acceptable.
(ii)
Uses a high-efficiency particulate air filter (HEPA
filter) for the exhaust from the control.
(iii)
The C-PEC shall
be externally vented in a manner where air is not pulled back into the facility
by the heating, ventilating, and air conditioning (HVAC) systems or by the
windows, doors, or other points of entry. Fans shall be placed downstream of
the HEPA filter so that contaminated ducts are maintained under negative
pressure.
(iv)
Paragraph (B)(2)(a)(iii) of this rule is effective
December 1, 2020 or upon any new construction or substantial modifications to
the C-PEC or containment secondary engineering control (C-SEC), whichever is
earlier. The board may grant a prescriber an extension of the external venting
requirements if the board determines, upon petition by the prescriber, that the
prescriber is unable to make any structural modifications due to an existing
building lease agreement. Any prescriber granted an extension shall provide to
the board documentation demonstrating how the prescriber will meet the external
venting requirements of this rule by the extension date approved by the
board.
(b)
Non-sterile hazardous drug preparations shall be
compounded in a C-PEC that is either externally vented or has redundant-HEPA
filters in series. Nonsterile hazardous compounding must be performed in a
C-PEC that provides personnel and environmental protection, such as a "Class I
Biological Safety Cabinet (BSC)" or "Containment Ventilated Enclosure" (CVE). A
class II BSC or a compounding aseptic containment isolator (CACI) may also be
used. For occasional nonsterile hazardous drug compounding, a C-PEC used for
sterile compounding may be used but must be decontaminated, cleaned, and
disinfected before resuming sterile compounding in that C-PEC. A C-PEC used
only for nonsterile compounding does not need to have unidirectional
airflow.
(c)
C-PECs used for hazardous drug compounding shall be
located in a containment secondary engineering control (C-SEC). The C-SEC shall
be one of the following:
(i)
For non-sterile hazardous drugs and sterile hazardous
compounded drugs with a beyond-use date that does not exceed twelve hours, an
unclassified containment segregated compounding area (C-SCA) that meets all of
the following:
(a)
Isolated from other areas and must be designed to avoid
unnecessary traffic and airflow disturbances from activity within the
controlled area.
(b)
Be of sufficient size to accommodate the containment
primary engineering control and to provide for the proper storage of drugs and
supplies under appropriate conditions of temperature, light, moisture,
sanitation, ventilation, and security.
(c)
If the C-PECs
used for sterile and nonsterile compounding are placed in the C-SCA, they must
be placed at least three feet apart and particle-generating activity must not
be performed when sterile compounding is in process.
(d)
Has a sink or
wash station available for hand washing as well as emergency access to water
for removal of hazardous substances from eyes and skin.
(ii)
For
sterile hazardous compounded drugs with a beyond-use date that exceeds twelve
hours, a containment secondary engineering control in accordance with the
United States Pharmacopeia Chapter <800>.
(d)
A C-PEC and C-SEC
used for the preparation of hazardous drugs shall not be used for the
preparation of a non-hazardous drug.
(e)
The facility
shall maintain supplies adequate to maintain an environment suitable for the
aseptic preparation of sterile products.
(f)
The facility
shall have sufficient current reference materials related to sterile
preparations to meet the needs of the facility staff.
(3)
Environmental quality and control
(a)
Environmental
wipe sampling to detect hazardous drug surface residue should be performed
routinely (e.g., initially as a benchmark and at least every six months, or
more often as needed, to verify containment). Common hazardous drug markers
that can be assayed include cyclophosphamide, ifosfamide, methotrexate,
fluorouracil and platinum-containing drugs.
(b)
Surface wipe
sampling should include:
(i)
Interior of the C-PEC and equipment contained in
it;
(ii)
Staging or work areas near the C-PEC;
(iii)
Areas adjacent
to C-PECs (e.g., floors directly under staging and dispensing
area);
(iv)
Patient administration areas;
(v)
Counters where
finished preparations are placed.
(c)
If any measurable
contamination is found, the responsible person shall identify, document, and
contain the cause of contamination. The facility shall perform thorough
deactivation (using an appropriate deactivating agent), decontamination, and
cleaning. The facility shall also consider, at a minimum, the following steps
to prevent further contamination:
(i)
Reevaluating work practices;
(ii)
Re-training
personnel; and
(iii)
Improving engineering controls.
