Chapter 480-25 NUCLEAR PHARMACIES AND PHARMACISTS
Unless a different meaning is required by the context, the
following terms as used in these rules and regulations shall have the meaning
hereinafter respectively ascribed to them:
| (a) |
"Authentication of product history"
means, but is not limited to, identifying the purchasing source, the ultimate
fate, and any intermediate handling of any component of a
radiopharmaceutical. |
| (b) |
"Board"
means the State Board of Pharmacy. |
| (c) |
"Compounding of radiopharmaceuticals"
means the addition of a radioactive substance to nonradioactive substances or
the use of a radioactive substance in preparation for single or multidose
dispensation upon the prescription order of a physician who is licensed to use
radioactive materials. Compounding of radiopharmaceuticals may include: loading
and eluting of radionuclide generators; using manufactured reagents; preparing
reagent kits; a liquoting reagents; formulation and quality assurance testing
of radiochemicals for use as radiopharmaceuticals, and radiolabeling of
compounds or products, including biological products, for use as
radiopharmaceuticals. |
| (d) |
"Department" means the Department of Natural Resources. |
| (e) |
"Governing Body" or "Management" means
the board of directors, trustees, partnership, corporation, association, person
or group of persons who maintain and control the operation of the nuclear
pharmacy, and who are legally responsible for its operation. |
| (f) |
"Internal Test Assessment" means, but is
not limited to conducting those tests of a quality assurance necessary to
ensure the integrity of the test. |
| (g) |
"Licensed Nuclear Pharmacist" means an
authorization granted by the Board to a pharmacist to practice as a nuclear
pharmacist. |
| (h) |
"Manufacturing of
radiopharmaceuticals" means the preparation, derivation, or production of a
product to which a radioactive substance is or will be added to provide a
radiopharmaceutical for sale, resale, redistribution, or
reconstitution. |
| (i) |
"Nuclear
pharmacist" means a pharmacist who compounds and dispenses radiopharmaceuticals
in the course of his/her pharmacy practice. |
| (j) |
"Nuclear Pharmacy" means a pharmacy
providing radiopharmaceutical services. |
| (k) |
"Nuclear Pharmacy Permit" means an
authorization granted by the Board to the governing body of a facility to
operate a nuclear pharmacy. |
| (l) |
"Pharmacist" means an individual who is currently licensed to practice pharmacy
under the provisions of O.C.G.A. Title 26, Chapter 4, Article 3. |
| (m) |
"Pharmacy Intern" means an individual who
is currently licensed to practice as a pharmacy intern under the provisions of
O.C.G.A. Title 26, Chapter 4, Article 3. |
| (n) |
"Physician" means an individual who is
currently licensed to practice medicine under the provisions of O.C.G.A. Title
43, Chapter 34. |
| (o) |
"Radiopharmaceutical" means radioactive drugs and chemical products used for
diagnostic and therapeutic purposes and includes the terms radioactive
pharmaceuticals, radioisotopes, and radioactive tracers. |
| (p) |
"Radiopharmaceutical quality assurance"
means, but is not limited to, the performance of appropriate chemical,
biological, and physical tests on radiopharmaceuticals and their component
materials and the interpretation of the resulting data to determine their
suitability for use in humans and animals, including internal test assessment,
authentication of product history, and the keeping of proper records. |
| (q) |
"Radiopharmaceutical service" means, but
is not limited to, the compounding, dispensing, labeling, and delivering of
radiopharmaceuticals; the participation in radiopharmaceutical selection and
radiopharmaceutical utilization review; the maintenance of radiopharmaceutical
quality assurance; and 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. |
| (r) |
"Unit dose transport container" (a/k/a
"lead pig") means a lead lined container designed to transport doses of
radiopharmaceutical agents and prevent the emission of radiation or radioactive
materials during the process. The terms "unit dose transport container" and
"lead pig" may be used interchangeably. |
| (1) |
All persons who manufacture, possess,
transport, or otherwise handle pharmaceuticals or radioactive materials
intended for radiopharmaceutical use prior to their arrival at a nuclear
pharmacy shall comply with the requirements of the Department's Rules and
Regulations for Radioactive Materials, and the requirements of the Rules and
Regulations of the Board. |
| (2) |
The
requirements of these Rules and Regulations are in addition to, and not in
