N.J. Admin. Code § 8:21-3.3

Current through Register Vol. 56, No. 21, November 4, 2024

Section 8:21-3.3 - Keeping of records by drug manufacturing businesses and wholesale drug businesses

(a) Drug manufacturing businesses shall maintain records identifying the source of each ingredient used in the manufacture or processing of a drug. Records identifying the source of each ingredient shall include the date of receipt of the ingredient, vendor's name and address, the name of the ingredient and the vendor's batch number, lot number, control number or other identifying symbol, if any, used by the vendor to identify the ingredient as well as the grade (such as U.S.P., N.F., reagent, technical or crude) and quantity of said ingredient.

(b) Drug manufacturing businesses shall maintain a system of record keeping that will permit the identification for purposes of recall of any lot or batch of a drug from the market when such is found to be unsafe for use. As part of this system, the manufacturer shall insure that the container of any drug at any stage in the process of manufacture and distribution bears an identifying name and number, commonly known as "lot" or "control" number, to make it possible to determine the complete manufacturing history of the package of the drug. This Section shall not require that the manufacturer keep a record of the control number of any given shipment of drugs if the manufacturer's overall records are such as to enable the manufacturer to recall an unsafe drug.

(c) Wholesale drug businesses shall maintain records identifying each drug received. Records of receipt shall include the date the drug was received, the vendor's name and address, the drug name and the quantity of the drug received. Such records in the form of vendors' invoices shall suffice for compliance with this regulation.

(d) Wholesale drug businesses shall maintain records of shipments which identify the recipient of the drug by name, street address, city and state, date of shipment, the drug name and the quantity of the drug shipped. Such records in the form of customers' invoices shall suffice for compliance with this regulation.

(e) Records required by this Section shall be maintained for not less than 24 consecutive months.

(f) The provisions of this section shall not apply to "commercial feeding stuff" as these articles are defined and administered under the provisions of N.J.S.A. 4:4-1 et seq.

N.J. Admin. Code § 8:21-3.3

Recodified from N.J.A.C. 8:21-3.13 by R.2000 d.427, effective 10/16/2000.
See: 32 New Jersey Register 2386(a), 32 New Jersey Register 3831(a).