(4)
Personal protective equipment (PPE) and safety
techniques
(a)
PPE includes, but is not limited to, gloves, gowns, head covers, hair covers,
shoe covers, eye/face protection.
(i)
Gloves, gowns, head, hair, and shoe covers (or
dedicated shoes) are required for compounding sterile and nonsterile hazardous
drugs.
(ii)
Chemotherapy gloves are required for compounding,
handling and administering hazardous drugs. Sterile chemotherapy gloves are
required for compounding of sterile hazardous drugs. Personnel should use
double gloving for all activities involving hazardous drugs making sure that
the outer glove extends over the cuff of the gown.
(iii)
Gowns are
required when compounding, handling and administering injectable antineoplastic
hazardous drugs.
(iv)
For all other activities, the facility's policy and
procedure manual must describe the appropriate PPE to be worn. The facility
must develop policies and procedures for PPE based on the risk exposure and
activities performed. Appropriate PPE must be worn handling hazardous drugs
during the following:
(a)
Receipt;
(b)
Storage;
(c)
Transport;
(d)
Compounding;
(e)
Administration;
(f)
Deactivation or
decontamination, cleaning, and disinfecting; and
(g)
Spill
control.
(v)
Chemotherapy gloves must be tested to ASTM standard
D6978 (or its successor) and must be powder-free. Gloves must be inspected for
physical defects before use and must be changed every thirty minutes or when
torn, punctured, or contaminated.
(b)
All personnel
handling hazardous drugs or hazardous drug waste shall wash hands with soap and
water before donning protective gloves and immediately after
removal.
(c)
Disposable gowns shall be tested and shown to resist
permeability by hazardous drugs. Gowns shall close in the back (i.e., no open
front), be long sleeved, and have closed cuffs that are elastic or knit. Gowns
shall not have seams or closures that could allow hazardous drugs to pass
through. Cloth laboratory coats, surgical scrubs, isolation gowns, or other
absorbent materials shall not be worn as outerwear when handling hazardous
drugs. Gowns shall be changed per the manufacturer's information for permeation
of the gown. If no permeation information is available for the gowns used, they
shall be changed every two to three hours or immediately after a spill or
splash. Gowns worn in hazardous drug handling areas shall not be worn to other
areas.
(d)
Appropriate eye and face protection must be worn when
there is a risk for spills or splashes of hazardous drugs or hazardous drug
waste materials (examples include, but are not limited to: administration in a
surgical suite, cleaning the C-PEC, working at or above eye level or cleaning a
spill). A full-face piece respirator provides eye and face protection. Goggles
shall be used when eye protection is needed. Eye glasses alone or safety
glasses with side shields do not protect the eyes adequately from splashes.
Face shields in combination with goggles provide a full range of protection
against splashes to the face and eyes. Face shields alone do not provide full
eye and face protection.
(e)
When a hazardous drug preparation is completed,
personnel shall:
(i)
Seal the final product in a plastic bag or other sealed
container for transport before taking it out of the C-PEC.
(ii)
Seal and wipe
all waste containers inside the C-PEC before removing them from the
cabinet.
(f)
When the dosage form allows, hazardous drugs shall be
administered using a drug-transfer device that mechanically prohibits the
transfer of environmental contaminants into the system and the escape of
hazardous drug or vapor concentrations outside of the system.
(g)
Hazardous drugs
shall be administered safely using protective techniques, including the spiking
or priming of IV tubing in the C-PEC and crushing hazardous tablets in plastic
sleeves.
(5)
Respiratory protection
Personnel shall use an appropriately
fitted national institute for occupational safety approved N95 or equivalent
respiratory protection during spill cleanup and whenever there is a significant
risk of inhalation exposure to hazardous drug particulates. Surgical masks do
not provide respiratory protection from drug exposure and shall not be
used.
(6)
Disposal of used personal protective equipment
(PPE)
All personal protective equipment worn
when handling hazardous drugs shall be placed in an appropriate waste container
and further disposed of per local, state, and federal regulations. PPE used
during compounding should be disposed of in the proper waste container before
leaving the C-SEC. Gloves worn during compounding shall be carefully removed
and discarded immediately in an approved hazardous waste container inside the
C-PEC or contained in a sealable bag for discarding outside the C-PEC.
Potentially contaminated clothing shall not be taken home under any
circumstances.
