Ohio Admin. Code 4729:5-3-18 - Dangerous drug recall procedures
(A)
A terminal
distributor of dangerous drugs shall develop and implement a written procedure
for the management of recalls by the manufacturer for dangerous drugs stocked
by the terminal distributor. Such procedures shall include, where appropriate,
contacting patients to whom the recalled drug products have been dispensed or
personally furnished.
(B)
The written procedure shall include, but not be limited
to, the following:
(1)
The terminal distributor shall make a reasonable
attempt to ensure that a recalled drug has been removed from inventory no later
than the next business day after receipt of the recall notice by the
responsible person or the responsible person's designee, and quarantined until
proper disposal, destruction, or return of the drug;
(2)
If the drug that
is the subject to a recall is maintained by the terminal distributor in a
container without a lot number, the terminal distributor shall consider this
drug included in the recall; and
(3)
Maintaining
records for activities taken by the terminal distributor in relation to a drug
recall.
(C)
The written procedures shall be updated as necessary
and maintained in a readily retrievable manner. All records documenting recall
activities shall be maintained for three years and shall be made readily
retrievable.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.26, 3719.28
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