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. 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 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 (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. 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. 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. 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.
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. 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.
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.
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). 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. 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. 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. 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. 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. 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 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.
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 (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. 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 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).