Ohio Admin. Code 4729:5-8-05 - Preparation, compounding, dispensing, and repackaging of radiopharmaceuticals by a nonresident pharmacy
(A)
Except as
otherwise provided in this rule, terms used in this rule have the same meaning
as in rule
4729:5-6-01 of the
Administrative Code.
(B)
Only a pharmacy licensed as a nonresident terminal
distributor of dangerous drugs may dispense or sell patient-specific
radiopharmaceuticals into this state and shall comply with all the
following:
(1)
All radiopharmaceuticals shall be dispensed pursuant to a
patient-specific prescription or order issued by a licensed health professional
authorized to prescribe drugs.
(a)
A limited quantity may be prepared and distributed in
anticipation of prescriptions based on routine, regularly observed prescribing
patterns.
(b)
In the event a patient's name is not available at the
time of dispensing, a nonresident nuclear pharmacy shall have up to seventy-two
hours to obtain the name of the patient. No later than seventy-two hours after
dispensing the radiopharmaceutical, the patient's name must be associated with
the prescription in the dispensing records maintained by the nonresident
pharmacy.
(2)
Comply with the requirements of USP
<825>.
(3)
Shall have an authorized nuclear pharmacist licensed in
this state as its responsible person. The requirement for the responsible
person to obtain Ohio licensure shall take effect on June 30,
2022.
(C)
Radiopharmaceuticals shall be labeled in accordance
with USP <825>.
(1)
In addition to the requirements in paragraph (C) of
this rule, the outer shielding shall also be labeled with the following:
(a)
The name and
telephone number of the pharmacy;
(b)
The prescription
number; and
(c)
The patient's name (first name and last name or first
initial and last name), if available at the time of dispensing.
(2)
In
addition to the requirements in paragraph (C) of this rule, the immediate
container shall also be labeled with the following information:
(a)
The prescription
number; and
(b)
The patient's name (first name and last name or first
initial and last name), if available at the time of dispensing.
(D)
A pharmacy licensed as a nonresident terminal
distributor shall ensure that all employees comply with all applicable local,
state, and federal requirements for the proper labeling, environmental
controls, integrity, and safety of all products transported.
(E)
A pharmacy
licensed as a nonresident terminal distributor shall ensure that all employees
comply with all applicable local, state, and federal requirements for the
disposal of radioactive and/or biohazardous waste in a manner so as not to
endanger the health and safety of the public.
(F)
A terminal
distributor shall report any event as a medical event, except for an event that
results from patient intervention, to the United States nuclear regulatory
commission in accordance with
10 CFR
35.3045 (6/2/2020).
(G)
A pharmacy
licensed as a nonresident terminal distributor shall report to the state board
of pharmacy, within seventy-two hours and in a manner determined by the board,
any warning letters, injunctions, or decrees issued by the United States food
and drug administration or any other federal or state agency.
(H)
If a pharmacy is
applying for an initial nonresident terminal distributor of dangerous drugs
license, renewal, or their license has lapsed, the pharmacy shall provide any
of the following, in a manner determined by the board, as part of the initial
or renewal application:
(1)
The most recent inspection report that is less than two
years old that demonstrates applicable compliance with USP <825>
conducted by an agent of the regulatory or licensing agency in the pharmacy's
resident jurisdiction or an agent of a regulatory or licensing agency from
another licensing jurisdiction;
(2)
The most recent
inspection report that is less than two years old that demonstrates applicable
compliance with USP <825> rule by the national association of boards of
pharmacy's verified pharmacy program; or
(3)
Any other
documentation of compliance as determined by the state board of
pharmacy.
(I)
This rule does not apply to a pharmacy licensed as a
nonresident terminal distributor of dangerous drugs that prepares compounded
drug preparations in accordance with rule
4729:5-8-04 of the
Administrative Code.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54, 4729.55
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