Section 330.260 Special Requirements for Issuance of Certain Specific Licenses for Radioactive Materials

Section 330

Section 330.260  Special

Requirements for Issuance of Certain Specific Licenses for Radioactive

Materials

a)         Specific Licenses to Medical Institutions for Human Use of

Radioactive Material. A specific license allowing a medical institution to use

radioactive material for medical diagnosis, medical therapy, or medical

research involving humans shall be issued only if the applicant has met the

requirements of this Part and 32 Ill. Adm. Code 335.

b)         Specific Licenses to Individual Physicians for Human Use of

Radioactive Material.  An application by an individual physician or group of

physicians for a specific license for human use of radioactive material shall

be approved only if:

1)         The applicant satisfies the general requirements specified in

this Part;

2)         The application is for use in the applicant's practice in an

office outside a medical institution; and

3)         The applicant has met the requirements of 32 Ill. Adm. Code

335.

c)         Specific Licenses for Distribution or Transfer of

Radiopharmaceuticals.  In addition to the requirements set forth in this Part,

persons licensed by the Agency for manufacture, preparation, or transfer for

commercial distribution of radiopharmaceuticals containing radioactive material

for medical use under 32 Ill. Adm. Code 335 shall meet the following additional

requirements:

1)         The

applicant satisfies the general requirements specified in Section 330.250;

2)         The

applicant submits evidence that the applicant is at least one of the following:

A)        Compliant

with the U.S

or

commercial distribution of radiopharmaceuticals containing radioactive material

for medical use under 32 Ill. Adm. Code 335 shall meet the following additional

requirements:

1)         The

applicant satisfies the general requirements specified in Section 330.250;

2)         The

applicant submits evidence that the applicant is at least one of the following:

A)        Compliant

with the U.S. Food and Drug Administration (FDA) registration requirements as

the owner or operator of a drug establishment that engages in the manufacture,

preparation, propagation, compounding, or processing of a drug under 21 CFR

Part 207;

B)        Registered

or licensed with a state agency as a drug manufacturer;

C)        Licensed

as a pharmacy by a state Board of Pharmacy;

D)        Operating

as a nuclear pharmacy within a federal medical institution; or

E)        A PET

drug production facility registered with a state agency;

3)         The

applicant submits information showing that:

A)        The radiopharmaceutical containing radioactive material will

be manufactured, labeled and packaged in accordance with the federal Food,

Drug, and Cosmetic Act, 21 U.S.C. 301-392 or the federal Public Health Service

Act, 42 U.S.C. 201-291; or

B)        The manufacture and distribution of the radiopharmaceutical

containing radioactive material is not subject to the federal Food, Drug, and

Cosmetic Act and the federal Public Health Service Act;

4)         The applicant submits information on the radionuclide; the

chemical and physical form; the maximum activity per vial, syringe, generator,

or other container of the radioactive drug; and the shielding provided by the

packaging to show it is appropriate for the safe handling and storage of the

radioactive drugs by medical use licensees;

5)         The

applicant commits to the following labeling requirements:

A)        A

label is affixed to each transport radiation shield, whether it is constructed

of lead, glass, plastic, or other material, of a radioactive drug to be

t

; and the shielding provided by the

packaging to show it is appropriate for the safe handling and storage of the

radioactive drugs by medical use licensees;

5)         The

applicant commits to the following labeling requirements:

A)        A

label is affixed to each transport radiation shield, whether it is constructed

of lead, glass, plastic, or other material, of a radioactive drug to be

transferred for commercial distribution.  The label shall include the radiation

symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER,

RADIOACTIVE MATERIAL"; the name of the radioactive drug or its

abbreviation; and the quantity of radioactivity at a specified date and time.  For

radioactive drugs with a half-life greater than 100 days, the time may be

omitted.

