# 25 Tex. Admin. Code § 289.256: 25 TAC § 289.256. Medical and Veterinary Use of Radioactive Material

> Texas · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_256

## Section

- **Citation:** 25 Tex. Admin. Code § 289.256
- **Heading:** 25 TAC § 289.256. Medical and Veterinary Use of Radioactive Material
- **Jurisdiction:** Texas
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Texas Administrative Code / Title 25 HEALTH SERVICES / Part 1 DEPARTMENT OF STATE HEALTH SERVICES / Chapter 289 RADIATION CONTROL / 25 TAC § 289.256

## Text

(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
(IV) a permit issued by an NRC master material licensee
 of broad scope authorizing 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
 designed to deliver a therapeutic dose within a distance of a few
 centimeters.
(9) High dose-rate remote afterloader--A device remotely
 delivering a dose rate more than 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 remotely
 delivering 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 in close proximity to a treatment
 site or directly in the tissue volume.
(14) Medical event--An event meeting 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 remotely
 delivering 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 or veterinary
 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 a department, 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 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 specified in the directions of the authorized user for
 procedures in subsections (ff) and (hh) of this section.
(26) Prescribed dose--Prescribed dose means:
(A) for gamma stereotactic radiosurgery, the total
 dose as documented in the written directive;
(B) for teletherapy, the total dose and dose per fraction
 as documented in the written directive;
(C) for brachytherapy, either the total sealed source
 strength and exposure time, or the total dose, as documented in the
 written directive; or
(D) for remote afterloaders, the total dose and dose
 per fraction as documented in the written directive.
(27) Pulsed dose-rate remote afterloader--A special
 type of remote afterloading device using a single sealed source capable
 of delivering dose rates greater than 1200 rads (12 Gy) per hour,
 but is approximately one-tenth of the activity of typical high dose-rate
 remote afterloader sealed sources and is used to simulate the radiobiology
 of a low dose-rate remote afterloader treatment by inserting the sealed
 source for a given fraction of each hour.
(28) Radiation safety officer (RSO)--For purposes of
 this section, an individual who:
(A) meets the requirements in subsections (h) and (m)
 of this section; or
(B) is identified as an RSO on:
(i) a specific license issued by the department, the
 NRC, or an agreement state authorizing the medical or veterinary use
 of radioactive material; or
(ii) a permit issued by an NRC master material licensee
 authorizing the medical or veterinary use of radioactive material.
(29) Sealed source and device registry--The national
 registry containing all registration certificates, generated by both
 the NRC and agreement states, summarizing the radiation safety information
 for sealed sources and devices and describing the licensing and use
 conditions approved for the product.
(30) Stereotactic radiosurgery--The use of external
 radiation in conjunction with a guidance device to very precisely
 deliver a dose to a tissue volume using three-dimensional coordinates.
(31) Technologist--A person (nuclear medicine technologist)
 skilled in the performance of nuclear medicine procedures under the
 supervision of a physician.
(32) Teletherapy--Therapeutic irradiation in which
 the sealed source is at a distance from the patient or human or animal
 research subject.
(33) Therapeutic dosage--The specified activity or
 range of activity of radioactive material intended to deliver a radiation
 dose to a patient or human or animal research subject for palliative
 or curative treatment.
(34) Therapeutic dose--A radiation dose delivered from
 a sealed source containing radioactive material to a patient or human
 or animal research subject for palliative or curative treatment.
(35) Treatment site--The anatomical description of
 tissue intended to receive a radiation dose, as described in a written
 directive.
(36) Type of use--Use of radioactive material as specified
 under:
(A) uptake, dilution, and excretion studies in subsection
 (ff) of this section;
(B) imaging and localization studies in subsection
 (hh) of this section;
(C) therapy with unsealed radioactive material in subsection
 (kk) of this section;
(D) manual brachytherapy with sealed sources in subsection
 (rr) of this section;
(E) sealed sources for diagnosis in subsection (bbb)
 of this section;
(F) sealed source in a remote afterloader unit, teletherapy
 unit, or gamma stereotactic radiosurgery unit in subsection (ddd)
 of this section; or
(G) other medical or veterinary uses of radioactive
 material or a radiation source approved for medical or veterinary
 use in subsection (q) of this section.
(37) Unit dosage--A dosage prepared for medical or
 veterinary use for administration as a single dosage to a patient
 or human or animal research subject without any further modification
 of the dosage after it is initially prepared.
(38) Veterinary use--The intentional internal or external
 administration of radioactive material, or the radiation from radioactive
 material, to animal patients under the supervision of an authorized
 user.
(39) Written directive--An authorized user's written
 order for the administration of radioactive material or radiation
 from radioactive material to a specific patient or human research
 subject, as specified in subsection (t) of this section.
(d) Provisions for research involving human subjects.
(1) A licensee may conduct research involving human
 subjects only if it uses the radioactive materials specified on its
 license for the uses authorized on the license.
(2) The licensee may conduct research specified in
 paragraph (1) of this subsection provided:
(A) the research is conducted, funded, supported, or
 regulated by a federal agency implementing the Federal Policy for
 the Protection of Human Subjects as required by
10 CFR §35.6
(Federal Policy); or
(B) the licensee has applied for and received approval
 of a specific amendment to its license before conducting the research.
(3) Before conducting research as specified in paragraph
 (1) of this subsection, the licensee must obtain:
(A) "informed consent," as defined and described in
 the Federal Policy, from the human research subjects; and
(B) review and approval of the research from an Institutional
 Review Board (IRB) as required by
45 CFR Part 46
, and
21 CFR Part
 56
, and in accordance with the Federal Policy.
(4) Nothing in this subsection relieves licensees from
 complying with the other requirements of this chapter.
(e) Implementation.
(1) If a license condition exempted a licensee from
 a provision of this section or §289.252 of this subchapter on
 the effective date of this rule, then the license condition continues
 to exempt the licensee from the requirements in the corresponding
 provision until there is a license amendment or license renewal modifying
 or removing the license condition.
(2) When a requirement in this section differs from
 the requirement in an existing license condition, the requirement
 in this section governs.
(3) Licensees must continue to comply with any license
 condition requiring implementation of procedures required by subsections
 (ggg) and (mmm) - (ooo) of this section until there is a license amendment
 or renewal modifying the license condition.
(f) Specific requirements for the issuance of licenses.
 In addition to the requirements in §289.252(e) of this subchapter
 and subsections (n) - (q) of this section, as applicable, a license
 is issued if the department determines:
(1) the applicant satisfies any applicable special
 requirement in this section;
(2) qualifications of the designated RSO as specified
 in subsection (h) of this section are adequate for the purpose requested
 in the application; and
(3) the information submitted by the applicant is approved,
 including:
(A) an operating, safety, and emergency procedures
 manual to include specific information on:
(i) radiation safety precautions and instructions;
(ii) methodology for measurement of dosages or doses
 to be administered to patients or human or animal research subjects;
(iii) calibration, maintenance, and repair of instruments
 and equipment necessary for radiation safety; and
(iv) waste disposal procedures; and
(B) any additional information required by this chapter
 requested by the department to assist in its review of the application;
 and
(C) qualifications of the:
(i) RSO as specified in subsection (c)(28) of this
 section;
(ii) authorized users as specified in subsection (c)(6)
 of this section as applicable to the uses being requested;
(iii) authorized medical physicist as specified in
 subsection (c)(4) of this section, if applicable;
(iv) authorized nuclear pharmacist as specified in
 subsection (c)(5) of this section, if applicable;
(v) ophthalmic physicist as specified in subsection
 (c)(19) of this section, if applicable;
(vi) Radiation Safety Committee (RSC), as specified
 in subsection (i) of this section, if applicable; and
(vii) ARSO as specified in subsection (c)(3) of this
 section, if applicable; and
(4) the applicant's permanent facility is located in
 Texas.
(g) Authority and responsibilities for the radiation
 protection program.
(1) In addition to the radiation protection program
 requirements of §289.202(e) of this chapter, a licensee's management
 must approve in writing:
(A) requests for a license application, renewal, or
 amendment before submittal to the department; and
(B) any individual before being allowed to work as
 an authorized user, authorized nuclear pharmacist, or authorized medical
 physicist.
(2) A licensee's management must appoint an RSO who
 agrees, in writing, to be responsible for implementing the radiation
 protection program. The licensee, through the RSO, must ensure radiation
 safety activities are being performed according to licensee-approved
 procedures and regulatory requirements. A licensee's management may
 appoint, in writing, one or more ARSO to support the RSO. The RSO,
 with written agreement of the licensee's management, must assign the
 specific duties and tasks to each ARSO. These duties and tasks are
 restricted to the types of use for which the ARSO is listed on a license.
 The RSO may delegate duties and tasks to the ARSO but must not delegate
 the authority or responsibilities for implementing the radiation protection
 program.
(3) Every licensee must establish in writing the authority,
 duties, and responsibilities of the RSO and ensure the RSO is provided
 sufficient authority, organizational freedom, time, resources, and
 management prerogative to perform the following duties:
(A) establish and oversee operating, safety, emergency,
 and as low as reasonably achievable (ALARA) procedures, and to review
 them at least annually to ensure procedures are current and conform
 with this chapter;
(B) ensure required radiation surveys and leak tests
 are performed and documented as specified in this chapter, including
 any corrective measures when levels of radiation exceed established
 limits;
(C) ensure individual monitoring devices are used properly
 by occupationally exposed personnel, records are kept of the monitoring
 results, and timely notifications are made as specified in §289.203
 of this chapter;
(D) investigate and report an individual or radiation
 level detected over the limits established by this chapter and each
 theft or loss of sources of radiation, to determine the causes, and
 take steps to prevent a recurrence;
(E) investigate and report to the department for each
 known or suspected case of release of radioactive material to the
 environment over the limits established by this chapter;
(F) have a thorough knowledge of management policies
 and administrative procedures of the licensee;
(G) identify radiation safety problems;
(H) assume control and initiate, recommend, or provide
 corrective actions, including shutdown of operations when necessary,
 in emergency situations or unsafe conditions;
(I) verify implementation of corrective actions;
(J) ensure records are maintained as required by this
 chapter;
(K) ensure proper storing, labeling, transport, use,
 and disposal of sources of radiation, storage, and transport containers;
(L) ensure inventories are performed in accordance
 with the activities for which the license application is submitted;
(M) ensure personnel are complying with this chapter,
 the conditions of the license, and the operating, safety, and emergency
 procedures of the licensee; and
(N) serve as the primary contact with the department.
(4) The RSO must ensure duties listed in paragraph
 (3)(A) - (N) of this subsection are performed.
(5) The RSO must be onsite periodically, commensurate
 with the scope of licensed activities, to satisfy the requirements
 of paragraphs (3) and (4) of this subsection.
(6) The RSO, or staff designated by the RSO, must be
 capable of physically arriving at the licensee's authorized use sites
 within a reasonable time of being notified of an emergency situation
 or unsafe condition.
