(B) A policy and procedure manual shall be prepared and maintained regarding the compounding, dispensing, and delivery of sterile product prescriptions. The policy and procedure manual shall include at a minimum:
(1) A quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, facilities, and guidelines regarding patient education.
(2) Justification for the chosen beyond use dates of compounded products.
(3) Handling of cytotoxic waste, if applicable.
The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy designated agent.
(C) Physical requirements
(1) The facility shall have a designated area with access limited to authorized personnel for preparing parenteral and sterile products. This area shall be isolated from other areas and must be designed to avoid unnecessary traffic and airflow disturbances from activity within the controlled area. It shall be used only for the preparations of these specialty products, It shall be of sufficient size to accommodate a laminar airflow hood or other primary engineering control devices that provide a class 100 environment and to provide for the proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation, and security.
(2) The facility compounding parenteral and sterile product prescriptions shall have:
(a) Appropriate primary engineering control devices capable of maintaining at least class 100 conditions in the work place where critical objects are exposed and critical activities are performed; furthermore, these devices are to be capable of maintaining class 100 conditions during normal activity. Examples of appropriate devices include laminar airflow hoods and zonal laminar flow of high efficiency particulate air (HEPA) filtered air;
(b) Appropriate disposal containers for used needles, syringes, etc. and, if applicable, for cytotoxic waste from the preparation of chemotherapy agents;
(c) Appropriate environmental control including approved biohazard cabinetry when cytotoxic drug products are prepared;
(d) Infusion devices and equipment, if appropriate;
(e) Appropriate temperature controlled transport containers.
(3) The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.
(4) The facility shall have sufficient current reference materials related to sterile products to meet the needs of the facility staff.
(5) The compounding of sterile products shall be done within a class 100 environment except in an emergency situation when the product is required to treat the immediate needs of a patient whose health would otherwise be jeopardized.
(D) Delivery service
The responsible person shall assure the environmental control of all products shipped to the patient.
(E) Disposal of cytotoxic and/or hazardous waste
The responsible person shall assure that there is a system for the disposal of cytotoxic and/or hazardous waste in a manner so as not to endanger the public health.
(F) Cytotoxic drugs
The following requirements are necessary for those facilities that prepare cytotoxic drugs to ensure the protection of the personnel involved:
(1) All cytotoxic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet or other appropriate Class II primary engineering control device.
(2) Protective apparel shall be worn by personnel compounding cytotoxic drugs. This shall include at least gloves and gowns with tight cuffs.
(3) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile products.
(4) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements.
(5) Written procedures for handling both major and minor spills of cytotoxic agents shall be developed and shall be included in the policy and procedure manual.
(6) Prepared doses of cytotoxic drugs shall be dispensed, labeled with proper precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.
(G) Patient training
Whenever possible, a pharmacist shall be involved in discussing with each patient receiving an outpatient parenteral or sterile product prescription, or the caregiver of such individual, the following matters:
(1) Dosage form, dosage, route of administration, and duration of drug therapy;
(2) Special directions and precautions for preparation and administration;
(3) Proper storage; and
(4) Stability or incompatibilities of the medication.
(H) Quality assurance
There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities.
(1) At a minimum, there shall be written quality assurance programs developed that address:
(a) Adequate training and continuing competency monitoring of all personnel in personal cleansing, proper attire, aseptic technique, proper clean room conduct, and clean room disinfecting procedures. Instructors shall have the appropriate knowledge and experience necessary to conduct the training;
(b) Continued verification of compounding accuracy including physical inspection of end products;
(c) Continued verification of automated compounding devices;
(d) Continued verification that appropriate beyond use dates are being assigned to compounded products;
(e) End product testing including, but not limited to, the appropriate sampling of products if microbial contamination is suspected. Additionally, if bulk compounding of parenteral or sterile products is being performed using nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine. This process must include appropriate tests for particulate matter and testing for pyrogens.
(2) All clean rooms, laminar flow hoods, 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.
R.C. 119.032 review dates: 09/28/2009 and 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.55
Prior Effective Dates: 7/4/88, 7/1/93, 3/1/99, 2/1/05