B)        A

label is affixed to each syringe, vial, or other container used to hold a

radioactive drug to be transferred for commercial distribution.  The label shall

include the radiation symbol and the words "CAUTION, RADIOACTIVE

MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier

that ensures that the syringe, vial, or other container can be correlated with

the information on the transport radiation shield label;

6)         A

licensee described by subsection (c)(2)(C) or (D):

A)        May

prepare radioactive drugs for medical use, as defined in 32 Ill. Adm. Code

335.20, provided that the radioactive drug is prepared by either an authorized

nuclear pharmacist, as specified in subsections (c)(6)(B) and (C), or an

individual under the supervision of an authorized nuclear pharmacist as

specified in subsection (c)(15).

B)        May

allow a pharmacist to work as an authorized nuclear pharmacist if the following

conditions are met:

i)          The

individual qualifies as an authorized nuclear pharmacist as defined in Section 330.20;

ii)         The

individual meets the requirements specified in subsections (c)(18)(B) and

the supervision of an authorized nuclear pharmacist as

specified in subsection (c)(15).

B)        May

allow a pharmacist to work as an authorized nuclear pharmacist if the following

conditions are met:

i)          The

individual qualifies as an authorized nuclear pharmacist as defined in Section 330.20;

ii)         The

individual meets the requirements specified in subsections (c)(18)(B) and

(c)(21), and the licensee has received an approved license amendment

identifying the individual as an authorized nuclear pharmacist; or

iii)        The

individual is designated as an authorized nuclear pharmacist in accordance with

subsection (c)(6)(C).

C)        May

designate a pharmacist (as defined in 32 Ill. Adm. Code 310.20) as an

authorized nuclear pharmacist if:

i)          The

individual was a nuclear pharmacist preparing only radioactive drugs containing

accelerator-produced radioactive material; and

ii)         The

individual practiced at a pharmacy at a government agency or federally

recognized Indian Tribe before November 30, 2007 or at all other pharmacies

before August 8, 2009, or an earlier date as noticed by the U.S. Nuclear

Regulatory Commission.

D)        Shall

provide to the Agency, no later than 30 days after the date a licensee allows

an individual to work as an authorized nuclear pharmacist under subsections

(c)(6)(B)(i), (c)(6)(B) (iii) or (c)(6)(C), a copy of the individual's State of

Illinois pharmacist license and:

i)          A

copy of each individual's certification by a specialty board whose

certification process has been recognized by the U.S. Nuclear Regulatory

Commission or an Agreement State as specified in subsection (c)(18)(A); or

ii)         U.S.

Nuclear Regulatory Commission or Agreement State license listing the individual

as an authorized nuclear pharmacist; or

iii)        A

U.S. Nuclear Regulatory Commission master materials licensee permit listing the

individual as an authorized nuclear pharmacist; or

iv)        A

permit issued by a licensee or U.S

n or an Agreement State as specified in subsection (c)(18)(A); or

ii)         U.S.

Nuclear Regulatory Commission or Agreement State license listing the individual

as an authorized nuclear pharmacist; or

iii)        A

U.S. Nuclear Regulatory Commission master materials licensee permit listing the

individual as an authorized nuclear pharmacist; or

iv)        A

permit issued by a licensee or U.S. Nuclear Regulatory Commission master material

permittee of broad scope or authorization from a commercial nuclear pharmacy

authorized to list its own authorized nuclear pharmacist; or

v)         Documentation

that only accelerator-produced radioactive materials were used 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 U.S. Nuclear Regulatory Commission;

E)        Shall

provide notification to the Agency no later than 30 days after an authorized

user or an authorized nuclear pharmacist permanently discontinues performance

of duties under the license or has a name change;

7)         A

licensee shall possess and use instrumentation to measure the radioactivity of

radioactive drugs.  The licensee shall have procedures for use of the

instrumentation.  The licensee shall measure, by direct measurement or by

combination of measurements and calculations, the amount of radioactivity in

dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to

transfer for commercial distribution

l possess and use instrumentation to measure the radioactivity of

radioactive drugs.  The licensee shall have procedures for use of the

instrumentation.  The licensee shall measure, by direct measurement or by

combination of measurements and calculations, the amount of radioactivity in

dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to

transfer for commercial distribution. In addition, the licensee shall:

