PURPOSE: The board is amending all sections of the
current rule to update, modernize, and clarify rule
requirements.
PURPOSE: This rule defines minimum standards for the
operation of nuclear pharmacies and the preparation, labeling, dispensing,
delivering, compounding, and repackaging of radio pharmaceuticals pursuant to a
prescription drug or medication order. This regulation is intended to
supplement other regulations of the Board of Pharmacy, as well as those of
other state and/or federal agencies.
(1) Definitions.
(A) "Agreement state" means any state that
has entered into an agreement under subsection 274b of the Atomic Energy Act of
1954, as amended, in which the United States Nuclear Regulatory Commission has
relinquished to such states the majority of its regulatory authority over
source material, by product, and special nuclear material in quantities not
sufficient to form a critical mass.
(B) "Authentication of product history" means
identifying the purchasing source, the ultimate fate, and any intermediate
handling of any component of a radio pharmaceutical or other drug.
(C) "Authorized address or location" means
the building or buildings that are identified on the license and where
by-product material may be received, prepared, used, or stored as defined by
10 CFR
35.2 or a temporary job site for providing
mobile nuclear medicine services in accordance with
10 CFR
35.80.
(D) "Authorized nuclear pharmacist" (ANP)
means a pharmacist who holds a current license issued by the board and who is
either certified as a nuclear pharmacist by the Board of Pharmacy Specialties,
has attained status as an authorized nuclear pharmacist, or an authorized user
of radioactive material, as specified by the Nuclear Regulatory Commission or
Agreement State regulations, including, but not limited to,
10
CFR
35.55,
35.57
and
35.59.
(E) "Contingency prescription drug order"
means a radioactive prescription drug order issued for contingency material for
a diagnostic purpose.
(F)
"Controlled access area" means an area outside of the restricted area but
inside the pharmacy, access to which will be limited to the public.
(G) "NRC" means the United States Nuclear
Regulatory Commission.
(H) "Nuclear
pharmacy" means the location that provides radio pharmaceutical services and
where radio pharmaceuticals and chemicals within the classification of legend
drugs, are prepared, compounded, repackaged, dispensed, stored, sold, or used
for nuclear medicine procedures. The term "nuclear pharmacy" does not include
the nuclear medicine facilities of hospitals or clinics where radio
pharmaceuticals are compounded or dispensed to patients under the supervision
of a licensed physician, authorized by the Nuclear Regulatory Commission or
Agreement State regulations. Nothing in this rule shall be construed as
requiring a licensed clinical laboratory, which is also licensed by the Nuclear
Regulatory Commission or Agreement State to handle radioactive materials, to
obtain the services of a nuclear pharmacist, or to have a pharmacy permit,
unless the laboratory is engaged in the commercial sale or resale of
radio-pharmaceuticals.
(I) "Nuclear
pharmacy technician" means a person who has successfully completed a nuclear
pharmacy technician training program provided by an accredited college program
or meets the American Pharmacist's Association's (APhA) Guidelines for Nuclear
Pharmacy Technician Training Program or an equivalent company sponsored program
that meets APhA guidelines for nuclear pharmacy technician training.
(J) "Practice of nuclear pharmacy" means a
patient-oriented service that embodies the scientific knowledge and
professional judgment required to improve and promote health through the
assurance of the safe and efficacious use of radio pharmaceuticals and other
drugs.
(K) "Preparing of radio
pharmaceuticals" means the addition of a radioactive substance, or the use of a
radioactive substance in preparation of a single-dose or multiple-dose
medication, pursuant to the prescription drug order/contingency prescription
drug order. Such preparing of radiopharmaceuticals includes, but is not limited
to, loading and eluting of radionuclide generators, using manufactured reagent
kits to prepare radiopharmaceuticals, preparing reagent kits, aliquoting
reagents, and conducting quality control tests of
radiopharmaceuticals.
(L)
"Prescription drug order" means a prescription drug order issued for a specific
patient for a diagnostic or therapeutic purpose.
(M) "Quality control testing" means, but is
not limited to, the performance of appropriate chemical, biological, physical,
radiochemical, and radionuclidic purity tests on radiopharmaceuticals and the
interpretation of the resulting data to determine their suitability for use in
humans and animals.
