Wholesale distributors shall establish, maintain, and adhere to
written policies and procedures that are in compliance with federal law for the
receipt, security, storage, inventory, and distribution of prescription drugs,
including policies and procedures for identifying, recording, and reporting
losses or thefts and for correcting all errors and inaccuracies in inventories.
Wholesale distributors shall also include in their written policies and
procedures the following:
(1)
Recalls and market withdrawals. A procedure to be followed for
handling recalls and withdrawals of prescription drugs.
a. The procedure shall be adequate to deal
with recalls and withdrawals due to:
(1) Any
action initiated at the request of the Food and Drug Administration or other
federal, state, or local law enforcement agency or other government agency,
including the board;
(2) Any
voluntary action by the manufacturer to remove defective or potentially
defective drugs from the market; or
(3) Any action undertaken to promote public
health and safety by replacing existing merchandise with an improved product or
new package design.
b.
The requirement of this subrule shall not apply to a returns
processor.
(2)
Emergency and disaster plan. A procedure to ensure that
wholesale distributors prepare for, protect against, and handle any crisis that
affects security or operation of any facility in the event of strike, fire,
flood, or other natural disaster, or other situations of local, state, or
national emergency.
(3)
Outdated drugs. A procedure to ensure that any outdated
prescription drugs shall be segregated from other drugs and either returned to
the manufacturer or destroyed. This procedure shall provide for written
documentation of the disposition of outdated prescription drugs. The
requirement of this subrule shall not apply to a returns processor.
(4)
Security and storage. A
procedure to ensure adequate security in accordance with rule
657-17.10(124,155A) and proper storage conditions in accordance with rule
657-17.11(155A). The requirement for proper storage conditions shall not apply
to a returns processor.
(5)
Drugs supplied to salesperson/representative. If supplying
drugs to wholesale distributor salespersons, a procedure directing that the
security, storage, and record-keeping requirements contained in these rules
shall be maintained by those salespersons.
(6)
Personnel. A procedure
to ensure the wholesale distributor employs personnel with the education and
experience appropriate to the responsibilities of the position held by the
individual. Licensed wholesale distributors shall establish and maintain lists
of officers, directors, managers, and other persons in charge of wholesale drug
distribution, storage, and handling, including a description of their duties
and a summary of their qualifications.