A)        Perform

tests, before initial use, periodically, and following repair, on each

instrument for accuracy, linearity, and geometry dependence as appropriate for

the use of the instrument and make adjustments when necessary; and

B)        Check

each instrument for constancy and proper operation at the beginning of each day

of use;

8)         Nothing

in this Section relieves the licensee from complying with applicable FDA or

other federal or State requirements governing radioactive drugs;

9)         Radiopharmaceuticals

dispensed, distributed or transferred for human use shall be either:

A)        Repackaged

from prepared radiopharmaceuticals that have been approved by the FDA for

medical use as defined in 32 Ill. Adm. Code 335.20; or

B)        Prepared

from generators and reagent kits that have been approved by the FDA for medical

use, or are subject to the Illinois Food, Drug and Cosmetic Act [410 ILCS 620]

or the Pharmacy Practice Act of 1987 [225 ILCS 85];

10)         Each

licensee preparing technetium-99m radiopharmaceuticals from

molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82

generators shall test the generator eluates for molybdenum-99 breakthrough or

strontium-82 and strontium-85 contamination, respectively, in accordance with 32

Ill. Adm. Code 335.4020.  The licensee shall record the results of each test

and retain each record for three years after the record is made

icals from

molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/rubidium-82

generators shall test the generator eluates for molybdenum-99 breakthrough or

strontium-82 and strontium-85 contamination, respectively, in accordance with 32

Ill. Adm. Code 335.4020.  The licensee shall record the results of each test

and retain each record for three years after the record is made.  The licensee

shall report the results of any test that exceeds the permissible concentration

listed in Section 335.4020(a) at the time of generator elution, in accordance

with Section 335.4020(d);

11)         The

licensee may distribute in vitro test kits to customers but shall neither

remove any package insert nor violate the packaging;

12)         The

licensee shall report to the Agency, within 10 days after occurrence, any

irregularities pertaining to identification, labeling, quality or assay of any radiopharmaceuticals

received under the authority of this license;

13)         A

licensee such as a nuclear pharmacy that is authorized to distribute

radiopharmaceuticals shall ensure that radiopharmaceuticals are dispensed only

under the prescription of a physician who is authorized by 32 Ill. Adm. Code

335 to use the radiopharmaceuticals.  The licensee shall verify that the

physician is authorized to receive the prescribed radiopharmaceutical prior to

transfer;

AGENCY NOTE:  In accordance with

32 Ill. Adm. Code 335.40(b), licensees authorized for medical use of

radiopharmaceuticals may permit work as an authorized user in limited

circumstances without first obtaining an amendment.  Therefore, possession of

the recipient's latest radioactive material license may not list all authorized

users

eive the prescribed radiopharmaceutical prior to

transfer;

AGENCY NOTE:  In accordance with

32 Ill. Adm. Code 335.40(b), licensees authorized for medical use of

radiopharmaceuticals may permit work as an authorized user in limited

circumstances without first obtaining an amendment.  Therefore, possession of

the recipient's latest radioactive material license may not list all authorized

users.

14)         A

licensee shall apply for and shall receive a license amendment before it

receives, prepares or uses radioactive material for a type of use that is

permitted under this Part but that is not authorized on the licensee's current

license issued under this Part;

15)         Individuals

Under Supervision of an Authorized Nuclear Pharmacist

A)        A

licensee that permits the preparation of radioactive material for medical use

by an individual under the supervision of an authorized nuclear pharmacist as

allowed by 32 Ill. Adm. Code 335.30(b)(2) shall:

i)          In

addition to the requirements in 32 Ill. Adm. Code 400.120, instruct the

supervised individual in the preparation of radiopharmaceutical material for

medical use as appropriate to that individual's involvement with radioactive

material; and

ii)         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 use, written radiation protection procedures

established by the licensee, the regulations of this Section, and license

conditions.

