Written policies and procedures
HRS §328-121
in effect328-121. Written policies and procedures
Wholesale distributors shall establish, maintain, and follow written policies and procedures 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 include in their written policies and procedures the following:
(1) A procedure whereby the oldest approved stock of
a prescription drug is distributed first. The procedure may permit deviation
from this requirement if the deviation is temporary and appropriate.
(2) A procedure for handling recalls and withdrawals
of prescription drugs. The procedure shall be adequate to deal with recalls
and withdrawals caused by:
(A) Any action initiated at the request of
the department, the Food and Drug Administration, or any other federal, state,
or local law enforcement or other government agency;
(B) Any voluntary action by the manufacturer
to remove defective or potentially defective drugs from the market; or
(C) Any action undertaken to promote public
health and safety by replacing existing merchandise with an improved product or
new package design.
(3) A procedure to ensure that the distributor
prepares for, protects against, and handles properly any crisis that affects
security or operation of any facility in the event of strike, fire, flood, or
other natural disaster, or in other emergencies.
(4) A procedure to ensure that all outdated
prescription drugs are segregated from other drugs and either returned to the
manufacturer or destroyed. This procedure shall require written documentation
of the disposition of outdated prescription drugs, which documentation shall be
maintained for five years after disposition of the outdated drugs.
[L 1992, c
196, pt of §2]
Source: Hawaii State Legislature (capitol.hawaii.gov), via Internet Archive capturesURL: http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0328/HRS_0328-0121.htmFetched: 11/10/2026