Wholesale Drug Distributor

Wholesale Drug Distributor

Any person, partnership, corporation, or business firm, or other entity that engages in the distribution of prescription drugs to a person other than a consumer or patient in this state.

Wholesale drug distributor includes manufacturers, repackagers, own-label distributors, jobbers, private-label distributors, brokers, warehouses, and wholesale drug warehouses, wholesale medical gas distributors, independent wholesale drug traders, and retail pharmacies that engage in wholesale drug distribution in this state.  Wholesale drug distributor also includes reverse distributors that are located in this state.

Wholesale drug distributor does not include a common carrier or other person or entity hired solely to transport prescription drugs if the common carrier, person, or entity does not store, warehouse, or take legal ownership of such drugs.

Applications/Licensure Requirements

Any person, partnership, corporation, or business firm, or other entity that engages in wholesale drug distribution in this state must first obtain a wholesale drug distributor license from the Department.  A separate license must be obtained for each facility engaged in wholesale drug distribution in this state.

A license is issued only for the premises and persons named in the application and is not transferrable or assignable.

Initial Licensure for a Wholesale Drug Distributor

An wholesale drug distributor applicant must:

  1. Submit a written pdf iconapplication to the Department which includes the information required by 172 NAC 131.003.02A;
  2. Obtain a pdf iconcriminal background check for the following personnel;
    1. The designated representative;
    2. The supervisor of the designated representative; and
    3. If the company is non-publicly held, each owner with greater than 10% interest in the wholesale drug distributor;
  3. Provide a proof of a bond as defined in 172 NAC 131-002.   Please note that the Department does not have their own bond form;
  4. Submit documentation of passing an initial inspection pursuant to 172 NAC 131-005.01; and
  5. Submit the required fee of $550.

Initial Application for a Wholesale Drug Distributor-Manufacturer

  1. Submit a written pdf iconapplication to the Department which includes the information required by 172 NAC 131.003.02A; and
  2. Submit the required fee of $550.

Initial Application for a Wholesale Drug Distributor-Medical Gas Distributor

  1. Submit a written pdf iconapplication to the Department which includes the information required by 172 NAC 131.003.02A;
  2. Submit documentation of passing an initial inspection pursuant to 172 NAC 131-005.01; and
  3. Submit the required fee of $550.

All wholesale drug distributor licenses expire July 1st each year.

All application materials must be submitted to:

DHHS-Division of Public Health
Licensure Unit
PO Box 94986
Lincoln NE 68509-4986

*Please note that request for criminal background checks are to be submitted directly to the Nebraska State Patrol.

Renewal Licensure

Wholesale drug distributor licenses expire on July 1 of each year.

Renewal Process:  At least 30 days before July 1 of each year, the Department will send a renewal notice by means of regular mail to each licensee at the licensee’s current mailing address as noted in the records of the Department.

Wholesale Drug Distributor

  1. The completed renewal notice;
  2. Proof of a bond;
  3. Proof of an acceptable inspection completed within the previous three years;
  4. Documentation relating to misdemeanor or felony conviction(s) of the designated representative of the licensee or licensure revocation, suspension, limitation or disciplinary action of the licensee since initial licensure or since the last renewal (whichever applies); and
  5. The renewal fee of $550.

Wholesale Drug Distributor-Manufacturer

  1. The completed renewal notice;
  2. Documentation of licensure revocation, suspension, limitation or disciplinary action of the licensee since initial licensure or since the last renewal (whichever applies); and
  3. The renewal fee of $550.

Wholesale Drug Distributor-Medical Gas Distributor

  1. The completed renewal notice;
  2. Proof of an acceptable inspection completed within the previous three years;
  3. Documentation relating to licensure revocation, suspension, limitation or disciplinary action of the licensee since initial licensure or since the last renewal (whichever applies); and
  4. The renewal fee of $550

A second renewal notice will be sent to each licensee who fails to renew their license by July 1 of each year.  The licensee is still required to submit the completed renewal notice, the required documents, the renewal fee of $550, and the renewal late fee of $100.

The Department can refuse to renew a license.  (See 172 NAC 131-011)

Failure to renew within 30 days of the expiration date will result in the revocation of the license without further notice or hearing.

Certification

If a wholesale drug distributor needs to have their license certified to another state, the wholesale drug distributor needs to submit a request in writing.   There is no fee for certification of a wholesale drug distributor license.