B)        A

licensee that permits supervised activities under this subsection (c)(15) is

responsible for the acts and omissions of the supervised individual;

16)         Authority

and responsibilities for the radiation protection program.

A)        In

addition to the radiation protection program requirements in 32 Ill. Adm

the licensee, the regulations of this Section, and license

conditions.

B)        A

licensee that permits supervised activities under this subsection (c)(15) is

responsible for the acts and omissions of the supervised individual;

16)         Authority

and responsibilities for the radiation protection program.

A)        In

addition to the radiation protection program requirements in 32 Ill. Adm. Code

340.110, a licensee's management shall approve in writing:

i)          Requests

for a license application, renewal, or amendment before submittal to the

Agency;

ii)         Any

individual before allowing that individual to work as an authorized nuclear

pharmacist; and

iii)        Radiation

protection program changes that do not require a license amendment.

B)        A

licensee's management shall appoint a Radiation Safety Officer who agrees, in

writing, to be responsible for implementing the radiation protection program. The

licensee, through the Radiation Safety Officer, shall ensure that radiation

safety activities are being performed in accordance with licensee-approved

procedures and regulatory requirements. A licensee's management may appoint, in

writing, one or more Associate Radiation Safety Officers to support the

Radiation Safety Officer. The Radiation Safety Officer, with written agreement

of the licensee's management, must assign the specific duties and tasks to each

Associate Radiation Safety Officer. These duties and tasks are restricted to

the types of use for which the Associate Radiation Safety Officer is listed on

a license. The Radiation Safety Officer may delegate duties and tasks to the

Associate Radiation Safety Officer but shall not delegate the authority or

responsibilities for implementing the radiation protection program

es and tasks to each

Associate Radiation Safety Officer. These duties and tasks are restricted to

the types of use for which the Associate Radiation Safety Officer is listed on

a license. The Radiation Safety Officer may delegate duties and tasks to the

Associate Radiation Safety Officer but shall not delegate the authority or

responsibilities for implementing the radiation protection program.

C)        For up

to 60 days each year, a licensee may permit an individual qualified to be a

Radiation Safety Officer, under subsections (c)(17) and (c)(21), to function as

a temporary Radiation Safety Officer and to perform the functions of a

Radiation Safety Officer, as provided in subsection (c)(16)(E), if the licensee

takes the actions required in subsections (c)(16)(B), (D), (E), and (F) and

notifies the Agency no later than 30 days after allowing the individual to

function as a temporary Radiation Safety Officer.

D)        A

licensee shall establish the authority, duties, and responsibilities of the

Radiation Safety Officer in writing.

E)        A

licensee shall provide the Radiation Safety Officer sufficient authority,

organizational freedom, time, resources, and management prerogative, to:

i)          Identify

radiation safety problems;

ii)         Initiate,

recommend or provide corrective actions;

iii)        Stop

unsafe operations; and

iv)        Verify

implementation of corrective actions.

F)         A

licensee shall retain a record of actions taken under subsections (c)(16)(A),

(B), and (D) as follows:

i)          A

licensee shall retain a record of actions taken by the licensee's management in

accordance with subsection (c)(16)(A) for five years. The record must include a

summary of the actions taken and a signature of licensee management

implementation of corrective actions.

F)         A

licensee shall retain a record of actions taken under subsections (c)(16)(A),

(B), and (D) as follows:

i)          A

licensee shall retain a record of actions taken by the licensee's management in

accordance with subsection (c)(16)(A) for five years. The record must include a

summary of the actions taken and a signature of licensee management.

ii)         The

licensee shall retain a copy of both authority, duties, and responsibilities of

the Radiation Safety Officer as required by subsection (c)(16)(E), and a signed

copy of each Radiation Safety Officer's agreement to be responsible for

implementing the radiation safety program, as required by subsection

(c)(16)(B), for the duration of the license. The records must include the

signature of the Radiation Safety Officer and licensee management.

iii)        For

each Associate Radiation Safety Officer appointed under subsection (c)(16)(B),

the licensee shall retain, for five years after the Associate Radiation Safety

Officer is removed from the license, a copy of the written document appointing

the Associate Radiation Safety Officer signed by the licensee's management.

