All entities shall establish, maintain and adhere to written
policies and procedures, which shall be followed for the receipt, security,
storage, inventory, transport, shipping and wholesale 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. Policies and procedures shall include the
following:
(a) A procedure to be
followed for handling recalls and withdrawals of prescription drugs due to:
(i) Any action initiated at the request of
the FDA or any other federal, state or local law enforcement or other
governmental agency, including the board of pharmacy; or
(ii) Any volunteer action by the manufacturer
to remove defective or potentially defective prescription drugs from the
market.
(b) A procedure
to ensure that all entities prepare for, protect against, and handle any crisis
that affects security or operation of any facility in the event of a strike,
fire, flood, natural disaster, or other situations of local, state or national
emergency;
(c) A procedure to
ensure that any outdated prescription drugs shall be segregated from other
prescription drugs and either returned to the manufacturer or third party
return processor or destroyed in accordance with federal and state laws,
including all necessary documentation and the appropriate witnessing. This
procedure shall provide for written documentation of the disposition of
outdated prescription drugs. This documentation shall be maintained for two (2)
years after disposition of the outdated prescription drugs;
(d) A procedure for the disposing and
destruction of containers, labels and packaging to ensure that the containers,
labels and packaging cannot be used in counterfeiting activities, including all
necessary documentation, maintained for a minimum of two (2) years, and the
appropriate witnessing of the destruction of any labels, packaging, immediate
containers or containers in accordance with all applicable federal and state
requirements;
(e) A procedure for
identifying, investigating and reporting significant prescription drug
inventory discrepancies involving suspect products, in the inventory and
reporting of such discrepancies within ten (10) business days to the Board and
appropriate federal or state agency upon discovery of such
discrepancies;
(f) A procedure for
reporting criminal or suspected criminal activities involving the inventory of
prescription drugs to the board, FDA and, if applicable, DEA, within three (3)
business days; and
(g) A procedure
for verifying security provisions of common carriers.