(7)
Personnel training
(a)
All personnel who
handle hazardous drugs shall be fully trained based on their job functions
(e.g., in the receipt, storage, handling, compounding, dispensing, and disposal
of hazardous drugs). Training shall occur before the employee independently
handles hazardous drugs. The effectiveness of training for hazardous drugs
handling competencies must be demonstrated by each employee. Personnel
competency must be reassessed at least every twelve months and when a new
hazardous drug or new equipment is used or a new or significant change in
process or standard operating procedure occurs. All training and competency
assessment must be documented. The training must include at least the
following:
(i)
Review of the entity's policies and procedures related to
handling of hazardous drugs;
(ii)
Proper use of
PPE;
(iii)
Proper use of equipment and devices (e.g., engineering
controls); and
(iv)
Spill management.
(b)
Compounding
personnel of reproductive capability shall confirm in writing that they
understand the risks of handling hazardous drugs.
(c)
Personnel who
handle hazardous drugs shall be reminded that they should undergo medical
examinations annually to update their medical, reproductive, and exposure
histories. The examinations should be complete, but the skin, mucous membranes,
cardiopulmonary and lymphatic systems, and liver should be
emphasized.
(8)
Facilities
Access to areas where hazardous drugs
are unpacked, stored and prepared shall be restricted to authorized staff to
protect persons not involved in hazardous drug handling. The location of the
hazardous drug compounding area shall be located away from break rooms and
refreshment areas for staff, patients, or visitors to reduce risk of exposure.
Signs designating the hazard shall be prominently displayed before entry into
the hazardous drug area.
(9)
Receipt of
hazardous drugs
Appropriate PPE shall be used when
unpacking hazardous drugs from their shipping containers.
(10)
Storage of hazardous drugs
(a)
Hazardous drugs shall be stored in a manner that
prevents spillage or breakage if the container falls. Hazardous drugs shall not
be stored on the floor.
(b)
Hazardous drugs shall be stored separately from other
inventory.
(c)
Hazardous drugs shall be stored in a manner to prevent
contamination and personnel exposure.
(11)
Decontamination,
deactivation, cleaning and disinfection
All areas where hazardous drugs are
handled (including during receiving, storage, compounding, transport,
administering, and disposal) and all reusable equipment and devices (e.g.,
C-PEC, carts, and trays) shall be routinely deactivated (using an appropriate
deactivating agent for the type of hazardous drugs compounded), decontaminated
and cleaned. Additionally, sterile compounding areas and devices must be
subsequently disinfected. Equipment used to perform deactivation, cleaning, and
disinfection shall not be used in areas where hazardous drugs are not handled.
The facility shall establish written procedures for decontamination,
deactivation, cleaning, and disinfection (for sterile compounding
areas).
(12)
Spill control
(a)
All personnel who
may be required to clean-up a spill of hazardous drugs shall receive proper
training in spill management and the use of PPE. Spills shall be contained and
cleaned immediately only by qualified personnel with appropriate PPE. Qualified
personnel must be available at all times in facilities handling hazardous
drugs. Signs must be available for restricting access to the spill area. Spill
kits containing all of the materials needed to clean hazardous drug spills
shall be readily available in all areas where hazardous drugs are routinely
handled. If hazardous drugs are being prepared or administered in a non-routine
healthcare area, a spill kit and respirator shall be available. All spill
materials shall be disposed of as hazardous waste.
(b)
Personnel who are
potentially exposed during the spill or spill clean-up or who have direct skin
or eye contact with hazardous drugs require immediate evaluation by a health
care professional. Non-employees exposed to a hazardous drug spill should
report to the designated emergency service for initial
evaluation.
(c)
An eyewash station and other emergency or safety
precautions that meet applicable laws and regulations must be readily
available.
(13)
Disposal
(a)
Disposal of all hazardous drug waste (including unused
and unusable hazardous drugs) must comply with all applicable federal, state,
and local regulations. All personnel who perform routine custodial waste
removal and cleaning activities in hazardous drug handling areas must be
trained in appropriate procedures to protect themselves and the environment to
prevent hazardous drug contamination.
(b)
All syringes and
needles used in the course of preparation shall be placed in appropriate
hazardous waste containers for hazardous disposal without being crushed or
clipped.
(14)
Maintenance personnel
Personnel that are charged with
cleaning the facility shall wear the appropriate personal protective equipment,
including appropriate use of gloves or gowns if they handle linens, feces or
urine from patients who have received hazardous drugs within the last
forty-eight hours. Appropriate eye and face protection shall be worn if
splashing is possible.