17)         Training

for Radiation Safety Officer and Associate Radiation Safety Officer.  Except as

provided in subsection (c)(20), the licensee shall require an individual

fulfilling the responsibilities of Radiation Safety Officer, or an individual

assigned duties and tasks as an Associate Radiation Safety Officer provided in

subsection (c)(16), at a nuclear pharmacy to be an individual who:

A)        Is

certified by a specialty board whose certification process has been recognized

by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and

who meets the requirements in subsection (c)(17)(D)

Officer, or an individual

assigned duties and tasks as an Associate Radiation Safety Officer provided in

subsection (c)(16), at a nuclear pharmacy to be an individual who:

A)        Is

certified by a specialty board whose certification process has been recognized

by the Agency, the U.S. Nuclear Regulatory Commission or an Agreement State and

who meets the requirements in subsection (c)(17)(D).  To have its certification

process recognized, a specialty board shall require all candidates for

certification to:

i)          Hold

a bachelor's or graduate degree from an accredited college or university in

physical science, engineering or biological science with a minimum of 20

college credits in physical science; and

•          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

•          Pass

an examination administered by diplomates of the specialty board that evaluates

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

AGENCY NOTE:  Specialty boards

whose certification processes have been recognized by the Agency, the U.S.

Nuclear Regulatory Commission or an Agreement State will be posted on the NRC's

website.

ii)         Hold

a master's or doctor's degree in physics, medical physics, or other physical

science, engineering, or applied mathematics from an accredited college or

university;

•           Have

two years of full-time practical training or supervised experience in medical

physics under the supervision of a medical physicist who is certified in

medical physics by a specialty board recognized by the Agency, the U.S

r's or doctor's degree in physics, medical physics, or other physical

science, engineering, or applied mathematics from an accredited college or

university;

•           Have

two years of full-time practical training or supervised experience in medical

physics under the supervision of a medical physicist who is certified in

medical physics by a specialty board recognized by the Agency, the U.S. Nuclear

Regulatory Commission, or an Agreement State or in clinical nuclear medicine

facilities providing diagnostic or therapeutic services under the direction of

physicians who meet the requirements for authorized users in Section 335.9160,

335.9040, or 335.9050; and

•           Pass

an examination, administered by diplomates of the specialty board, that

assesses knowledge and competence in clinical diagnostic radiological or

nuclear medicine physics and in radiation safety; or

B)        Has

completed a structured educational program consisting of:

i)          200

hours of classroom and laboratory training in the following areas:  radiation

physics and instrumentation, radiation protection, mathematics pertaining to

the use and measurement of radioactivity, radiation biology and radiation

dosimetry;

ii)         One

year of full-time radiation safety experience under the supervision of the

individual identified as the Radiation Safety Officer on an Agency, U.S.

Nuclear Regulatory Commission, or Agreement State license or a permit issued by

a U.S. Nuclear Regulatory Commission master material licensee that authorizes

similar types and uses of radioactive material.  An Associate Radiation Safety

Officer may provide supervision for those areas for which the Associate

Radiation Safety Officer is authorized on a U.S. Nuclear Regulatory Commission

or an Agreement State license or permit issued by a U.S. Nuclear Regulatory

Commission master material licensee

y Commission master material licensee that authorizes

similar types and uses of radioactive material.  An Associate Radiation Safety

Officer may provide supervision for those areas for which the Associate

Radiation Safety Officer is authorized on a U.S. Nuclear Regulatory Commission

or an Agreement State license or permit issued by a U.S. Nuclear Regulatory

Commission master material licensee.  The full-time radiation safety experience

shall involve the following:

•           Shipping,

receiving and performing related radiation surveys;

•           Using

and performing checks for proper operation of instruments used to determine the

activity of dosages, survey meters, and instruments used to measure

radionuclides;

•           Securing

and controlling radioactive material;

•           Using

administrative controls to avoid mistakes in the administration of radioactive

material;

