§461-10.5  Remote dispensing pharmacy;
operations.  [Section repealed on January 2, 2014.  L 2009, c 96, §3.] 
(a)  A remote dispensing pharmacy shall be under the direct supervision of the
registered pharmacist in charge of the responsible pharmacy who shall:



(1)  Ensure that the remote dispensing pharmacy is in
compliance with all laws and rules governing the practice of pharmacy and
remote dispensing;



(2)  Ensure that the remote dispensing pharmacy is
appropriately staffed by a qualified remote dispensing technician; and



(3)  Be responsible for the integrity of the drugs in
the remote dispensing machine and ensure that drugs for the remote dispensing
machine are provided to the remote dispensing pharmacy only from the
responsible pharmacy.



(b)  A remote dispensing pharmacy shall:



(1)  Be effectively secured to prevent unauthorized
access at all times and limit entry to authorized personnel only;



(2)  Be connected via live computer link, video link,
and audio link to the responsible pharmacy through the information technology
system of the responsible pharmacy;



(3)  Conspicuously display at the remote dispensing
machine:



(A)  A copy of the license of the responsible
pharmacy; and



(B)  A copy of the license of the pharmacist in
charge of the responsible pharmacy; and



(4)  Have a confidential area available for
communication between the patient and the pharmacist at the responsible
pharmacy.



(c)  No remote dispensing pharmacy shall
operate within a five mile radius of any pharmacy as defined under section 461-1;
provided that:



(1)  This subsection shall not apply to any remote
dispensing pharmacy established prior to July 3, 2008 that has previously
dispensed and will continue to dispense only prescription medications acquired
pursuant to section 340B of the Public Health Service Act, Title 42 United
States Code section 256b;



(2)  If an appropriately designated pharmacy, as
defined in section 461-1, is established within a five mile radius of an
existing remote dispensing pharmacy exempted by this subsection, all
appropriate measures shall be taken to encourage the relocation of the existing
remote dispensing machine within the newly established pharmacy; and



(3)  This subsection shall not apply to any remote
dispensing pharmacy established in a facility operated by a health maintenance
organization regulated pursuant to chapter 432D for the exclusive use of
patients served at the facility.



(d)  Remote dispensing pharmacies shall not
provide medications to patients with health insurance coverage, except for:



(1)  Patients covered by QUEST;



(2)  Patients served at a facility operated by a
health maintenance organization regulated pursuant to chapter 432D; or



(3)  Patients residing on an island without a pharmacy
or in remote areas without an existing pharmacy within a five mile radius.  A
remote dispensing pharmacy established pursuant to this subsection may continue
to operate in the same location if a pharmacy is subsequently established on
the same island as the remote dispensing pharmacy or in the remote area without
an existing pharmacy within a five mile radius; provided that the remote
dispensing pharmacy shall no longer be authorized to dispense controlled
substances.



(e)  The remote dispensing technician shall
offer each patient the option of receiving counseling by a pharmacist at the
responsible pharmacy for all prescriptions.



(f)  A pharmacist at the responsible pharmacy
shall approve each prescription before it is dispensed to the patient.



(g)  Each remote dispensing machine shall be
operated by only one responsible pharmacy.  A responsible pharmacy may operate
more than one remote dispensing machine.



(h)  The remote dispensing machine shall have
the following features to ensure that it is appropriately secure at all times
and that all transactions are properly documented:



(1)  Secure double-locked cabinets;



(2)  Bar-coding or similar technology that effectively
recognizes the product;



(3)  A cabinet that delivers only one bar-coded
unit-of-use container per dispensation, per prescription;



(4)  A scanner and printer that, upon releasing the
unit-of-use container from the remote dispensing machine, scans the container
to confirm it is the correct container, and if confirmed, prints a
patient-specific label that has a bar code which is scanned to confirm it is
the correct label for the prescription; and



(5)  A video component that allows the patient to have
a "face-to-face" consultation with the pharmacist at the responsible
pharmacy.