(7) For up to 60 days each calendar year, a licensee
 may permit an authorized user or an individual qualified to be an
 RSO, under subsections (h) and (m) of this section, to function as
 a temporary RSO and to perform the duties of an RSO as specified in
 paragraph (3) of this subsection, provided the licensee takes the
 actions required in paragraphs (2), (3), and (9) of this subsection,
 and notifies the department as specified in subsection (r)(5) of this
 section. Records of qualifications and dates of service must be maintained
 as specified in subsection (xxx) of this section for inspection by
 the department.
(8) A licensee may simultaneously appoint more than
 one temporary RSO as specified in paragraph (7) of this subsection,
 if needed to ensure the licensee has a temporary RSO satisfying the
 requirements to be an RSO for each of the different types of uses
 of radioactive material permitted by the license.
(9) The licensee must maintain records, as specified
 in subsection (xxx) of this section, as follows.
(A) A licensee must retain a record of actions taken
 by the licensee's management as specified in paragraph (1) of this
 subsection. The record must include a summary of the actions taken
 and a signature of licensee management.
(B) The authority, duties, and responsibilities of
 the RSO as required by paragraph (3) of this subsection, and a signed
 copy of each RSO's agreement to be responsible for implementing the
 radiation safety program, as required by paragraph (2) of this subsection.
 The records must include the signature of the RSO and licensee management.
(C) A copy of the written document appointing the ARSO,
 for each ARSO appointed under paragraph (2) of this subsection. The
 record must include the signature of licensee management.
(h) Training for an RSO and ARSO. Except as provided
 in subsection (l) of this section, the licensee must require the individual
 fulfilling the responsibilities of an RSO or an individual assigned
 duties and tasks as an ARSO as specified in subsection (g) of this
 section for licenses for medical or veterinary use of radioactive
 material, to be an individual who:
(1) is certified by a specialty board whose certification
 process has been recognized by the department, the NRC, or an agreement
 state and who meets the requirements in paragraph (4) of this subsection.
 The names of board certifications recognized by the department, the
 NRC, or an agreement state are posted on the NRC's Medical Uses Licensee
 Toolkit web page.
(A) To have its certification process recognized, a
 specialty board must require all candidates for certification to:
(i) hold a bachelor's or graduate degree from an accredited
 college or university in physical science or engineering or biological
 science with a minimum of 20 college credits in physical science;
(ii) have five or more years of professional experience
 in health physics (graduate training may be substituted for no more
 than two years of the required experience) including at least three
 years in applied health physics; and
(iii) pass an examination, administered by diplomates
 of the specialty board evaluating knowledge and competence in radiation
 physics and instrumentation, radiation protection, mathematics pertaining
 to the use and measurement of radioactivity, radiation biology, and
 radiation dosimetry; or
(B) to have its certification process recognized, a
 specialty board must require all candidates for certification to:
(i) hold a master's or doctoral degree in physics,
 medical physics, other physical science, engineering, or applied mathematics
 from an accredited college or university;
(ii) have two years of full-time practical training
 or supervised experience in medical physics as follows:
(I) under the supervision of a medical physicist who
 is certified in medical physics by a specialty board recognized by
 the department, the NRC, or an agreement state; or
(II) in clinical nuclear medicine facilities providing
 diagnostic or therapeutic services under the direction of physicians
 who meet the requirements for authorized users in subsections (l),
 (jj), or (nn) of this section; and
(iii) pass an examination, administered by diplomates
 of the specialty board, assessing knowledge and competence in clinical
 diagnostic radiological or nuclear medicine physics and in radiation
 safety; or
(2) has:
(A) completed a structured educational program consisting
 of both:
(i) 200 hours of classroom and laboratory training
 in:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) radiation biology; and
(V) radiation dosimetry; and
(ii) one year of full-time radiation safety experience
 under the supervision of the individual identified as the RSO on a
 department, NRC, or agreement state license or on a permit issued
 by an NRC master material licensee authorizing similar types of use
 of radioactive material. An ARSO may provide supervision for those
 areas for which the ARSO is authorized on a department, NRC, or an
 agreement state license or a permit issued by an NRC master material
 licensee. The full-time radiation safety experience must involve:
(I) shipping, receiving, and performing related radiation
 surveys;
(II) using and performing checks for proper operation
 of instruments used to determine the activity of dosages, survey meters,
 and instruments used to measure radionuclides;
(III) securing and controlling radioactive material;
(IV) using administrative controls to avoid mistakes
 in the administration of radioactive material;
(V) using procedures to prevent or minimize radioactive
 contamination and using proper decontamination procedures;
(VI) using emergency procedures to control radioactive
 material; and
(VII) disposing of radioactive material; and
(B) obtained written attestation, signed by a preceptor
 RSO or ARSO experienced with the radiation safety aspects of similar
 types of use of radioactive material for which the individual is seeking
 approval as an RSO or an ARSO. The written attestation must state
 the individual has satisfactorily completed the requirements in paragraphs
 (2)(A) and (4) of this subsection, and is able to independently fulfill
 the radiation safety-related duties as an RSO or as an ARSO for a
 medical or veterinary use license; or
(3) meets one of the following:
(A) is a medical physicist certified by a specialty
 board whose certification process has been recognized by the department,
 the NRC, or an agreement state as specified in subsection (j)(1) of
 this section, has experience with the radiation safety aspects of
 similar types of use of radioactive material for which the licensee
 is seeking approval of the individual as the RSO or ARSO, and meets
 the requirements in paragraph (4) of this subsection;
(B) is an authorized user, authorized medical physicist,
 or authorized nuclear pharmacist identified on a department, NRC,
 or another agreement state's license; a permit issued by an NRC master
 material licensee; a permit issued by the department, the NRC, or
 another agreement state licensee of broad scope; or a permit issued
 by an NRC master material license broad scope permittee, has experience
 with the radiation safety aspects of similar types of use of radioactive
 material for which the licensee is seeking the approval of the individual
 as the RSO or ARSO, and who meets the requirements in paragraph (4)
 of this subsection; or
(C) has experience with the radiation safety aspects
 of the types of use of radioactive material for which the individual
 is seeking simultaneous approval both as the RSO and the authorized
 user on the same new medical or veterinary use license or new medical
 use permit issued by an NRC master material licensee. The individual
 must also meet the requirements in paragraph (4) of this subsection;
 and
(4) has training in the radiation safety, regulatory
 issues, and emergency procedures for the types of use for which a
 licensee seeks approval, and this training requirement may be satisfied
 by completing training supervised by an RSO, an ARSO, authorized medical
 physicist, authorized nuclear pharmacist, or authorized user, as appropriate,
 who is authorized for the types of use for which the licensee is seeking
 approval.
(i) Radiation safety committee (RSC). Licensees of
 broad scope and licensees who are authorized for two or more different
 types of uses of radioactive material requiring a written directive
 under subsections (q), (kk), (rr), and (ddd) of this section, or two
 or more types of therapeutic units under subsections (q) and (ddd)
 of this section, must establish an RSC to oversee all uses of radioactive
 material permitted by the license.
(1) The RSC must be composed of the following individuals:
(A) an authorized user of each type of use permitted
 by the license;
(B) the RSO;
(C) a representative of the nursing service, if applicable;
(D) a representative of management who is neither an
 authorized user nor the RSO; and
(E) other members as the licensee deems appropriate.
(2) Duties and responsibilities of the RSC.
(A) For licensees without broad scope authorization,
 the duties and responsibilities of the RSC include:
(i) meeting as often as necessary to conduct business
 but no less than three times a year;
(ii) reviewing summaries of information presented by
 the RSO, including:
(I) doses over the occupational or public limits;
(II) significant incidents, including spills, contamination,
 or medical events; and
(III) items of non-compliance following an inspection;
(iii) reviewing the program for maintaining doses ALARA,
 and providing any necessary recommendations to ensure doses are ALARA;
 and
(iv) reviewing the audit of the radiation safety program
 and acting upon the findings.
(B) For licensees of broad scope, the duties and responsibilities
 of the RSC include the items in subparagraph (A) of this paragraph
 and:
(i) reviewing the overall compliance status for authorized
 users;
(ii) sharing responsibility with the RSO to conduct
 periodic audits of the radiation safety program;
(iii) developing criteria to evaluate training and
 experience of new authorized user applicants;
(iv) evaluating and approving authorized user applicants
 who request authorization to use radioactive material at the facility;
 and
(v) reviewing and approving permitted program and procedural
 changes before implementation.
(3) Records documenting the RSC meetings must be made
 and maintained for inspection by the department as specified in subsection
 (xxx) of this section. The record must include the date, names of
 individuals in attendance, minutes of the meeting, and any actions
 taken.
(j) Training for an authorized medical physicist. Except
 as provided in subsection (l) of this section, the licensee must require
 the authorized medical physicist to be:
(1) an individual certified by a specialty board whose
 certification process has been recognized by the department, the NRC,
 or an agreement state and who meets the requirements in paragraph
 (3) of this subsection. The names of board certifications recognized
 by the department, the NRC, or an agreement state are posted on the
 NRC's Medical Uses Licensee Toolkit web page. To have its certification
 process recognized, a specialty board must require all candidates
 to:
(A) hold a master's or doctoral degree in physics,
 medical physics, other physical science, engineering, or applied mathematics
 from an accredited college or university;
(B) complete two years of full-time practical training
 or supervised experience in medical physics as follows:
(i) under the supervision of a medical physicist who
 is certified in medical physics by a specialty board whose certification
 process has been recognized by the department, the NRC, or an agreement
 state; or
(ii) in clinical radiation facilities providing high-energy,
 external beam therapy (photons and electrons with energies greater
 than or equal to 1 million electron volts) and brachytherapy services
 under the direction of physicians meeting the requirements for authorized
 users in subsections (l), (zz), or (ttt) of this section; and
(C) pass an examination, administered by diplomates
 of the specialty board, assessing knowledge and competence in clinical
 radiation therapy, radiation safety, calibration, quality assurance,
 and treatment planning for external beam therapy, brachytherapy, and
 stereotactic radiosurgery; or
(2) an individual who:
(A) holds a post graduate degree and experience, including:
(i) a master's or doctoral degree in physics, medical
 physics, other physical science, engineering, or applied mathematics
 from an accredited college or university; and
(ii) completion of one year of full-time training in
 medical physics and an additional year of full-time work experience
 under the supervision of an individual meeting the requirements for
 an authorized medical physicist for the types of use for which the
 individual is seeking authorization. This training and work experience
 must be conducted in clinical radiation facilities providing high-energy,
 external beam therapy (photons and electrons with energies greater
 than or equal to 1 million electron volts) and brachytherapy services
 and must include:
(I) performing sealed source leak tests and inventories;
(II) performing decay corrections;
(III) performing full calibration and periodic spot
 checks of external beam treatment units, stereotactic radiosurgery
 units, and remote afterloading units as applicable; and
(IV) conducting radiation surveys around external beam
 treatment units, stereotactic radiosurgery units, and remote afterloading
 units as applicable; and
(B) has obtained written attestation the individual
 has satisfactorily completed the requirements in paragraphs (2)(A)
 and (3) of this subsection and is able to independently fulfill the
 radiation safety-related duties as an authorized medical physicist
 for each type of therapeutic medical unit for which the individual
 is requesting authorized medical physicist status. The written attestation
 must be signed by a preceptor authorized medical physicist meeting
 the requirements in subsection (l) of this section, this subsection,
 or equivalent NRC or agreement state requirements for an authorized
 medical physicist for each type of therapeutic medical unit for which
 the individual is requesting authorized medical physicist status;
 and
(3) an individual trained for the types of use for
 which authorization is sought, including hands-on device operation,
 safety procedures, clinical use, and the operation of a treatment
 planning system. This training requirement may be satisfied by satisfactorily
 completing either a training program provided by the vendor or by
 training supervised by an authorized medical physicist authorized
 for the types of use for which the individual is seeking authorization.
