Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
rule, "mobile opioid treatment program" has the same meaning as "mobile
narcotic treatment program" as used in 21 CFR part 1301
(7/12/2021).
(B)
For any opioid treatment program intending to operate a
mobile opioid treatment program, the licensee shall notify the local drug
enforcement administration (DEA) office, in writing, its intent to do so, and
the opioid treatment program must receive explicit written approval from the
local DEA office prior to operating the mobile opioid treatment program. The
mobile opioid treatment program may only operate in the same state in which the
opioid treatment program is registered with the DEA.
(1)
Licensees are not
required to obtain a separate terminal distributor of dangerous drugs license
for conveyances (mobile components) utilized by the licensee to transport
dangerous drugs away from licensed locations for use as part of a mobile opioid
treatment program. Vehicles must possess valid county/city and state
information (e.g., a vehicle identification number (VIN) or license plate
number) on file at the licensed location of the opioid treatment program
licensed by the board.
(2)
A mobile opioid treatment program is not permitted to
reverse distribute, share, or transfer dangerous drugs from one mobile
component to another mobile component while deployed outside of the licensed
location. These mobile components of opioid treatment programs may not function
as hospitals, long-term care facilities, or emergency medical service vehicles,
and shall not transport patients.
(C)
For any
conveyance operated as a mobile opioid treatment program, a securely locked
safe must be installed and used to store dangerous drugs in schedules II-V for
the purpose of maintenance or detoxification treatment, when not located at the
licensee's licensed location.
(1)
The safe must conform to the requirements set forth in
paragraph (a)(1) of
21
CFR 1301.72 (7/12/2021).
(2)
The mobile
component shall also be equipped with an alarm system that conforms to the
requirements set forth paragraph (a)(1)(iii) of
21
CFR 1301.72 (7/12/2021).
(3)
The storage area
of the mobile component must conform to the accessibility requirements in
paragraph (d) of
21
CFR 1301.72 (7/12/2021).
(4)
The storage area
for controlled substances in a mobile component of an opioid treatment program
must not be accessible from outside of the vehicle.
(a)
Authorized
personnel transporting the controlled substances on behalf of the mobile opioid
treatment program are required to retain control over the controlled substances
when transferring controlled substances between the licensed location and the
conveyance, from the conveyance to the location where medication will be
administered or personally furnished, and when administering or personally
furnishing medication. At all other times during transportation, all controlled
substances must be properly secured in the safe.
(b)
Upon completion
of the operation of the conveyance on a given day, the conveyance must be
immediately returned to the licensed location, and all controlled substances
must be removed from the conveyance and secured within the licensed opioid
treatment program. After the conveyance has returned to the registered location
and the controlled substances have been removed, the conveyance may be parked
until its next use at the licensed location or any secure, fenced-in area, once
the local DEA office has been notified of the location of this secure,
fenced-in area.
(c)
A mobile opioid treatment program may apply to the DEA
for an exception to the requirements in paragraph (C)(4)(b) of this rule.
(i)
The application
for such an exception shall be submitted in accordance with
21
CFR 1301.72.
(ii)
If an exception
is granted, the licensee shall comply with the security conditions set forth in
the approval granted by the DEA. Any conveyance maintained in accordance with
an exception granted under this rule shall be subject to inspection by a board
of pharmacy agent.
(iii)
If an exception is revoked or otherwise rescinded by
the DEA, the licensee shall comply with the requirements in paragraph (C)(4)(b)
of this rule.
(iv)
All approvals from the DEA shall be maintained at the
licensed location and made immediately available for inspection by an agent of
the state board of pharmacy.
(d)
All opioid
treatment programs with mobile components shall be required to establish a
standard operating procedure to ensure, if the mobile component becomes
inoperable (mechanical failure, accidents, fire, etc.), that the controlled
substances on the inoperable conveyance are accounted for, removed from the
inoperable conveyance, and secured at the licensed location.
(5)
Only
prescribers, pharmacists, and nurses licensed under Chapter 4723. of the
Revised Code may have access to controlled substances maintained by the mobile
opioid treatment program.
(D)
Persons enrolled
in any opioid treatment program, including those receiving treatment at a
mobile opioid treatment program, will be required to wait in an area that is
physically separated from the medication storage area and areas used for
administration or personally furnishing by a physical entrance such as a door
or other entryway. Patients will need to wait outside of a mobile opioid
treatment program if that unit does not have seating or a reception area that
is separated from the medication storage area and areas used for administration
or personally furnishing. This requirement shall be enforced by the terminal
distributor of dangerous drugs and the licensee's employees.
(E)
Any controlled
substances being transported for disposal from the location where the drugs are
administered or personally furnished shall be secured and disposed of in
compliance with 21 CFR 1317 (7/12/2021) and rule
4729:5-3-01 of the
Administrative Code.
(F)
A conveyance used as part of a mobile opioid treatment
program may only be supplied with controlled substance dangerous drugs by the
licensed opioid treatment program that operates such conveyance. Persons
permitted to administer or personally furnish controlled substances from mobile
opioid treatment programs shall not:
(1)
Receive controlled substances from other mobile opioid
treatment program or any other entity;
(2)
Deliver
controlled substances to other mobile opioid treatment program or any other
entity; or
(3)
Conduct reverse distribution of controlled substances
on a mobile opioid treatment program.
(G)
A mobile opioid
treatment program shall maintain records with the following information for
each dangerous drug:
(1)
Name of drug;
(2)
Strength of
drug;
(3)
Dosage form;
(4)
Date
dispensed;
(5)
Adequate identification of patient
(consumer);
(6)
Amount consumed;
(7)
Amount and dosage
form taken home by patient; and
(8)
Initials of the
employee personally furnishing or administering a drug.
(H)
The
records required by paragraph (G) of this rule shall be maintained in a log at
the licensed opioid treatment program.
(1)
As an alternative
to maintaining a paper log, an opioid treatment program may also use an
automated/computerized data processing system for the storage and retrieval of
the program's records, if the following conditions are met:
(a)
The automated
system maintains the information required in paragraph (G) if this
rule;
(b)
The automated system has the capability of producing a
hard copy printout of the records required in paragraph (G) of this
rule;
(c)
The opioid treatment program or its mobile component
prints a hard copy of each day's log, which is then initialed appropriately by
each person who personally furnished/administered the medication to the
program's patients;
(d)
The automated system is approved by
DEA;
(e)
The opioid treatment program or its mobile component
maintains an offsite back-up of all computer generated program information;
and
(f)
The automated system is capable of producing accurate
summary reports for both the licensed site of the opioid treatment program and
any mobile component, for any time-frame selected by DEA personnel during an
investigation. If these summary reports are maintained in hard copy form, they
must be kept in a systematically organized file located at the licensed opioid
treatment program.
(2)
The opioid
treatment program must retain all records for any mobile component three years
from the date of execution.
(I)
A mobile opioid
treatment program shall comply with all other applicable requirements of 21 CFR
1301 (7/12/2021).
