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 of this Part;

 

2)         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 or the Public Health Service Act; 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 Public Health Service Act;

 

3)         The applicant submits information on the radionuclide, chemical and physical form, packaging, including maximum activity per package, and shielding provided by the packaging of the radioactive material that is appropriate for safe handling and storage of radiopharmaceuticals by specific licensees;

 

4)         The label affixed to each package of the radiopharmaceutical contains information on the radionuclide, activity and activity assay date and the label affixed to each package, or the leaflet or brochure that accompanies each package, contains a statement that the radiopharmaceutical is licensed by the Agency for distribution to persons licensed pursuant to subsection (a) of this Section for radioactive material specified in 32 Ill. Adm. Code 335.3010, 335.4010 or 335.5010, as appropriate, or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State.  The labels, leaflets or brochures required by this subsection (c)(4) are in addition to the labeling required by the U.S. Food and Drug Administration (FDA) and may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA;

 

5)         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;

 

6)         The applicant satisfies 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 must 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 must 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;

 

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, other Federal and 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)         The licensee shall perform radiometric tests for molybdenum breakthrough for the first elute of a molybdenum-99/technetium-99m generator following transfer in accordance with the requirements of 32 Ill. Adm. Code 335;

 

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)         For licensees authorized to dispense radiopharmaceuticals (such as nuclear pharmacies), the licensee shall ensure radiopharmaceuticals are dispensed only under the prescription of a physician who is authorized in a specific license to use the radiopharmaceuticals.  The licensee shall maintain a copy of the recipient's radioactive material license and shall verify that the physician is authorized to receive the prescribed radiopharmaceutical prior to transfer;

 

14)         A licensee shall apply for and must 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 who is an authorized user 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 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 of this subsection (c)(15) is responsible for the acts and omissions of the supervised individual;

 

16)         A licensee shall apply for and must receive a license amendment identifying an authorized nuclear pharmacist as defined in 32 Ill. Adm. Code 330.20, and the invididual meets the requirements in 330.260(c)(18) and 330.260(c)(21) or for an experienced nuclear pharmacist, 330.260(c)(20) before it allows this individual to work as an authorized nuclear pharmacist;

 

17)         The licensee shall require an individual fulfilling the responsibilities of Radiation Safety Officer to be an individual who:

 

A)        Is certified by a specialty board whose certification has been recognized by the Agency, the U.S. Nuclear Regulatory Commission, an Agreement State or a Licensing State and who meets the requirements in subsections (D) and (E) of this section.  To be recognized, a specialty board shall require all candidates for certification to meet the following requirements 

 

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 5 or more years of professional experience in health physics (graduate training may be substituted for no more than 2 years of the required experience), including at least 3 years in applied health physics; and

 

iii)         Pass an examination administered by diplomats of the specialty board, which 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

 

B)        Has met the requirements of subsections (D) and (E) of this Section and completed a structured educational program consisting of:

 

i)          200 hours of didactic training in the following areas:  radiation physics and instrumentation; radiation protection; mathematics pertaining to the use and measurement of radioactivity; radiation biology; radiation dosimetry; and

 

ii)         1 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, Agreement State or Licensing State license or permit issued by the U.S. Nuclear Regulatory Commission master material licensee that authorizes similar types and uses of radioactive material involving shipping, receiving and performing related radiation monitoring;

 

iii)         Using and performing checks for proper operation of instruments used to determine the activity of dosages, instruments used to measure radionuclides and survey meters;

 

iv)        Securing and controlling radioactive material;

 

v)         Using administrative controls to avoid mistakes in the administration of radioactive material;

 

vi)        Using procedures to prevent or minimize radioactive contamination and using proper decontamination procedures;

 

vii)        Using emergency procedures to control radioactive material; and

 

viii)       Disposing of radioactive material; or

 

C)        Is an authorized nuclear pharmacist identified on the licensee's license, meets the requirements of subsections (D) and (E) of this Section and has experience with the radiation safety aspects of similar types of use of radioactive material for which the individual has Radiation Safety Officer responsibilities; and

 

D)        Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist Radiation Safety Officer, that the individual has satisfactorily completed the requirements in Subsection (E) and subsections (c)(17)(A)(i) and (ii) or (B) or (C) of this Section and has achieved a level of radiation safety knowledge sufficient to function independently as an authorized nuclear pharmacist Radiation Safety Officer; and

 

E)         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 or authorized nuclear pharmacist, as appropriate, who is authorized for the types of use for which the licensee is seeking approval.

 

18)         Before a licensee permits anyone to work as an authorized nuclear pharmacist under his or her license, except for subsection (c)(19) of this Section, 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, Agreement State or Licensing State and who meets the requirements in subsections (B)(iii) of this subsection.  To be recognized, a specialty board shall require all candidates for certification to meet the following requirements:

 

i)           Has graduated from a pharmacy program accredited by the American Council of Pharmaceutical Education ACPE or have passed 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 2000 hours of the required training and experience; and

 

iv)         Pass an examination in nuclear pharmacy, administered by the diplomats of the specialty board, that assessed knowledge and competency in the procurement, compounding, quality assurance, dispensing, distribution, health and safety, radiation safety, provision of information and consultation, monitoring patient outcomes, and research and development; or

 

B)        Has completed 700 hours in a structured educational program consisting of both didactic training in radiation physics and instrumentation or radiation protection; with

 

i)          200 hours of didactic training in radiation physics and instrumentation; radiation protection; mathematics pertaining ot the use and measurement of radioactivity; chemistry of radioactive material for medical use; 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 byproduct 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 subsection (A)(i-iii) or (B) of this Section and has achieved a level of competency sufficient to function independently as an authorized nuclear pharmacist;

 

19)         An individual identified as an authorized nuclear pharmacist on an Agency, U.S. Nuclear Regulatory Commission, Agreement State or Licensing State license or permit issued by an Agency, U.S. Nuclear Regulatory Commission, Agreement State broad scope licensee or master materials license permit or by a master materials license permittee of broad scope;

 

20)         Training for Experienced Nuclear Pharmacist.  A State of Illinois licensed pharmacist who has completed a structured educational program as specified in subsection (c)(18)(B) of this Section before October 24, 2007 and who is working in a nuclear pharmacy would qualify as an experienced nuclear pharmacist.  An experienced nuclear pharmacist need not comply with the requirements for a preceptor statement and recentness of training to qualify as an authorized nuclear pharmacist;

 

21)         Recentness of Training.  The training and experience specified in subsection (c)(18) of this Section must have been obtained within the 7 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;

 

22)         Resolution of Conflicting Requirements During Transition Period

 

A)        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.

 

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, an Agreement State or a Licensing State will be posted on the NRC's Web page.

 

(Source:  Amended at 32 Ill. Reg. 9199, effective June 13, 2008)