Section R. 338.569 - Wholesale distributor and wholesale distributor-broker recordkeeping and policy requirementsRule 69.
(1) A wholesale distributor shall establish and maintain inventories and records of transactions regarding the receipt, if applicable, and the distribution or other disposition of prescription drugs or devices. These records must include all of the following information:(a) The source of the prescription drugs or devices, including the name and principal address of the seller or transferor and the address from which the prescription drugs or devices were shipped.(b) The identity and quantity of the prescription drugs or devices received, if applicable, and distributed or disposed of.(c) The dates of receipt, if applicable, and distribution of the prescription drugs or devices.(2) A wholesale distributor shall establish and maintain a list of officers, directors, managers, and other individuals who are in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.(3) A wholesale distributor shall have written policies and procedures that include all of the following: (a) A procedure where the oldest stock of a prescription drug is distributed first. The procedure may allow deviation from this requirement if the deviation is temporary and appropriate.(b) A procedure for handling recalls and withdrawals of the prescription drugs or devices. The procedure must deal with recalls and withdrawals due to any of the following: (i) Any action initiated at the request of the FDA; other federal, state, or local law enforcement agency; or other governmental agency.(ii) Any voluntary action by the manufacturer to remove defective or potentially defective prescription drugs or devices from the market.(iii) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.(c) A procedure to ensure that a wholesale distributor prepares for, protects against, and handles any crises that affects security or operation of any facility, including employee strike, flood, fire, or other natural disaster, or other local, state, or national emergency.(d) A procedure to ensure that any outdated prescription drugs or devices are segregated from other prescription drugs or devices and either returned to the manufacturer or destroyed. This procedure must include a provision for the written documentation of the disposition of outdated prescription drugs or devices that must be maintained for 2 years after the disposition of the outdated prescription drugs or devices.(e) Procedures for identifying, recording, and reporting losses or thefts of prescription drugs or devices and for correcting errors and inaccuracies in inventory.(4) A wholesale distributor-broker shall establish and maintain a list of officers, directors, managers, and other individuals who are in charge of wholesale drug delivery and trade, including a description of their duties and a summary of their qualifications.(5) A wholesale distributor-broker shall maintain for not less than 7 years the transaction history, transaction statements, and transaction information required by section 17748e of the code, MCL 333.17748e.(6) The records described in subrules (1) to (5), and (8) of this rule and section of 17748e of the code, MCL 333.17748e, must be made available for inspection and photocopying by the department, board, authorized federal, state, or local law enforcement agency officials. The records that are maintained on-site or that are immediately retrievable by computer or other electronic means must be readily available for an authorized inspection during the retention period described in subrules (5) and (7) of this rule. Records that are maintained at a central location apart from the site must be made available for inspection within 2 working days after a request.(7) A wholesale distributor shall retain the records described in this rule for a minimum of 2 years after the disposition of the prescription drugs or devices.(8) A purchasing pharmacy using a wholesale distributor-broker to facilitate a transaction from a pharmacy that is not licensed in this state shall request the transaction history, transaction statement, or transaction information for the drugs supplied.Mich. Admin. Code R. 338.569
2020 AACS; 2022 AACS; 2024 MR 5, Eff. 2/29/2024