(k) Training for an authorized nuclear pharmacist.
 Except as provided in subsection (l) of this section, the licensee
 must require the authorized nuclear pharmacist to be a pharmacist
 who:
(1) is certified by a specialty board whose certification
 process has been recognized by the department, the NRC, or an agreement
 state. The names of board certifications recognized by the department,
 the NRC, or an agreement state are posted on the NRC's Medical Uses
 Licensee Toolkit web page. To have its certification process recognized,
 a specialty board must require all candidates for certification to:
(A) have graduated from a pharmacy program accredited
 by the Accreditation Council for Pharmacy Education or have passed
 the Foreign Pharmacy Graduate Examination Committee examination;
(B) hold a current, active license to practice pharmacy
 in the State of Texas;
(C) provide evidence of having acquired at least 4000
 hours of training/experience in nuclear pharmacy practice. Academic
 training may be substituted for no more than 2000 hours of the required
 training and experience; and
(D) pass an examination in nuclear pharmacy, administered
 by diplomates of the specialty board, assessing knowledge and competency
 in procurement, compounding, quality assurance, dispensing, distribution,
 health and safety, radiation safety, provision of information and
 consultation, monitoring patient outcomes, and research and development;
 or
(2) has:
(A) completed a 700-hour structured educational program,
 including both:
(i) 200 hours of classroom and laboratory training
 in:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemistry of radioactive material for medical
 use; and
(V) radiation biology; and
(ii) supervised practical experience in a nuclear pharmacy
 involving:
(I) shipping, receiving, and performing related radiation
 surveys;
(II) using and performing checks for proper operation
 of instruments used to determine the activity of dosages, survey meters,
 and, if appropriate, instruments used to measure alpha- or beta-emitting
 radionuclides;
(III) calculating, assaying, and safely preparing dosages
 for patients or human research subjects;
(IV) using administrative controls to avoid medical
 events in the administration of radioactive material; and
(V) using procedures to prevent or minimize radioactive
 contamination and using proper decontamination procedures; and
(B) obtained written attestation, signed by a preceptor
 authorized nuclear pharmacist, the individual has satisfactorily completed
 the requirements in paragraph (2)(A) of this subsection and is able
 to independently fulfill the radiation safety-related duties as an
 authorized nuclear pharmacist.
(l) Training for experienced RSO, teletherapy or medical
 physicist, authorized medical physicist, authorized user, nuclear
 pharmacist, and authorized nuclear pharmacist.
(1) An individual identified on a department, NRC,
 or an agreement state license or a permit issued by the department,
 the NRC, or an agreement state broad scope licensee or master material
 license permit, or by a master material license permittee of broad
 scope as an RSO, a teletherapy or medical physicist, an authorized
 medical physicist, a nuclear pharmacist, or an authorized nuclear
 pharmacist on or before January 14, 2019, need not comply with the
 training requirements of subsections (h), (j), and (k) of this section,
 respectively, except the RSO and authorized medical physicists identified
 in this paragraph must meet the training requirements in subsections
 (h)(4) or (j)(3) of this section, as appropriate, for any material
 or uses for which they were not authorized before this date.
(2) Any individual certified by the American Board
 of Health Physics in Comprehensive Health Physics; American Board
 of Radiology; American Board of Nuclear Medicine; American Board of
 Science in Nuclear Medicine; Board of Pharmaceutical Specialties in
 Nuclear Pharmacy; American Board of Medical Physics in radiation oncology
 physics; Royal College of Physicians and Surgeons of Canada in nuclear
 medicine; American Osteopathic Board of Radiology; or American Osteopathic
 Board of Nuclear Medicine on or before October 24, 2005, need not
 comply with the training requirements of subsection (h) of this section
 to be identified as an RSO or as an ARSO on a department, NRC, or
 agreement state license or NRC master material license permit for
 those materials and uses these individuals performed on or before
 October 24, 2005.
(3) Any individual certified by the American Board
 of Radiology in therapeutic radiological physics, Roentgen ray and
 gamma ray physics, x-ray and radium physics, or radiological physics,
 or certified by the American Board of Medical Physics in radiation
 oncology physics, on or before October 24, 2005, need not comply with
 the training requirements for an authorized medical physicist described
 in subsection (j) of this section, for those materials and uses these
 individuals performed on or before October 24, 2005.
(4) An RSO, a medical physicist, or a nuclear pharmacist
 who used only accelerator-produced radioactive materials, discrete
 sources of radium-226, or both, for medical or veterinary uses or
 in the practice of nuclear pharmacy at a government agency or federally
 recognized Indian Tribe before November 30, 2007, or at all other
 locations of use before August 8, 2009, or an earlier date as noticed
 by the NRC, need not comply with the training requirements of subsections
 (h), (j), or (k) of this section, respectively, when performing the
 same uses. A nuclear pharmacist who prepared only radioactive drugs
 containing accelerator-produced radioactive materials, or a medical
 physicist who used only accelerator-produced radioactive materials,
 at the locations and during the time period identified in this paragraph,
 qualifies as an authorized nuclear pharmacist or an authorized medical
 physicist, respectively, for those materials and uses performed before
 these dates, for the purposes of this chapter.
(5) An individual identified as a physician, dentist,
 podiatrist, or veterinarian authorized for the medical or veterinary
 use of radioactive material.
(A) Physicians, dentists, podiatrists, or veterinarians
 identified as authorized users for the medical or veterinary use of
 radioactive material on a license issued by the department, the NRC,
 or an agreement state; a permit issued by an NRC master material licensee;
 a permit issued by the department, the NRC, or an agreement state
 broad scope licensee; or a permit issued by an NRC master material
 license broad scope permittee on or before January 14, 2019, who perform
 only those medical or veterinary uses for which they were authorized
 on or before that date need not comply with the training requirements
 of subsections (gg) through (ttt) of this section.
(B) Physicians, dentists, podiatrists, or veterinarians
 identified as authorized users for the medical or veterinary use of
 radioactive material on a license issued by the department, the NRC,
 or an agreement state; a permit issued by an NRC master material licensee;
 a permit issued by the department, the NRC, or an agreement state
 broad scope licensee; or a permit issued under an NRC master material
 broad scope license on or before October 24, 2005, need not comply
 with the training requirements of subsections (gg) through (ttt) of
 this section for those materials and uses these individuals performed
 on or before October 24, 2005, as follows:
(i) for uses authorized under subsections (ff) or (hh)
 of this section, or oral administration of sodium iodide I-131 requiring
 a written directive for imaging and localization purposes, a physician
 who was certified on or before October 24, 2005, in nuclear medicine
 by the American Board of Nuclear Medicine; diagnostic radiology by
 the American Board of Radiology; diagnostic radiology or radiology
 by the American Osteopathic Board of Radiology; nuclear medicine by
 the Royal College of Physicians and Surgeons of Canada; or American
 Osteopathic Board of Nuclear Medicine in nuclear medicine;
(ii) for uses authorized under subsection (kk) of this
 section, a physician who was certified on or before October 24, 2005,
 by the American Board of Nuclear Medicine; the American Board of Radiology
 in radiology, therapeutic radiology, or radiation oncology; nuclear
 medicine by the Royal College of Physicians and Surgeons of Canada;
 or the American Osteopathic Board of Radiology after 1984;
(iii) for uses authorized under subsections (rr) or
 (ddd) of this section, a physician who was certified on or before
 October 24, 2005, in radiology, therapeutic radiology, or radiation
 oncology by the American Board of Radiology; radiation oncology by
 the American Osteopathic Board of Radiology; radiology, with specialization
 in radiotherapy, as a British "Fellow of the Faculty of Radiology"
 or "Fellow of the Royal College of Radiology"; or therapeutic radiology
 by the Canadian Royal College of Physicians and Surgeons; and
(iv) for uses authorized under subsection (bbb) of
 this section, a physician who was certified on or before October 24,
 2005, in radiology, diagnostic radiology, therapeutic radiology, or
 radiation oncology by the American Board of Radiology; nuclear medicine
 by the American Board of Nuclear Medicine; diagnostic radiology or
 radiology by the American Osteopathic Board of Radiology; or nuclear
 medicine by the Royal College of Physicians and Surgeons of Canada.
(C) Physicians, dentists, podiatrists, or veterinarians
 who used only accelerator-produced radioactive materials, discrete
 sources of radium-226, or both, for medical or veterinary uses performed
 at a government agency or federally recognized Indian Tribe before
 November 30, 2007, or at all other locations of use before August
 8, 2009, or an earlier date as noticed by the NRC, need not comply
 with the training requirements of subsections (gg) through (ttt) of
 this section when performing the same medical or veterinary uses.
 A physician, dentist, podiatrist, or veterinarian who used only accelerator-produced
 radioactive materials, discrete sources of radium-226, or both, for
 medical or veterinary uses at the locations and time period identified
 in this paragraph, qualifies as an authorized user for those materials
 and uses performed before these dates, for the purposes of this chapter.
(6) Individuals who need not comply with training requirements
 in this subsection may serve as preceptors for, and supervisors of,
 applicants seeking authorization on a department, NRC, or agreement
 state license for the same uses for which these individuals are authorized.
(m) Recentness of training. The training and experience
 specified in subsections (h), (j), and (gg) - (ttt) of this section
 for medical and veterinary use must have been obtained within the
 seven years preceding the date of application or the individual must
 have had related continuing education and experience since the required
 training and experience was completed.
(n) Licenses for medical and veterinary uses of radioactive
 material without broad scope authorization. In addition to the requirements
 of subsection (f) of this section, a license for medical and veterinary
 use of radioactive material as described in the applicable subsections
 (ff), (hh), (kk), (rr), (bbb), and (ddd) of this section is issued
 if the department approves documentation showing:
(1) the physicians or veterinarians designated on the
 application as the authorized users are qualified as specified in
 subsections (gg), (jj), (nn) - (qq), (zz), (aaa), (ccc), and (ttt)
 of this section, as applicable;
(2) the radiation detection and measuring instrumentation
 is appropriate for performing surveys and procedures for the uses
 involved;
(3) the radiation safety operating procedures are adequate
 for the handling and disposal of the radioactive material involved
 in the uses; and
(4) an RSC has been established as specified in subsection
 (i) of this section, if applicable.
