Environmental Health

Frequently Asked Questions


REQUESTS FOR CONSULTATION

Q: May I contact your office for advice, guidance, or recommendations for my specific circumstances?
The New Jersey Department of Health, Wholesale Drug Project does not and cannot provide specific legal advice.  We do not provide any kind of advice, explanation, opinion, or recommendation to a business or consumer about possible legal rights, remedies, defenses, options, selection of forms or strategies. Therefore, if you need legal advice for your specific problem, you should consult a licensed attorney in your area.

Related: Qualifications for Designated Representative

 

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HOW AND WHEN TO SUBMIT FORMS, NOTICES, OR CHANGE REQUESTS

Q: When is it appropriate to submit a new application form F-2?
Utilize the Registration of Drug or Medical Device Manufacturing or Wholesale Drug or Medical Device Business application form F-2 only to apply for a new registration for a new legal entity. All submissions of form F-2, upon approval, will result in a new registration number.


Q: Do I need to submit a new application for a new or changed location?
Multiple locations that are operated by the same business entity may be registered under the same registration number. There is no need to submit a new application for each location.


Q: How do I add, change or remove a location on my 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.
  • For each new out-of-state location, attach a copy of the resident state wholesale license.
  • $20 Processing Fee per letter (if submitted separately from the annual renewal).
  • The fee is only applicable to new locations. There is no fee to remove a location. There is no fee to correct an address if there is no physical move.

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.


Q: How do I change the business name on my registration?
You may CHANGE your business name at any time of the year by submitting a signed letter request. Attach a copy of the resident state license showing the new business name, if applicable, or legal documentation to verify the name change. Include documentation that the EIN of the business has not changed.There is no fee to change the name on your registration.


Q: How and when should I notify the Department of company changes?
Within 30 days following a change of corporate structure, change of parent or grandparent company, change of officers, or change of designated representative that will not result in a direct modification of the New Jersey wholesale registration, notification may be submitted via email with your “500-“ series registration number to: wholesaledrugs@doh.nj.gov

Q: What documents must I submit for a change of ownership?
If a new EIN is required as a result of the change of ownership, submit a new initial application form F-2 for a new NJ registration. The registration is not transferable.

If the EIN will remain the same following the transaction, review the initial application form F-2 and submit any information from the application that will change as a result of the change of ownership. These notices may be submitted as application pages or as a cover letter by mail or via email to: wholesaledrugs@doh.nj.gov


Q: How do I avoid an interruption of business in the event of a change of ownership?
In the event of a change of ownership which will result in the issuance of a new registration for the buyer, form F-2 must be submitted as indicated above. To avoid interruption of business during the transition, and to ensure the new entity may continue operations prior to inspection, please include the following with the form F-2 submission:


Provide a cover letter from each of the involved companies that verifies the intent of each party to the transaction, including the selling party’s registration number, the closing date, a statement that there are no changes in operations or personnel associated with the change (other than the corporate officers and other management and staff who would be listed on the application for registration), and any address(es) to be removed from the seller’s active registration upon issuance of the buyer’s registration.

 

Q: What is the reporting requirement for disciplinary actions from other states?
Submit any disciplinary actions as attachments with your annual renewal.


Q: How do I discontinue my registration?
If you are ceasing wholesale activities and wish to DISCONTINUE your registration please submit a signed letter on company letterhead indicating the registration number to be discontinued, the reason for discontinuance, and the effective date. 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. Attach the most recent original NJ wholesale license, if available.

 

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APPLICATIONS FOR NEW REGISTRATIONS

Q: Does my business need to be registered with the Department?
This office is unable to offer legal advice to businesses and cannot evaluate for licensure without submission of application. Requirements for registration are based on the definitions and exemptions provided in NJAC 8:21-3A.3, NJSA 24:1-1 and NJSA 24:6B-14.

Q: Does this registration apply to over-the-counter drugs?
Yes.

Q: Does this registration apply to class 1 medical devices?
Yes.