•           Using

procedures to prevent or minimize radioactive contamination and using proper

decontamination procedures;

•           Using

emergency procedures to control radioactive material; and

•           Disposing

of radioactive material; and

iii)        Written

attestation, signed by a preceptor Radiation Safety Officer or Associate

Radiation Safety Officer who has experience with the radiation safety aspects

of similar types of use of byproduct material for which the individual is

seeking approval as a Radiation Safety Officer.  The written attestation must

state that the individual has satisfactorily completed the requirements in

subsections (c)(17)(B)(i), (B)(ii) and (D), and is able to independently

fulfill the radiation safety-related duties as a Radiation Safety Officer or

Associate Radiation Safety Officer for a nuclear pharmacy license; or

C)        Meets

the training requirements in subsection (c)(17)(D); and

i)          Is a

medical physicist who has been certified by a specialty board whose

certification process has been recognized by the Agency, the U.S

d is able to independently

fulfill the radiation safety-related duties as a Radiation Safety Officer or

Associate Radiation Safety Officer for a nuclear pharmacy license; or

C)        Meets

the training requirements in subsection (c)(17)(D); and

i)          Is a

medical physicist who has been certified by a specialty board whose

certification process has been recognized by the Agency, the U.S. Nuclear

Regulatory Commission, or an Agreement State under 32 Ill. Adm. Code

335.9150(a), has experience with the radiation safety aspects of similar types

of use of radioactive material for which the licensee seeks the approval of the

individual as Radiation Safety Officer or an Associate Radiation Safety

Officer; or

ii)         Is

an authorized nuclear pharmacist identified on a specific nuclear pharmacy

license issued by the Agency, the U.S. Nuclear Regulatory Commission, or an

Agreement State; a nuclear pharmacy use permit issued by a U.S. Nuclear

Regulatory Commission master material licensee; a permit issued by a U.S.

Nuclear Regulatory Commission or an Agreement State broad scope medical use

licensee; or a permit issued by a U.S. Nuclear Regulatory Commission master

material license broad scope medical use permittee; and has experience with the

radiation safety aspects of similar types of use of radioactive material for

which the licensee seeks the approval of the individual as the Radiation Safety

Officer or Associate Radiation Safety Officer; or

iii)        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

Radiation Safety Officer and the authorized user on the same new nuclear

pharmacy license.

D)        Has

training in the radiation safety, regulatory issues, and emergency procedures

for the types of use for which a licensee seeks approval

erience with the radiation safety aspects of the types of use of radioactive

material for which the individual is seeking simultaneous approval both as the

Radiation Safety Officer and the authorized user on the same new nuclear

pharmacy license.

D)        Has

training in the radiation safety, regulatory issues, and emergency procedures

for the types of use for which a licensee seeks approval.  This training

requirement may be satisfied by completing training that is supervised by a

Radiation Safety Officer, Associate Radiation Safety Officer, or authorized

nuclear pharmacist, as appropriate, who is authorized for the types of use for

which the licensee is seeking approval.

18)         Training

for an authorized nuclear pharmacist.  Except as provided in subsection

(c)(19), the licensee shall require the authorized nuclear pharmacist to be a

State of Illinois licensed pharmacist who:

A)        Is

certified as a nuclear pharmacist by a specialty board whose certification

process has been recognized by the U.S. Nuclear Regulatory Commission or an

Agreement State.  To be recognized, a specialty board shall require a candidate

for certification to:

i)          Graduate

from a pharmacy program accredited by the Accreditation Council for Pharmacy

Education (ACPE) (previously named the American Council of Pharmaceutical Education)

or pass the Foreign Pharmacy Graduate Examination Committee (FPGEC)

examination;

ii)         Hold a current,

active license to practice pharmacy;

iii)        Provide

evidence of having acquired at least 4000 hours of training/experience in

nuclear pharmacy practice

d by the Accreditation Council for Pharmacy

Education (ACPE) (previously named the American Council of Pharmaceutical Education)

