N.J. Admin. Code § 8:21-3A.16

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

Section 8:21-3A.16 - Policies and procedures

(a) Wholesale prescription drug distributors shall establish, maintain, and adhere to written policies and procedures which shall be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventory. Wholesale drug distributors shall include in their policy and procedures the following:

1. A procedure whereby the oldest approved stock of a prescription drug is distributed first. The procedure may permit deviation from this requirement if the deviation is temporary and appropriate;

2. A procedure to be followed for, and which shall be adequate for, handling recalls and withdrawals due to:

i. Any action initiated by the request of the Food and Drug Administration or other Federal, state, local law enforcement or other government agency, including the State registering agency;

ii. Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

iii. Any action undertaken to promote public health, and safety by replacing existing merchandise with an approved product or new package design.

3. A procedure to ensure that a wholesale distributor prepares for, protects against, and handles any crisis that affects security or the operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of a local, State or national emergency; and

4. A procedure to ensure that outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. Such procedure shall provide for written documentation of the disposition of the outdated prescription drugs and shall be maintained for three years after disposition of the outdated prescription drugs.

N.J. Admin. Code § 8:21-3A.16

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)4, substituted "three" for "two".