Georgia-2011-HB199-Amended

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:

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);"

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."

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:

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."

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;"

"(806) Pseudoephedrine -- See exceptions Reserved;"

"(935) Reserved Tesamorelin;"

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;"

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;"

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;"