substitution of, other applicable Rules and Regulations by the Department for
radioactive materials and applicable Rules and Regulations promulgated by the
Board for pharmacists and pharmacies. |
| (3) |
Nothing in these Rules and Regulations
shall be construed as requiring a licensed physician to obtain a separate
license as a nuclear pharmacist, when his/her use of radiopharmaceuticals is
limited to the diagnosis and treatment of his/her own patients. |
| (4) |
Nothing in these Rules and Regulations
shall be construed so as to require a licensed clinical laboratory which is
also licensed by the Department to handle radioactive materials to obtain the
services of a nuclear pharmacist, or to have a nuclear pharmacy license, unless
the laboratory is engaged in the commercial sale or resale of
radiopharmaceuticals. |
| (5) |
Nothing
in these Rules and Regulations shall be construed to require a department of
nuclear medicine which is located in a hospital of 250 beds or less, which has
a board certified radiologist in the practice of nuclear medicine, and which is
licensed by the Department to handle radioactive materials to obtain the
services of a nuclear pharmacist or to have a nuclear pharmacy
license. |
| (1) |
Except as provided for in Rule
480-25-.02, all acts of compounding
and dispensing radiopharmaceuticals in the State of Georgia shall be performed
by persons licensed as nuclear pharmacists; provided, however, that licensed
pharmacists and licensed pharmacy interns/externs under the direct supervision
and control of a nuclear pharmacist may compound and dispense
radiopharmaceuticals without being separately licensed as nuclear
pharmacists. |
| (2) |
An applicant for a
license as a nuclear pharmacist shall:
| (a) |
Be
a currently licensed pharmacist in the State of Georgia, and |
| (b) |
Submit to the Board a completed
application and the appropriate fee, on forms to be provided by the Board, and
an affidavit of training and experience which indicates that the applicant:
| 1. |
Meets the minimum requirements to use
radioactive materials as required by the Department's Rules and Regulations for
Radioactive Materials, and either
| (i) |
Is
certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties of
the American Pharmaceutical Association; or |
| (ii) |
Has completed a minimum of 200 contact
hours of didactic instruction in nuclear pharmacy from an accredited college of
pharmacy, and, completed a minimum of 500 hours of clinical nuclear pharmacy
training:
| (I) |
Under the direct supervision of
a licensed nuclear pharmacist in a licensed nuclear pharmacy providing nuclear
pharmacy service; or |
| (II) |
In a
certified nuclear pharmacy residency program approved by the American Society
of Hospital Pharmacists or the Board; or |
| (III) |
In a structured nuclear pharmacy
training program of an accredited college of pharmacy. |
|
|
|
|
| (3) |
Pharmacists engaged in the practice of nuclear pharmacy in the State of Georgia
prior to March 18, 1983 shall be exempt from the requirements listed in
subsection (2)(b)1. (i) and (2)(b)1. (ii). |
| (4) |
A license as a nuclear pharmacist may be
issued to any pharmacist who makes application to the Board, together with a
required fee, and meets the requirements of these Rules and Regulations. The
Board may refuse to issue a license for any of the grounds set forth in
O.C.G.A. Section
26-4-60,
and may also refuse to issue a license to an applicant who makes any false
statement in the application or cheats in any manner upon any examination
administered pursuant to these Rules and Regulations. |
| (5) |
Licenses shall be renewed biennially on
odd numbered years by application to the Board for renewal. |
| (6) |
The Board may limit, suspend, or revoke
licenses issued under the provisions of these Rules and Regulations, or impose
any other reasonable sanctions upon holders of such licenses upon violation of
these Rules and Regulations or violation of O.C.G.A. Section
26-4-60. |
| (1) |
No nuclear pharmacy shall be operated in
the State of Georgia without a valid permit. |
| (2) |
The governing body of the facility shall
submit a completed application with the required fee to the Board for a permit
using forms provided by the Board. |
| (3) |
Separate applications and permits are
required for nuclear pharmacies maintained on separate premises, even though
they are owned or operated by the same person(s), business or corporation; and
may be doing business under the same trade name. |
| (4) |
Permits are not transferable or
assignable. |
| (5) |
The applicant shall
comply with additional application requirements as may be required by the
