Ga. Comp. R. & Regs. 511-5-12-.01

Current through Rules and Regulations filed through October 17, 2024

Rule 511-5-12-.01 - Definitions

As used in this Chapter, 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 CFR Part 1308.

(2) "Donor" shall mean any person, including an individual member of the public, or any entity legally authorized to possess drugs with a license or permit in good standing in the state in which it is located, including but not limited to a wholesaler or distributor, third party logistic providers, pharmacy, dispenser, clinic, surgical or health center, detention and rehabilitation centers, laboratory, medical or pharmacy school, prescriber or other health care professional, or healthcare facility. Donor shall also mean government agencies and entities that are federally authorized to possess drugs including but not limited to drug manufacturers, repackagers, relabelers, outsourcing facilities, Veteran Affairs hospitals, and prisons.

(3) "Drugs" means both prescription and non-prescription ("over-the-counter") drugs.

(4) "Eligible patient" means an indigent person; provided, however, that if the recipient's supply of donated drugs exceed the need for donated drugs by indigent patients, then any other person in need of a particular drug can be an eligible patient.

(5) "Eligible recipient" means a pharmacy, wholesaler, reverse distributor, hospital, federally qualified health center, nonprofit clinic, healthcare facility, an entity participating in a drug donation or repository program pursuant to another state's law, or private office of a healthcare professional which has been authorized by the Office of Pharmacy of the Department of Public Health as provided in DPH Rule 511-5-12-.04.

(6) "Healthcare facility" means a facility licensed by the Georgia Department of Community Health in accordance with Title 31, Chapter 7 as a:

(a) Nursing home;

(b) Personal care home;

(c) Assisted living community;

(d) Residential care facility for the elderly;

(e) Hospice;

(f) Hospital;

(g) Home health agency; or

(h) A similar entity licensed in the state in which it is located.

(7) "Health care professional" means a person who is licensed by the State of Georgia to practice as a:

(a) Physician;

(b) Registered nurse or licensed practical nurse;

(c) Physician assistant;

(d) Dentist or dental hygienist;

(e) Optometrist; or

(f) Pharmacist

(8) "Indigent patient" means a patient whose income is at or below the income eligibility requirements of the Georgia Medicaid program, or who is uninsured, underinsured, or enrolled in a public assistance health benefits program.

(9) "Program" means the donated drug repository program established by this Department pursuant to Code Section 31-8-301.

(10) "Transaction date" means the date on which ownership of the drugs is transferred between two participants of the program as established by contract or other arrangement. If no such contract or arrangement exists, the transaction date shall be the date the drug was accepted into inventory by the recipient.

Ga. Comp. R. & Regs. R. 511-5-12-.01

§§ 31-2A-6, 31-8-304.

Original Rule was filed as Emergency Rule 511-5-12-0.1-.01 on January 3, 2017; effective January 1, 2017, to remain in effect for a period of 120 days or until the effective date of a permanent Rule covering the same subject matter superseding this Emergency Rule is adopted, as specified by the Agency.

Adopted: Permanent Rule entitled "Definitions." F. Feb. 14, 2017; eff. Mar. 6, 2017.