§ 106‑145.7. Storage, handling, and records of prescription drugs.
(a) Facilities. All facilities at which prescription drugs arestored, warehoused, handled, held, offered, marketed, or displayed forwholesale distribution shall meet the following requirements:
(1) Be of suitable size and construction to facilitate cleaning,maintenance, and proper operations.
(2) Have storage areas designed to provide adequate lighting,ventilation, temperature, sanitation, humidity, space, equipment, and securityconditions.
(3) Have a quarantine area for the storage of prescription drugsthat are outdated, damaged, deteriorated, misbranded, or adulterated, or thatare in immediate or sealed secondary containers that have been opened.
(4) Be maintained in a clean and orderly condition.
(5) Be free from infestation by insects, rodents, birds, orvermin of any kind.
(b) Security. All facilities used for wholesale distributionshall be secure from unauthorized entry. Access from outside the premisesshall be kept to a minimum and be well‑controlled. The outside perimeterof the premises shall be well‑lighted. Entry into areas whereprescription drugs are held shall be limited to authorized personnel. Thefacilities shall be equipped with the following:
(1) An alarm system to detect entry after hours.
(2) A security system that will provide suitable protectionagainst theft and diversion. When appropriate, the security system shallprovide protection against theft or diversion that is facilitated or hidden bytampering with computers or electronic records.
(c) Storage. All prescription drugs for wholesale distributionshall be stored at appropriate temperatures and under appropriate conditions inaccordance with any requirements stated in the labeling of the prescriptiondrugs or with requirements in the current edition of an official compendium,such as the United States Pharmacopeia/National Formulary (USP/NF). If thelabeling of a prescription drug or a compendium do not establish storagerequirements for a prescription drug, the drug may be held at"controlled" room temperature, as defined in an official compendium,to help ensure that its identity, strength, quality, and purity are notadversely affected.
(d) Examination of Materials. A wholesale distributor shallvisually examine each outside shipping container upon receipt for identity andto prevent the acceptance of contaminated prescription drugs or prescriptiondrugs that are otherwise unfit for distribution. The examination shall beadequate to reveal container damage that would suggest possible contaminationor other damage to the contents. A wholesale distributor shall carefullyinspect each outgoing shipment for identity of the prescription drugs and toensure that no prescription drugs that have been damaged in storage or heldunder improper conditions are delivered.
(e) Returned, Damaged, and Outdated Prescription Drugs. Awholesale distributor shall quarantine and physically separate prescriptiondrugs that are outdated, damaged, deteriorated, misbranded, or adulterated fromother prescription drugs until their destruction or their return to theirsupplier. A prescription drug whose immediate or sealed outer or sealedsecondary container has been opened or used shall be identified as having beenopened or used and shall be treated in the same manner as outdated prescriptiondrugs.
If the conditions under which a prescription drug has been returned toa wholesale distributor cast doubt on the drug's safety, identity, strength,quality, or purity, then the drug shall be destroyed or returned to itssupplier unless examination, testing, or other investigation proves that thedrug meets appropriate standards of safety, identity, strength, quality, andpurity. In determining whether the conditions under which a prescription drughas been returned cast doubt on the drug's safety, identity, strength, quality,or purity, the wholesale distributor shall consider, among other things, theconditions under which the drug has been held, stored, or shipped before orduring its return and the condition of the drug and its container, carton, orlabeling as a result of storage or shipping. (1991, c. 699, s. 2.)
§ 106‑145.7. Storage, handling, and records of prescription drugs.
(a) Facilities. All facilities at which prescription drugs arestored, warehoused, handled, held, offered, marketed, or displayed forwholesale distribution shall meet the following requirements:
(1) Be of suitable size and construction to facilitate cleaning,maintenance, and proper operations.
(2) Have storage areas designed to provide adequate lighting,ventilation, temperature, sanitation, humidity, space, equipment, and securityconditions.
(3) Have a quarantine area for the storage of prescription drugsthat are outdated, damaged, deteriorated, misbranded, or adulterated, or thatare in immediate or sealed secondary containers that have been opened.
(4) Be maintained in a clean and orderly condition.
(5) Be free from infestation by insects, rodents, birds, orvermin of any kind.
(b) Security. All facilities used for wholesale distributionshall be secure from unauthorized entry. Access from outside the premisesshall be kept to a minimum and be well‑controlled. The outside perimeterof the premises shall be well‑lighted. Entry into areas whereprescription drugs are held shall be limited to authorized personnel. Thefacilities shall be equipped with the following:
(1) An alarm system to detect entry after hours.
(2) A security system that will provide suitable protectionagainst theft and diversion. When appropriate, the security system shallprovide protection against theft or diversion that is facilitated or hidden bytampering with computers or electronic records.
(c) Storage. All prescription drugs for wholesale distributionshall be stored at appropriate temperatures and under appropriate conditions inaccordance with any requirements stated in the labeling of the prescriptiondrugs or with requirements in the current edition of an official compendium,such as the United States Pharmacopeia/National Formulary (USP/NF). If thelabeling of a prescription drug or a compendium do not establish storagerequirements for a prescription drug, the drug may be held at"controlled" room temperature, as defined in an official compendium,to help ensure that its identity, strength, quality, and purity are notadversely affected.
