Mich. Admin. Code R. 338.569 - Wholesale distributor and wholesale distributor-broker recordkeeping and policy requirements
Rule 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(d) A procedure to ensure that any outdated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.
Notes
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