(o) License for medical and veterinary uses of radioactive
 material with broad scope authorization. In addition to the requirements
 of subsection (f) of this section, a license for medical or veterinary
 use of radioactive material with broad scope authorization is issued
 if the department approves documentation showing:
(1) the review of authorized user qualifications by
 the RSC is as specified in subsections (gg), (jj), (nn) - (qq), (zz),
 (aaa), (ccc), and (ttt) of this section, as applicable;
(2) the application is for a license authorizing unspecified
 forms or multiple types of radioactive material for medical research,
 diagnosis, and therapy;
(3) the radiation detection and measuring instrumentation
 is appropriate for performing surveys and procedures for the uses
 involved;
(4) the radiation safety operating procedures are adequate
 for the handling and disposal of the radioactive material involved
 in the uses;
(5) staff has substantial experience in the use of
 a variety of radioactive material for a variety of human and animal
 uses;
(6) the full-time RSO meets the requirements of subsection
 (h) of this section; and
(7) an RSC has been established as specified in subsection
 (i)(1) of this section.
(p) License for the use of remote afterloader units,
 teletherapy units, or gamma stereotactic radiosurgery units. In addition
 to the requirements of subsection (f) of this section, a license for
 the use of remote afterloader units, teletherapy units, or gamma stereotactic
 radiosurgery units is issued if the department approves documentation
 showing:
(1) the physicians designated on the application as
 the authorized users are qualified as specified in subsection (ttt)
 of this section;
(2) the radiation detection and measuring instrumentation
 is appropriate for performing surveys and procedures for the uses
 involved;
(3) the radiation safety operating procedures are adequate
 for the handling and disposal of the radioactive material involved
 in the uses;
(4) the radioactive isotopes to be possessed;
(5) the sealed source manufacturer names and the model
 numbers of the sealed sources to be installed;
(6) the maximum number of sealed sources of each isotope
 to be possessed, including the activity of each sealed source;
(7) the manufacturer and model designation of the following
 units, as applicable:
(A) remote afterloader unit;
(B) teletherapy unit; or
(C) gamma stereotactic radiosurgery unit;
(8) the authorized medical physicist designated on
 the application is qualified as specified in subsection (j) of this
 section;
(9) the safety procedures and instructions as required
 by subsection (ggg) of this section;
(10) the spot check procedures as required by subsections
 (mmm) - (ooo) of this section, as applicable; and
(11) an RSC has been established as specified in subsection
 (i) of this section, if applicable.
(q) License for other medical or veterinary uses of
 radioactive material or a radiation source approved for medical or
 veterinary use not specifically addressed in this section. In addition
 to the requirements of subsection (f) of this section, a licensee
 may use radioactive material or a radiation source approved for medical
 or veterinary use not specifically addressed in this section if:
(1) the department approves the following documentation
 submitted by the applicant:
(A) any additional aspects of the medical or veterinary
 use of the material applicable to radiation safety not addressed in,
 or different from, requirements in this section;
(B) identification of and commitment to follow the
 applicable radiation safety program requirements in this section appropriate
 for the specific medical or veterinary use;
(C) any additional specific information on:
(i) radiation safety precautions and instructions;
(ii) methodology for measurement of dosages or doses
 to be administered to patients or human or animal research subjects;
 and
(iii) calibration, maintenance, and repair of instruments
 and equipment necessary for radiation safety; and
(D) any other information requested by the department
 in its review of the application; and
(2) the applicant or licensee has received written
 approval from the department in a license or license amendment and
 the licensee uses the material in accordance with the regulations
 and specific conditions the department considers necessary for the
 medical or veterinary use of the material.
(r) License amendments and notifications.
(1) Requests for amendment of a license or deletion
 of an authorized use site must be filed as specified in §289.252(aa)
 of this subchapter.
(2) A licensee must apply for and must receive a license
 amendment before:
(A) receiving or using radioactive material for a type
 of use authorized by this section, but not authorized on their current
 license issued under this section;
(B) permitting anyone to work as an authorized user,
 authorized nuclear pharmacist, authorized medical physicist, or ophthalmic
 physicist under the license except an individual who is identified
 as an authorized user, an authorized nuclear pharmacist, authorized
 medical physicist, or an ophthalmic physicist:
(i) on a department, NRC, or agreement state license
 or other equivalent permit or license recognized by the department
 authorizing the use of radioactive material in medical or veterinary
 use or in the practice of nuclear pharmacy;
(ii) on a permit issued by a department, NRC, or agreement
 state specific license of broad scope authorized to permit the use
 of radioactive material in medical or veterinary use or in the practice
 of nuclear pharmacy;
(iii) on a permit issued by an NRC master material
 licensee authorized to permit the use of radioactive material in medical
 use or in the practice of nuclear pharmacy; or
(iv) by a commercial nuclear pharmacy authorized to
 identify authorized nuclear pharmacists.
(C) changing RSOs, except as provided in subsection
 (g)(7) of this section;
(D) receiving radioactive material more than the amount
 or in a different form, or receiving a different radionuclide than
 authorized on the license;
(E) adding or changing the areas where radioactive
 material is used or stored and identified in the application or on
 the license, including areas used as specified in subsection (ff)
 or (hh) of this section if the change includes addition or relocation
 of either an area where positron emission tomography (PET) radionuclides
 are produced or a PET radioactive drug delivery line from the PET
 radionuclide/PET radioactive drug production area. Other areas of
 use where radioactive material is used only as specified in either
 subsection (ff) or (hh) of this section, are exempt;
(F) changing the addresses of use identified in the
 application or on the license;
(G) changing operating, safety, and emergency procedures;
 however, a licensee may revise its radiation protection program without
 the department's approval if the revision does not require a license
 amendment under the other provisions of this paragraph; and
(i) the revision does not reduce the safety of an affected
 facility;
(ii) the revision is in compliance with the rules in
 this chapter and the license;
(iii) the revision has been reviewed and approved by
 the RSO and licensee management;
(iv) the affected individuals are instructed on the
 revised program before the changes are implemented;
(v) all changes to the radiation protection program
 are submitted to the department after the provisions of this subparagraph
 are completed; and
(vi) the licensee retains a record of each change to
 the radiation protection program as specified in §289.202(mm)
 of this chapter.
(H) before permitting anyone to work as an ARSO, or
 before the RSO assigns duties and tasks to an ARSO differing from
 those for which this individual is authorized on the license; and
(I) before receiving a sealed source from a different
 manufacturer or of a different model number than authorized by its
 license unless the sealed source is used for manual brachytherapy,
 is listed in the Sealed Source and Device Registry, and is in a quantity
 and for an isotope authorized by the license.
(3) A licensee possessing a Type A specific license
 of broad scope for medical or veterinary use, issued under §289.252(h)(2)
 of this subchapter, is exempt from:
(A) the provisions of subsection (q)(1) of this section
 regarding the need to file an amendment to the license for medical
 or veterinary use of radioactive material;
(B) the provisions of paragraph (2)(B) of this subsection;
(C) the provisions of paragraph (2)(E) of this subsection
 regarding additions to or changes in the areas of use at the addresses
 identified in the application or on the license;
(D) the provisions of paragraph (4) of this subsection;
(E) the provisions of paragraph (5)(A) of this subsection
 for an authorized user, an authorized nuclear pharmacist, an authorized
 medical physicist, or an ophthalmic physicist;
(F) the provisions of paragraph (5)(C) of this subsection;
 and
(G) the provisions of subsection (u)(1) of this section.
(4) A licensee must notify the department in the form
 of a license amendment request no later than 30 days after the date
 that the licensee permits an individual to work under the provisions
 of this subsection as an authorized user, authorized medical physicist,
 ophthalmic physicist, or authorized nuclear pharmacist providing the
 individual is authorized on a license for the same use. A licensee
 includes with the notification the following documentation:
(A) a copy of the department, NRC, or agreement state
 license;
(B) the permit issued by an NRC master material licensee;
(C) the permit issued by the department, the NRC, or
 an agreement state licensee of broad scope; or
(D) the permit issued by an NRC master material license
 broad scope permittee.
(5) A licensee must notify the department in the form
 of a license amendment request no later than 30 days after:
(A) an authorized user, an authorized nuclear pharmacist,
 an RSO, an ARSO, an authorized medical physicist, or an ophthalmic
 physicist permanently discontinues performance of duties under the
 license or has a name change;
(B) the licensee permits an individual qualified to
 be an RSO under subsections (h) and (m) of this section to function
 as a temporary RSO and to perform the functions of an RSO as specified
 in subsection (g)(6) of this section;
(C) the licensee has added to or changed the areas
 of use identified in the application or on the license where radioactive
 material is used as specified in either subsection (ff) or (hh) of
 this section, if the change does not include addition or relocation
 of either an area where PET radionuclides are produced or a PET radioactive
 drug delivery line from the PET radionuclide/PET radioactive drug
 production area; or
(D) the licensee obtains a sealed source for use in
 manual brachytherapy from a different manufacturer or with a different
 model number than authorized by its license for which it did not require
 a license amendment as provided in paragraph (1) of this subsection.
 The notification must include the manufacturer and model number of
 the sealed source, the isotope, and the quantity per sealed source.
(s) Supervision. A licensee may permit the receipt,
 possession, use, or transfer of radioactive material by an individual
 under the supervision of an authorized user, unless prohibited by
 license condition.
(1) A licensee who permits the receipt, possession,
 use, or transfer of radioactive material by an individual under the
 supervision of an authorized user must:
(A) instruct the supervised individual in the licensee's
 written operating, safety, and emergency procedures, written directive
 procedures, requirements of this chapter, and license conditions with
 respect to the use of radioactive material; and
(B) require the supervised individual to follow the
 instructions of the supervising authorized user for medical or veterinary
 uses of radioactive material, written operating, safety, and emergency
 procedures established by the licensee, written directive procedures,
 requirements of this chapter, and license conditions with respect
 to the medical or veterinary use of radioactive material.
(2) A licensee who permits the preparation of radioactive
 material for medical or veterinary use by an individual under the
 supervision of an authorized nuclear pharmacist or authorized user
 must:
(A) instruct the supervised individual in the preparation
 of radioactive material for medical or veterinary use, as appropriate
 to that individual's involvement with radioactive material; and
(B) require the supervised individual to follow the
 instructions of the supervising authorized user or authorized nuclear
 pharmacist regarding the preparation of radioactive material for medical
 or veterinary use, the written operating, safety, and emergency procedures
 established by the licensee, the requirements of this chapter, and
 license conditions.
(3) A licensee who permits supervised activities as
 specified in paragraphs (1) and (2) of this subsection is responsible
 for the acts and omissions of the supervised individual.
(4) Only an authorized user may authorize the medical
 or veterinary use of radioactive material.
(t) Written directives.
(1) A written directive must be dated and signed by
 an authorized user before any administration of sodium iodide I-131
 greater than 30 microcuries (µCi) (1.11 megabequerels (MBq)),
 administration of any therapeutic dosage of unsealed radioactive material,
 or administration of any therapeutic dose of radiation from radioactive
 material. If, because of the emergent nature of the patient's condition,
 a delay to provide a written directive would jeopardize the patient's
 health, an oral directive is acceptable. The information contained
 in the oral directive must be documented in writing as soon as possible
 in the patient's record. A written directive must be prepared and
 signed by the authorized user within 48 hours of the oral directive.
(2) The written directive must contain the patient
 or human research subject's name and the following information for
 each application.
