N.J. Admin. Code § 8:21-3A.13

Current through Register Vol. 56, No. 23, December 2, 2024

Section 8:21-3A.13 - Recordkeeping

(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.

N.J. Admin. Code § 8:21-3A.13

Amended by R.2006 d.391, effective 11/20/2006.
See: 37 N.J.R. 3899(a), 38 N.J.R. 4857(b).
In (a)1 through (a)3, inserted "prescription" preceding "drugs"; in (a)2, deleted "and" from the end; added (a)4, (a)5, and (b) through (d).