Rule 511-5-12-.02 - Authority and waivers(1) A donor or eligible recipient may request a waiver or variance from the Department with regard to any regulation related to this program in accordance with DPH Rule 511-1-1-.05. Notwithstanding DPH Rule 511-1-1-.05(2)(a), a donor or eligible recipient may request a waiver or variance from any provision of Title 31, Chapter 8, Article 10, upon a showing that such action would be in the interest of public health and safety.(2) Pursuant to Code Section 31-8-304, this Department and its rules have sole regulatory authority over the program. Notwithstanding any other administrative regulation, including but not limited to Ga. R. &Regs. (a)480-10-.17, 480-24-.05(2)(b), and 480-24-.06, a person or entity may dispose of an eligible drug by donating it to an eligible recipient in accordance with the rules of this program.(b)480-10-.21 and 480-16-.08, an eligible recipient including but not limited to a pharmacy may receive drugs from a donor as defined in 511-5-12-.01(2) in accordance with the rules of this program.(c)480-7-.03(7)(e)(1), an eligible recipient may accept donated drugs that are in tamper-evident packaging in accordance with DPH Rule 511-5-12-.03(1)(b), including but not limited to drugs that have a tamper-evident seal on either their immediate, outer, secondary, or shipping container.(d) 480-7.02(1)(d), an eligible recipient, including but not limited to a pharmacy, may receive, accept, replenish, repackage, and store donated drug samples in accordance with the rules of this program.Ga. Comp. R. & Regs. R. 511-5-12-.02
§§ 31-2A-6, 31-8-304.
Original Rule was filed as Emergency Rule 511-5-12-0.1-.02 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 "Authority and waivers." F. Feb. 14, 2017; eff. Mar. 6, 2017.