(A) For any administration of quantities greater than
 30 µCi (1.11 MBq) of sodium iodide I-131: the dosage.
(B) For an administration of a therapeutic dosage of
 a radiopharmaceutical other than sodium iodide I-131: the radiopharmaceutical,
 the dosage, and the route of administration.
(C) For gamma stereotactic radiosurgery: the total
 dose, the treatment site, and the values for the target coordinate
 settings per treatment for each anatomically distinct treatment site.
(D) For teletherapy: the total dose, the dose per fraction,
 the number of fractions, and the treatment site.
(E) For high-dose rate remote afterloading brachytherapy:
 the radionuclide, the treatment site, the dose per fraction, the number
 of fractions, and the total dose.
(F) For permanent implant brachytherapy:
(i) before implantation: the treatment site, the radionuclide,
 and the total source strength; and
(ii) after implantation but before the patient leaves
 the post-treatment recovery area: the treatment site, the number of
 sources implanted, the total source strength implanted, and the date.
(G) For all other brachytherapy, including low, medium,
 and pulsed rate afterloaders:
(i) before implantation: the treatment site, the radionuclide,
 and the dose;
(ii) after implantation but before completion of the
 procedure: the radionuclide, the treatment site, the number of sealed
 sources, the total sealed source strength, exposure time (or the total
 dose), and the date.
(3) A written revision to an existing written directive.
(A) A written revision to an existing written directive
 may be made if the revision is dated and signed by an authorized user
 before the administration of the dosage of unsealed radioactive material,
 the brachytherapy dose, the gamma stereotactic radiosurgery dose,
 the teletherapy dose, or the next fractional dose.
(B) If, because of the patient's condition, a delay
 to provide a written revision to an existing written directive would
 jeopardize the patient's health, an oral revision to an existing written
 directive is acceptable. The oral revision must be documented as soon
 as possible in the patient's record. A revised written directive must
 be signed by the authorized user within 48 hours of the oral revision.
(4) The licensee must retain the written directive
 as specified in subsection (xxx) of this section for inspection by
 the department.
(5) Procedures for administrations requiring a written
 directive.
(A) For any administration requiring a written directive,
 the licensee must develop, implement, and maintain written procedures
 to provide high confidence:
(i) the patient's or human research subject's identity
 is verified before each administration; and
(ii) each administration is in accordance with the
 written directive.
(B) The procedures required by subparagraph (A) of
 this paragraph must, at a minimum, address the following items applicable
 for the licensee's use of radioactive material:
(i) verifying the identity of the patient or human
 research subject;
(ii) verifying the administration is in accordance
 with the treatment plan, if applicable, and the written directive;
(iii) checking both manual and computer-generated dose
 calculations;
(iv) verifying any computer-generated dose calculations
 are correctly transferred into the consoles of therapeutic medical
 units authorized by subsections (q) and (ddd) of this section;
(v) determining if a medical event, as defined in subsection
 (uuu) of this section, has occurred; and
(vi) determining, for permanent implant brachytherapy,
 within 60 calendar days from the date the implant was performed, the
 total source strength administered outside of the treatment site compared
 to the total source strength documented in the post-implantation portion
 of the written directive, unless a written justification of patient
 unavailability is documented.
(C) A licensee must maintain a copy of the procedures
 required by subparagraph (A) of this paragraph as specified in subsection
 (xxx) of this section.
(u) Suppliers for sealed sources or devices for medical
 or veterinary use. A licensee may only use the following for medical
 or veterinary use:
(1) sealed sources or devices manufactured, labeled,
 packaged, and distributed as specified in a license issued under §289.252(o)
 of this subchapter or equivalent requirements of the NRC or an agreement
 state;
(2) sealed sources or devices non-commercially transferred
 from an NRC or agreement state medical or veterinary use licensee;
 or
(3) teletherapy sources manufactured and distributed
 as specified in a license issued by the department, the NRC, or an
 agreement state.
(v) Possession, use, and calibration of dose calibrators
 to measure the activity of unsealed radioactive material.
(1) For direct measurements performed as specified
 in subsection (x) of this section, the licensee must possess and use
 instrumentation to measure the activity of unsealed radioactive material
 before it is administered to each patient or human or animal research
 subject.
(2) The licensee must calibrate the instrumentation
 specified in paragraph (1) of this subsection in accordance with nationally
 recognized standards or the manufacturer's instructions.
(3) The calibration required by paragraph (2) of this
 subsection must include tests for constancy, accuracy, linearity,
 and geometry dependence, as appropriate to demonstrate proper operation
 of the instrument. The tests for constancy, accuracy, linearity, and
 geometry dependence must be conducted at the following intervals:
(A) constancy at least once each day before assay of
 patient dosages;
(B) linearity at installation, repair, relocation,
 and at least quarterly thereafter;
(C) geometry dependence at installation; and
(D) accuracy at installation and at least annually
 thereafter.
(4) The licensee must maintain a record of each instrument
 calibration as specified in subsection (xxx) of this section. The
 record must include:
(A) model and serial number of the instrument and calibration
 sources;
(B) complete date of the calibration including the
 month, day, and year;
(C) results of the calibration; and
(D) name of the individual who performed the calibration.
(w) Calibration of survey instruments. A licensee must
 calibrate the survey instruments used to show compliance with this
 subsection and with §289.202 of this chapter before first use,
 annually, and following a repair affecting the calibration. A licensee
 must:
(1) calibrate all scales with readings up to 10 millisieverts
 (mSv) (1000 millirem (mrem)) per hour with a radiation source;
(2) calibrate two separated readings on each scale
 or decade used to show compliance;
(3) conspicuously note on the instrument the complete
 date of the calibration including the month, day, and year;
(4) not use survey instruments if the difference between
 the indicated exposure rate and the calculated exposure rate is more
 than 20 percent; and
(5) maintain a record of each survey instrument calibration
 as specified in subsection (xxx) of this section.
(x) Determination of dosages of unsealed radioactive
 material for medical or veterinary use.
(1) Before medical or veterinary use, the licensee
 must determine and record the activity of each dosage.
(2) For a unit dosage, this determination must be made
 by:
(A) direct measurement of radioactivity; or
(B) a decay correction, based on the activity or activity
 concentration determined by:
(i) a manufacturer or preparer licensed as specified
 in §289.252(r) of this subchapter, or under an equivalent NRC
 or agreement state license;
(ii) an NRC or agreement state licensee for use in
 research in accordance with a Radioactive Drug Research Committee-approved
 protocol or an Investigational New Drug (IND) protocol accepted by
 the FDA; or
(iii) a PET radioactive drug producer licensed as specified
 in §289.252(kk) of this subchapter or equivalent NRC or agreement
 state requirements.
(3) For other than unit dosages, this determination
 must be made by:
(A) direct measurement of radioactivity;
(B) combination of measurement of radioactivity and
 mathematical calculations; or
(C) combination of volumetric measurements and mathematical
 calculations, based on the measurement made by:
(i) a manufacturer or preparer licensed as specified
 in §289.252(r) of this subchapter, or under an equivalent NRC
 or agreement state license; or
(ii) a PET radioactive drug producer licensed as specified
 in §289.252(kk) of this subchapter or equivalent NRC or agreement
 state requirements.
(4) Unless otherwise directed by the authorized user,
 a licensee must not use a dosage if the dosage does not fall within
 the prescribed dosage range or if the dosage differs from the prescribed
 dosage by more than 20 percent.
(5) A licensee restricted to only unit doses prepared
 as specified in §289.252(r) of this subchapter need not comply
 with paragraph (2) of this subsection unless the administration time
 of the unit dose deviates from the nuclear pharmacy's pre-calibrated
 time by 15 minutes or more.
(6) A licensee must maintain a record of the dosage
 determination required by this subsection as specified in subsection
 (xxx) of this section for inspection by the department. The record
 must include:
(A) the radiopharmaceutical;
(B) patient's or human or animal research subject's
 name or identification number, if one has been assigned;
(C) prescribed dosage;
(D) determined dosage or a notation the total activity
 is less than 30 µCi (1.1 MBq);
(E) the date and time of the dosage determination;
 and
(F) the name of the individual who determined the dosage.
(y) Authorization for calibration, transmission, and
 reference sources.
(1) Any licensee authorized by subsections (n), (o),
 (p), or (q) of this section for medical or veterinary use of radioactive
 material may receive, possess, and use any of the following radioactive
 material for check, calibration, transmission, and reference use:
(A) sealed sources, not exceeding 30 millicuries (mCi)
 (1.11 gigabecquerel (GBq)) each, manufactured and distributed by a
 person licensed under §289.252(o) of this subchapter or equivalent
 NRC or agreement state regulations;
(B) sealed sources, not exceeding 30 mCi (1.11 GBq)
 each, redistributed by a licensee authorized to redistribute the sealed
 sources manufactured and distributed by a person licensed under §289.252(o)
 of this subchapter or equivalent NRC or agreement state regulations,
 provided the redistributed sealed sources are in the original packaging
 and shielding and are accompanied by the manufacturer's approved instructions;
(C) any radioactive material with a half-life not longer
 than 120 days in individual amounts not to exceed 15 mCi (0.56 GBq);
(D) any radioactive material with a half-life longer
 than 120 days in individual amounts not to exceed the smaller of 200 µCi
 (7.4 MBq) or 1000 times the quantities in §289.202(ggg)(3) of
 this chapter; and
(E) technetium-99m in amounts as needed.
(2) Radioactive material in sealed sources authorized
 by this subsection must not be:
(A) used for medical or veterinary use as defined in
 subsection (c) of this section except as specified in the requirements
 in subsection (bbb) of this section; or
(B) combined (i.e., bundled or aggregated) to create
 an activity greater than the maximum activity of any single sealed
 source authorized under this section.
(3) A licensee using calibration, transmission, and
 reference sources as specified in the requirements in paragraph (1)
 or (2) of this subsection need not list these sources on a specific
 medical or veterinary use license.
(z) Requirements for possession of sealed sources and
 brachytherapy sealed sources. A licensee in possession of any sealed
 source or brachytherapy source must:
(1) follow the radiation safety and handling instructions
 supplied by the manufacturer and the leakage test requirements as
 specified in §289.201(g) of this chapter and reporting requirements
 in §289.202(bbb) of this chapter; and
(2) conduct a physical inventory at intervals not to
 exceed six months to account for all sealed sources in its possession.
 Records of the inventory must be made and maintained for inspection
 by the department as specified in subsection (xxx) of this section
 and must include:
(A) model number of each source and serial number if
 one has been assigned;
(B) identity of each source and its nominal activity;
(C) location of each source;
(D) date of the inventory; and
(E) name of the individual who performed the inventory.
(aa) Labeling of vials and syringes. Each syringe and
 vial containing a radiopharmaceutical must be labeled to identify
 the radioactive drug. Each syringe shield and vial shield must also
 be labeled unless the label on the syringe or vial is visible when
 shielded.
(bb) Surveys for ambient radiation exposure rate.
(1) In addition to the requirements of §289.202(p)
 of this chapter and except as provided in paragraph (2) of this subsection,
 a licensee must survey, with a radiation detection survey instrument,
 at the end of each day of use, all areas where radioactive material
 requiring a written directive was prepared for use or administered.
