Current through September 24, 2024
In addition to all other applicable sections of the
Mississippi Code of 1972, ARTICLE XXVII of the Mississippi Board of Pharmacy
Regulation pertains specifically to nuclear pharmacy and
radiopharmaceuticals.
1. DEFINITIONS
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. A nuclear
pharmacy is a pharmacy providing the services of storing, compounding,
dispensing, labeling or distributing radiopharmaceuticals;
C. Practice of Nuclear Pharmacy means a
patient-orient 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 radiopharmaceuticals and other related
drugs.
D. A qualified licensed
professional means an individual (such as a physician, nurse, or technologist)
who possesses a current state license if applicable, and who has sufficient
training and experience to safely handle radiopharmaceuticals as defined by the
Mississippi State Department of Health, Division of Radiological
Health;
E. A qualified nuclear
pharmacist means a currently licensed pharmacist in the state of Mississippi
who is certified by the Mississippi State Department of Health, Division of
Radiological Health, or who meets the following standards:
(1) Minimum standards of training for
"authorized user status" of radioactive materials as defined by Mississippi
State Department of Health, Division of Radiological Health;
(2) Completed a minimum of two hundred (200)
contact hours of instruction in nuclear pharmacy and the safe handling and the
use of radioactive materials from a program approved by the Mississippi Board
of Pharmacy, and United States Nuclear Regulatory Commission or Agreement State
Agency, with emphasis in the following areas:
(a)Radiation Physics and
Instrumentation;
(b)Radiation
Protection;
(c)Mathematics of
Radioactivity;
(d)Radiation
Biology;
(e)Radiopharmaceutical
Chemistry.
(3) Attain a
minimum of five hundred (500) hours of clinical nuclear pharmacy training under
the supervision of a qualified nuclear pharmacist.
F. Nuclear pharmacy technician means a person
who works under the supervision of a qualified nuclear pharmacist and who is
currently registered with the Mississippi Board of Pharmacy. The duties and
responsibilities of these personnel must be consistent with their training and
experience.
G. Radiopharmaceutical
is any substance defined as a drug in Section 201(g) (1) of the Federal Food,
Drug and Cosmetic Act which also contains unstable nuclei which undergo
spontaneous disintegration with the emission of nuclear radiation.
Radiopharmaceuticals also include any non-radioactive reagent kit or
radionuclide generator which is intended to be used in the preparation of
radiopharmaceutical doses.
H.
Radiopharmaceutical Service means, but shall not be limited to the procurement,
storage, handling, compounding, quality control testing, dispensing, delivery,
recordkeeping, and disposal of radiopharmaceutical and other drugs as well as
quality control procedure, radiological health activities, any consulting
activities associated with the use of radiopharmaceuticals, health physics and
any other activities required for provision of pharmaceutical care.
I. Radiopharmaceutical Compounding means the
preparation, mixing assembling, packaging, or labeling of a reagent kit or
biological substance with radioactivity.
J. Radiopharmaceutical quality control means,
but is not limited to, the performance of appropriate chemical, biological and
physical tests on potential and prepared radiopharmaceuticals and the
interpretation of the resulting data to determine their suitability for use in
humans or animals.
Assurance that variances in the processes are clearly
identified, assessed and improved upon if necessary is required for adequate
quality control. All quality control procedures must be a set of planned,
defined and systematic activities to provide adequate confidence that the
product optimally fulfils professional expectations and requirements.
K. The restricted area of a
Nuclear Pharmacy is an area with limited access for the purpose of protecting
individuals against the undue risks from exposure to radiation and radioactive
materials. Generally, the restricted area(s) consists of the
compounding/dispensing area, radioactive material storage area and radioactive
dose return or breakdown area.
2. NUCLEAR PHARMACY STANDARDS AND EQUIPMENT
Written procedures and policy showing proof of adequate space
and equipment for all operations involving radioactive material must be
submitted to the Mississippi Board of Pharmacy along with a certified copy of
the RADIOACTIVE MATERIAL LICENSE issued by the Mississippi State Department of
Health, Division of Radiological Health, before a permit to operate as a
Nuclear Pharmacy is issued.
Compliance with applicable radiation protection regulations of
the Mississippi State Department of Health, Division of Radiological Health, is
further required. Violation of rules and regulations established by the
Mississippi State Department of Health, Division of Radiological Health, that
directly affects public health and safety, shall serve as prima facie evidence
of violation of this ARTICLE.
The restricted area of a nuclear pharmacy shall have at least
the following supplies and equipment:
A. Radiation detection and measuring
instruments capable of accurately measuring quantities of radioactivity and
radiation; and
B. Refrigerator,
microscope and a hemacytometer; and
C. Radiochemical fume hood and filter system
with suitable air sampling equipment if storing or dispensing volatile
substances; and
D. Laminar air flow
hood and appropriate supplies to ensure sterile practices for parental
solutions; and
E. Syringes, vials,
filters and other necessary supplies needed to compound and dispense any oral
or sterile parenteral drug product; and
F. Adequate shielding for syringes vials
drawing stations and returned dose storage area: and
G.Materials needed for decontamination; and
H. All supplies needed to perform
quality control testing;
and
I. Appropriate shielding for
the transportation of D. O. T. approved outer transport containers;
and
J. Required labels and other
supplies for proper shipment of radioactive material.
