2016 New Jersey Revised Statutes
Title 24 - Food And Drugs
Section 24:6B-23 - Authentication Of Distribution Of Prescription Drug.

NJ Rev Stat § 24:6B-23 (2016) What's This?

24:6B-23 Authentication of distribution of prescription drug.
14. a. (1) A wholesale distributor shall authenticate every distribution of a prescription drug back to the manufacturer if the wholesale distributor has reason to believe that a prescription drug purchased from another wholesale distributor is adulterated, misbranded or counterfeit.

(2)A wholesale distributor who distributed a prescription drug that is the subject of an authentication pursuant to this section shall provide, upon request, information regarding the distribution of the prescription drug, including: date of purchase; sales invoice number; and contact information for the wholesale distributor who sold the prescription drug, including the name, address, telephone number and e-mail address, if available.

(3)If a wholesale distributor is unable to authenticate each transfer, the wholesale distributor shall quarantine the prescription drug and report this to the department within 14 days after completing the attempted authentication.

(4)If the wholesale distributor satisfactorily completes the authentication, the wholesale distributor shall maintain records of the authentication for two years, and produce them to the department and the Department of Law and Public Safety, upon request.

b. (1) A wholesale distributor shall conduct annual random authentications on at least 10% of pedigrees as required by this act.

(2)A wholesale distributor shall conduct annual random authentications on at least 90% of the pedigrees of prescription drugs designated on the specified list of susceptible products for which a pedigree is required.

(3)A wholesale distributor and a manufacturer from whom other wholesale distributors have purchased prescription drugs shall cooperate with random authentications of pedigrees and provide requested information in a timely manner.


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