(15)
Patient
training
Whenever possible, a licensed health
care provider shall be involved in discussing with each patient receiving a
hazardous compounded drug, or the caregiver of such individual, the following
matters:
(a)
Dosage form, dosage, route of administration, and
duration of drug therapy;
(b)
Special directions and precautions for preparation and
administration; and
(c)
Stability or incompatibilities of the
medication.
(16)
Quality assurance
(a)
There shall be a
documented, ongoing quality assurance control program that monitors personnel
performance, equipment, finished compounded drug preparations, and facilities.
At a minimum, there shall be written quality assurance programs developed that
address:
(i)
Adequate training and continuing competency monitoring, including an initial
skills assessment and examination as well as annual assessments, of compounding
personnel in all of the following areas:
(a)
Personal
cleansing including proficiency of proper hand hygiene;
(b)
Proper
attire;
(c)
Aseptic technique;
(d)
Proper clean room
conduct; and
(e)
Clean room disinfecting procedures.
(ii)
Continued verification of compounding accuracy including
physical inspection of end products.
(iii)
Continued
verification of automated compounding devices.
(iv)
End product
testing including, but not limited to, the appropriate sampling of products if
microbial contamination is suspected.
(b)
Instructors shall
have the appropriate knowledge and experience necessary to conduct the
training.
(c)
All clean rooms and other primary engineering devices
shall have environmental monitoring performed at least every six months to
certify operational efficiency. There shall be a plan in place for immediate
corrective action if operational efficiency is not certified. Records
certifying operational efficiency shall be maintained for at least three years
and shall be readily retrievable.
(17)
Packaging and
transport
(a)
Compounding personnel must select and use packaging
containers and materials that will maintain physical integrity, stability, and
sterility (if needed) of the hazardous drugs during transport. Packaging
materials must protect the hazardous drug from damage, leakage, contamination,
and degradation, while protecting healthcare workers who transport hazardous
drugs. The entity shall have written standard operating procedures to describe
appropriate shipping containers and insulating materials, based on information
from product specifications, vendors, mode of transport, and experience of the
compounding personnel.
(b)
Hazardous drugs that need to be transported must be
labeled, stored, and handled in accordance with applicable federal, state, and
local regulations. Hazardous drugs must be transported in containers that
minimize the risk of breakage or leakage. Pneumatic tubes must not be used to
transport any liquid or antineoplastic hazardous drugs because of the potential
for breakage and contamination.
(C)
Records of
hazardous drug compounding shall be maintained pursuant to rule 4729:7-3-06 of
the Administrative Code.
(D)
A hazardous compounded drug that is personally
furnished by a prescriber must be labeled according to rule
4729:5-19-02
of the Administrative Code and must include the appropriate beyond-use date, in
accordance with United States Pharmacopeia Chapter <797> or <795>
and complete list of ingredients. The statement "Hazardous Compounded Drug"
shall also be displayed prominently on the label.
(E)
A prescriber
shall not compound hazardous drugs in anticipation of prescriptions based on
routine prescribing patterns.
(F)
A prescriber is
required to perform medication validation ("final check") of the finished
hazardous compounded drug preparation prior to it being administered to a
patient.
(G)
Paragraph (F) of this rule does not apply if a
hazardous compounded drug is being administered to a patient in the facility by
a nurse licensed under Chapter 4723. of the Revised Code in accordance with
their applicable scope of practice 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
following:
(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 the following:
(a)
Drug
name;
(b)
Drug dose;
(c)
Drug
volume;
(d)
Rate of administration;
(e)
Route of
administration;
(f)
Expiration dates/times; and
(g)
Appearance and
physical integrity of the drugs.
(4)
Indicate in the
compounding record verification was completed.
(5)
Extravasation
management procedures are defined.
(6)
Antidote order
sets and antidotes are accessible.
(7)
A prescriber is
on-site and immediately available.
(H)
A prescriber may
designate an appropriately trained agent to assist the prescriber in the
compounding of hazardous drugs.
(I)
For non-sterile
hazardous compounded drugs, the prescriber shall also comply with United States
Pharmacopeia Chapter <795>.
(J)
Sterile hazardous
compounded drugs prepared with beyond-use dates greater than twelve hours,
shall comply with beyond-use dating requirements in accordance with United
States Pharmacopeia Chapter <797>.
Replaces: 4729-16-11
