| (a) Purpose.
(1) This section establishes requirements for medical
and veterinary use of radioactive material and the issuance of specific
licenses authorizing medical and veterinary use of radioactive material.
Unless otherwise exempted, persons must not manufacture, produce,
receive, possess, use, transfer, own, or acquire radioactive material
for medical or veterinary use except as authorized in a license issued
as specified in this section.
(2) A person who manufactures, produces, receives,
possesses, uses, transfers, owns, or acquires radioactive material
before 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 as specified 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
or veterinary use as specified 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:
(A) §289.201 of this chapter (relating to General
Provisions for Radioactive Material);
(B) §289.202 of this chapter (relating to Standards
for Protection Against Radiation from Radioactive Materials);
(C) §289.203 of this chapter (relating to Notices,
Instructions, and Reports to Workers; Inspections);
(D) §289.204 of this chapter (relating to Fees
for Certificates of Registration, Radioactive Material Licenses, Emergency
Planning and Implementation, and Other Regulatory Services);
(E) §289.205 of this chapter (relating to Hearing
and Enforcement Procedures);
(F) §289.252 of this subchapter (relating to Licensing
of Radioactive Material); and
(G) §289.257 of this subchapter (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 must 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, 45 Code of Federal Regulations (CFR) Parts 160 and 164)
may be subject to privacy standards governing how information identifying
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, 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 have the following meaning unless the context
clearly indicates otherwise.
(1) Address of use--The building or buildings identified
on the license where radioactive material may be prepared, received,
used, or stored.
(2) Area of use--A portion of an address of use 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 or veterinary 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:
(A) meets the requirements in subsections (j) and (m)
of this section; or
(B) is identified as an authorized medical physicist
or teletherapy physicist on:
(i) a specific medical or veterinary 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:
(A) meets the requirements in subsections (k) and (m)
of this section; or
(B) is identified as an authorized nuclear pharmacist
on:
(i) a specific license issued by the department, the
NRC, or an agreement state authorizing medical use or the practice
of nuclear pharmacy;
(ii) a permit issued by an NRC master material licensee
authorizing 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 authorizing medical use
or the practice of nuclear pharmacy; or
(iv) a permit issued by an NRC master material license
broad scope medical use permittee authorizing medical use or the practice
of nuclear pharmacy; or
(C) is identified as an authorized nuclear pharmacist
by a commercial nuclear pharmacy authorized to identify authorized
nuclear pharmacists; or
(D) is designated as an authorized nuclear pharmacist
as specified in §289.252(r) of this subchapter; 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:
(I) a department, NRC, or agreement state license authorizing
the medical use of radioactive material;
(II) a permit issued by an NRC master material licensee
authorizing 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 authorizing 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 as specified in subsections
(gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt) of this section
as applicable; or
(iii) is identified as an authorized user on:
(I) a department, NRC, or agreement state license authorizing
the veterinary use of radioactive material;
(II) a permit issued by an NRC master material licensee
authorizing 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
Cont'd... |