(N) "Quality
assurance procedures" means all activities necessary to assure the quality of
the process used to provide radiopharmaceutical services, including
authentication of product history and maintenance of all records as required by
pertinent regulatory agencies. handling of any component of a
radiopharmaceutical or other drug.
(O) "Radiopharmaceutical" means any drug
which exhibits spontaneous disintegration of unstable nuclei with the emission
of nuclear particles or photons and includes any nonradioactive reagent kit or
nuclide generator which is intended to be used in the preparation of any such
substance but does not include drugs such as carbon-containing compounds or
potassium-containing salts which contain trace quantities of naturally
occurring radionuclides. The term "radiopharmaceutical" also includes any
biological product which is labeled with a radionuclide or intended solely to
be labeled with a radionuclide.
(P)
"Radiopharmaceutical services" means, but not limited to, the procurement,
storage, handling, compounding, preparation, repackaging, labeling, quality
control testing, dispensing, delivery, transfer, record-keeping, and disposal
of radiochemicals, radiopharmaceuticals, and ancillary drugs; the participation
in radiopharmaceutical selection and radiopharmaceutical utilization review,
and also includes quality assurance procedures, radiological healthcare
activities, any consulting activities associated with the use of
radiopharmaceuticals, and any other activities required for provision of
radiopharmaceutical care; the responsibility for advising, where necessary or
where regulated, of therapeutic values, hazards and use of
radiopharmaceuticals; and the offering or performing of those acts, services,
operations, or transactions necessary in the conduct, operation management, and
control of a nuclear pharmacy.
(Q)
"Restricted area" means an area within the pharmacy that is secured from the
Controlled Access Area and to which access is limited for the purpose of
protecting individuals against exposure to radiation and radioactive
materials.
(R) "Therapeutic
prescription drug order" means a radioactive prescription drug issued for a
specific patient for a therapeutic purpose.
(S) "Unit dose container" (e.g., shield or
"pig") means a container designed to hold doses of radiopharmaceutical agents
and to prevent or minimize/reduce the emission of radiation or radioactive
materials by using appropriate shielding materials.
(2) General Requirements for Pharmacies
Providing Radiopharmaceutical Services.
(A)
No person may receive, acquire, possess, prepare, compound, dispense,
repackage, transfer, dispose of, or manufacture for sale or resale any
radiopharmaceutical except in accordance with the provisions of this rule and
the conditions of rules and regulations promulgated by the Nuclear Regulatory
Commission or applicable Agreement State.
(B) Nuclear pharmacies shall post, in a
conspicuous area of the pharmacy, a copy of the current registration with the
Board of Pharmacy and a copy of the most current U.S. NRC or applicable
Agreement State license which details a listing of its authorized nuclear
pharmacists. A reference to its specific location within the pharmacy is
acceptable.
(C) A nuclear pharmacy
must have on file a copy of the current radioactive materials license for the
licensed facility requesting any radiopharmaceutical before the radioactive
drug is permitted to be dispensed to that facility. The radiopharmaceutical may
only be delivered to the authorized addresses or locations listed in, or
temporary job sites as authorized by, the NRC/Agreement State license. The
authorized physician ordering radiopharmaceuticals is hereby recognized as the
patient's authorized designee for delivery purposes. This section is an
exemption for Class E pharmacies to
20 CSR
2220-2.013(2) Prescription Delivery
Requirements, which details authorized delivery sites.
(D) Nuclear pharmacies shall comply with any
applicable requirements of other governing agencies regarding its daily
operations and the disposal of any biohazardous medical waste. Appropriately
labeled and, when required shielded, disposal containers shall be used for
radioactive and biohazardous waste from the preparation or the return of
radiopharmaceuticals. Disposal of biohazardous waste shall comply with all
applicable local, state, and federal requirements.
(E) Any reusable unit dose container that is
returned shall be considered to be contaminated. No pharmacy shall utilize a
reusable unit dose container for radioactive doses without either an effective
process to decontaminate the container of biohazardous substances or an
effective mechanism to avoid contamination of the container. No pharmacy may
reuse a unit dose container that remains contaminated with blood or other
biohazardous substances.
(F) A
Class E pharmacy may accept returns and waste as authorized by the
NRC/Agreement State regulations.