or pass the Foreign Pharmacy Graduate Examination Committee (FPGEC)

examination;

ii)         Hold a current,

active license to practice pharmacy;

iii)        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 2,000 hours of the required training and experience; and

iv)        Pass

an examination in nuclear pharmacy, administered by diplomate of the specialty

board, that evaluates knowledge and competency in procurement, compounding,

quality assurance, dispensing, distribution, health and safety, radiation

safety, provision of information and consultation, monitoring patient outcomes,

research, and development; or

B)        Has

completed 700 hours in a structured educational program consisting of:

i)          200

hours of classroom and laboratory training in radiation physics and

instrumentation, radiation protection, mathematics pertaining to the use and

measurement of radioactivity, chemistry of radioactive material for medical use

and, radiation biology; and

ii)         Supervised

practical experience in a nuclear pharmacy involving shipping, receiving and

performing related radiation surveys; 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; calculating, assaying and safely preparing dosages for patients

or human research subjects; use of administrative controls to avoid medical

events in the administration of radioactive material; use of procedures to

prevent or minimize radioactive contamination and use of proper decontamination

procedures; and

iii)        Has

obtained written attestation, signed by a preceptor authorized nuclear

pharmacist, that the individual has satisfactorily complet

s

or human research subjects; use of administrative controls to avoid medical

events in the administration of radioactive material; use of procedures to

prevent or minimize radioactive contamination and use of proper decontamination

procedures; and

iii)        Has

obtained written attestation, signed by a preceptor authorized nuclear

pharmacist, that the individual has satisfactorily completed the requirements

in subsections (c)(18)(B)(i) and (ii) and is able to independently fulfill the

radiation safety-related duties as an authorized nuclear pharmacist;

19)         An

individual identified as an authorized nuclear pharmacist on an Agency, U.S.

Nuclear Regulatory Commission, or Agreement State license or a permit issued by

an Agency, U.S. Nuclear Regulatory Commission or Agreement State broad scope

licensee or master materials license permit or by a master materials license

permittee of broad scope on or before January 14, 2022 need not comply with the

training requirements in subsection (c)(18);

20)         Training

for Experienced Radiation Safety Officer, nuclear pharmacist, or authorized

nuclear pharmacist.

A)        An

individual identified on an Agency,  U.S. Nuclear Regulatory Commission, or an

Agreement State license or a permit issued by an Agency, U.S. Nuclear

Regulatory Commission, or an Agreement State broad scope licensee or master

material license permit or by a master material license permittee of broad

scope as a Radiation Safety Officer, a nuclear pharmacist or an authorized

nuclear pharmacist on or before January 14, 2022, need not comply with the

training requirements of 32 Ill. Adm. Code 335.9010, 335.9150, or subsection (c)(18),

respectively, except the Radiation Safety Officers identified in this

subsection shall meet the training requirements in 32 Ill. Adm. Code

335.9010(e) or 335.9150(d) for any material or uses for which they were not

authorized prior to this date

armacist on or before January 14, 2022, need not comply with the

training requirements of 32 Ill. Adm. Code 335.9010, 335.9150, or subsection (c)(18),

respectively, except the Radiation Safety Officers identified in this

subsection shall meet the training requirements in 32 Ill. Adm. Code

335.9010(e) or 335.9150(d) for any material or uses for which they were not

authorized prior to this date.

B)        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 (c)(17) to be

identified as a Radiation Safety Officer or as an Associate Radiation Safety

Officer on an Agency license for those materials and uses that these

individuals performed on or before October 24, 2005.

C)        A

Radiation Safety Officer or a nuclear pharmacist, who used only

accelerator-produced radioactive materials, discrete sources of radium-226, or

both, for medical 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 recognized

by NRC, need not comply with the training requirements of subsection (c)(17) or

accelerator-produced radioactive materials, discrete sources of radium-226, or

both, for medical 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 recognized

by NRC, need not comply with the training requirements of subsection (c)(17) or

(c)(18), respectively, when performing the same uses.  A nuclear pharmacist,

who only prepared radioactive drugs containing accelerator-produced radioactive

material at the locations and during the time period identified in this

subsection, qualifies as an authorized nuclear pharmacist for those materials

and uses performed before these dates, for the purposes of this Section.

