| (a) Purpose.
(1) This section establishes requirements for the medical
and veterinary use of radioactive material and for the issuance of
specific licenses authorizing the medical and veterinary use of radioactive
material. Unless otherwise exempted, no person shall manufacture,
produce, receive, possess, use, transfer, own, or acquire radioactive
material for medical or veterinary use except as authorized in a license
issued in accordance with this section.
(2) A person who manufactures, produces, receives,
possesses, uses, transfers, owns, or acquires radioactive material
prior to receiving a license is subject to the requirements of this
chapter.
(3) A specific license is not needed for a person who:
(A) receives, possesses, uses, or transfers radioactive
material in accordance with the regulations in this chapter under
the supervision of an authorized user as provided in subsection (s)
of this section, unless prohibited by license condition; or
(B) prepares unsealed radioactive material for medical
use in accordance with the regulations in this chapter under the supervision
of an authorized nuclear pharmacist or authorized user as provided
in subsection (s) of this section, unless prohibited by license condition.
(b) Scope.
(1) In addition to the requirements of this section,
all licensees, unless otherwise specified, are subject to the requirements
of §289.201 of this title (relating to General Provisions for
Radioactive Material), §289.202 of this title (relating to Standards
for Protection Against Radiation from Radioactive Materials), §289.203
of this title (relating to Notices, Instructions, and Reports to Workers;
Inspections), §289.204 of this title (relating to Fees for Certificates
of Registration, Radioactive Material Licenses, Emergency Planning
and Implementation, and Other Regulatory Services), §289.205
of this title (relating to Hearing and Enforcement Procedures), §289.252
of this title (relating to Licensing of Radioactive Material), and §289.257
of this title (relating to Packaging and Transportation of Radioactive
Material).
(2) Veterinarians who receive, possess, use, transfer,
own, or acquire radioactive material in the practice of veterinary
medicine shall comply with the requirements of this section except
for subsections (d), (dd) and (uuu) of this section.
(3) An entity that is a "covered entity" as that term
is defined in HIPAA (the Health Insurance Portability and Accountability
Act of 1996, Title 45, Code of Federal Regulations (CFR), Parts 160
and 164) may be subject to privacy standards governing how information
that identifies a patient can be used and disclosed. Failure to follow
HIPAA requirements may result in the department making a referral
of a potential violation to the United States Department of Health
and Human Services.
(4) In accordance with the requirements of the Texas
Medical Board, Title 22, Texas Administrative Code (TAC), Chapter
160, medical licensees must use the services of a licensed medical
physicist for activities falling within the medical physicist scope
of practice as identified in 22 TAC §160.17 unless exempted under
22 TAC §160.5.
(c) Definitions. The following words and terms when
used in this section shall have the following meaning unless the context
clearly indicates otherwise.
(1) Address of use--The building or buildings that
are identified on the license and where radioactive material may be
prepared, received, used, or stored.
(2) Area of use--A portion of an address of use that
has been set aside for the purpose of preparing, receiving, using,
or storing radioactive material.
(3) Associate radiation safety officer (ARSO)--An individual
who:
(A) meets the requirements in subsections (h) and (m)
of this section; and
(B) is currently identified as an ARSO for the types
of use of radioactive material for which the individual has been assigned
duties and tasks by the radiation safety officer (RSO) on:
(i) a specific medical use license issued by the department,
the United States Nuclear Regulatory Commission (NRC), or an agreement
state; or
(ii) a medical use permit issued by an NRC master material
licensee.
(4) Authorized medical physicist--An individual who
meets the following:
(A) the requirements in subsections (j) and (m) of
this section; or
(B) is identified as an authorized medical physicist
or teletherapy physicist on one of the following:
(i) a specific medical use license issued by the department,
the NRC, or an agreement state;
(ii) a medical use permit issued by an NRC master material
licensee;
(iii) a permit issued by an NRC, or agreement state
broad scope medical use licensee; or
(iv) a permit issued by an NRC master material license
broad scope medical use permittee; and
(C) holds a current Texas license under the Medical
Physics Practice Act, Texas Occupations Code, Chapter 602, in therapeutic
radiological physics for uses in subsections (rr) and (ddd) of this
section.
(5) Authorized nuclear pharmacist--A pharmacist who
meets the following:
(A) the requirements in subsections (k) and (m) of
this section; or
(B) is identified as an authorized nuclear pharmacist
on one of the following:
(i) a specific license issued by the department, the
NRC, or an agreement state that authorizes medical use or the practice
of nuclear pharmacy;
(ii) a permit issued by an NRC master material licensee
that authorizes medical use or the practice of nuclear pharmacy;
(iii) a permit issued by the department, the NRC, or
an agreement state licensee of broad scope that authorizes medical
use or the practice of nuclear pharmacy; or
(iv) a permit issued by an NRC master material license
broad scope medical use permittee that authorizes medical use or the
practice of nuclear pharmacy; or
(C) is identified as an authorized nuclear pharmacist
by a commercial nuclear pharmacy that has been authorized to identify
authorized nuclear pharmacists; or
(D) is designated as an authorized nuclear pharmacist
in accordance with §289.252(r) of this title; and
(E) holds a current Texas license under the Texas Pharmacy
Act, Texas Occupations Code, Chapters 551 - 566, 568, and 569, as
amended, and who is certified as an authorized nuclear pharmacist
by the Texas State Board of Pharmacy.
