(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provisions for the return of outdated prescription drugs, both full and partial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.
Wholesale drug distributors shall establish a written policy consistent with
for the return of outdated prescription drugs sold to a client by such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.
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:
(a) Influenza Vaccines
(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
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.
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.
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
(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.
entitled "Credit for Returned Expired Drugs" adopted. F.
Jan. 29, 2003; eff.
Feb. 18, 2003.
Amended: F. Mar. 21,
2018; eff. Apr. 10, 2018.