(d) Examination of Materials. A wholesale distributor shallvisually examine each outside shipping container upon receipt for identity andto prevent the acceptance of contaminated prescription drugs or prescriptiondrugs that are otherwise unfit for distribution. The examination shall beadequate to reveal container damage that would suggest possible contaminationor other damage to the contents. A wholesale distributor shall carefullyinspect each outgoing shipment for identity of the prescription drugs and toensure that no prescription drugs that have been damaged in storage or heldunder improper conditions are delivered.
(e) Returned, Damaged, and Outdated Prescription Drugs. Awholesale distributor shall quarantine and physically separate prescriptiondrugs that are outdated, damaged, deteriorated, misbranded, or adulterated fromother prescription drugs until their destruction or their return to theirsupplier. A prescription drug whose immediate or sealed outer or sealedsecondary container has been opened or used shall be identified as having beenopened or used and shall be treated in the same manner as outdated prescriptiondrugs.
If the conditions under which a prescription drug has been returned toa wholesale distributor cast doubt on the drug's safety, identity, strength,quality, or purity, then the drug shall be destroyed or returned to itssupplier unless examination, testing, or other investigation proves that thedrug meets appropriate standards of safety, identity, strength, quality, andpurity. In determining whether the conditions under which a prescription drughas been returned cast doubt on the drug's safety, identity, strength, quality,or purity, the wholesale distributor shall consider, among other things, theconditions under which the drug has been held, stored, or shipped before orduring its return and the condition of the drug and its container, carton, orlabeling as a result of storage or shipping. (1991, c. 699, s. 2.)
§ 106‑145.7. Storage, handling, and records of prescription drugs.
(a) Facilities. All facilities at which prescription drugs arestored, warehoused, handled, held, offered, marketed, or displayed forwholesale distribution shall meet the following requirements:
(1) Be of suitable size and construction to facilitate cleaning,maintenance, and proper operations.
(2) Have storage areas designed to provide adequate lighting,ventilation, temperature, sanitation, humidity, space, equipment, and securityconditions.
(3) Have a quarantine area for the storage of prescription drugsthat are outdated, damaged, deteriorated, misbranded, or adulterated, or thatare in immediate or sealed secondary containers that have been opened.
(4) Be maintained in a clean and orderly condition.
(5) Be free from infestation by insects, rodents, birds, orvermin of any kind.
(b) Security. All facilities used for wholesale distributionshall be secure from unauthorized entry. Access from outside the premisesshall be kept to a minimum and be well‑controlled. The outside perimeterof the premises shall be well‑lighted. Entry into areas whereprescription drugs are held shall be limited to authorized personnel. Thefacilities shall be equipped with the following:
(1) An alarm system to detect entry after hours.
(2) A security system that will provide suitable protectionagainst theft and diversion. When appropriate, the security system shallprovide protection against theft or diversion that is facilitated or hidden bytampering with computers or electronic records.
(c) Storage. All prescription drugs for wholesale distributionshall be stored at appropriate temperatures and under appropriate conditions inaccordance with any requirements stated in the labeling of the prescriptiondrugs or with requirements in the current edition of an official compendium,such as the United States Pharmacopeia/National Formulary (USP/NF). If thelabeling of a prescription drug or a compendium do not establish storagerequirements for a prescription drug, the drug may be held at"controlled" room temperature, as defined in an official compendium,to help ensure that its identity, strength, quality, and purity are notadversely affected.
(d) Examination of Materials. A wholesale distributor shallvisually examine each outside shipping container upon receipt for identity andto prevent the acceptance of contaminated prescription drugs or prescriptiondrugs that are otherwise unfit for distribution. The examination shall beadequate to reveal container damage that would suggest possible contaminationor other damage to the contents. A wholesale distributor shall carefullyinspect each outgoing shipment for identity of the prescription drugs and toensure that no prescription drugs that have been damaged in storage or heldunder improper conditions are delivered.
(e) Returned, Damaged, and Outdated Prescription Drugs. Awholesale distributor shall quarantine and physically separate prescriptiondrugs that are outdated, damaged, deteriorated, misbranded, or adulterated fromother prescription drugs until their destruction or their return to theirsupplier. A prescription drug whose immediate or sealed outer or sealedsecondary container has been opened or used shall be identified as having beenopened or used and shall be treated in the same manner as outdated prescriptiondrugs.
If the conditions under which a prescription drug has been returned toa wholesale distributor cast doubt on the drug's safety, identity, strength,quality, or purity, then the drug shall be destroyed or returned to itssupplier unless examination, testing, or other investigation proves that thedrug meets appropriate standards of safety, identity, strength, quality, andpurity. In determining whether the conditions under which a prescription drughas been returned cast doubt on the drug's safety, identity, strength, quality,or purity, the wholesale distributor shall consider, among other things, theconditions under which the drug has been held, stored, or shipped before orduring its return and the condition of the drug and its container, carton, orlabeling as a result of storage or shipping. (1991, c. 699, s. 2.)