(2) A licensee is not required to perform the surveys
 required by paragraph (1) of this subsection in an area where patients
 or human research subjects are confined when they cannot be released
 as specified in subsection (cc) of this section or an animal that
 is confined. Once the patient or human or animal research subject
 is released from confinement, the licensee must survey with a radiation
 survey instrument the area in which the patient or human or animal
 research subject was confined.
(3) A record of each survey must be retained as specified
 in subsection (xxx) of this section for inspection by the department.
 The record must include:
(A) date of the survey;
(B) results of the survey;
(C) manufacturer's name, model, and serial number of
 the instrument used to make the survey; and
(D) name of the individual who performed the survey.
(cc) Release of individuals containing radioactive
 drugs or implants containing radioactive material.
(1) The licensee may authorize the release from its
 control, any individual administered radioactive drugs or implants
 containing radioactive material if the total effective dose equivalent
 (TEDE) to any other individual from exposure to the released individual
 is not likely to exceed 0.5 rem (5 mSv).
(2) The licensee must provide the released individual,
 or the individual's parent or guardian, with written instructions
 on actions recommended to maintain doses to other individuals ALARA
 if the TEDE to any other individual is likely to exceed 0.1 rem (1
 mSv). If the TEDE to a nursing infant or child could exceed 0.1 rem
 (1 mSv), assuming there was no interruption of breast-feeding, the
 instructions must include:
(A) guidance on the interruption or discontinuation
 of breast-feeding; and
(B) information on the potential consequences, if any,
 of failure to follow the guidance.
(3) The licensee must maintain for inspection by the
 department, a record as specified in subsection (xxx) of this section
 of each patient released according to paragraph (1) of this subsection.
 The record must include:
(A) the basis for authorizing the release of an individual;
 and
(B) the instructions provided to a breast-feeding woman
 if the radiation dose to the infant or child from continued breast-feeding
 could result in a TEDE exceeding 0.5 rem (5 mSv).
(dd) Mobile nuclear medicine service. A license for
 a mobile nuclear medicine service for medical or veterinary use of
 radioactive material is issued if the department approves the documentation
 submitted by the applicant as specified in the requirements of subsections
 (f) and (n) of this section. The clients of the mobile nuclear medicine
 service must be licensed if the client receives or possesses radioactive
 material to be used by the mobile nuclear medicine service.
(1) A licensee providing mobile nuclear medicine service
 must:
(A) obtain a letter signed by the management of each
 client for which services are rendered permitting the use of radioactive
 material at the client's address and clearly delineating the authority
 and responsibility of the licensee and the client;
(B) check instruments used to measure the activity
 of unsealed radioactive material for proper function before medical
 or veterinary use at each client's address or on each day of use,
 whichever is more frequent. As a minimum, the check for proper function
 required by this subparagraph must include a constancy check;
(C) have at least one fixed facility where records
 are maintained and radioactive material is delivered by manufacturers
 or distributors each day before the mobile nuclear medicine licensee
 dispatches its vehicles to client sites;
(D) agree to have an authorized physician user directly
 supervise each technologist at a reasonable frequency;
(E) check survey instruments for proper operation with
 a dedicated check source before use at each client's address; and
(F) before leaving a client's address, survey all areas
 of use to ensure compliance with the requirements of §289.202
 of this chapter.
(2) A mobile nuclear medicine service must not have
 radioactive material delivered from the manufacturer or the distributor
 to the client unless the client has a license allowing possession
 of the radioactive material. Radioactive material delivered to the
 client must be received and handled in conformance with the client's
 license.
(3) A licensee providing mobile nuclear medicine services
 must maintain records, for inspection by the department, as specified
 in subsection (xxx) of this section including the letter required
 in paragraph (1)(A) of this subsection and the record of each survey
 required in paragraph (1)(F) of this subsection.
(ee) Decay-in-storage.
(1) The licensee may hold radioactive material with
 a physical half-life of less than or equal to 120 days for decay-in-storage
 and dispose of it without regard to its radioactivity if the licensee:
(A) monitors radioactive material at the surface before
 disposal and determines its radioactivity cannot be distinguished
 from the background radiation level with an appropriate radiation
 detection survey meter set on its most sensitive scale and with no
 interposed shielding; and
(B) removes or obliterates all radiation labels, except
 for radiation labels on materials within containers and handled as
 biomedical waste after it has been released from the licensee.
(2) The licensee must retain a record of each disposal
 as required by paragraph (1) of this subsection as specified in subsection
 (xxx) of this section for inspection by the department. The record
 must include:
(A) date of the disposal;
(B) manufacturer's name, model number, and serial number
 of the survey instrument used;
(C) background radiation level;
(D) radiation level measured at the surface of each
 waste container; and
(E) name of the individual who performed the survey.
(ff) Use of unsealed radioactive material for uptake,
 dilution, and excretion studies not requiring a written directive.
 Except for quantities that require a written directive as specified
 in subsection (t) of this section, a licensee may use any unsealed
 radioactive material prepared for medical or veterinary use for uptake,
 dilution, or excretion studies:
(1) obtained from:
(A) a manufacturer or preparer licensed as specified
 in §289.252(r) of this subchapter or equivalent NRC or agreement
 state requirements; or
(B) a PET radioactive drug producer licensed as specified
 in §289.252(kk) of this subchapter or equivalent NRC or agreement
 state requirements; or
(2) excluding production of PET radionuclides, prepared
 by:
(A) an authorized nuclear pharmacist; or
(B) a physician or veterinarian who is an authorized
 user and who meets the requirements specified in subsections (jj)
 or (nn) and (jj)(3)(A)(ii)(VII) of this section; or
(C) an individual under the supervision, as specified
 in subsection (s) of this section, of the authorized nuclear pharmacist
 in subparagraph (A) of this paragraph, or the physician or veterinarian
 who is an authorized user in subparagraph (B) of this paragraph; or
(3) obtained from and prepared by an NRC or agreement
 state licensee for use in research in accordance with a Radioactive
 Drug Research Committee-approved protocol or an IND protocol accepted
 by the FDA; or
(4) prepared by the licensee for use in research in
 accordance with a Radioactive Drug Research Committee-approved application
 or an IND protocol accepted by the FDA.
(gg) Training for uptake, dilution, and excretion studies.
 Except as provided in subsection (l) of this section, the licensee
 must require an authorized user of unsealed radioactive material for
 the uses authorized in subsection (ff) of this section to be:
(1) a physician certified by a medical specialty board
 whose certification process is recognized by the department, the NRC,
 or an agreement state. The names of board certifications recognized
 by the department, the NRC, or an agreement state are posted on the
 NRC's Medical Uses Licensee Toolkit web page. To have its certification
 recognized, a specialty board must require all candidates for certification
 to:
(A) complete 60 hours of training and experience in
 basic radionuclide handling techniques and radiation safety applicable
 to the medical use of unsealed radioactive material for uptake, dilution,
 and excretion studies as described in paragraph (3)(A) of this subsection;
 and
(B) pass an examination, administered by diplomates
 of the specialty board, assessing knowledge and competence in radiation
 safety, radionuclide handling, and quality control; or
(2) an authorized user as specified in subsections
 (jj) or (nn) of this section or equivalent NRC or agreement state
 requirements; or
(3) a physician or veterinarian who:
(A) completes 60 hours of training and experience,
 including a minimum of eight hours of classroom and laboratory training,
 in basic radionuclide handling techniques applicable to the medical
 or veterinary use of unsealed radioactive material for uptake, dilution,
 and excretion studies. The training and experience must include:
(i) classroom and laboratory training in:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemistry of radioactive material for medical
 or veterinary use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
 user meeting the requirements of this subsection, subsections (l),
 (jj), or (nn) of this section, or equivalent NRC or agreement state
 requirements involving:
(I) ordering, receiving, and unpacking radioactive
 materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
 used to determine the activity of dosages and performing checks for
 proper operation of survey meters;
(III) calculating, measuring, and safely preparing
 patient or human or animal research subject dosages;
(IV) using administrative controls to prevent a medical
 event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
 material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
 patients or human or animal research subjects; and
(B) obtains written attestation the individual has
 satisfactorily completed the requirements in subparagraph (A) of this
 paragraph and is able to independently fulfill the radiation safety-related
 duties as an authorized user for the medical or veterinary uses authorized
 under subsection (ff) of this section. The attestation must be obtained
 from either:
(i) a preceptor authorized user who meets the requirements
 of subsection (l) of this section, this subsection, or subsections
 (jj) or (nn) of this section, or equivalent NRC or agreement state
 requirements; or
(ii) a residency program director affirming in writing
 the attestation represents the consensus of the residency program
 faculty where at least one faculty member is an authorized user who
 meets the requirements in subsections (l), (gg), (jj), or (nn) of
 this section, or equivalent NRC or agreement state requirements, and
 concurs with the attestation provided by the residency program director.
 The residency training program must be approved by the Residency Review
 Committee of the Accreditation Council for Graduate Medical Education,
 the Royal College of Physicians and Surgeons of Canada, or the Council
 on Postdoctoral Training of the American Osteopathic Association and
 must include training and experience specified in subparagraph (A)
 of this paragraph.
(hh) Use of unsealed radioactive material for imaging
 and localization studies not requiring a written directive. Except
 for quantities requiring a written directive as specified in subsection
 (t) of this section, a licensee may use any unsealed radioactive material
 prepared for medical or veterinary use for imaging and localization
 studies:
(1) obtained from:
(A) a manufacturer or preparer licensed as specified
 in §289.252(r) of this subchapter or equivalent NRC or agreement
 state requirements; or
(B) a PET radioactive drug producer licensed as specified
 in §289.252(kk) of this subchapter or equivalent NRC or agreement
 state requirements; or
(2) excluding production of PET radionuclides prepared
 by:
(A) an authorized nuclear pharmacist; or
(B) a physician or veterinarian who is an authorized
 user and who meets the requirements specified in subsections (jj)
 or (nn) and (jj)(3)(A)(ii)(VII) of this section; or
(C) an individual under the supervision, as specified
 in subsection (s) of this section, of the authorized nuclear pharmacist
 in subparagraph (A) of this paragraph, or the physician or veterinarian
 who is an authorized user in subparagraph (B) of this paragraph; or
(3) obtained from and prepared by an NRC or agreement
 state licensee for use in research in accordance with a Radioactive
 Drug Research Committee-approved protocol or an IND protocol accepted
 by the FDA; or
(4) prepared by the licensee for use in research in
 accordance with a Radioactive Drug Research Committee-approved application
 or an IND protocol accepted by the FDA.
(ii) Permissible molybdenum-99, strontium-82, and strontium-85
 concentrations.
(1) The licensee may not administer to humans a radiopharmaceutical
 containing:
(A) more than 0.15 µCi of molybdenum-99 per mCi
 of technetium-99m (0.15 kilobecquerel (kBq) of molybdenum-99 per MBq
 of technetium-99m); or
(B) more than 0.02 µCi of strontium-82 per mCi
 of rubidium-82 chloride (0.02 kBq of strontium-82 per MBq of rubidium-82
 chloride) injection; or
(C) more than 0.2 µCi of strontium-85 per mCi
 of rubidium-82 (0.2 kBq of strontium-85 per MBq of rubidium-82 chloride)
 injection.
