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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.256Medical and Veterinary Use of Radioactive Material

(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

Cont'd...

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