Rule 480-7-.07 - Credit for Returned Expired Drugs(1) Effective with all drug orders placed on or after July 1, 2002, all wholesale drug distributors shall make adequate provisions for the return of outdated prescription drugs, both full and partial containers, for up to six months after the labeled expiration date for prompt full credit or replacement.(2) Wholesale drug distributors shall establish a written policy consistent with O.C.G.A. Section 26-4-115(c)providing for the return of outdated prescription drugs sold to a client by such wholesale drug distributor. Such policy may include a procedure for the drugs to be returned to the drug manufacturer, may include a requirement that the drugs be returned in the original containers in which it was purchased, and may include the use of a reverse drug distributor. Said policy shall be available to the Board or its agents upon request.(3) The Board has determined the following listed drugs will be exempt from the requirements of this provision as they are essential to health care treatment and have an expiration date of less than one year from the date such drug is manufactured: (4) In order to be eligible for full credit or replacement, the drug must be received by the wholesale drug distributor, or if not the wholesale drug distributor, its agent designated in its return policy, no later than the sixth month from the labeled expiration date. A signed delivery receipt shall constitute evidence of the drugs having been returned.(5) Prompt full credit to the purchaser shall occur within sixty days from the date the return drugs were received by the wholesale drug distributor or its designated agent. If the wholesale drug distributor determines that the drugs were not returned within six months of the labeled expiration date, or were not returned consistent with the written return policy, then the wholesale drug distributor shall notify said purchaser in writing within thirty (30) days of the receipt of the drugs of its intent not to give full credit or replacement. Wholesale drug distributors shall maintain documentation supporting its refusal to give full credit or replacement for a period of two (2) years. Such documentation shall be available to the Board or its agent upon request. (a) "Full credit" shall be defined to include a cash refund or credit with the drug wholesale distributor for the purchase price of the drug as established by drug invoice less a reasonable fee for handling of the returned drugs. A reasonable fee shall not be more than 7% of the total invoice price of the returned drugs.(6) In lieu of full credit, a wholesale drug distributor may elect to replace the drug. Said replacement drug must be a drug of like value mutually agreed upon by the wholesale drug distributor and the original drug purchaser. Said replacement drug must be sent to the original drug purchaser within sixty (60) days from the date of return.(7) Wholesale drug distributors shall maintain records of all credits and replacements made under this rule for a period of two (2) years and such record shall be made available to the Board or its agent upon request.(8) The submission of drugs by a purchaser licensed by the Board in State of Georgia for refund or credit to a wholesale drug distributor pursuant to O.C.G.A. Section 26-4-115 and this rule when said drugs are in a container other than the one in which it was purchased, when said drugs were not purchased from that wholesale drug distributor, or when the drugs were purchased for a pharmacy or facility outside the State Of Georgia shall constitute fraudulent and unprofessional conduct and may subject the purchaser to disciplinary action by the Board.(9) The return of drugs under this rule shall also be consistent with all other applicable Federal, State, and local laws and regulations. Ga. Comp. R. & Regs. R. 480-7-.07
O.C.G.A.§§ 26-4-27, 26-4-28, 26-4-115.
Original Rule entitled "Credit for Returned Expired Drugs" adopted. F. Jan. 29, 2003; eff. Feb. 18, 2003.Amended: F. Mar. 21, 2018; eff. Apr. 10, 2018.