(3) Permits. Any pharmacy providing
radiopharmaceutical services must obtain a Class E radiopharmaceutical permit
from the board. Nuclear pharmacies preparing, compounding or repackaging
sterile preparations must have Class H Sterile Product Compounding on their
permit.
(A) A permit to operate a nuclear
pharmacy shall only be issued to a person who is, or who employs, an authorized
nuclear pharmacist. All personnel performing tasks in the preparation and
distribution of radiopharmaceuticals and ancillary drugs shall be under the
direct supervision of an authorized nuclear pharmacist. The
pharmacist-in-charge shall be an authorized nuclear pharmacist and be
responsible for all operations of the pharmacy.
(B) The permit to operate a nuclear pharmacy
is effective only if the pharmacy also holds a current Nuclear Regulatory
Commission and/or Agreement State radioactive materials license. Copies of the
most recent regulatory inspection reports must be made available upon request
to the board for inspection.
(C)
The nuclear pharmacist-in-charge shall notify the Board of Pharmacy by letter
of the outcome of any hearings under state or federal laws or regulations
governing radioactive materials involving or against the pharmacy location
licensed by the board. Notification must be within thirty (30) days of the date
of the outcome.
(4)
Space, Security, Record-Keeping and Equipment.
(A) Nuclear pharmacies shall have adequate
space and equipment, commensurate with the scope of services provided, and as
required by the Nuclear Regulatory Commission or Agreement State radioactive
materials license or as required by
20 CSR
2220-2.200 Sterile Compounding,
20 CSR
2220-2.400 Compounding Standards of Practice or other
applicable rules of the board. Radionuclide generators shall be stored and
operated in an ISO 8 or better classified area. All pharmacies handling
radiopharmaceuticals shall include, but not be limited to, the following areas:
1. Radiopharmaceutical nonsterile and sterile
preparation/dispensing area;
2.
Radioactive material shipping/receiving area;
3. Radioactive material storage area;
and
4. Radioactive waste decay
area.
(B) The nuclear
pharmacy restricted area shall be secured against unauthorized personnel and
must be totally enclosed and lockable.
(C) Nuclear pharmacies shall maintain records
of acquisition, inventory, preparing, compounding, repackaging, dispensing,
distribution, and disposition of all radioactive drugs and other radioactive
materials in accordance with State Board of Pharmacy and Nuclear Regulatory
Commission or Agreement State rules/requirements.
(D) Nuclear pharmacies shall prepare,
compound, repackage, and dispense radiopharmaceuticals in accordance with
accepted standards of nuclear pharmacy practice and in compliance with
20 CSR
2220-2.200 Sterile Compounding and
20 CSR
2220-2.400 Compounding Standards of Practice.
Appropriate safety and containment techniques for preparing, repackaging, and
compounding radiopharmaceuticals shall be used in conjunction with the aseptic
techniques required for sterile preparations. Only authorized nuclear
pharmacists, intern pharmacists, and nuclear pharmacy technicians may prepare,
compound, repackage, or dispense radiopharmaceuticals.
(E) Unless required by other rule or
applicable law, all records required by this rule must be maintained for two
(2) years and must be made available to the board or its representative upon
request.
(5) Dispensing,
Packaging, Labeling.
(A) A radiopharmaceutical
shall be dispensed only to a a practitioner or facility authorized by the
Nuclear Regulatory Commission or an Agreement State to possess, use and
administer such drug, provided that a radiopharmaceutical may be transferred to
a person who is authorized to possess the drug in accordance with the
regulations of the NRC/Agreement State. A radiopharmaceutical shall not be
dispensed directly to a patient. A nuclear pharmacy may distribute radionuclide
elutions to other authorized users to meet a drug shortage.
(B) The amount of radioactivity shall be
determined by dose calibrator, appropriate radiometric methods, or decay
calculation methods for each individual dose immediately prior to
dispensing.