Board. |
| (6) |
Following inspection and
evidence of compliance with these Rules and Regulations, the Board may issue a
nuclear pharmacy permit to the applicant(s). The Board may refuse to issue a
permit to any applicant for any of the grounds set forth in O.C.G.A. Section
26-4-113,
and may also refuse to issue or revoke a permit if an applicant makes any false
statements in the application. |
| (7) |
Permits shall be renewed biennially on even numbered years by application to
the Board for renewal. |
| (8) |
The
Board may limit, suspend, or revoke permits issued under the provisions of
these Rules and Regulations, or impose any other reasonable sanctions upon
holders of such permits upon violation of these Rules and Regulations or
violation of O.C.G.A. Section
26-4-113. |
| (1) |
Any nuclear
pharmacy shall be open during all business hours for observation and
examination by properly identified representatives of the Board and the
Department. |
| (2) |
All nuclear
pharmacies shall be inspected by the Board prior to licensure and may be
inspected at the discretion of the Board or the Department to determine whether
it continues to meet these requirements. |
| (1) |
In addition to complying with these Rules
and Regulations, nuclear pharmacies shall comply with the Rules and Regulations
of the Board and with all applicable Federal and State laws and regulations
pertaining to nonradioactive drugs and pharmaceuticals. |
| (2) |
The pharmacist in charge at a nuclear
pharmacy shall be a licensed nuclear pharmacist. All personnel performing tasks
in the preparation and distribution of radiopharmaceuticals shall be under the
direct supervision of a licensed nuclear pharmacist. All acts of compounding
and dispensing of radiopharmaceuticals shall be performed by the nuclear
pharmacist or by a pharmacist or pharmacy intern, under the direct supervision
and control of a nuclear pharmacist. A nuclear pharmacist shall be responsible
for all operations of the nuclear pharmacy and shall be in personal attendance
at all times when the acts of compounding and dispensing are performed and the
pharmacy is open for business. |
| (3) |
Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with
acceptable professional standards of radiopharmaceutical quality
assurance. |
| (4) |
Radiopharmaceuticals
are to be dispensed only upon prescription drug order by a practitioner who is
authorized by the Department to possess, use, and administer radioactive
materials. |
| (5) |
A nuclear pharmacist
may transfer to authorized persons radioactive materials not intended for drug
use, in accordance with the Department Rules and Regulations for Radioactive
Materials. A nuclear pharmacy may also furnish radioactive materials for use to
practitioners, for individual patient use in accordance with subsection (4) of
this regulation. |
| (6) |
The amount of
radioactivity dispensed in each individual preparation shall be determined by
the nuclear pharmacist through radiometric methods immediately prior to
dispensing. |
| (7) |
Nuclear pharmacies
may redistribute Federal Food and Drug Administration approved
radiopharmaceuticals if the pharmacy does not possess the radiopharmaceuticals
in any manner or violate the product packaging. Such redistribution may only be
made to another nuclear pharmacy or other authorized person or
institution. |
| (1) |
Nuclear pharmacies shall have adequate
space, commensurate with the scope of service required and provided and meet
the minimal space requirements of all pharmacies in the State. |
| (2) |
Nuclear pharmacies shall have a minimum
area, secured from unauthorized personnel, which comprise at least 600 square
feet designed for the compounding and dispensing and quality assurance of
radiopharmaceuticals. |
| (3) |
The
foregoing nuclear pharmacy areas shall be exclusive from other pharmacy areas
such as those for nonradioactive drugs and office space. |
| (4) |
Detailed floor plans shall be submitted
to the Board before the permit is granted. |
| (1) |
In addition to
other articles and equipment required by the Board for all pharmacies in the
State, the nuclear pharmacy shall have:
| (b) |
vertical
laminar flow hood; |
| (c) |
single or
multiple channel scintillation analyzer; |
| (d) |
microscope and hemocytometer; |
| (e) |
adequate glassware, utensils, and
gloves; |
| (g) |
laboratory incubator; |
| (i) |
aluminum ion test kit; and |
| (j) |
adequate apparatus and supplies for
performing chromatography. |
|
| (2) |
Nuclear pharmacies shall also have
equipment required for the safe handling and storage of radioactive materials,