Q: Does this registration apply to active pharmaceutical ingredients?
Yes.


Q: Does this registration apply to combination prescription drug devices?
Yes.

Q: Does this registration apply to veterinary drugs?
Yes.

Q: Does this registration apply to dietary supplements?
No. Facilities in New Jersey that manufacture or store dietary supplements for wholesale distribution must register as a wholesale food-cosmetic establishment.

Q: Does this registration apply to blood or blood components?
No.


Q: Is this the correct registration for a Durable Medical Equipment provider?
The Drug and Medical Device Registration is not applicable to direct-to-patient equipment providers.

Q: Is this the correct registration for Research and Development activities?
The Drug and Medical Device Registration is not applicable to research and development activities.


Q: Is this the correct registration for a Reverse Distributor?
If the Reverse Distributor takes ownership of the product or is responsible for directing the sale or disposition of product within New Jersey, it is considered to be engaged in wholesale distribution and is subject to registration.


Q: Is this the correct registration for a 503B Registered Outsourcing Facility?
Outsourcing facilities registered under Section 503B of the FD&C Act may apply for a wholesale drug/medical device registration.

Q: Is this the correct registration for a Third-Party Logistics Provider?
H.R. 3204, DQSA, Uniform National Policy, Sec. 585 (b)(2) New Jersey does not regulate third-party logistics providers as wholesale distributors. The Drug and Medical Device Registration is not applicable to third party logistics providers.

Q: How do I apply for a Third-Party Logistics Provider registration?
New Jersey does not offer drug/medical device registration for third-party logistics provider activities. Third-Party Logistics Providers that handle controlled dangerous substances contact the NJ Drug Control Unit. Warehouse facilities that store food, dietary supplements, or cosmetics are subject to licensure as a wholesale food-cosmetic establishment.

Q: Is this the correct registration for a retail pharmacy?
The Drug and Medical Device registration is not applicable to retail pharmacies. Contact the NJ Board of Pharmacy.

Q: Is this the correct registration for a virtual manufacturer/virtual distributor/broker?
If the entity takes ownership of the product or is responsible for directing the sale or disposition of product within New Jersey, regardless of physical possession of the product, it is considered to be engaged in wholesale distribution and is subject to registration.


Q: How long is the review process for a new application?
The review process for a new wholesale registration application is 30 days. If the application is found to be deficient, a letter will be mailed to the mailing address specified on the application form. NJ resident distribution locations and offices will be subject to inspection before approval.

Q: Which locations must be listed on pages 1-2 of the new registration application?

  • Locations operated by the applicant company that conduct wholesale business into or within New Jersey that are submitted for registration under this application, including office locations.
  • Contract manufacturers, third-party logistics providers, chain pharmacy distribution centers, and any other third-party companies and locations contracted by the above applicant locations.

Q: What information must be submitted for each location?

For ALL LOCATIONS, applicant and third-party:

  • The name of the business that operates each location.
  • Activity Conducted must be declared within the checkboxes according to definitions recognized by the State of New Jersey.
  • Provide the name and contact phone number of the Designated Representative.
  • For each location outside New Jersey, submit copies of all applicable current resident licenses or registrations.
  • Submit proof of applicable FDA registrations, DEA registrations, or Controlled Dangerous Substance licenses.
  • Submit a complete copy of the most recent resident state or FDA inspection report.


Q: May I submit a residential home office for registration?

Per NJSA 24:6B-20 all establishments which conduct wholesale distribution activities, including all office operations, must be a commercial location. Applications which list a residential location for registration will be ineligible for approval.

Q: May I submit a post office box as a registered location?
No. 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.

Q: My product is handled by a third-party logistics provider. May I register their location under my company's name?
All registered locations must be commercial offices or facilities directly operated by the registrant.

Q: My business is conducted remotely. Why do I need a secure commercial office?
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.

Q: May I register a location that is operated by a separate business?
Per N.J.S.A. 24:6B-20f facilities used for wholesale distribution must be secure from unauthorized entry. Provide documentation of common ownership and control of each separate business at the same location. Multiple registrations at the same address must have common parent ownership.