(C)
Radiopharmaceuticals are to be dispensed only upon a non-refillable
prescription drug order or a contingency prescription drug order from a
practitioner or facility authorized by the Nuclear Regulatory Commission or
Agreement State to possess, use, and administer radiopharmaceuticals or the
practitioner's/facility's designated agent. The prescription drug
order/contingency prescription drug order must be taken by an authorized
nuclear pharmacist, intern pharmacist, or nuclear pharmacy technician under the
supervision of an authorized nuclear pharmacist. Only authorized nuclear
pharmacists may receive verbal therapeutic prescription drug orders. The
prescription record shall contain all information as required in
20 CSR
2220-2.018 Prescription Requirements and shall also
include:
1. The date of dispensing and the
calibration time of the radio-pharmaceutical; and
2. The patient's name for therapeutic
prescription drug orders and blood-containing products.
(D) The unit dose container of a
radiopharmaceutical to be dispensed shall be labeled with-
1. The name and address of the
pharmacy;
2. The name and address
of the authorized prescriber/facility where the prescription drug
order/contingency prescription drug order is to be administered;
3. The date of dispensing and a unique
readily retrievable identifier;
4.
The standard radiation symbol;
5.
The words "Caution Radioactive Material";
6. The name of the procedure, if
known;
7. The name or generally
recognized and accepted abbreviation of the radiopharmaceutical, radionuclide,
and chemical form;
8. The requested
amount of radioactivity at the calibration date and time;
9. The radiopharmaceutical beyond-use
date;
10. The quantity
dispensed;
11. If applicable,
Molybdenum-99 content to United States Pharmacopoeia (USP) limits of
<0.15uCi Mo-99 per 1mCi Tc-99m at time of administration or product
expiration; and
12. The patient
name or the words "Physician's Use Only," "Contingency Prescription Drug
Order," "Per Physician's Order," or similar wording in the absence of a patient
name. If no patient name is used, the pharmacy must be able to retrieve the
name of the patient from the authorized prescriber/facility within three (3)
days if requested. When the prescription is for a therapeutic or
blood-containing radiopharmaceutical, the patient name shall appear on the
label.
(E) The immediate
inner container label of a radiopharma-ceutical to be dispensed shall be
labeled with-
1. The standard radiation
symbol;
2. The words "Caution
Radioactive Material";
3. The
identity of the radiopharmaceutical;
4. The unique, readily retrievable identifier
of the radiopharmaceutical; and
5.
The patient's name, if known or the words "Physician's Use Only," "Contingency
Prescription Drug Order," "Per Physician's Order," or similar wording in the
absence of a patient name.
(F) Radiopharmaceuticals approved by the
United States Food and Drug Administration are not subject to the unit dose
container labeling requirements in subsection (D) or the radiometric
measurement requirements of this rule if the nuclear pharmacy does not process
the radioactive drugs in any manner nor violate the original manufacturer
product packaging/labeling.
(6) Reference Manuals. Each nuclear pharmacy
shall have a current copy of, or electronic access to-
(A) Applicable reference materials
commensurate with the scope of services provided;
(B) A current print or electronic edition of
statutes and rules governing the pharmacy's practice, including, but not
limited to, Chapters 338 and 195, RSMo, 20 CSR 2220 and, if applicable, 19 CSR
30 governing controlled substances; and
(C) Agreement State and/or NRC regulations
governing the safe storage, handling, use, dispensing, transport, and disposal
of radioactive material, including but not limited to Title 10 and Title 49 of
the United States Code of Federal Regulations.
(7) Special Conditions.
(A) To comply with NRC exposure guidelines of
keeping radiation exposure as low as reasonably achievable (ALARA), the
required pharmacist verification of the preparation shall be deemed satisfied
if a pharmacist has previously verified the correct ingredients and
calculations. Additionally, a pharmacist must verify the accuracy of the
prescription/drug order information used and the label information prior to
dispensing.
(B) At its discretion,
for a pharmacy preparing, compounding, repackaging, or dispensing
radiopharmaceuticals the board may grant an exemption to regulation
requirements that do not pertain to the practice of nuclear pharmacy for a time
period designated by the board if such exemption is not contrary to other law
and the exemption will provide equal or greater protection of the public
safety, health, or welfare. Exemption requests must be submitted in writing and
identify the specific exemption requested, the grounds for exemption, the
requested exemption length, and any proposed procedures or safeguards for
protecting the public safety, health, or welfare if the exemption is approved.
If deemed appropriate, the board may grant an exemption to all nuclear
pharmacies based on one (1) pharmacy's request.