(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>.
