| Customer verification | Federal rules apply |
|---|---|
| Records to keep | 3 years |
| Separate device or DME distributor license | Yes |
What New Jersey requires before you ship
We did not find a New Jersey rule beyond federal law that spells out how a distributor must verify its customers. Federal rules still require it. New Jersey's rules require due diligence on suppliers: before first buying from another wholesaler, a distributor must collect its licenses, inspection reports and officer list, and update them yearly. We found no New Jersey rule that expressly requires a distributor to verify a customer's license before selling. Distributors must keep a monthly-updated list of every establishment they buy from or sell to. Federal DSCSA trading-partner rules still apply.
Source: N.J.A.C. 8:21-3A.13(d), 8:21-3A.14
Records to keep
Wholesale distributors must keep records of all receipts and distributions of prescription drugs, including the source and dates, and a monthly-updated list of all retail and wholesale firms they trade with. Records must be kept for three years after the drugs are disposed of. Off-site records must be produced within two working days.
Source: N.J.A.C. 8:21-3A.13, 8:21-3A.15
Licenses a distributor needs in New Jersey
Prescription drug wholesale distributor
A wholesale distributor of prescription drugs in New Jersey, whether located in the state or not, must be licensed by the Department of Health, with each location licensed and renewed every year. Drug manufacturers and wholesale non-prescription drug businesses must file a registration with the department. Registrations can be checked on the department's online verification portal.
Source: N.J.S.A. 24:6B-1, 24:6B-15; N.J.A.C. 8:21-3A
Medical device and DME distributors
In the registration act, 'drugs' is defined to include devices, and the department says any business that distributes prescription or non-prescription drugs or medical devices must register. The department also says DME providers that do not do wholesale business may not register. We found no rule limiting who device distributors may sell to.
Source: N.J.S.A. 24:6B-1, 24:6B-12(c)
Controlled substances
Every person or firm that manufactures, distributes or dispenses controlled dangerous substances in New Jersey needs a state CDS registration for each location, renewed every year, in addition to DEA registration.
Source: N.J.S.A. 24:21-10
Where to look up a New Jersey license
- Pharmacies and pharmacy permits: New Jersey Board of Pharmacy
- Physicians and other practitioners: New Jersey State Board of Medical Examiners
- NPI: NPPES NPI Registry
- DEA registrations: DEA Diversion Control Division
Federal rules that apply in every state
- A prescription device "is to be sold only to or on the prescription or other order of such practitioner," or to a business lawfully distributing it (21 CFR 801.109).
- A prescription drug wholesale distributor's trading partners "may be only authorized trading partners," which for a pharmacy means one licensed under state law (21 U.S.C. 360eee-1(c)(3)).
How WorkdID handles New Jersey accounts
WorkdID by Workd checks every New Jersey customer you sell to against the state's pharmacy and medical boards, the NPI registry, and the DEA, every day. It flags an expiration or a board action within a day of posting, and in Workd order entry it can hold the order until your compliance team clears the account. Every check is saved with the date and the board record, so your New Jersey file is ready when someone asks for it.
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