as required by the Department's Rules and Regulations for radioactive
materials. |
| (3) |
Each nuclear
pharmacy shall utilize unit dose transport containers, a/k/a lead pigs,
| (a) |
Unit dose transport containers, a/k/a
lead pigs, for radioactive doses shall include:
| 1. |
an effective tamper-evident seal; |
| 2. |
an effective mechanism to avoid radioactive
contamination; and |
| 3. |
an effective
system to prevent contamination of the transport container with blood, bodily
fluids, or other biohazardous substances. |
|
| (b) |
No nuclear pharmacist or nuclear pharmacy
shall re-use a unit dose transport container or lead pig that has been
contaminated with blood, bodily fluids, or other hazardous
substances. |
| (c) |
Any unit dose
transport container or lead pig returned to a nuclear pharmacy with the
tamper-evident seal broken and containing an exposed unit dose syringe shall be
considered contaminated. |
| (d) |
Section 3 of this Rule shall not apply to:
| 1. |
an individual prescriber preparing
radiopharmaceuticals for administration to his or her own patients; |
| 2. |
transfer of radioactive material, not
intended for use as a drug, to other legally authorized persons; and |
| 3. |
the occasional transfer of bulk
radiopharmaceuticals to other authorized entities or persons to meet
shortages. |
|
| (e) |
Biohazardous prevention systems containing a barrier that if used properly
eliminates or substantially reduces the potential for contamination of the unit
dose transport container, or lead pig, would meet the requirements of these
regulations. Improper use of such system resulting in ineffective sanitation of
the unit dose transport container, or lead pig, would require that such
containers be effectively sanitized prior to subsequent use or discarding of
that container. |
|
All radiopharmaceuticals dispensed from a nuclear pharmacy
shall be dispensed in appropriate containers and labeled in accordance with the
following:
| (a) |
The immediate inner
container shall be labeled with:
| 1. |
the
identifying prescription number; and |
| 2. |
the name of the radioactive
drug. |
|
| (b) |
In addition to
any labeling standards established by law the immediate outer container shall
be labeled with:
| 1. |
the name of the
radionuclide; |
| 3. |
the amount of radioactive
material contained, in millicuries (mCi) or microcuries (uCi); |
| 4. |
if a liquid, the volume expressed in
cubiccentimeters (cc) or milliliters (ml); |
| 5. |
the requested calibration time and
date; |
| 6. |
the words "For Physician
Use Only" in the absence of the name of the patient; |
| 7. |
the name and address of the institution
where the radiopharmaceutical will be administered; |
| 8. |
the expiration date and time of the
radioactive drug; |
| 9. |
auxillary
instructions for use, if applicable; |
| 10. |
name of the procedure for which drug is
intended; |
| 11. |
name of prescribing
practitioner; |
| 12. |
The standard
radiation symbol; and |
| 13. |
The words
"Caution - Radioactive Material". |
|
In addition to any reference material required by the Board of
all pharmacies in the State, a nuclear pharmacy shall maintain a reference
library which shall include the following:
| (a) |
Current U.S. Pharmacopoeia/National
Formulary with supplements or computer or electronic access to same; |
| (b) |
Computer or electronic access to Federal
and State Laws and Regulations relating to pharmacy practice in
Georgia; |
| (c) |
A minimum of three
texts dealing with nuclear medicine; |
| (d) |
Current Department of Human Resources
Rules and Regulations for Radioactive Materials. |
The nuclear pharmacy shall maintain acquisition and disposition
records as required by the Board of all pharmacies in the
State.
The enforcement and administration of these Rules and
Regulations shall be as prescribed in the Georgia Administrative Procedure Act,
O.C.G.A., Title 50, Chapter 13, Title 26, Chapter 4, and Title 43, Chapter
1.
In the event that any rule, sentence, clause or phrase or any
of these rules and regulations may be construed by any court of competent
jurisdiction to be invalid, illegal, unconstitutional, or otherwise
unenforceable, such determination or adjudication shall in no manner affect the
remaining rules or portions thereof and such remaining rules or portions
thereof shall remain of full force and effect, as if such rule or portions
thereof so determined, declared or adjudged invalid or unconstitutional were
not originally a part hereof. It is the intent of the Board of Pharmacy to
establish rules and regulations that are constitutional and enforceable so as
to safeguard the health and well-being of the people of the
State.