(2) The licensee using molybdenum-99/technetium-99m
 generators for preparing a technetium-99m radiopharmaceutical must
 measure the molybdenum-99 concentration in each eluate from a generator
 to demonstrate compliance with paragraph (1) of this subsection.
(3) The licensee using a strontium-82/rubidium-82 generator
 for preparing a rubidium-82 radiopharmaceutical must, before the first
 patient use of the day, measure the concentration of radionuclides
 strontium-82 and strontium-85 to demonstrate compliance with paragraph
 (1) of this subsection.
(4) If the licensee is required to measure the molybdenum-99
 or strontium-82 and strontium-85 concentrations, the licensee must
 retain a record of each measurement as specified in subsection (xxx)
 of this section for inspection by the department. The record must
 include:
(A) for each measured elution of technetium-99m:
(i) the ratio of the measures expressed as µCi
 of molybdenum-99 per mCi of technetium-99m (kBq of molybdenum-99 per
 MBq of technetium-99m);
(ii) time and date of the measurement; and
(iii) name of the individual who made the measurement.
(B) for each measured elution of rubidium-82:
(i) the ratio of the measures expressed as µCi
 of strontium-82 per mCi of rubidium (kBq of strontium-82 per MBq of
 rubidium-82);
(ii) the ratio of the measures expressed as µCi
 of strontium-85 per mCi of rubidium (kBq of strontium-85 per MBq of
 rubidium-82);
(iii) time and date of the measurement; and
(iv) name of the individual who made the measurement.
(5) The licensee must report any measurement that exceeds
 the limits in paragraph (1) of this subsection at the time of generator
 elution, as specified in subsection (www) of this section.
(jj) Training for imaging and localization studies.
 Except as provided in subsection (l) of this section, the licensee
 must require an authorized user of unsealed radioactive material for
 the uses authorized in subsection (hh) of this section to be:
(1) a physician certified by a medical specialty board
 whose certification process is recognized by the department, the NRC,
 or an agreement state. The names of board certifications recognized
 by the department, the NRC, or an agreement state are posted on the
 NRC's Medical Uses Licensee Toolkit web page. To have its certification
 process recognized, a specialty board must require all candidates
 for certification to:
(A) complete 700 hours of training and experience in
 basic radionuclide handling techniques and radiation safety applicable
 to the medical use of unsealed radioactive material for imaging and
 localization studies as described in paragraph (3) of this subsection;
 and
(B) pass an examination, administered by diplomates
 of the specialty board, assessing knowledge and competence in radiation
 safety, radionuclide handling, and quality control; or
(2) an authorized user as specified in subsection (nn)
 of this section and who meets the requirements of paragraph (3)(A)(ii)(VII)
 of this subsection or equivalent NRC or agreement state requirements;
 or
(3) a physician or veterinarian who:
(A) completes 700 hours of training and experience,
 including a minimum of 80 hours of classroom and laboratory training,
 in basic radionuclide handling techniques applicable to the medical
 or veterinary use of unsealed radioactive material for imaging and
 localization studies. The training and experience must include:
(i) classroom and laboratory training in:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemistry of radioactive material for medical
 or veterinary use; and
(V) radiation biology; and
(ii) work experience under the supervision of an authorized
 user who meets the requirements in subsection (l) of this section,
 this subsection, or paragraph (3)(A)(ii)(VII) of this section, and
 subsection (nn) of this section, or equivalent NRC or agreement state
 requirements. An authorized nuclear pharmacist who meets the requirements
 in subsections (k) or (l) of this section may provide the supervised
 work experience for subclause (VII) of this clause. Work experience
 must involve:
(I) ordering, receiving, and unpacking radioactive
 materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
 used to determine the activity of dosages and performing checks for
 proper operation of survey meters;
(III) calculating, measuring, and safely preparing
 patient or human or animal research subject dosages;
(IV) using administrative controls to prevent a medical
 event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
 material safely and using proper decontamination procedures;
(VI) administering dosages of radioactive drugs to
 patients or human or animal research subjects; and
(VII) eluting generator systems appropriate for preparation
 of radioactive drugs for imaging and localization studies, measuring
 and testing the eluate for radionuclide purity, and processing the
 eluate with reagent kits to prepare labeled radioactive drugs; and
(B) obtains written attestation the individual has
 satisfactorily completed the requirements in this paragraph and is
 able to independently fulfill the radiation safety-related duties
 as an authorized user for the medical or veterinary uses authorized
 under subsections (ff) and (hh) of this section. The attestation must
 be obtained from either:
(i) a preceptor authorized user meeting the requirements
 of subsection (l) of this section, this subsection, or paragraph (3)(A)(ii)(VII)
 of this subsection, and subsection (nn) of this section, or equivalent
 NRC or agreement state requirements; or
(ii) a residency program director affirming in writing
 the attestation represents the consensus of the residency program
 faculty where at least one faculty member is an authorized user meeting
 the requirements in subsections (l), (jj), or (nn) of this section
 and paragraph (3)(A)(ii)(VII) of this subsection, or equivalent NRC
 or agreement state requirements, and concurs with the attestation
 provided by the residency program director. The residency training
 program must be approved by the Residency Review Committee of the
 Accreditation Council for Graduate Medical Education, the Royal College
 of Physicians and Surgeons of Canada, or the Council on Postdoctoral
 Training of the American Osteopathic Association and must include
 training and experience specified in this paragraph.
(kk) Use of unsealed radioactive material requiring
 a written directive. A licensee may use any unsealed radioactive material
 identified in subsection (nn)(2)(A)(ii)(VI) of this section prepared
 for medical or veterinary use requiring a written directive:
(1) obtained from:
(A) a manufacturer or preparer licensed as specified
 in §289.252(r) of this subchapter or equivalent NRC or agreement
 state requirements;
(B) a PET radioactive drug producer licensed as specified
 in §289.252(kk) of this subchapter or equivalent NRC or agreement
 state requirements; or
(2) excluding production of PET radionuclides prepared
 by:
(A) an authorized nuclear pharmacist; or
(B) a physician or veterinarian who is an authorized
 user and meets the requirements specified in subsections (jj) or (nn)
 of this section; or
(C) an individual under the supervision, as specified
 in subsection (s) of this section, of the authorized nuclear pharmacist
 in subparagraph (A) of this paragraph, or the physician or veterinarian
 who is an authorized user in subparagraph (B) of this paragraph; or
(3) obtained from and prepared by an NRC or agreement
 state licensee for use in research in accordance with an IND protocol
 accepted by the FDA; or
(4) prepared by the licensee for use in research in
 accordance with an IND protocol accepted by the FDA.
(ll) Safety instruction to personnel.
(1) The licensee must provide radiation safety instruction,
 initially and at least annually, to personnel caring for patients
 or human or animal research subjects who cannot be released as specified
 in subsection (cc) of this section. The instruction must be appropriate
 to the personnel's assigned duties and include:
(A) patient or human or animal research subject control;
 and
(B) visitor control, including:
(i) routine visitation to hospitalized individuals
 or animals as specified in §289.202(n) of this chapter;
(ii) contamination control;
(iii) waste control; and
(iv) notification of the RSO, or his or her designee,
 and an authorized user if the patient or the human or animal research
 subject has a medical emergency or dies.
(2) The licensee must maintain a record for inspection
 by the department, as specified in subsection (xxx) of this section,
 of individuals receiving instruction. The record must include:
(A) list of the topics covered;
(B) date of the instruction or training;
(C) names of the attendees; and
(D) names of the personnel who provided the instruction.
(mm) Safety precautions. For each human patient or
 human research subject who cannot be released as specified in subsection
 (cc) of this section, the licensee must:
(1) provide a private room with a private sanitary
 facility; or
(2) provide a room with a private sanitary facility
 with another individual who also has received therapy with an unsealed
 radioactive material and who also cannot be released as specified
 in subsection (cc) of this section;
(3) post the patient's or the research subject's room
 with a "Radioactive Materials" sign and note on the door and in the
 patient's or research subject's chart where and how long visitors
 may stay in the patient's or the research subject's room; and
(4) either monitor material and items removed from
 the patient's or the research subject's room to determine their radioactivity
 cannot be distinguished from the natural background radiation level
 with a radiation detection survey instrument set on its most sensitive
 scale and with no interposed shielding, or, handle such material and
 items as radioactive waste; and
(5) notify the RSO, or his or her designee, and the
 authorized user immediately if the patient or research subject has
 a medical emergency or dies.
(nn) Training for use of unsealed radioactive material
 requiring a written directive. Except as provided in subsection (l)
 of this section, the licensee must require an authorized user of unsealed
 radioactive material for the uses authorized in subsection (kk) of
 this section to be:
(1) a physician certified by a medical specialty board
 whose certification process is recognized by the department, the NRC,
 or an agreement state and who meets the requirements in paragraph
 (2)(A)(ii)(VI) of this subsection. The names of board certifications
 recognized by the department, the NRC, or an agreement state are posted
 on the NRC's Medical Uses Licensee Toolkit web page. To be recognized,
 a specialty board must require all candidates for certification to:
(A) successfully complete residency training in a radiation
 therapy or nuclear medicine training program or a program in a related
 medical specialty. These residency training programs must include
 700 hours of training and experience as described in paragraph (2)(A)(i)
 - (2)(A)(ii)(V) of this subsection. Eligible training programs must
 be approved by the Residency Review Committee of the Accreditation
 Council for Graduate Medical Education, the Royal College of Physicians
 and Surgeons of Canada, or the Council on Postdoctoral Training of
 the American Osteopathic Association; and
(B) pass an examination, administered by diplomates
 of the specialty board assessing knowledge and competence in radiation
 safety, radionuclide handling, quality assurance, and clinical use
 of unsealed radioactive material for which a written directive is
 required; or
(2) a physician or veterinarian who:
(A) completes 700 hours of training and experience,
 including a minimum of 200 hours of classroom and laboratory training,
 in basic radionuclide handling techniques applicable to the medical
 or veterinary use of unsealed radioactive material requiring a written
 directive. The training and experience must include:
(i) classroom and laboratory training in:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemistry of radioactive material for medical
 or veterinary use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
 user meeting the requirements of subsection (l) of this section, this
 subsection, or equivalent NRC or agreement state requirements. A supervising
 authorized user meeting the requirements of this paragraph must have
 experience in administering dosages in the same dosage category or
 categories (i.e., subclause (VI) of this clause) as the individual
 requesting authorized user status. The work experience must involve:
(I) ordering, receiving, and unpacking radioactive
 materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
 used to determine the activity of dosages and performing checks for
 proper operation of survey meters;
(III) calculating, measuring, and safely preparing
 patient or human or animal research subject dosages;
(IV) using administrative controls to prevent a medical
 event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
 material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
 patients or human or animal research subjects from the three categories
 in the following items. Radioactive drugs containing radionuclides
 in categories not included in this paragraph are regulated under subsection
 (q) of this section. For each category in which the individual is
 requesting authorized user status, the work experience must involve
 a minimum of three cases in:
(-a-) oral administration of less than or equal to
 33 mCi (1.22 GBq) of sodium iodide I-131, for which a written directive
 is required;
(-b-) oral administration of greater than 33 mCi (1.22
 GBq) of sodium iodide I-131 (experience with at least three cases
 in this item also satisfies the requirement of item (-a-) of this
 subclause); and
(-c-) parenteral administration of any radioactive
 drug that contains a radionuclide primarily used for its electron
 emission, beta radiation characteristics, alpha radiation characteristics,
 or photon energy of less than 150 kiloelectron volts (keV) for which
 a written directive is required; and
(B) obtains written attestation the individual has
 satisfactorily completed the requirements of paragraph (2)(A) of this
 subsection and is able to independently fulfill the radiation safety-related
 duties as an authorized user for the medical or veterinary uses authorized
 under subsection (kk) of this section for which the individual is
 requesting authorized user status. The attestation must be obtained
 from either:
(i) a preceptor authorized user meeting the requirements
 of subsection (l) of this section, this subsection, or equivalent
 NRC or agreement state requirements and has experience in administering
 dosages in the same dosage category or categories as the individual
 requesting authorized user status; or
(ii) a residency program director affirming in writing
 the attestation represents the consensus of the residency program
 faculty where at least one faculty member is an authorized user meeting
 the requirements in subsections (l) or (nn) of this section, or equivalent
 NRC or agreement state requirements, has experience in administering
 dosages in the same dosage category or categories as the individual
 requesting authorized user status, and concurring with the attestation
 provided by the residency program director. The residency training
 program must be approved by the Residency Review Committee of the
 Accreditation Council for Graduate Medical Education, the Royal College
 of Physicians and Surgeons of Canada, or the Council on Postdoctoral
 Training of the American Osteopathic Association and must include
 training and experience specified in this paragraph.
