Environmental Health

Drug and Medical Device Registration

LICENSE VERIFICATION

Look Up or Verify a Current New Jersey Wholesale Drug or Medical Device Registration

License Verification Forms for Other State Agency Applications are Not Accepted
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.

 

Verify Wholesale Drug Distributor Licenses in Other States
FDA maintains an online list of every State agency that is responsible for licensure of prescription drug distributors.

 

Verify FDA Registration and Inspection Information
The FDA firm and supplier database includes data associated with inspections classification, inspections citations, compliance actions, recalls, and imports.

 

REQUEST A DUPLICATE LICENSE

To request a duplicate wholesale/manufacturer license, send an email to wholesaledrugs@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.

 

SUBMIT CHANGES TO A CURRENT REGISTRATION
  • To register a new location to a current registration, submit the following:
    • A signed letter which includes:
      • The 7-digit registration number beginning "500"
      • The name and contact information of the Designated Representative at the new location
      • A short description of operations at the new location
      • The effective date of the change
      • The address to be removed from the registration, if applicable
      • If a manufacturing or warehouse facility is closing, include verification that all remaining drug, medical device or API inventory has been accounted for, reclaimed and/or disposed of properly.
    • A copy of the resident state license for each new nonresident location
    • A processing fee of $20 is required to add a location. Please note this is NOT a "license reprint" fee, and is only applicable to the addition of a registered location to a current registration.
    • Email your submission to wholesaledrugs@doh.nj.gov
    • All New Jersey locations are subject to inspection before registration.

  • To submit, change, or add an operator, owner, partner, sole proprietor, corporate officer, or director:
    • For each individual, submit a signed letter which includes:
      • Full legal name
      • Business address
      • Social Security Number
      • Date of birth
    • MAIL the original document.

      Via USPS:

      NJ Department of Health
      Public Health & Food Protection
      PO Box 369
      Trenton, NJ 08625

      Via UPS/FedEx/DHL:

      NJ Department of Health
      Public Health & Food Protection
      135 East State Street
      Trenton, NJ 08608

  • To submit, change, or add a Designated Representative:
    • For each individual, submit a signed letter which includes:
      • Full legal name
      • Business address
      • Direct telephone number
      • Direct email address
    • Notice may be submitted via email to wholesaledrugs@doh.nj.gov 

For more information, see the FAQ.

 

DEFINITIONS

N.J.A.C. 8:21-3A.3

"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.

NJSA 24:6B

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

"Drug" 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

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

"Drug 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.

 

See the Wholesale Drug Rules for a full list of definitions, qualifications, and requirements.

 

QUALIFICATIONS FOR REGISTRATION
  • Wholesale Distributors and Manufacturers are required to register. If you are uncertain whether your business qualifies under the definition of wholesale distributor or manufacturer, consult a licensed attorney.

  • Section 503B registered drug compounding outsourcing facilities may submit application as wholesale distributors and manufacturers.

  • Registered facilities may include production facilities, warehouses, or commercial offices that are operated by the registrant. Residential addresses and virtual addresses are not registered. Facilities which are not directly operated by the applicant are not registered.

  • Each registered facility must have a qualified Designated Representative.

  • A retail pharmacy wishing to conduct a wholesale business shall operate the wholesale business under a separate name and at a separate location, other than that of the pharmacy name and address.

  • All registered facilities must be secure from unauthorized entry.

 

See the Wholesale Drug Rules for a full list of definitions, qualifications, and requirements.

 

RELATED REGISTRATIONS AND INQUIRIES
  • Controlled Dangerous Substance Registration: Manufacturers and wholesalers must register with the New Jersey Drug Control Unit if they will handle controlled dangerous substances. The State of New Jersey has established a Drug Control Unit within the Department of Law and Public Safety, for the purpose of assisting in the enforcement of those provisions of the New Jersey Controlled Dangerous Substances (CDS) Act which relate to persons who, or firms that, manufacture, prescribe, distribute, dispense or conduct research or analysis utilizing controlled substances. To register to handle CDS, please contact the New Jersey Drug Control Unit.

