Current through Register Vol. 56, No. 18, September 16, 2024
(a) Wholesale
distributors of prescription drugs shall establish and maintain inventories and
records of all transactions regarding the receipt and distribution or other
disposition of prescription drugs. Records shall include the following
information:
1. The source of the
prescription drugs, including the name and principal address of the seller or
transferor, and the address of the location from which the prescription drugs
were shipped;
2. The identity and
quantity of the prescription drugs received and distributed or disposed
of;
3. The dates of receipt and
distribution or other disposition of the prescription drugs;
4. Invoices that shall reflect the amount
billed per prescription drug product; and
5. Inventory: A complete and accurate record
of all stock of prescription drugs on hand must be made annually by wholesale
distributors.
i. A physical inventory of
prescription drugs must be conducted at least annually unless perpetual
inventory records are maintained, in which case the physical inventory may be
conducted on a biennial basis.
ii.
If a wholesale distributor does not maintain a perpetual inventory, the annual
physical inventory shall be retained for a period of three years following
their creation date.
iii.
Significant inventory discrepancies shall be investigated, and handled in
accordance with written policies and procedures;
(b) Originals or true copies of
required records documentation of drugs shall be maintained by the person
involved in the transaction, including brokers and agents.
1. If electronic methods are used to maintain
records related to drugs and these methods do not maintain a true copy of the
original record, such as the actual image of the original document, then the
security system of the wholesale distributor must provide protection against
tampering with computers or electronic records.
2. Originals, true copies and electronical
methods of records involving drugs shall be readily available and readily
retrievable for inspection by an authorized State official and any other
governmental agency charged with enforcement of these rules.
(c) Wholesale distributors shall
establish and maintain inventories and records of all transactions regarding
the receipt and distribution, quarantine or other disposition of
drugs.
(d) Wholesale distributors
shall establish and maintain an ongoing listing of all retail and wholesale
establishments with whom they purchase, acquire, sell, transfer, or dispose of
drugs. At a minimum, this listing shall be updated monthly.