(oo) Training for the oral administration of sodium
 iodide I-131 requiring a written directive in quantities less than
 or equal to 33 mCi (1.22 GBq). Except as provided in subsection (l)
 of this section, the licensee must require an authorized user for
 the oral administration of sodium iodide I-131 requiring a written
 directive in quantities less than or equal to 33 mCi (1.22 GBq) to
 be:
(1) a physician certified by a medical specialty board
 whose certification process includes all the requirements of paragraph
 (3)(A) of this subsection and whose certification is recognized by
 the department, the NRC, or an agreement state (names of board certifications
 recognized by the department, the NRC, or an agreement state are posted
 on the NRC's Medical Uses Licensee Toolkit web page); or
(2) an authorized user as specified in subsection (nn)
 of this section for uses listed in subsection (nn)(2)(A)(ii)(VI)(-a-)
 or (-b-) of this section, or subsection (pp) of this section, or equivalent
 NRC or agreement state requirements; or
(3) a physician or veterinarian who:
(A) successfully completes 80 hours of classroom and
 laboratory training and work experience applicable to the medical
 or veterinary use of sodium iodide I-131 for procedures requiring
 a written directive. The training and experience must include:
(i) classroom and laboratory training, including:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemistry of radioactive material for medical
 or veterinary use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
 user meeting the requirements of subsection (l) of this section, this
 subsection, subsection (nn) or subsection (pp) of this section, or
 equivalent NRC or agreement state requirements. A supervising authorized
 user meeting the requirements in subsection (nn)(2) of this section
 must also have experience in administering dosages as specified in
 subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section. The work
 experience must involve:
(I) ordering, receiving, and unpacking radioactive
 materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
 used to determine the activity of dosages and performing checks for
 proper operation of survey meters;
(III) calculating, measuring, and safely preparing
 patient or human or animal research subject dosages;
(IV) using administrative controls to prevent a medical
 event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
 material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
 patients or human or animal research subjects that includes at least
 three cases involving the oral administration of less than or equal
 to 33mCi (1.22 GBq) of sodium iodide I-131; and
(B) obtains written attestation the individual has
 satisfactorily completed the requirements of paragraph (3)(A) of this
 subsection and is able to independently fulfill the radiation safety-related
 duties as an authorized user for oral administration of less than
 or equal to 33 mCi (1.22 GBq) of sodium iodide I-131 for medical or
 veterinary uses authorized under subsection (kk) of this section.
 The attestation must be obtained from either:
(i) a preceptor authorized user meeting the requirements
 of subsection (l) of this section, this subsection, subsection (nn)
 or subsection (pp) of this section, or equivalent NRC or agreement
 state requirements and has experience in administering dosages as
 specified in subsection (nn)(2)(A)(ii)(VI)(-a-) or (-b-) of this section;
 or
(ii) a residency program director affirming in writing
 that the attestation represents the consensus of the residency program
 faculty where at least one faculty member is an authorized user meeting
 the requirements in subsections (l), (nn), (oo), or (pp) of this section,
 or equivalent NRC or agreement state requirements, has experience
 in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-a-)
 or (-b-), and concurring with the attestation provided by the residency
 program director. The residency training program must be approved
 by the Residency Review Committee of the Accreditation Council for
 Graduate Medical Education, the Royal College of Physicians and Surgeons
 of Canada, or the Council on Postdoctoral Training of the American
 Osteopathic Association and must include training and experience specified
 in this paragraph.
(pp) Training for the oral administration of sodium
 iodide I-131 requiring a written directive in quantities greater than
 33 mCi (1.22 GBq). Except as provided in subsection (l) of this section,
 the licensee must require an authorized user for the oral administration
 of sodium iodide I-131 requiring a written directive in quantities
 greater than 33 mCi (1.22 GBq) to be:
(1) a physician certified by a medical specialty board
 whose certification process includes all the requirements in paragraph
 (3)(A) of this subsection and whose certification is recognized by
 the department, the NRC, or an agreement state (names of board certifications
 recognized by the department, the NRC, or an agreement state are posted
 on the NRC's Medical Uses Licensee Toolkit web page); or
(2) an authorized user as specified in subsection (nn)
 of this section or equivalent NRC or agreement state requirements
 for uses listed in subsection (nn)(2)(A)(ii)(VI)(-b-) of this section;
 or
(3) a physician or veterinarian who:
(A) successfully completes 80 hours of classroom and
 laboratory training applicable to the medical or veterinary use of
 sodium iodide I-131 for procedures requiring a written directive.
 The training and experience must include:
(i) classroom and laboratory training, including:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemistry of radioactive material for medical
 or veterinary use; and
(V) radiation biology; and
(ii) work experience, under the supervision of an authorized
 user meeting the requirements of subsection (l) of this section, subsections
 (nn) or (pp) of this section, or equivalent NRC or agreement state
 requirements. A supervising authorized user meeting the requirements
 of subsection (nn)(2) of this section must also have experience in
 administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-)
 of this section. The work experience must involve:
(I) ordering, receiving, and unpacking radioactive
 materials safely and performing the related radiation surveys;
(II) performing quality control procedures on instruments
 used to determine the activity of dosages and performing checks for
 proper operation of survey meters;
(III) calculating, measuring, and safely preparing
 patient or human or animal research subject dosages;
(IV) using administrative controls to prevent a medical
 event involving the use of unsealed radioactive material;
(V) using procedures to contain spilled radioactive
 material safely and using proper decontamination procedures; and
(VI) administering dosages of radioactive drugs to
 patients or human or animal research subjects that includes at least
 three cases involving the oral administration of greater than 33 mCi
 (1.22 GBq) of sodium iodide I-131; and
(B) obtains written attestation the individual has
 satisfactorily completed the requirements of paragraph (3)(A) of this
 subsection and is able to independently fulfill the radiation safety-related
 duties as an authorized user for oral administration of greater than
 33 mCi (1.22 GBq) of sodium iodide I-131 for medical or veterinary
 uses authorized under subsection (kk) of this section. The attestation
 must be obtained from either:
(i) a preceptor authorized user meeting the requirements
 in subsections (l) or (nn) of this section, this subsection, or equivalent
 NRC or agreement state requirements and has experience in administering
 dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-) of this
 section; or
(ii) a residency program director affirming in writing
 that the attestation represents the consensus of the residency program
 faculty where at least one faculty member is an authorized user meeting
 the requirements in subsections (l), (nn), or (pp) of this section,
 or equivalent NRC or agreement state requirements, has experience
 in administering dosages as specified in subsection (nn)(2)(A)(ii)(VI)(-b-)
 of this section, and concurring with the attestation provided by the
 residency program director. The residency training program must be
 approved by the Residency Review Committee of the Accreditation Council
 for Graduate
Medical Education, the Royal College of Physicians and
 Surgeons of Canada, or the Council on Postdoctoral Training of the
 American Osteopathic Association and must include training and experience
 specified in this paragraph.
(qq) Training for the parenteral administration of
 unsealed radioactive material requiring a written directive.
(1) Except as provided in subsection (l) of this section,
 the licensee must require an authorized user for the parenteral administration
 of unsealed radioactive materials requiring a written directive to
 be:
(A) an authorized user as specified in subsection (nn)
 of this section for uses listed in subsection (nn)(2)(A)(ii)(VI)(-c-)
 of this section or equivalent NRC or agreement state requirements;
 or
(B) an authorized user under subsections (zz) or (ttt)
 of this section or equivalent NRC or agreement state requirements
 and meeting the requirements of paragraph (2) of this subsection;
 or
(C) a physician certified by a medical specialty board
 whose certification process is recognized by the department, the NRC,
 or an agreement state as specified in subsections (zz) or (ttt) of
 this section, and meets the requirements of paragraph (2) of this
 subsection.
(2) The physician or veterinarian must also:
(A) successfully complete 80 hours of classroom and
 laboratory training applicable to parenteral administrations listed
 in subsection (nn)(2)(A)(ii)(VI)(-c-) of this section.
(B) complete training and experience to include:
(i) classroom and laboratory training, including:
(I) radiation physics and instrumentation;
(II) radiation protection;
(III) mathematics pertaining to the use and measurement
 of radioactivity;
(IV) chemis

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## Nearby sections

- [25 Tex. Admin. Code § 289.251 25 TAC § 289.251. Exemptions, General Licenses, and General License Acknowledgements](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_251.md)
- [25 Tex. Admin. Code § 289.252 25 TAC § 289.252. Licensing of Radioactive Material](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_252.md)
- [25 Tex. Admin. Code § 289.253 25 TAC § 289.253. Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_253.md)
- [25 Tex. Admin. Code § 289.255 25 TAC § 289.255. Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_255.md)
- [25 Tex. Admin. Code § 289.256 25 TAC § 289.256. Medical and Veterinary Use of Radioactive Material](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_256.md)
- [25 Tex. Admin. Code § 289.257 25 TAC § 289.257. Packaging and Transportation of Radioactive Material](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_257.md)
- [25 Tex. Admin. Code § 289.258 25 TAC § 289.258. Licensing and Radiation Safety Requirements for Irradiators](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_258.md)
- [25 Tex. Admin. Code § 289.259 25 TAC § 289.259. Licensing of Naturally Occurring Radioactive Material (NORM)](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_259.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T25_P1_C289_S289_256. Check the current official text before relying on it. Not legal advice.