Haw. Code R. § 16-95-30 - Wholesale prescription drug distributor license requirements

(a) Application for a wholesale prescription drug distributor license shall be made under oath on a form to be provided by the board. In addition to providing information required by section 16-95-21(b), the applicant shall provide the following information as it pertains to the applicant including any officer, director, manager, or other persons in charge of wholesale drug distribution, storage, or handling:

(1) Any convictions under any federal, state, or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;

(2) Any felony conviction under federal, state, or local laws;

(3) Each person's past experience in the manufacture or distribution of prescription and controlled drugs;

(4) Any suspension, revocation, disciplinary action, or pending investigation by any federal, state, or local government of any license currently or previously held for the manufacture or distribution of any drugs, including controlled substances;

(5) Verification of at least one year of experience in the distribution or handling of prescription drugs for any person responsible for the distribution of drugs; and

(6) A current list of officers, directors, managers, and other persons in charge of the wholesale distribution, storage, and handling of prescription drugs, including a description of each person's duties and a summary of each person's qualifications.

(b) A map of the facilities shall also be submitted. The map shall identify:

(1) The storage area for drugs;

(2) The storage area for quarantined drugs; and

(3) The placement of the lighting, ventilation, and temperature control equipment.

(c) No license shall be issued prior to receipt of a satisfactory inspection report from the state department of health. At a minimum, the board requests that the department of health shall ensure that:

(1) The facilities are of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(2) The storage areas are designed to provide adequate ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(3) A quarantine area is available for prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or whose immediate or sealed outer or sealed secondary containers have been opened;

(4) The facility is maintained in a clean and orderly fashion;

(5) The facility is free from infestation by insects, rodents, birds, or vermin of any kind;

(6) The facility is secure from unauthorized entry;

(7) Access from outside the premises is kept to a minimum and well controlled;

(8) The outside perimeter of the premises is well-lighted;

(9) Entry into areas where prescription drugs are held is limited to authorized personnel;

(10) The facilities are equipped with an alarm system to detect entry after hours;

(11) The facilities are equipped with a security system that will provide suitable protection against theft and diversion;

(12) All prescription drugs are stored at appropriate temperatures and under appropriate conditions in accordance with 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 adopted by the state department of health.

(A) If no storage requirements are established for a prescription drug, the drug may be held at controlled room temperature, as defined in the current United States Pharmacopeia National Formulary and all supplements, 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;

(13) Upon receipt, each outside shipping container of prescription drugs is examined visually to confirm the identity of the drugs and to prevent the acceptance of contaminated prescription drugs that are unfit for distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents;

(14) Each outgoing shipment of prescription drugs is inspected carefully to confirm the identity of the drugs and to ensure that no prescription drugs are delivered that have been damaged in storage or held under improper conditions;

(15) Returned, damaged, outdated, deteriorated, mishandled, or adulterated prescription drugs are physically separated from other prescription drugs and stored, in such a way that no cross-contamination or confusion is possible, until they are destroyed or returned to the supplier;

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

(17) 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 is 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, strength, 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.

(d) Written policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts and for correcting all errors and inaccuracies in inventories shall be submitted. Written policies and procedures shall include:

(1) A procedure whereby the oldest approved stock of a prescription drug is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate;

(2) A procedure for handling recalls and withdrawals of prescription drugs. The procedures shall be adequate to deal with recalls and withdrawals caused by:

(A) Any action initiated at the request of the department of health, the Food and Drug Administration, or any other federal, state, or local law enforcement or other government agency;

(B) Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(C) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;

(3) A procedure to ensure that the distributor prepares for, protects against, and handles properly any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or in other emergencies; and

(4) A procedure to ensure that all outdated prescription drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall require written documentation of the disposition of outdated prescription drugs. The documentation shall be maintained for five years after disposition of the outdated drugs.

Notes

Haw. Code R. § 16-95-30

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