D)        Individuals

who need not comply with training requirements as described in this Section may

serve as preceptors for, and supervisors of, applicants seeking authorization

on Agency licenses for the same uses for which these individuals are

authorized.

21)         Recentness

of Training.  The training and experience specified in subsections (c)(17) and

(c)(18) shall have been obtained within the seven years preceding the date of

application or the individual shall have had related continuing education and

experience since the required training and experience was completed;

22)         Resolution

of Conflicting Requirements During Transition Period.  If this Part conflicts

with the licensee's radiation safety program as identified in its license, this

Part shall apply unless the statements, representations, conditions and

procedures in the license are more restrictive.  However, if the licensee

exercises its privilege to amend its license, the portion amended must comply

with the requirements of this Part.

23)        Licensing

the production of PET radioactive drugs for noncommercial distribution within a

consortium

d in its license, this

Part shall apply unless the statements, representations, conditions and

procedures in the license are more restrictive.  However, if the licensee

exercises its privilege to amend its license, the portion amended must comply

with the requirements of this Part.

23)        Licensing

the production of PET radioactive drugs for noncommercial distribution within a

consortium.  An application from a medical facility or educational institution

to produce PET radioactive drugs for noncommercial distribution within its

consortium for use under 32 Ill. Adm. Code 335 or equivalent regulations of the

U.S. Nuclear Regulatory Commission or an Agreement State shall include:

A)        A

request for authorization to produce PET radionuclides or evidence of an

existing license issued under this Part or equivalent regulations of the U.S.

Nuclear Regulatory Commission or an Agreement State; and

B)        Evidence

that the applicant is qualified to produce radioactive drugs for medical use by

meeting one of the criteria in subsection (c)(2); and

C)        If the

applicant is a nuclear pharmacy:

i)          Verification

that the applicant satisfies the requirements of this Section that apply to

nuclear pharmacies; and

ii)         Identification

of each individual authorized to prepare the PET radioactive drugs and documentation

that each meets the requirements of an authorized nuclear pharmacist; and

D)        The

information required by subsection (c)(4) for each PET radioactive drug to be

noncommercially distributed within the consortium; and

E)        Verification

that the applicant is in compliance with:

i)          Applicable

FDA and other Federal and State requirements governing radioactive drugs; and

ii)         The

labeling requirements of subsection (c)(5) for each PET radioactive drug

transport radiation shield and each syringe, vial or other container used to

hold a PET radioactive drug intended for noncommercial distribution to members

of its consortium; and

iii)        The

nce with:

i)          Applicable

FDA and other Federal and State requirements governing radioactive drugs; and

ii)         The

labeling requirements of subsection (c)(5) for each PET radioactive drug

transport radiation shield and each syringe, vial or other container used to

hold a PET radioactive drug intended for noncommercial distribution to members

of its consortium; and

iii)        The

requirements of subsections (c)(7), (12), (13), (14), (17), and (22).

AGENCY NOTE:  Subsection (c)(7)

contains requirements for measuring the radioactivity of radioactive drugs.

24)        A

licensee shall satisfy the labeling requirements in subsection (c)(5).

d)         Use

of Sealed Sources in Industrial Radiography.  A specific license for use of

sealed sources in industrial radiography shall be issued only if the applicant

has met the requirements of this Part and 32 Ill. Adm. Code 350 and 405.

e)         Use of Radioactive Materials in Wireline Service Operations

and Subsurface Tracer Studies.  A specific license for use of radioactive

material in wireline operations shall be issued only if the applicant has met

the requirements of this Part and 32 Ill. Adm. Code 351.

AGENCY NOTE:  Specialty boards

whose certification processes have been recognized by the Agency, the U.S.

Nuclear Regulatory Commission or an Agreement State will be posted on NRC's website.