(A) An application
for a specific license to manufacture, prepare, or transfer for commercial
distribution radioactive drugs containing radioactive material for use by
persons authorized pursuant to Chapter 3701:1-58 of the Administrative Code or
equivalent regulations of an agreement state will be approved if:
(1) The applicant satisfies the general
requirements specified in rule
3701:1-40-15
of the Administrative Code;
(2) The
applicant submits evidence that the applicant is at least one of the following:
(a) Registered with the United States food
and drug administration as the owner or operator of a drug establishment that
engages in the manufacture, preparation, propagation, compounding, or
processing of a drug under 21 C.F.R. 207.20(a) (as in effect on the effective date of this
rule);
(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 positron emission tomography (PET) drug
production facility registered with a state agency.
(3) 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;
and
(4) 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 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 one hundred 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.
(B) A licensee described by paragraph
(A)(2)(c) or (A)(2)(d) of this rule:
(1) May
prepare radioactive drugs for medical use, as defined in rule
3701:1-38-01 of the
Administrative Code, provided that the radioactive drug is prepared by either
an authorized nuclear pharmacist, as specified in paragraphs (B)(2) and (B)(3)
of this rule, or an individual under the supervision of an authorized nuclear
pharmacist as specified in rule
3701:1-58-14 of the
Administrative Code.
(2) May allow
a pharmacist to work as an authorized nuclear pharmacist if:
(a) This individual qualifies as an
authorized nuclear pharmacist as defined in rule
3701:1-58-01 of the
Administrative Code,
(b) This
individual meets the requirements specified in paragraph (B) of rule
3701:1-58-20
of the Administrative Code and rule
3701:1-58-22
of the Administrative Code and the licensee has received an approved license
amendment identifying this individual as an authorized nuclear pharmacist,
or
(c) This individual is
designated as an authorized nuclear pharmacist in accordance with paragraph
(B)(4) of this rule.
(3)
The actions authorized in paragraphs (B)(1) and (B)(2) of this rule are
permitted in spite of more restrictive language in license
conditions.
(4) May designate a
pharmacist as an authorized nuclear pharmacist if:
(a) The individual was a nuclear pharmacist
preparing only radioactive drugs containing accelerator-produced radioactive
material, and
(b) 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 United States nuclear regulatory
commission.
(5) Shall
provide to the director a copy of:
(a)
A copy of
each individual's certification by a specialty board whose certification
process has been recognized by the United States nuclear regulatory commission
or an agreement state as specified in paragraph (A) of rule
3701:1-58-20
of the Administrative Code ; or
(b) The United States nuclear regulatory
commission or agreement state license; or
(c) The permit issued by a United States
nuclear regulatory commission master materials licensee; or
(d) The permit issued by a licensee or United
States nuclear regulatory commission master materials permittee of broad scope;
or
(e) The authorization from a
commercial nuclear pharmacy authorized to list its own authorized nuclear
pharmacist; or
(f) 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 United States nuclear regulatory
commission; and
(g) State pharmacy
licensure or registration, no later than thirty days after the date that the
licensee allows, under paragraphs (B)(2)(a) and (B)(2)(c) of this rule, the
individual to work as an authorized nuclear pharmacist.
(C) 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:
(1) 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
(2)
Check each instrument for constancy and proper operation at the beginning of
each day of use.
(D)
A licensee shall satisfy the labeling requirements in
paragraph (A)(4) of this rule.
(E) Nothing in this
rule relieves the licensee from complying with applicable United States food
and drug administration, other federal, and state requirements governing
radioactive drugs.