A pharmacy exclusively handling radiopharmaceuticals may be
exempt from the general requirements of conventional pharmacies as regards to
equipment and inventory.
3. OPERATION OF A NUCLEAR PHARMACY
A. Nuclear Pharmacy License. A license to
operate a pharmacy providing radiopharmaceutical services shall only be issued
to a qualified nuclear pharmacist. All personnel performing tasks in the
preparation and distribution of radioactive drugs shall be under the direct
supervision of a qualified nuclear pharmacist. A qualified nuclear pharmacist
shall be responsible for all operations of the pharmacy.
B. Nuclear pharmacies shall have adequate
space and equipment, commensurate with the scope of services required and
provided.
C. The nuclear pharmacy
restricted area shall be secured from unobserved entry and/or unauthorized
personnel.
D. Nuclear pharmacies
shall maintain complete and accurate records of acquisition, inventory, and
disposition of all radioactive drugs and other radioactive materials, in
accordance with guidelines established by the Mississippi State Department of
Health, Division of Radiological Health.
E. All pharmacies handling
radiopharmaceuticals shall provide a radioactive storage and product decay area
in accordance with guidelines established by the Mississippi State Department
of Health, Division of Radiological Health.
F. Radiopharmaceuticals are to be dispensed
only upon receipt of a prescription drug order, from a licensed practitioner or
his agent. Validation that he is authorized to possess, use or administer
radiopharmaceuticals is required.
G. Nuclear pharmacies shall, in addition to
this ARTICLE XXVII and the Mississippi State Department of Health, Division of
Radiological Health's applicable regulations, comply with any applicable
requirements of other governing agencies regarding its daily operations and the
disposal of any biohazardous medical waste.
4. DISPENSING OF RADIOPHARMACEUTICALS
Radiopharmaceuticals shall be dispensed/transferred only to a
licensed practitioner authorized by the Nuclear Regulatory Commission and/or
the Mississippi State Department of Health, Division of Radiological Health to
possess, use and administer such drug. A radiopharmaceutical shall be dispensed
for medical use only upon receipt of a prescription or medication order from
such authorized practitioner. Otherwise, a radiopharmaceutical may be
transferred to a person who is authorized by federal or state law to possess
and use such drug for non-medical applications. All prescriptions/orders shall
be readily retrievable if requested by any governing agency.
A nuclear pharmacy, upon receiving an oral prescription order
for a radiopharmaceutical, shall have the prescription order reduced to writing
or recorded in a data processing system, which the written or electronic record
shall contain at least the following:
A. The name of the institution and prescriber
or if applicable the prescriber's agent;
B. The date of dispensing and the calibration
time of the radiopharmaceutical;
C.
The name of the procedure;
D. The
name of the radiopharmaceutical;
E.
The activity of 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
initials of the pharmacist who dispensed the order.
Whenever an order is for a therapeutic or blood-product
radiopharmaceutical, the patient's name must be obtained and recorded prior to
dispensing.
The immediate outer container transportation shield of a
radiopharmaceutical to be dispensed shall be labeled with:
A. The name and address of the pharmacy and
prescriber;
B. Activity dispensed,
expiration date and time, calibration time, serial number and date of
dispensing;
C. The standard
radiation symbol and the words "Caution Radioactive Material";
D. The name of the procedure and the
radiopharmaceutical, including pharmacy oot number associated with
dose;
E. If a liquid, the volume,
if a gas, the number of ampules or vials and if a solid, the number of items or
weight;
F. Molybdenum 99 content to
USP limits (0.15 mCi Mo-99 per 1.0 mCi Tc 99m at time of administration or
expiration); and
G. The name of the
patient or the words "per physician order" in the absence of a patients name.
When the prescription is for a therapeutic or blood product
radiopharmaceutical, the patient's name shall appear on the label. The
requirements of this subsection shall be met when the name of the patient is
readily retrievable from the physician upon demand.
The immediate inner container label of a radiopharmaceutical
to be dispensed shall be labeled with:
A. Identity of the radiopharmaceutical and
the serial number;
B. The standard
radiation symbol and the words "Caution Radioactive Material";
C. The chemical form; and
D. The name of the procedure and date
dispensed.
For a radiopharmaceutical intended for a specific patient, the
immediate inner container shall be labeled with:
A. The standard radiation symbol and the
words, "Caution - Radioactive Material";
B. The prescription number and name of
patient;
C. Identity and activity
or quantity, of the radiopharmaceutical.
When a radiopharmaceutical is dispensed under the authority of
an Investigational New Drug Application (IND) the nuclear pharmacy records
shall include an investigator's protocol for the preparation of the
radiopharmaceutical, a copy of the Institutional Review Board approval form or
letter, and a letter from the manufacturer (sponsor) indicating that the
physician requesting the radiopharmaceutical is a qualified
investigator.