  • Logistics Provider means an entity that receives drugs from the original manufacturer and delivers them at the direction of that manufacturer, and does not purchase, sell, trade, or take title to the drugs. Logistics Providers are not wholesale distributors and may not register. Logistics Providers that are located in New Jersey and are engaged in the storage or packing of food, vitamin supplements, or cosmetics must register as a wholesale food-cosmetic establishment.

  • Durable Medical Equipment Provider means an entity that delivers durable medical equipment directly to the consumer or patient. Durable Medical Equipment Providers which do not conduct wholesale distribution business may not register. Licensure for Durable Medical Equipment Providers is not available through this office. Consult your local Medicare/Medicaid office for further guidance.

  • Vitamin Supplement or Cosmetic Manufacturers or Distributors which operate a facility in New Jersey that stores or manufactures vitamin supplements or cosmetics must register as a wholesale food-cosmetic establishment.

 

INITIAL APPLICATIONS
  • Initial Application Form (F-2) 
    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.

    1. Pay online with check or credit card or enclose a check made out to "NJ Department of Health" ("Treasurer, State of New Jersey" is also acceptable)

    2. Send the original notarized paper application and attachments via UPS/FedEx/Courier to:

      NJ Department of Health
      Wholesale Drug Project
      135 East State St
      Trenton, NJ 08608

 

 

RENEWAL APPLICATIONS
  • Renewal Application Form (F-13)
    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.

    1. Pay online with check or credit card
      The online payment portal is NOT a renewal. The completed renewal form F-13 is required to be completed and submitted by mail or email.

    2. Email the completed renewal application and payment confirmation number to wholesaledrugs@doh.nj.gov 

 

INSPECTIONS

INITIAL INSPECTION

All new in-state locations which conduct wholesale distribution activities, including office operations, will receive an inspection by the Department.

Upon completion of review of the initial application or request to add a new location, the listed Responsible Person or Designated Representative of the location will receive a call from an inspector to schedule the initial inspection.

Upon completion of the inspection, the facility will be provided with the inspection report. If the facility receives a Satisfactory rating the report will undergo review by the office for issuance of a Drug and Medical Device registration. A Conditional Satisfactory rating will result in a reinspection. The registration will only be issued to the facilities that have received a satisfactory inspection rating and have concluded final review.

 

ROUTINE INSPECTIONS

The State of New Jersey conducts inspections of all wholesale distributors of drugs and medical devices that are currently registered or have applied for the registration in NJ on a three-year schedule.

Routine inspections of currently registered facilities may be unannounced.

 

REQUESTS FOR INSPECTION

A facility may request an inspection by mail or via email to wholesaledrugs@doh.nj.gov with your “500-“ series registration number and “REQUEST FOR INSPECTION” in the subject line. Please provide the name and contact phone number of the Person In Charge at the location, and a brief description of operations at the location to be inspected.

 

INSPECTION REQUIREMENTS

Inspections are conducted to determine compliance with the Registration of Wholesale Distributors of Drugs regulations, N.J.A.C. 8:21-3A.

Drug/medical device storage and distribution facilities as well as office-only locations that qualify for NJ drug and medical device registration are subject to and responsible for meeting the same requirements of N.J.A.C. 8:21-3A Registration of Wholesale Distributors of Drugs.

Distributors of prescription drugs, including medical gases, over-the-counter drugs and medical devices are subject to and responsible for meeting the same requirements of N.J.A.C. 8:21-3A Registration of Wholesale Distributors of Drugs.

 

MEDICAL DEVICE BUSINESSES ARE REQUIRED TO BE INSPECTED

Pursuant to N.J.A.C. 8:21-3A.3 Definitions,  "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. N.J.S.A. 24:6B-12 further specifies, for the purposes of this registration act, unless otherwise required by the context: "Drugs" means "drugs" and "devices" as defined in R.S.24:1-1.

 

Last Reviewed: 10/22/2021