Md. Code Regs. 10.13.02.05

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.13.02.05 - Quarantine, Destruction, and Return of Prescription Drugs and Devices

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A designated Department representative shall quarantine and physically separate prescription drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs and devices until the quarantined and separated prescription drugs and devices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.

Md. Code Regs. 10.13.02.05