The Department can no longer complete license verification forms for applications for other states. Verification certificates are only available from the online verification webpage. Print the certificate and attach a copy of the current New Jersey registration to fulfill verification requirements in other states.

FDA maintains an online list of every State agency that is responsible for the licensure of prescription drug distributors.

The FDA firm and supplier database includes data associated with inspection classification, inspection citations, compliance actions, recalls, and imports.

To request a duplicate wholesale/manufacturer license, send an email to dmd@doh.nj.gov and include the following information:

1. Your name, title, and relationship with the registered business.
2. The 500- series registration number. All registration numbers begin: "500"
3. Indicate whether you would like an email PDF copy, a duplicate mailed license, or both.

"Drug" shall have the meaning set forth at N.J.S.A. 24:1-1 and as used throughout this subchapter shall include both non-prescription and prescription drugs.

"Non-prescription or Non-legend or O.T.C. drugs" mean drugs directly available to the consumer over the counter, without a physician's prescription.

"Prescription drug" means any human drug required by Federal law or regulation to be dispensed only by a prescription, including dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug and Cosmetic Act.

"Wholesale Distribution" means the distribution of drugs or devices to persons other than a consumer or patient.

"Wholesale Distributor" means anyone engaged in wholesale distribution including, but not limited to, manufacturers; repackagers; own-label distributors; private label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; and independent wholesale drug traders, but does not include a retail pharmacy whose sales of prescription drugs to other than the ultimate user, including physicians for office use, nursing homes, institutions, etc. does not exceed five percent of the total gross annual sales of prescription drugs of the pharmacy.

"Manufacturer" means anyone who is engaged in the manufacturing of drugs or devices, or engaged in the manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug.

"Designated Representative" means an individual who is designated by a wholesale distributor to serve as the primary contact person for the wholesale distributor with the Department, and who is responsible for managing the company's operations at that licensed location.

24:1-1. Definitions as used in this Title

"Drugs" means (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories.

"Device" means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; or (2) to affect the structure or any function of the body of man or other animals.

24:6B-12. Definitions

"Distribute" means to sell, offer to sell, deliver, offer to deliver, broker, give away, or transfer a prescription drug, whether by passage of title, physical movement, or both. The term does not mean to: dispense or administer; deliver or offer to deliver in the usual course of business as a common carrier or logistics provider, or provide a sample to a patient by a licensed practitioner, a health care professional acting at the direction and under the supervision of a practitioner, or the pharmacist of a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) acting at the direction of a practitioner.

"Drugs" means "drugs" and "devices" as defined in R.S.24:1-1

"Drugs manufacturing business" means the business of creating, making, or producing drugs by compounding, growing, or other process. This definition shall apply to persons engaged in the drug manufacturing business who do not maintain a manufacturing location in this State but do operate distribution depots or warehouses of such business in this State. This definition shall not apply to licensed pharmacies or to licensed professional individuals such as, but not limited to, pharmacists, physicians, dentists, or veterinarians when engaged in the lawful pursuit of their professions.

24:6B-14 Definitions relative to pharmaceutical wholesale distributors

"Drug" means: a. an article or substance recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them; b. an article or substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; c. an article or substance, other than food, intended to affect the structure of any function of the body of man or animals; and d. an article or substance intended for use as a component of any article or substance specified in clause a., b., or c.; but does not include devices or their components, parts, or accessories. Drug includes a prefilled syringe or needle.

Submit only when applying for a new registration. All submissions of form F-2 will result in the creation of a new registration number. Do not submit form F-2 if a current registration exists for the registered applicant. Please allow 4 weeks for application review. Expedited service is not available. At the conclusion of review, if more information is needed, a letter will be mailed to the applicant. If the registrant facility is in New Jersey, an inspector will reach out directly to the Designated Representative to schedule an inspection.

Initial Application Form (F-2)

Submit an electronic payment and receive a payment confirmation email.

24:6B-4 Certification Fees

A fee shall accompany each registration submission:

$200 - Single location in the State or out of State
$500 - 2 or more locations in State or out of State
$50 - for each location in the State if the gross total annual business in drugs does not exceed 3% of the gross total annual volume.

Submit an electronic payment

Due to the sensitive nature of information collected in the drug and medical device registration application, initial applications are not accepted via email. The State of New Jersey utilizes the secure cloud transfer MOVEit service to accept secure files.

1. Send an email to dmd@doh.nj.gov to request a secure-send link
   1. Title the email “Request for file share”
   2. In the body of the email, include the following:
      1. The business name of the registrant as it appears on page 1 of the application
      2. The current New Jersey registration number, if applicable
      3. The type of application you intend to submit securely (“Initial application”)
      4. The email address to which we should send a file-share request.
         
         
2. Please allow three (3) working business days for processing. The email address that you provide will receive an email from noreply@moveitcloud.com that contains further instructions.

Download the renewal form and complete all attestations before signature. Electronic and scanned signatures are accepted. All registrations expire January 31. Submit annually by December 31 to renew an active registration. Please allow 3-4 weeks for processing. There is no penalty payment for late submission. Renewals for the following year are accepted beginning October 1.

Renewal Application Form (F-13)

Applications received without attachments will not be processed.

1. For each location registered to the license for renewal, a copy of the resident state wholesale distributor or manufacturer license is required.
2. Submit an updated list of regulated products manufactured or offered for wholesale distribution by the registrant.

The online payment portal is for payment processing only. Submission of online payment alone is insufficient to renew your registration. The completed renewal form F-13 is required to be completed and submitted by email. Submit a separate payment for each registration number. Do not combine fees.

Submit an electronic payment

Email the completed renewal application and attachments to dmd@doh.nj.gov. 
If any attestation is marked Yes on the application form, attach supporting documentation.

For further submission process information and instructions for fees, CPA signatures, update notices, changes of ownership, corporate structure, officers, designated representatives, product lists, and locations, see the FAQ.