Current through Register Vol. 51, No. 19, September 20, 2024
A. A designated
Department representative shall quarantine and physically separate prescription
drugs and devices that are outdated, damaged, deteriorated, misbranded, or
adulterated from other prescription drugs and devices until the quarantined and
separated prescription drugs and devices are destroyed or returned to their
supplier for disposal.
B. A
designated Department representative shall identify, mark, quarantine, and
physically separate from other prescription drugs and devices those
prescription drugs and devices whose immediate or sealed outer or sealed
secondary containers have been opened or used, until the prescription drugs and
devices are either destroyed or returned to their supplier for
disposal.
C. Prescription Drugs.
(1) If the conditions under which a
prescription drug has been returned by a local health department or a health
care provider cast doubt on the prescription drug's safety, identity, strength,
quality, or purity, then a designated Department representative shall destroy
the prescription drug or return the prescription drug to the supplier, unless
examination, testing, or other investigation proves that the prescription drug
meets appropriate standards of safety, identity, strength, quality, and
purity.
(2) In determining whether
the conditions under which a prescription drug has been returned by a local
health department or a health care provider cast doubt on the prescription
drug's safety, identity, strength, quality, or purity, a designated Department
representative shall consider, at a minimum, the:
(a) Conditions under which the prescription
drug has been held, stored, or shipped before or during the return of the
prescription drug; and
(b)
Condition of the prescription drug and its container, carton, or labeling, as a
result of storage or shipping.
D. Prescription Devices.
(1) If the conditions under which a
prescription device has been returned cast doubt on the prescription device's
safety, identity, or quality, then a designated Department representative shall
destroy or return the prescription device to the supplier, unless examination,
testing, or other investigation proves that the prescription device meets
appropriate standards of safety, identity, strength, and quality.
(2) In determining whether the conditions
under which a prescription device has been returned by a local health
department or a health care provider cast doubt on the prescription device's
safety, identity, or quality, a designated Department representative shall
consider, at a minimum, the:
(a) Conditions
under which the prescription device has been held, stored, or shipped before or
during return of the prescription device; and
(b) Condition of the prescription device and
the device's container, carton, or labeling, as a result of storage or
shipping.
E.
A designated Department representative shall follow the record-keeping
requirements in Regulation .06 of this chapter for outdated, damaged,
deteriorated, misbranded, or adulterated prescription drugs and
devices.
