Chapter 4729-15 Nuclear Pharmacies

4729-15-01 Definitions.

As used in Chapter 4729-15 of the Administrative Code:

(A) "Class 100 environment" means an atmospheric environment that contains no more than one hundred particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E". A class 100 environment is equivalent to ISO class 5.

(B) "Class 100,000 environment" means an atmospheric environment that contains no more than one hundred thousand particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E". A class 100,000 environment is equivalent to ISO class 8.

(C) "Nuclear pharmacist" shall be a licensed pharmacist holding a current identification card in the state of Ohio, and meets the following standards:

(1) Be certified as a nuclear pharmacist by the "Board of Pharmaceutical Specialties"; or

(2) Meet minimal standards of training for an "authorized user" of radioactive material or for an "authorized nuclear pharmacist (ANP)" designation by the proper nuclear regulatory agency, the United States nuclear regulatory commission, or the appropriate state agency including:

(a) Have received a minimum of two hundred contact hours of didactic instruction in nuclear pharmacy and the safe handling and use of radioactive materials from an accredited college of pharmacy or a program approved by the nuclear regulatory commission, with emphasis in the following areas:

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics of radioactivity;

(iv) Radiation biology;

(v) Radiopharmaceutical chemistry.

(b) Attain a minimum of five hundred hours of clinical nuclear pharmacy training under the supervision of a pharmacist trained in nuclear pharmacy and who is an "authorized user" or an "authorized nuclear pharmacist" as defined by the nuclear regulatory commission.

(D) "Nuclear pharmacy" is a pharmacy where prescriptions for radiopharmaceuticals are filled or where radiopharmaceuticals are compounded or dispensed by a pharmacist licensed by the proper authorities to receive, possess, and use such drugs. A nuclear pharmacy shall be licensed by the United States nuclear regulatory commission or the appropriate state nuclear regulatory agencies, other appropriate state agencies, and by the state board of pharmacy.

(E) "Radiopharmaceutical," a dangerous drug as defined in division (F) of section 4729.01 of the Revised Code, shall include any article that exhibits spontaneous decay or disintegration of an unstable atomic nucleus, usually accompanied by the emission of ionizing radiation and any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such article.

Replaces: 4729-15-01

Effective: 01/01/2010
R.C. 119.032 review dates: 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 3719.01 , 4729.01
Prior Effective Dates: 4/1/78, 9/1/89, 7/1/94, 3/1/99, 2/1/05

4729-15-02 Responsibility for nuclear pharmacy.

A nuclear pharmacist shall maintain supervision and control of radiopharmaceuticals as provided in division (B) of section 4729.55 of the Revised Code.

(A) The responsible nuclear pharmacist whose name appears on the terminal distributor of dangerous drugs license shall sign the license and shall maintain the license in a readily available place in the principal location of the business.

(B) The responsible nuclear pharmacist is responsible for maintaining adequate supervision and control over the dangerous drugs acquired and dispensed by the terminal distributor of dangerous drugs and maintaining all records required by this chapter and federal law to be kept at the establishment or place described in the license.

(C) If there is a change in the responsible nuclear pharmacist, the board of pharmacy shall be notified within thirty days thereof of the date of change and the name of the new responsible nuclear pharmacist.

(1) This notice to the board of pharmacy shall be made by completing, signing, and returning the form supplied by the board by regular mail or by verified facsimile transmission.

(2) A complete inventory of the controlled substances on hand shall be taken, pursuant to federal regulations, with the new responsible nuclear pharmacist. The new responsible nuclear pharmacist shall be responsible for the accuracy of this inventory.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54 , 4729.55 , 4729.57
Prior Effective Dates: 4/1/1978, 9/1/1989, 7/1/1994, 1/1/2004

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 4729-19-04 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: 01/01/2010
R.C. 119.032 review dates: 09/28/2009 and 12/01/2014
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54 , 4729.55
Prior Effective Dates: 2/1/05

4729-15-04 Labeling of radiopharmaceuticals.

All radiopharmaceuticals dispensed for use by inpatients of an institutional facility are exempt from the labeling requirements of rule 4729-17-10 of the Administrative Code. All radiopharmaceuticals dispensed for use by outpatients are exempt from the labeling requirements of rule 4729-5-16 of the Administrative Code.

(A) No radiopharmaceutical may be dispensed unless a label is affixed to the immediate container bearing the following information:

(1) The standard radiation symbol.

(2) The words "Caution - Radioactive Material."

(3) The prescription number.

(4) The radionuclide and chemical form.

(B) No radiopharmaceutical may be dispensed unless a tamper-evident seal is applied and a label is affixed to the outer or delivery container of each dose bearing the following information:

(1) The standard radiation symbol.

(2) The words "Caution - Radioactive Material."

(3) The radionuclide and chemical form.

(4) The volume if in liquid form.

(5) The requested activity and the calibration date and time.

(6) The prescription number.

(7) Labels for radiolabeled blood components and therapeutic dosages must always contain the patient's name at the time of dispensing. Where the patient's name is not available at the time of dispensing for diagnostic dosing, a seventy-two-hour exemption is allowed to obtain the name of the patient. No later than seventy-two hours after dispensing the radiopharmaceutical, the patient's name must be associated with the prescription in a readily retrievable manner and must be retained for a period of three years.

(8) The telephone number of the nuclear pharmacy, and the name and address of the nuclear pharmacy as it appears on the terminal distributor of dangerous drugs license.

(9) The name of the end authorized user, who must also be a prescriber as defined in section 4729.01 of the Revised Code.

(10) The lot number of the preparation.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.64 , 3719.08
Prior Effective Dates: 4/1/1978, 9/1/1989, 7/1/1994, 3/1/1999

4729-15-05 Prohibitions.

(A) No person shall receive, possess, or transfer radiopharmaceuticals except in accordance with section 4729.51 of the Revised Code.

(B) No person, other than a nuclear pharmacist, shall be personally in full and actual charge of a nuclear pharmacy.

(C) No person shall conduct a nuclear pharmacy except in accordance with section 4729.28 of the Revised Code, state board of pharmacy rules, regulations of the United States nuclear regulatory commission or the appropriate state nuclear regulatory agencies, and regulations of other appropriate state agencies.

(D) No person shall utilize reusable unit dose transport containers for radioactive dosages without either an effective process to decontaminate the transport container of blood or other biohazardous substances or an effective mechanism to avoid contamination of the transport container.

(E) No person shall re-use a unit dose transport container that remains contaminated with blood or other biohazardous substances. Any unit dose transport container that is returned with the tamper-evident seal broken and the unit dose syringe included must be considered to be contaminated.

(F) This rule does not apply to:

(1) An individual prescriber who prepares radiopharmaceuticals for administration to the prescriber's patients as provided in section 4729.29 of the Revised Code.

(2) The transfer of radioactive material not intended for use as a drug to authorized persons.

(3) The occasional transfer of bulk quantities of radiopharmaceuticals to other authorized persons to meet shortages.

Effective: 05/22/2014
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 3715.69 , 3719.28 , 4729.26
Rule Amplifies: 3715.63 , 3719.09 , 4729.27 , 4729.28 , 4729.51
Prior Effective Dates: 4/1/1978, 9/1/1989, 7/1/1994, 3/1/1999, 4/27/2007