Q: May I operate a wholesale business from a pharmacy?
Per NJAC 8:21-3A.5 a retail pharmacy or dispensing location wishing to conduct wholesale business shall operate the wholesale business under a separate name and at a separate location other than that of the pharmacy or dispensing location.

Q: Do I need a qualified Designated Representative?
Each registered facility and office location shall employ a qualified designated representative.

Q: What are the qualifications for a Designated Representative?
The Designated Representative is required to be actively involved in and aware of the actual daily operations of the wholesale distributor. Actively involved, means being employed full-time in a managerial position; physically present at the facility during normal business hours; and knowledgeable about all policies and procedures pertaining to the wholesale distributor's operations. A designated representative shall be knowledgeable of, and adhere to, written policies for operational due diligence including but not limited to facility inspections.


Q: Do I need a New Jersey Registered Agent?
All non-resident applicants are required to submit the name, contact information and New Jersey office address of an appointed New Jersey Registered Agent. The Department cannot recommend a Registered Agent.


Q: Do I need to submit a full product list?
A full product list is required to be submitted. Longer lists may be attached as a CD or flash drive. If the required product information is available on the business website, a web address is also acceptable. If a new business does not yet have a list of products, or if the list fluctuates frequently, please provide detailed information regarding the type and source of products to be distributed.

Q: My product list contains controlled dangerous substances. What additional documents must I submit with my application?
New Jersey facilities that store or handle controlled dangerous substances contact the New Jersey Drug Control Unit. All applicants submit a current copy of the resident state controlled dangerous substance registration and DEA license with your wholesale drug/medical device registration application. If your business utilizes a third-party logistics provider, submit applicable controlled dangerous substance licenses for each contracted facility.

Q: Do I need the wholesale drug/medical device registration before I can apply for a controlled dangerous substance license?
No. A wholesale drug/medical device registration application that includes controlled dangerous substances will not be approved without applicable controlled dangerous substance licenses.

Q: What licenses does my out-of-state business need to distribute controlled dangerous substances into New Jersey?
Out-of-state distributors of drugs that are considered controlled dangerous substances must maintain all applicable licenses with DEA and with the resident state agency that licenses controlled dangerous substances. The entity that takes ownership of the drug or is responsible for directing the sale or distribution of the drug must maintain the wholesale drug/medical device registration with this office. In-state distributors of controlled dangerous substances contact the New Jersey Drug Control Unit for licensure. The wholesale drug/medical device registration must be accompanied by applicable resident state and DEA controlled dangerous substance licenses where verification of licensure is required.

Q: Do I need to submit the full Articles of Formation for my business?
It is not necessary to submit the full Articles of Formation. A valid Certificate of Incorporation or Certificate of Formation is sufficient to satisfy the attachment requirement for an established business.

Q: What is a Federal ID Tax Certificate and where can I find it?
Please submit a document or letter provided by the IRS which verifies the company’s Tax ID number. If this is not available, a W-9 form is also acceptable.


Q: Does a CPA need to sign my form?
The Certified Public Accountant Signature section of the initial application form is only required if the company is submitting a fee of only $50. A CPA must sign only to verify that the company qualifies for the discounted application fee. If a company submits $200 or more, a CPA signature is not required.

Q: How do I request an expedited review process of my application?
This office does not offer expedited processing and cannot under any circumstance guarantee a processing time less than 30 days. An applicant is welcome to submit a cover letter to describe emergency time constraints, which may be considered during the review process. Applications will not be expedited based on phone calls or e-mail correspondence.

Q: Can a business operate in New Jersey while its application is under review?
An applicant may not conduct wholesale drug or medical device business in the State until a registration is issued in the applicant’s name.

