4729-15-03 Minimum standards for a nuclear pharmacy.

(A) A nuclear pharmacy shall comply with all applicable local, state, and federal requirements. If a nuclear pharmacy compounds parenteral or sterile product prescriptions other than radiopharmaceuticals or biohazardous materials, the pharmacy shall also comply with rule 4729-16-03 of the Administrative Code.

(B) A policy and procedure manual shall be prepared and maintained regarding the compounding, dispensing, and delivery of sterile radiopharmaceutical 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) Proper handling, storage, and disposal of drugs, radiopharmaceuticals, and radioactive waste;

(4) Proper handling, storage, and disposal of biohazardous materials, if applicable;

(5) Handling of spills and exposure to radioactive and biohazardous materials;

(6) Proper documentation and reporting of adverse events;

(7) Procedures to resolve conflicts when sterile product preparation may interfere with radiation safety practices and equipment. These procedures should use the principle of as clean as reasonably achievable.

The policy and procedure manual shall be current and available for inspection and copying by a state board of pharmacy agent.

(C) Physical requirements

(1) The facility shall have a designated area with access limited to authorized personnel for preparing sterile radiopharmaceutical 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 radiopharmaceutical prescriptions shall have appropriate:

(a) 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; at a minimum, there shall be a physical barrier separating the area where biohazardous products such as human blood are prepared; 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) Shielding of radioactive materials;

(c) Compounding devices and equipment;

(d) Storage conditions for drugs, radiopharmaceuticals, and biohazardous materials;

(e) Appropriate disposal containers for used needles, syringes, etc.

(3) The facility shall maintain supplies adequate to maintain an environment suitable for the aseptic preparation of sterile products.

(4) The compounding of sterile products shall be done within a class 100 environment except in an emergency situation when the product is required to meet the immediate needs of a patient whose health would otherwise be jeopardized.

(D) Delivery service

The responsible nuclear pharmacist shall ensure that all employees comply with all applicable local, state, and federal requirements to assure the proper labeling, environmental controls, integrity, and safety of all products transported.

(E) Disposal of radioactive and/or biohazardous waste

The responsible nuclear pharmacist shall ensure that all employees comply with all applicable local, state, and federal requirements to assure that there is a system for the disposal of radioactive and/or biohazardous waste in a manner so as not to endanger the public health.

(F) Health care professional counseling

When appropriate, a nuclear pharmacist shall be involved in discussing with each health care professional responsible for receiving, storing, and administering a radiopharmaceutical product, the following matters:

(1) Dosage form, dosage, calibrated activity, route of administration, and duration of therapy;

(2) Special directions and precautions for preparation and administration;

(3) Proper storage; and

(4) Stability or incompatibilities of the medication.

(G) Quality assurance

(1) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment, finished compounded drug products, and facilities.

(2) 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 and including when possible 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. If bulk compounding of sterile products is being performed using nonsterile chemicals, extensive end product testing must be documented prior to the release of the product from quarantine;

(f) All clean rooms and laminar flow hoods 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 operation efficiency shall be maintained for at least three years.

Effective: 10/16/2015
Five Year Review (FYR) Dates: 10/31/2014 and 10/16/2020
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54, 4729.55
Prior Effective Dates: 2/1/05, 1/1/10