Kentucky Administrative Regulations
Title 201 - GENERAL GOVERNMENT CABINET
Chapter 2 - Board of Pharmacy
Section 201 KAR 2:215 - Nuclear pharmacy services
Universal Citation: 201 KY Admin Regs Service 2:215
Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO: KRS Chapter 315
NECESSITY, FUNCTION, AND CONFORMITY: The Kentucky Board of Pharmacy shall be responsible for imposing minimum standards in all settings where drug products are dispensed and to ensure the safety of all drug products provided to the citizens of the Commonwealth. This administrative regulation applies to pharmacies as defined in KRS 315.010. The requirement of these administrative regulations are in addition to, and not in substitution of, other applicable administrative regulations promulgated by the Cabinet for Human Resources for radioactive materials and applicable administrative regulations promulgated by the Kentucky Board of Pharmacy.
Section 1. Definitions.
(1) "Nuclear pharmacy" means a pharmacy
providing radiopharmaceutical services.
(2) "Radiopharmaceutical services" means
those acts, services, operations and transactions necessary in the conduct,
operation, management and control of a nuclear pharmacy, including, for
example:
(a) The compounding, dispensing,
labeling and delivery of radiopharmaceuticals;
(b) The participation in radiopharmaceutical
utilization reviews; and
(c) The
proper and safe storage and distribution of radiopharmaceuticals.
(3) "Radiopharmaceutical" means
any substance defined as a drug in Section 201(g)(1) of the Federal Food, Drug
and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei
with the emission of nuclear particles or photons and includes any of those
drugs intended to be made radioactive. This includes nonradioactive reagent
kits and nuclide generators which are intended to be used in the preparation of
any such substance, but does not include drugs which are carbon-containing
compounds or potassium-containing compounds or potassium-containing salts which
contain trace quantities of naturally occurring radionuclides.
(4) "Radiopharmaceutical quality assurance"
means the performance of appropriate chemical, biological and physical tests on
radiopharmaceuticals and the interpretation of the resulting data to determine
their suitability for use in humans and animals, and it shall include, for
example, internal test assessment, authentication of product history and the
keeping of proper records.
(5)
"Internal test assessment" means conducting those tests necessary to insure the
integrity of the test.
(6)
"Authentication of product history" means identifying the purchase source, the
ultimate use or disposition and any intermediate handling of any components of
a radiopharmaceutical.
(7)
"Authorized practitioner" means a practitioner duly authorized by applicable
federal and state law to possess, use and administer radiopharmaceuticals. This
person shall be named on a radioactive materials license issued by the
Radiation Control Branch of the Cabinet for Human Resources.
(8) "Designated agent" means an individual
who shall be under the direct supervision of an authorized practitioner and who
shall be authorized to communicate that practitioner's instructions to a
nuclear pharmacy.
(9) "Nuclear
pharmacist" means a pharmacist licensed to practice in the Commonwealth of
Kentucky and who meets minimal standards of training and experience in the
handling of radioactive materials in accordance with the requirements of the
Radiation Control Branch of the Cabinet for Human Resources.
(10) "Direct supervision" means that the
supervising nuclear pharmacist shall be physically present in the general area
or location where the supportive personnel are performing supportive duties and
shall conduct in-process and final checks.
Section 2. General Requirements for Pharmacies Providing Radiopharmaceutical Services.
(1) A license to operate a pharmacy providing
radiopharmaceutical services shall only be issued to a pharmacy operating under
the direct supervision of a nuclear pharmacist. All personnel performing tasks
in the preparation and distribution of radioactive drugs shall be under the
direct supervision of a nuclear pharmacist. A nuclear pharmacist shall be
responsible for all operations of the licensed area and in personal attendance
at all times that the pharmacy is open for business.
(2) Nuclear pharmacies may be exempted from
the general space requirements for pharmacies, but shall:
(a) Have adequate space, commensurate with
the scope of services required and meeting Radiation Control Branch, Cabinet
for Human Resources, requirements established for all radioactive material
licensees in the Commonwealth;
(b)
Be separate from the pharmacy areas for nonradioactive drugs;
(c) Be inaccessible to all unauthorized
personnel; and
(d) Have a
radioactive storage and decay area.
(3) The process used for handling radioactive
materials by any license holder shall involve appropriate procedures for the
purchase, receipt, storage, manipulation, compounding, distribution and
disposal of radioactive materials as approved in a Kentucky radioactive
materials license. In order to ensure the public health and safety in this
respect, a nuclear pharmacy shall first meet the following general
environmental requirements where the handling of radiopharmaceutical materials
takes place:
(a) Proper ventilation so that
radioactive materials cannot be airborne from that environment to other
nonoccupationally unrestricted areas;
(b) Proper location so that the receipt and
dispersal of radioactive materials do not result in inadvertent and undesired
contamination of other nonoccupationally labeled areas; and
(c) Proper design to allow radioactive
materials to be contained in given areas to ensure adequate safety and
protection to personnel working in or near them and to ensure proper operation
of the corresponding assay equipment.
(4) Nuclear pharmacies shall maintain records
of acquisition and disposition of all radioactive drugs in accordance with
administrative regulations of the Radiation Control Branch of the Cabinet for
Human Resources.
