Wholesale Drug Distributor or Wholesale Drug Distributor - Medical Gas Distributor

 
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What you need to know

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.

With the passing of the Drug Quality and Security Act (DQSA) by the Food & Drug Administration (FDA), Nebraska is no longer requiring a state license for those entities whose business is limited solely to that of a Manufacturer or Third Party Logistics Provider (3PL).   


Please contact Tressa Waterman, Health Licensing Specialist, at (402) 471-2118 or at tressa.waterman@nebraska.gov to determine whether you are required to obtain Nebraska's Wholesale Drug Distributor license.  


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 or 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 form for a new representative to the Department.

An applicant or licensee must notify the Department when there is a change in the name of the facility by submitting an amendment to the Department.

Amendment Application

Applications, Requirements & Fees

Notice: The fee for criminal background checks increased to $45.25 on January 1, 2017. Submit request for criminal background check directly to the Nebraska State Patrol.

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

Initial Licensure for a Wholesale Drug Distributor

A wholesale drug distributor applicant must: 

  • Submit a written application to the Department which includes the information required by 172 NAC 131.003.02A
  • Obtain a criminal background check for the following personnel:
    • The designated representative
    • The supervisor of the designated representative; and
    • If the company is non-publicly held, each owner with greater than 10 percent interest in the wholesale drug distributor
  • 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.
  • Submit documentation of passing an initial inspection pursuant to 172 NAC 131-005.01; and
  • Submit the required fee of $550. 
     

Initial Licensure for a Wholesale Drug Distributor - Medical Gas Distributor

A Wholesale Drug Distributor - Medical Gas Distributor must submit: 

  • A written application to the Department which includes the information required by 172 NAC 131.003.02A
  • Documentation of passing an initial inspection pursuant to 172 NAC 131-005.01; and
  • The required fee of $550 

Application materials* must be submitted to:

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

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

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 172 NAC 131-005.01.
  • For licensee and department responsibilities for triennial inspections see 172 NAC 131-005.02.
  • Inspection fee - $3,000 plus actual costs for transportation, lodging and meals for the pharmacy inspector who conducts the inspection.
  • Re-inspection fee - $750 plus actual costs for transportation, lodging and meals for the pharmacy inspector who conducts the re-inspection.

Renewal Information

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

If a licensee fails to renew their license by July 1 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.

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 Distributors must submit:

  • The completed renewal notice
  • Proof of a bond
  • Proof of an acceptable inspection completed within the previous three years
  • 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
  • The renewal fee of $550


Wholesale Drug Distributor - Medical Gas Distributors must submit:

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

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

Within One Year After Revocation for Non-Renewal, a Wholesale drug distributor must:

  • Submit a completed Application to Reinstate a Wholesale Drug Distributor License   
  • Provide proof of a bond
  • Provide proof of an inspection; and 
  • Submit the required fees (the renewal fee of $550 and reinstatement fee of $50).

Wholesale Drug Distributor - Medical Gas Distributor must: 

  • Submit a completed Application to Reinstate form
  • Provide proof of an inspection; and 
  • 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.

Office of Medical & Specialized Health
Department of Health & Human Services/Division of Public Health/Licensure Unit 
Phone Number
(402) 471-2118
 
Fax Number
(402) 742-8355
Mailing & Physical Addresses

DHHS Licensure Unit
PO Box 94986

Lincoln NE 68509-4986


 

Nebraska State Office Building

301 Centennial Mall South
14th & M Streets  1st Floor
Lincoln NE 68508

Hours: Monday - Friday 8:00 a.m. - 5:00 p.m. Closed federal holidays.