Duplicate License

Duplicate request pdf iconform

Reinstatement

Within One Year After Revocation for Non-Renewal

Wholesale drug distributor must:

  1. Submit a completed pdf iconapplication form;
  2. Provide proof of a bond;
  3. Provide proof of an inspection; and
  4. Submit the required fees (the renewal fee of $550 and reinstatement fee of $50).

Wholesale drug distributor-Manufacturer must:

  1. Submit a completed pdf iconapplication form; and
  2. Submit the required fees (the renewal fee of $550 and reinstatement fee of $50).

Wholesale drug distributor-Medical Gas Distributor must:

  1. Submit a completed pdf iconapplication form;
  2. Provide proof of an inspection; and
  3. Submit the required fees (the renewal fee of $550 and reinstatement fee of $50).

After One Year of Revocation for Non-Renewal

Any wholesale drug distributor whose license has been revoked for more than one year for not meeting renewal requirements, may reapply to the Department for a license.  Reapplication is made in the same manner as an application for initial licensure.

Reinstatement After Disciplinary Action

Any wholesale drug distributor whose license has been suspended or revoked for disciplinary action may reinstated by the Department upon recommendation of the Board after a definite period of time as described in 172 NAC 131-010.03A and 131-010.03B.  The licensee would submit an application in the same manner as an application for initial licensure

Amendments

A license is issued only for the premises and person(s) named in the application and is not transferable or assignable.  Change of ownership or change of premises terminates the license.  The owner(s) must apply for a new wholesale drug distributor license.

An applicant or licensee must notify the Department when there is a change in the designated representative.  The applicant of licensee is responsible for meeting the requirements pursuant to 172 NAC 131.003.02A item 3 and may amend the wholesale drug distributor application or license by submitting the required information regarding the pdf iconnew designated representative to the Department. 

An applicant or license must notify the Department when there is a change in the name of the facility by submitting an pdf iconamendment application.

Links:

pdf icon Application
pdf icon Application for Manufacturer
pdf icon Application for Medical Gas Distributor
pdf icon Application to AMEND a Wholesale Drug Distributor License
pdf icon Instructions for Criminal Background Check
pdf icon Application to REINSTATE a Wholesale Drug Distributor License

Fees

Initial Licensure fee  - $550.00

Renewal Licensure fee - $550.00

Renewal Late fee - $100.00

Duplicate License fee - $10.00

Inspection fee - $3,000.00 plus actual costs for transportation, lodging and meals for the pharmacy inspector who conducts the inspection.

Re-inspection fee - $750.00 plus actual costs for transportation, lodging and meals for the pharmacy inspector who conducts the re-inspection.

Reinstatement fee - $50.00

Reinstatement After Discipline fee - $75.00

Administrative Fee - $25.00 (for a denied credential or a withdrawn application)

Rules and Regulations

pdf icon Pharmacy statutes

Regulations pdf icon 172 NAC 131

Other related contacts

National Association of Boards of Pharmacy (NABP)
1600 Feehanville Dr.
Mount Prospect, IL60056
Phone: (847) 391-4406
Fax: (847) 391-4502
Web: www.nabp.net

Criminal Background Check

pdf icon Instructions for Criminal Background Checks

Disciplinary Actions

Grounds for discipline are in pdf icon172 NAC 131-011

Inspections

Each wholesale drug distributor doing business in Nebraska must be inspected onsite by the Department, by a nationally recognized accreditation program approved by the Board, or by another state or federal regulatory agency approved by the Board. Such inspections will occur as a condition of receiving and retaining a wholesale drug distributor license.

For applicant and department responsibilities for the initial inspection see pdf icon172 NAC 131-005.01.

For licensee and department responsibilities for triennial inspections see pdf icon172 NAC 131-005.02.

Listings/Labels/Rosters

List and Labels

Complaints

DHHS Investigations

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Contact Us

Office Address:

Mailing Address Physical Address
Nebraska Department of Health and Human Services
Division of Public Health
Licensure Unit
PO Box 94986
Lincoln, NE 68509-4986
Nebraska State Office Building
301 Centennial Mall South
14th and M Streets
3rd Floor
Lincoln, Nebraska

Phone: (402) 471-2115
Fax: (402) 471-8614

Office Hours:

8:00 a.m. to 5:00 p.m. (central time)
Monday through Friday

Vonda Apking, Health Licensing Coordinator
Phone: (402) 471-2118
e-mail: vonda.apking@nebraska.gov

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