07 LC
36 0803S
The
House Committee on Regulated Industries offers the following substitute
to
SB 178:
SB 178:
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Code Section 26-4-60 of the Official Code of Georgia Annotated, relating
to grounds for suspension, revocation, or refusal to grant licenses by the State
Board of Pharmacy, so as to provide that the use of the mails or other common
carriers to sell, distribute, and deliver a prescription drug directly to a
patient under certain circumstances shall not be considered grounds for
sanctioning the license of a pharmacist; to provide for related matters; to
repeal conflicting laws; and for other purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Code
Section 26-4-60 of the Official Code of Georgia Annotated, relating to grounds
for suspension, revocation, or refusal to grant licenses by the State Board of
Pharmacy, is amended by revising paragraph (11) of subsection (a) as
follows:
"(11)
Regularly employing the mails or other common carriers to sell, distribute, and
deliver a drug which requires a prescription directly to a patient; provided,
however, that this provision shall not prohibit the use of the mails or other
common carriers to sell, distribute, and deliver a prescription drug directly
to:
(A)
A patient or directly to a patient´s guardian or caregiver or a physician
or physician acting as the patient´s agent for whom the prescription drug
was prescribed if:
(i)
Such prescription drugs are prescribed for complex chronic, terminal, or rare
conditions;
(ii)
Such prescription drugs require special administration, comprehensive patient
training, or the provision of supplies and medical devices or have unique
patient compliance and safety monitoring requirements;
(iii)
Due to the prescription drug´s high monetary cost, short shelf life,
special manufacturer specified packaging and shipping requirements or
instructions which require temperature sensitive storage and handling, limited
availability or distribution, or other factors, the drugs are not generally
carried in the regular inventories of retail pharmacies such that the drugs
could be immediately dispensed to multiple retail walk-in patients;
(iv)
Such prescription drug has an annual retail value to the patient of more than
$6,000.00;
(v)
The patient receiving the prescription drug consents to the delivery of the
prescription drug via expedited overnight common carrier and designates the
specialty pharmacy to receive the prescription drug on his or her
behalf;
(vi)
The specialty pharmacy utilizes, as appropriate and in accordance with standards
of the manufacturer, United States Pharmacopeia, and Federal Drug Administration
and other standards adopted by the State Board of Pharmacy, temperature tags,
time temperature strips, insulated packaging, or a combination of these;
and
(vii)
The specialty pharmacy establishes and notifies the enrollee of its policies and
procedures to address instances in which medications do not arrive in a timely
manner or in which they have been compromised during shipment and to assure that
the pharmacy replaces or makes provisions to replace such drugs; or
(B)
An
an
institution or to sell, distribute, or deliver prescription drug refills, upon
his or her request, to an enrollee in a health benefits plan of a group model
health maintenance organization or its affiliates by a pharmacy which is
operated by that same group model health maintenance organization and licensed
under Code Section 26-4-110. Any pharmacy using the mails or other common
carriers to dispense prescriptions pursuant to this paragraph shall comply with
the following conditions:
(A)(i)
The pharmacy shall provide an electronic, telephonic, or written communications
mechanism which reasonably determines whether the medications distributed by the
mails or other common carriers have been received by the enrollee and through
which a pharmacist employed by the group model health maintenance organization
or a pharmacy intern under his or her direct supervision is enabled to offer
counseling to the enrollee as authorized by and in accordance with his or her
obligations under Code Section 26-4-85, unless the enrollee refuses such
consultation or counseling pursuant to subsection (e) of such Code section. In
addition, the enrollee shall receive information indicating what he or she
should do if the integrity of the packaging or medication has been compromised
during shipment;
(B)(ii)
In accordance with clinical and professional standards, the State Board of
Pharmacy shall promulgate a list of medications which may not be delivered by
the mails or other common carriers. However, until such list is promulgated,
the group model health maintenance organization shall not deliver by use of the
mails or other common carriers Class II controlled substance medications,
medications which require refrigeration, chemotherapy medications deemed by the
federal Environmental Protection Agency as dangerous, medications in suppository
form, and other medications which, in the professional opinion of the dispensing
pharmacist, may be clinically compromised by distribution through the mail or
other common carriers;
(C)(iii)
The pharmacy shall utilize, as appropriate and in accordance with standards of
the manufacturer, United States Pharmacopeia, and Federal Drug Administration
and other standards adopted by the State Board of Pharmacy, temperature tags,
time temperature strips, insulated packaging, or a combination of these;
and
(D)(iv)
The pharmacy shall establish and notify the enrollee of its policies and
procedures to address instances in which medications do not arrive in a timely
manner or in which they have been compromised during shipment and to assure that
the pharmacy replaces or makes provisions to replace such drugs.
For
purposes of
subparagraph
(B) of this paragraph, the term 'group
model health maintenance organization' means a health maintenance organization
that has an exclusive contract with a medical group practice to provide or
arrange for the provision of substantially all physician services to enrollees
in health benefits plans of the health maintenance
organization;"
SECTION
2.
All
laws and parts of laws in conflict with this Act are repealed.