11 AM 36
0262
ADOPTED
Senator
Carter of the 1st offered the following amendment:
Amend
HB 199 by striking
lines 1 through 4 and
inserting in lieu thereof the
following:
To amend Chapter 13 of Title
16 of the Official Code of Georgia Annotated, relating to controlled substances,
so as to change certain provisions relating to Schedule I, III, IV, and V
controlled substances; to change certain provisions relating to the definition
of "dangerous drug"; to provide an effective date; to repeal conflicting laws;
and for other purposes.
By
striking lines 7 and 8
and inserting in lieu
thereof
the
following:
Chapter 13 of Title 16 of
the Official Code of Georgia Annotated, relating to controlled substances, is
amended by revising paragraph (3) as follows:
By
striking "Code section"
on line 78 and
inserting in lieu thereof
"chapter".
By
deleting lines 92 through 95 and inserting in lieu thereof the
following:
SECTION
3.
Said
chapter is further amended in Code Section 16-13-27, relating to Schedule III
controlled substances, by revising subparagraph (L) of paragraph (2) as
follows:
"(L)
Tiletamine/Zolozepam
(Telazol)
Tiletamine/Zolazepam
(Telazol);"
SECTION
4.
Said
chapter is further amended in Code Section 16-13-27, relating to Schedule III
controlled substances, by replacing the period at the end of paragraph (11)
with a semicolon and by adding a new paragraph to read as follows:
"(12)
Any drug product in hard or soft gelatin capsule form containing natural
dronabinol (derived from the cannabis plant) or synthetic dronabinol (produced
from synthetic materials) in sesame oil, for which an abbreviated new drug
application (ANDA) has been approved by the FDA under Section 505(j) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 355(j)) which references
as its listed drug the drug product referred to in paragraph (8) of this Code
section."
SECTION
5.
Said
chapter is further amended in Code Section 16-13-28, relating to Schedule IV
controlled substances, by adding a new paragraph to subsection (a) to read as
follows:
"(30.03)
Propofol;"
SECTION
6.
Said
chapter is further amended in Code Section 16-13-29, relating to Schedule V
controlled substances, by deleting "or" at the end of paragraph (3), by
replacing the period at the end of paragraph (4) with "; or", and by adding a
new paragraph to read as follows:
"(5)
Pseudoephedrine as an exempt over-the-counter (OTC) Schedule V controlled
substance distributed in the same manner as set forth in Code Section
16-13-29.2; provided, however, that such exemption shall take effect immediately
and shall not require rulemaking by the State Board of Pharmacy; provided,
further, that wholesale drug distributors located within this state and licensed
by the State Board of Pharmacy and which are registered and regulated by the
United States Drug Enforcement Administration (DEA) shall not be subject to any
board requirements for controlled substances for the storage, reporting,
recordkeeping, or physical security of drug products containing pseudoephedrine
which are more stringent than those included in DEA
regulations."
SECTION
7.
Said
chapter is further amended in Code Section 16-13-71, relating to the definition
of dangerous drug, by revising the following paragraphs of subsection (b) as
follows:
"(143)
Reserved
Carglumic
Acid;"
"(383.5)
Fexofenadine
– See
exceptions;"
"(406.93)
Fospropofol;"
"(793.5)
Propofol;"
"(806)
Pseudoephedrine
-- See exceptions
Reserved;"
"(935)
Reserved
Tesamorelin;"
SECTION
8.
Said
chapter is further amended in Code Section 16-13-71, relating to the definition
of dangerous drug, by adding new paragraphs to subsection (b) to read as
follows:
"(19.3)
Alcaftadine;"
"(122.3)
Cabazitaxel;"
"(153.35)
Ceftaroline;"
"(213.1)
Collagenase clostridium
histolyticum;"
"(235.5)
Dabigatran;"
"(237.1)
Dalfampridine;"
"(247.7)
Denosumab;"
"(273.5)
Dienogest;"
"(346.05)
Eribulin;"
"(386.7)
Fingolimod;"
"(469.05)
IncobotulinumtoxinA;"
"(525.2)
Liraglutide;"
"(531.7)
Lurasidone;"
"(692.517)
Pegloticase;"
"(747.4)
Polidocanol;"
"(1018.5)
Ulipristal;"
"(1027.3)
Velaglucerase;"
SECTION
9.
Said
chapter is further amended in Code Section 16-13-71, relating to the definition
of dangerous drug, by adding a new paragraph to subsection (c) to read as
follows:
"(9.6)
Fexofenadine – when packaged for distribution as an over-the-counter (OTC)
drug product;"
SECTION
10.
Said
chapter is further amended in Code Section 16-13-71, relating to the definition
of dangerous drug, by revising paragraph (23) of subsection (c) as
follows:
"(23)
Pseudoephedrine
-- when a single dosage unit is 60 mg. or less or when manufactured in an
extended release form with a dosage unit of 240 mg. or
less
Reserved;"
SECTION
11.
This
Act shall become effective upon its approval by the Governor or upon its
becoming law without such approval.
SECTION
12.