(i)  A pharmacist shall be in charge of the
remote dispensing machine and shall ensure that:



(1)  Written policies and procedures are developed
before the machine is used that:



(A)  Ensure the safe and effective dispensing
of pharmaceutical products;



(B)  Ensure that the remote dispensing pharmacy
and the remote dispensing machine are operating safely, accurately, and
securely; and



(C)  Define the conditions for access to the
remote dispensing machine and to medications contained within or associated
with the machine, including policies that assign, discontinue, or change access
to the remote dispensing machine and medications;



(2)  A pharmacist licensed in this State and employed
by the responsible pharmacy has secured access to the drugs in the remote
dispensing machine;



(3)  Access to the drugs in the remote dispensing
machine complies with state and federal laws, rules, and regulations;



(4)  No prescription drug is dispensed at the remote
dispensing pharmacy until a pharmacist at the responsible pharmacy has verified
the finished prescription;



(5)  Only one prescription is dispensed and labeled
from the remote dispensing machine at a time;



(6)  All prescriptions dispensed have a label affixed
to the final drug container that meets the requirements set forth in section
328-16 and includes the address of the remote dispensing pharmacy;



(7)  If a patient refuses the prescription drug at the
time it is dispensed, the prescription drug is locked in a secured cabinet;



(8)  There is proper inventory control at the remote
dispensing pharmacy and only a registered pharmacist or a remote dispensing
technician assigned by the pharmacist in charge of the responsible pharmacy
shall stock the remote dispensing machine;



(9)  A reconciliation of the physical inventory of the
remote dispensing pharmacy is conducted at least annually;



(10)  All personnel who operate the remote dispensing
machine at the remote dispensing pharmacy are properly trained.  Training shall
ensure the competence and ability of all personnel who operate any component of
the remote dispensing machine and the remote dispensing pharmacy. 
Documentation of training shall be kept by the responsible pharmacy; and



(11)  The remote dispensing machine is stocked
accurately and in accordance with established written policies and procedures. 
The pharmacist shall check the accuracy of the product supplied for stocking
the remote dispensing machine.



(j)  Controlled substances shall not be
dispensed from any remote dispensing machine or remote dispensing pharmacy,
except:



(1)  On islands without a pharmacy, or in remote areas
without an existing pharmacy within a five mile radius; and



(2)  In a facility operated by a health maintenance
organization regulated pursuant to chapter 432D for the exclusive use of
patients served at the facility.



(k)  Drugs dispensed from the remote dispensing
machine shall be dispensed as packaged, with no changes to the drug, its
strength, or its unit quantity, except for the addition of water for
reconstitution of dry powder drugs.



(l)  Prescription labels for the product
dispensed from the remote dispensing machine shall only be generated at the
remote dispensing pharmacy.



(m)  Records of prescriptions filled at the
remote dispensing pharmacy shall be maintained at the responsible pharmacy and
shall be distinguishable from those records filled at the responsible
pharmacy.  All responsible pharmacies shall maintain, on-site at the remote
dispensing pharmacy and have available for inspection at all times, records and
documentation of the following:



(1)  All prescriptions dispensed at the remote dispensing
pharmacy;



(2)  All inventory movement at the remote dispensing
pharmacy; and



(3)  A policies and procedures manual of the remote
dispensing pharmacy.



(n)  No health insurance provider group,
hospital, or medical service plan regulated under article 431:10A or 432:1 shall
operate a remote dispensing pharmacy.



(o)  This section shall not apply to:



(1)  Mobile medical clinics, provided that no such
clinic shall operate in counties with a population less than one hundred
thousand persons; or



(2)  Federally qualified health centers, provided that
no remote dispensing pharmacy shall operate within a five mile radius of any
pharmacy as defined under section 461-1, except for those federally qualified
health centers that are exempt under subsection (c)(1).



As used in this subsection, "mobile medical
clinic" means a motor vehicle retrofitted for exclusive use as a medical
office or clinic for medical services licensed under chapter 321. [L 2008, c
212, §2; am L 2009, c 96, §2]