Environmental Health

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

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.

To add, change or remove a location on an existing registration:

Multiple locations may be associated with one registration. You may CHANGE, ADD or REMOVE a location on your registration at any time by submitting the following:

• Signed letter explanation of the changes to be made. Include:
  • Registration number (beginning with “500”)
  • Name and contact information of the Designated Representative for each new location.
  • Short description of operations at each new location.
  • The effective date of the change.
  • 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.

  Only your first-party locations need to be listed on your registration. Please do not include contract manufacturers, third-party logistics providers, chain pharmacy distribution centers or any other third-party locations.

  Submit all attachments via email to wholesaledrugs@doh.nj.gov

  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

    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

      For more information, see the FAQ.

      See the Wholesale Drug Rules (N.J.A.C. 8:21-3A and N.J.S.A. 24:6B) for a full list of definitions, qualifications, and requirements.

      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.

      “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

      "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 (N.J.A.C. 8:21-3A and N.J.S.A. 24:6B) for a full list of definitions, qualifications, and requirements.