Haw. Code R. § 16-95-96 - Record keeping for wholesale prescription drug distributors

(a) Wholesale distributors shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These inventories and records shall include the following information:

(1) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

(2) The identity and quantity of the drugs received and distributed or disposed of; and

(3) The dates of receipt and distribution or other disposition of the drugs.

(b) The wholesale distributor shall also maintain records to reflect:

(1) Storage. All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with the requirements, if any, in the labeling of the drugs, or in accordance with the standards regarding conditions and temperatures for the storage of prescription drugs.

(A) If no storage requirements are established 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 not adversely affected.

(B) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be used to document the proper storage of prescription drugs.

(2) Examination of materials.

(A) Documentation shall be maintained for at least five years demonstrating that each outside shipping container of prescription drugs was examined visually to confirm the identity of the drugs and to prevent the acceptance of contaminated prescription drugs or prescription drugs that are otherwise unfit for distribution shall be maintained. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(B) Documentation shall be maintained for at least five years demonstrating that each outgoing shipment of prescription drugs was inspected carefully to confirm the identity of the drugs and to ensure that no prescription drugs were delivered that have been damaged in storage or held under improper conditions.

(3) Returned, damaged, outdated, deteriorated, misbranded, and adulterated prescription drugs.

(A) Prescription drugs that are damaged, outdated, deteriorated, misbranded, or adulterated shall be physically separate from other prescription drugs and stored, in such a way that no cross-contamination or confusion are possible, until they are destroyed or returned to the supplier.

(B) Any prescription drugs whose immediate or sealed outer or sealed secondary containers are found upon arrival to have been opened or used shall be identified as such, and shall be physically separated from other prescription drugs and stored, in such a way that no cross-contamination or confusion are possible, until they are destroyed or returned to the supplier.

(C) If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, then the drug shall be either destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, quality, or purity, the wholesale distributor shall consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the condition of the drug and its container, carton, or labeling as a result of storage or shipping.

(c) Inventories and records shall be made available for inspection and photocopying by the department or any authorized federal, state, or local law enforcement officials for a period of five years following disposition of the drugs.

(d) Records described in this section that are kept at the inspection site or that can be retrieved immediately by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by the department or any authorized official of a federal, state, or local law enforcement agency.

Notes

Haw. Code R. § 16-95-96

[Eff and comp 12/24/92; comp 12/25/04] (Auth: HRS § 461-4.5) (Imp: Act 196, SLH 1992) Am and comp 06/22/15; Comp 8/15/2016