(6) Authorized user--An authorized user is defined
as follows:
(A) for human use, a physician licensed by the Texas
Medical Board; or a dentist licensed by the Texas State Board of Dental
Examiners; or a podiatrist licensed by the Texas State Board of Podiatric
Medicine who:
(i) meets the requirements in subsection (m) and subsections
(gg), (jj), (nn) - (qq), (zz), (aaa), (ccc) or (ttt) of this section;
or
(ii) is identified as an authorized user on any of
the following:
(I) an agency, NRC, or agreement state license that
authorizes the medical use of radioactive material;
(II) a permit issued by an NRC master material licensee
that is authorized to permit the medical use of radioactive material;
(III) a permit issued by a specific licensee of broad
scope issued by the department, the NRC, or an agreement state authorizing
the medical use of radioactive material; or
(IV) a permit issued by an NRC master material licensee
of broad scope that is authorized to permit the medical use of radioactive
material.
(B) for veterinary use, an individual who is, a veterinarian
licensed by the Texas State Board of Veterinary Medical Examiners;
and
(i) is certified by the American College of Veterinary
Radiology for the use of radioactive materials in veterinary medicine;
or
(ii) has received training in accordance with subsections
(gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt) of this section
as applicable; or
(iii) is identified as an authorized user on any of
the following:
(I) an agency, NRC, or agreement state license that
authorizes the veterinary use of radioactive material;
(II) a permit issued by an NRC master material licensee
that is authorized to permit the medical use of radioactive material;
(III) a permit issued by a specific licensee of broad
scope issued by the department, the NRC, or an agreement state authorizing
the medical or veterinary use of radioactive material; or
(IV) a permit issued by an NRC master material licensee
of broad scope that authorizes the medical use of radioactive material.
(7) Brachytherapy--A method of radiation therapy in
which plated, embedded, activated, or sealed sources are utilized
to deliver a radiation dose at a distance of up to a few centimeters,
by surface, intracavitary, intraluminal, or interstitial application.
(8) Brachytherapy sealed source--A sealed source or
a manufacturer-assembled source train, or a combination of these sources
that is designed to deliver a therapeutic dose within a distance of
a few centimeters.
(9) High dose-rate remote afterloader--A device that
remotely delivers a dose rate in excess of 1200 rads (12 gray (Gy))
per hour at the point or surface where the dose is prescribed.
(10) Institutional Review Board (IRB)--Any board, committee,
or other group formally designated by an institution and approved
by the United States Food and Drug Administration (FDA) to review,
approve the initiation of, and conduct periodic review of biomedical
research involving human subjects.
(11) Low dose-rate remote afterloader--A device that
remotely delivers a dose rate of less than or equal to 200 rads (2
Gy) per hour at the point or surface where the dose is prescribed.
(12) Management--The chief executive officer or other
individual delegated the authority to manage, direct, or administer
the licensee's activities.
(13) Manual brachytherapy--A type of brachytherapy
in which the sealed sources, for example, seeds and ribbons, are manually
inserted either into the body cavities that are in close proximity
to a treatment site or directly in the tissue volume.
(14) Medical event--An event that meets the criteria
in subsection (uuu)(1) of this section.
(15) Medical institution--An organization in which
several medical disciplines are practiced.
(16) Medical use--The intentional internal or external
administration of radioactive material, or the radiation from radioactive
material, to patients or human research subjects under the supervision
of an authorized user.
(17) Medium dose-rate afterloader--A device that remotely
delivers a dose rate greater than 200 rads (2 Gy) and less than or
equal to 1200 rads (12 Gy) per hour at the point or surface where
the dose is prescribed.
(18) Mobile nuclear medicine service--A licensed service
authorized to transport radioactive material to, and medical use of
the material at, the client's address. Services transporting calibration
sources only are not considered mobile nuclear medicine licensees.
(19) Ophthalmic physicist--An individual who:
(A) meets the requirements in subsections (m) and (xx)(1)(B)
of this section; and
(B) is identified as an ophthalmic physicist on:
(i) a specific medical use license issued by the department,
the NRC, or an agreement state;
(ii) a permit issued by an agency, NRC, or agreement
state broad scope medical use licensee;
(iii) a medical use permit issued by an NRC master
material licensee; or
(iv) a permit issued by an NRC master material licensee
broad scope medical use permittee.
(20) Output--The exposure rate, dose rate, or a quantity
related in a known manner to these rates from a teletherapy unit,
a brachytherapy source, a remote afterloader unit, or a gamma stereotactic
radiosurgery unit, for a specified set of exposure conditions.
(21) Patient--A human or animal under medical care
and treatment.
(22) Patient intervention--Actions by the patient or
human research subject, whether intentional or unintentional, such
as dislodging or removing treatment devices or prematurely terminating
the administration.
(23) Permanent facility--A building or buildings that
are identified on the license within the State of Texas and where
radioactive material may be prepared, received, used, or stored. This
may also include an area or areas where administrative activities
related to the license are performed.
(24) Preceptor--An individual who provides, directs,
or verifies the training and experience required for an individual
to become an authorized user, an authorized medical physicist, an
authorized nuclear pharmacist, an RSO, or an ARSO.
(25) Prescribed dosage--The specified activity or range
of activity of unsealed radioactive material as documented in a written
directive or in accordance with the directions of the authorized user
for procedures in subsections (ff) and (hh) of this section.
(26) Prescribed dose--Prescribed dose means one of
the following:
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