(5) A nuclear
pharmacy, upon receiving an oral prescription for a radiopharmaceutical, shall
immediately have the prescription reduced to writing or recorded in a data
processing system, which writing or record shall contain at least the
following:
(a) The name of the authorized
user or his agent;
(b) The date of
distribution and the time of administration of the
radiopharmaceutical;
(c) The name
of the procedure;
(d) The name of
the radiopharmaceutical;
(e) The
dose or quantity of the radiopharmaceutical;
(f) The serial number assigned to the order
for the radiopharmaceutical;
(g)
Any specific instructions; and
(h)
The patient's name, whenever an order is for a therapeutic or blood-product
radiopharmaceutical.
(6)
The immediate outer container (shield) of a radioactive drug to be dispensed
shall be labeled with the:
(a) Standard
radiation symbol;
(b) Words,
"Caution-Radioactive Material";
(c)
Radionuclide;
(d) Chemical
form;
(e) Amount of radioactive
material contained in millicuries or microcuries;
(f) Volume in cubic centimeters, if a
liquid;
(g) Requested calibration
time for the radioactivity contained;
(h) Name, address, and telephone number of
the nuclear pharmacy;
(i)
Prescription number;
(j) Date;
and
(k) Space for patient's
name.
(7) The immediate
container shall be labeled with the:
(a)
Standard radiation symbol;
(b)
Words, "Caution-Radioactive Material";
(c) Prescription number; and
(d) Name of the
radiopharmaceutical.
(8)
Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with
acceptable professional standards of radiopharmaceutical quality
assurance.
(9) A nuclear pharmacist
may transfer to authorized persons, in accordance with the provisions of a
Kentucky radioactive materials license, radioactive materials not intended for
drug use and radio-pharmaceuticals intended for individual patient
use.
(10) Nuclear pharmacies shall
comply with all applicable laws and regulations of federal and state agencies
including those laws and regulations governing nonradioactive drugs. For
nuclear pharmacies handling radiopharmaceuticals exclusively, the Kentucky
Board of Pharmacy may waive regulations pertaining to pharmacy licenses for
nonradiopharmaceuticals which requirements do not pertain to the practice of
nuclear pharmacy.
(11) Radioactive
drugs are to be dispensed only upon a nonrefillable prescription order from a
Radiation Control Branch, Cabinet for Human Resources, licensed medical
practitioner (or the designated agent) authorized to possess, use and
administer radiopharmaceuticals.
(12) Prescription orders for delivery of
radioactive drugs for use in the medical practice of a Radiation Control
Branch, Cabinet for Human Resources, licensed medical practitioner may be
placed on a telephone answering and recording device, only if the practitioner
(or the designated agent) is identified in such a manner that is clearly
recognized by the nuclear pharmacist dispensing the radioactive drug.
(13)
(a) A
nuclear pharmacist in charge of a nuclear pharmacy shall have the authority to
delegate to any qualified and properly trained person or persons, acting under
his direct supervision, any nuclear pharmacy act which a reasonable and prudent
nuclear pharmacist would find is within the scope of sound pharmaceutical
judgment to delegate.
(b) The
delegation shall only occur if, in the professional opinion of the delegating
nuclear phar-macist-in-charge, the act may be properly and safely performed by
the person to whom the act is delegated.
(c) The delegated act shall only be performed
in its customary manner and not in violation of other statutes.
(d) Persons to whom nuclear pharmacy acts are
delegated shall not hold themselves out to the public as being authorized to
practice pharmacy.
Section 3. Minimum Requirements for Space, Equipment, Supplies, and Library.
(1) Each nuclear pharmacy must meet
the following requirements for space:
(a) The
area for the storage, compounding, and dispensing of radioactive drugs shall be
completely separate from pharmacy areas for nonradioactive drugs;
(b) Hot lab and storage area shall be a
minimum of 120 square feet; and
(c)
The compounding and dispensing area shall be a minimum of 300 square
feet.
(2) Each nuclear
pharmacy shall be equipped with at least the following items of equipment:
(a) Dose calibrator;
(b) Refrigerator;
(c) Drawing station;
(d) Well scintillation counter;
(e) Microscope;
(f) Chromatagraphic apparatus or comparable
means of effectively assuring tagging efficiency;
(g) Portable radiation survey meter;
and
(h) Other equipment deemed
necessary for radiopharmaceutical quality assurance for products compounded or
dispensed as shall be determined by the Radiation Control Branch, Cabinet for
Human Resources, and the Kentucky Board of Pharmacy.
(3) Each nuclear pharmacy shall have on the
premises current editions or revisions of the following reference materials:
(a) United States Pharmacopedia-National
Formulary with supplements;
(b)
State statutes and administrative regulations relating to pharmacy;
(c) State and federal regulations governing
the use of applicable radioactive materials; and
(d) Text relating to the practice of nuclear
pharmacy and radiation safety.
Section 4. Radiopharmaceutical Quality Assurance. The holder of a nuclear pharmacy license shall be responsible for the radiopharmaceutical quality assurance of all radiopharmaceuticals, including biologicals, dispensed or manufactured.
STATUTORY AUTHORITY: KRS 315.191(1)
Disclaimer: These regulations may not be the most recent version. Kentucky may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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