N.M. Admin. Code § 16.19.18.7 - DEFINITIONS
A. The
"Practice of Nuclear Pharmacy" means a patient-oriented service
that embodies the scientific knowledge and professional judgement required to
improve and promote health through the assurance of the same and efficacious
use of radiopharmaceuticals and other drugs.
B.
"Nuclear Pharmacy" means a
pharmacy which provides radiopharmaceutical services, and shall be licensed by
the Board as a wholesaler or retail pharmacy.
C.
"Qualified Nuclear
Pharmacist" means a pharmacist currently licensed by the Board who meets
either of the following criteria:
(1) Must be
currently certified as a Nuclear Pharmacist by the Board of Pharmaceutical
Specialties; or
(2) Must have
successfully completed the requirements of Subparagraphs (a) and (b) of this
Paragraph.
(a) Must have attained a minimum
of 500 contact hours of experiential training in nuclear pharmacy under the
supervision of a qualified nuclear pharmacist in, but not limited to, the
following areas:
(i) procurement of
radioactive materials;
(ii)
compounding of radiopharmaceuticals;
(iii) maintenance of a quality assurance
program;
(iv) dispensing of
radiopharmaceuticals;
(v)
distribution of radiopharmaceuticals;
(vi) implementation of basic health and
safety practices and procedures; and
(vii) provision of information and
consultation related to the practice of nuclear pharmacy and the use of
radiopharmaceuticals.
(b) 200 contact hours of didactic instruction
in nuclear pharmacy and the safe handling and use of radioactive materials,
from a nationally-accredited college of pharmacy or other training program
sponsored by an ACPE-accredited provider of continuing pharmaceutical
education, in the following five areas:
(i)
radiation physics and instrumentation;
(ii) radiation protection;
(iii) mathematics pertaining to the use and
measurement of radioactivity;
(iv)
radiation biology; and
(v)
radiopharmaceutical chemistry.
(3) Any pharmacist who has been legally
listed on a radioactive material license for a nuclear pharmacy in the State of
New Mexico for at least six months prior to the 1994 effective date of these
regulations, is exempt from Paragraphs (1) and (2) of Subsection C of
16.19.18.7 NMAC.
D.
"Radiopharmaceutical
Services" means the procurement, storage, handling, compounding,
labeling, quality control testing, dispensing, distribution, transfer, record
keeping and disposal of radiochemicals, radiopharmaceuticals and ancillary
drugs, and also includes quality assurance procedures, radiological health
activities, any consulting activities associated with the use of
radiopharmaceuticals, and any other activities required for provision of
pharmaceutical care.
E.
"Quality Control Testing" means the performance of appropriate
chemical, biological and physical tests on compounded radiopharmaceuticals and
the interpretation of the resulting data to determine their suitability for use
in humans and animals.
F.
"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.
G.
"Authentication of Product
History" means identifying the purchasing source, the ultimate fate, and
any intermediate handling of any component of a radiopharmaceutical or other
drug.
H.
"Radiopharmaceutical" means any drug which exhibits spontaneous
disintegration of unstable nuclei with the emission of nuclear particles or
protons 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.
Notes
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