06 LC 33
1301S
The
House Committee on Health and Human Services offers the following
substitute to HB 1178:
substitute to HB 1178:
A
BILL TO BE ENTITLED
AN ACT
AN ACT
To
amend Chapter 4 of Title 26 of the Official Code of Georgia Annotated, relating
to pharmacists and pharmacies, so as to provide for the establishment of a
program through which unused prescription drugs may be distributed for use by
medically indigent persons; to provide for a short title; to provide for
definitions; to provide for a pilot program; to provide for the establishment of
rules and regulations; to provide for timelines; to provide for limited
liability; to provide for construction; to amend Article 7 of Chapter 4 of Title
49 of the Official Code of Georgia Annotated, relating to medical assistance
generally, so as to provide for certain coverage for pharmacy restocking fees;
to provide for related matters; to repeal conflicting laws; and for other
purposes.
BE
IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:
SECTION
1.
Chapter
4 of Title 26 of the Official Code of Georgia Annotated, relating to pharmacists
and pharmacies, is amended by adding a new Article 11 to read as
follows:
"ARTICLE
11
26-4-190.
This
article shall be known and may be cited as the 'Utilization of Unused
Prescription Drugs Act.'
26-4-191.
As
used in this article, the term:
(1)
'Controlled substance' means a drug, substance, or immediate precursor in
Schedules I through V of Code Sections 16-13-25 through 16-13-29 and Schedules I
through V of 21 C.F.R. Part 1308.
(2)
'Health care facility' means an institution which is licensed as a nursing home,
intermediate care home, personal care home, home health agency, or hospice
pursuant to Chapter 7 of Title 31.
(3)
'Medically indigent person' means:
(A)
A person who is Medicaid eligible under the laws of this state; or
(B)
A person:
(i)
Who is without health insurance; or
(ii)
Who has health insurance that does not cover the injury, illness, or condition
for which treatment is sought; and
whose
family income does not exceed 200 percent of the federal poverty level as
defined annually by the federal Office of Management and Budget.
26-4-192.
(a)
The Georgia State Board of Pharmacy, the Department of Human Resources, and the
Department of Community Health shall jointly develop and implement a state-wide
program consistent with public health and safety standards through which unused
prescription drugs, other than prescription drugs defined as controlled
substances, may be transferred from health care facilities to pharmacies
designated or approved by the Department of Human Resources for the purpose of
distributing such drugs to residents of this state who are medically indigent
persons.
(b)
The Georgia State Board of Pharmacy, the Department of Human Resources, and the
Department of Community Health shall be authorized to develop and implement a
pilot program to determine the safest and most beneficial manner of implementing
the program prior to the state-wide implementation of the program required in
subsection (a) of this Code section.
(c)
The Georgia State Board of Pharmacy, in consultation with the Department of
Human Resources and the Department of Community Health, shall develop and
promulgate rules and regulations to establish procedures necessary to implement
the program and pilot program, if applicable, provided for in this Code section.
The rules and regulations shall provide, at a minimum:
(1)
For an inclusionary formulary for the prescription drugs to be distributed
pursuant to the program;
(2)
For the protection of the privacy of the individual for whom a prescription drug
was originally prescribed;
(3)
For the integrity and safe storage and safe transfer of the prescription drugs,
which may include, but shall not be limited to, limiting the drugs made
available through the program to those that were originally dispensed by unit
dose or an individually sealed dose and that remain in intact packaging;
provided, however, that the rules and regulations shall authorize the use of any
remaining prescription drugs;
(4)
For the tracking of and accountability for the prescription drugs;
and
(5)
For other matters necessary for the implementation of the program.
(d)
The state-wide program required by this Code section shall be implemented no
later than January 1, 2007, unless a pilot program is implemented pursuant to
subsection (b) of this Code section, in which case state-wide implementation
shall occur no later than July 1, 2008.
26-4-193.
In
accordance with the rules and regulations promulgated pursuant to Code Section
26-4-192, the resident of a health care facility, or the representative or
guardian of a resident, may donate unused prescription drugs, other than
prescription drugs defined as controlled substances, for dispensation to
medically indigent persons.
26-4-194.
(a)
Physicians, pharmacists, other health care professionals, and health care
facilities shall not be subject to liability for transferring or receiving
unused prescription drugs pursuant to this article when acting within the scope
of practice of their respective licenses and in good faith compliance with the
rules and regulations promulgated pursuant to Code Section
26-4-192.
(b)
Pharmacists and pharmacies shall not be subject to liability for dispensing
unused prescription drugs pursuant to this article when such services are
provided without reimbursement and when performed within the scope of their
practice and in good faith compliance with the rules and regulations promulgated
pursuant to Code Section 26-4-192. For purposes of this subsection, a
restocking fee paid to a pharmacy pursuant to Code Section 49-4-152.5 shall not
be considered reimbursement.
(c)
Nothing in this Code section shall be construed as affecting, modifying, or
eliminating the liability of a manufacturer of prescription drugs or its
employees or agents under any legal claim, including but not limited to product
liability claims. Drug manufacturers shall not be subject to liability for any
acts or omissions of any physician, pharmacist, other health care professional,
health care facility, or pharmacy providing services pursuant to this
article.
26-4-195.
This
article shall be construed in concert with Code Section
49-4-152.3."
SECTION
2.
Article
7 of Chapter 4 of Title 49 of the Official Code of Georgia Annotated, relating
to medical assistance generally, is amended by adding a new Code section to read
as follows:
"49-4-152.5.
In
the provision of medical assistance pursuant to this article, the department
shall allow for the payment and coverage of appropriate restocking fees incurred
by a pharmacy which receives and dispenses prescription drugs pursuant to the
'Utilization of Unused Prescription Drugs Act' in Article 11 of Chapter 4 of
Title
26."
SECTION
3.
All
laws and parts of laws in conflict with this Act are repealed.