Q: What is the status of my new application?
New application forms must be submitted via courier or certified mail to enable tracking capability. Please use the date of delivery as verification that your application has been received by this office. Please allow 30 days for processing and review. If the review finds the application deficient, a letter will be mailed to the mailing address on the application, to the attention of the signing officer. If an applicant location qualifies for inspection, at the conclusion of the review a State inspector will directly contact the Responsible Person of the location to schedule an inspection. Upon issuance, the new registration information will immediately become available on the Drug and Medical Device registration verification webpage.


Q: My resident state license has not yet been issued. May I submit the NJ application?
A non-resident application will not be approved for registration unless a license has been issued by the resident state.

 

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INSPECTIONS

Q: Will my New Jersey location receive an inspection?
All new in-state locations which conduct wholesale distribution activities, including office operations, will receive an inspection by the Department.

Q: Why am I required to have an inspection?
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. 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.

Q: Will an inspector call me to schedule an inspection?
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. Routine inspections of currently registered facilities may be unannounced.

Q: How can I prepare for the inspection?
The inspections are done to determine compliance with the Registration of the Wholesale Distributors of Drugs rule, NJAC 8:21-3A.

Q: What happens if an inspection results in a Conditionally Satisfactory evaluation?
After the inspection is conducted the facility is provided with an inspection report. Facilities rated Conditional Satisfactory will be reinspected on or after 30 days from the date of the initial inspection. 60% or more of the violations are expected to be corrected in order to receive a satisfactory rating on the reinspection.

Q: When will I receive the new license for my New Jersey location?
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.

Q: Do I need an inspection in order to apply for a license in other states?
Follow the requirements of the State where you apply for the registration. If your firm is registered in NJ the NJ inspection report may be required to obtain an out-of-state registration.

Q: How may I request a new inspection of a currently registered location?
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.

 

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ACTIVE REGISTRATIONS

Q: When does my registration expire?
All Drug and Medical Device Registrations expire on January 31st of each year.

Q: How do I verify the status of my current registration?
The status of a NJ Drug and Medical Device registration is available online.

Q: How do I submit a license verification form for completion by the Department?
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.

Q: How may I request a copy of my registration?
Please send an email request to wholesaledrugs@doh.nj.gov with your “500-“ series registration number and “REQUEST FOR COPY OF REGISTRATION” in the subject line. Please specify whether an email or printed registration copy is requested. Registration copies are available to representatives of the registered business.

 

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REGISTRATION RENEWAL

Q: When should I expect to receive my renewal form?
Renewals are accepted beginning October 1. Renewal reminders are mailed in mid-November. The renewal form F-13 is available on the Department website.

Q: May I submit my renewal early?
Renewal applications will begin to be accepted October 1.

Q: The form I have shows an incorrect “Period Ending” year. May I use it for this year?
No. The current renewal form is available online.

Q: The owner is not available to sign the renewal form. Who may sign the document?
Please attach proof of power of attorney for the signing agent.

 

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SUBMISSION PROCESS

Q: What methods of payment are available?
Payments may be made via check/money order or online payment. Online payment with a credit card or e-check is available at our website.

Q: Who should I make a check payable to?
Checks and money orders should be made payable to NJ Department of Health.

Q: May I submit a check and application separately?
Checks and applications which are received separately will not be processed and will be returned to the applicant.

Q: Is my registration automatically renewed when I submit an online payment?
Renewal payments submitted via the online payment system are not sufficient to renew a registration. The renewal form F-13 is required to be completed and submitted.

Q: May I submit my renewal application electronically?
If payment was made online, the completed and signed renewal form F-13 may be sent as a PDF attachment via email to: wholesaledrugs@doh.nj.gov

Q: May I submit my initial application electronically?
Initial application form F-2 must be notarized and mailed to this office.

Q: Where should I mail my application?
Paper applications, attachments and payment may be mailed to the following address:

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

 

Q: May I drop off my application in person?
Walk-ins are not accepted and there is no receptacle for personally delivered applications. All paper applications must be mailed via USPS or courier to ensure proper processing. Submit applications via email when they do not contain personally identifiable information.

 

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Last Reviewed: 7/22/2022