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WEBSITE OF THE STATE OF SOUTH DAKOTA DEPARTMENT OF HEALTH
Kim Malsam-Rysdon, Secretary of Health

South Dakota Board of Pharmacy

Licensure of Wholesale Drug or other Distributors

Wholesale and Other Drug Distributor renewals are changing November 1, 2018!

 

PAPER RENEWALS WILL NOT BE ACCEPTED!


Beginning November 1, 2018, the wholesale renewals will need to be done online! Information and links will be available at a later date. Please check back for more information. We will email information as it becomes available.

New Wholesale Licensure or Change of Ownership Applications

Wholesale initial licensure and change of ownership will need to be completed on our paper form. A downloadable application will be available in late October.

Notification Form

A notification form will need to be used to change a Designated Representative, facility name, address, or if there is a facility closure. A downloadable notification form is available below. Complete the form and provide any requested documentation.



Current South Dakota wholesale drug distributor statutes and rules are located at the following links: SDCL 36-11A and ARSD 20:67

All South Dakota Wholesale Drug Distributor licenses expire on December 31. The renewal period begins approximately 60 days prior to expiration.  Please allow ten working days for processing. The application process will be delayed when incomplete or illegible information is provided.

Changes to information provided on the application must be made within 60 days of change. Please return your license if a new permit is desired. Changes in officers or directors can be provided upon renewal.

The following is required for licensure:

  • Completed application form and fee of $250, $200 for 503b Outsourcing Facilities. 
  • A copy of the home state license issued by the Board of Pharmacy or regulatory department.
  • A copy of the most recent inspection report. If none is provided, please explain.
  • Controlled substance registration – If your firm distributes controlled substances into the state of South Dakota, it is required to be registered with the South Dakota Department of Health. Please complete the Controlled Substances Registration form, and return it to the South Dakota Department of Health, 615 E. 4th St., Pierre, SD 57501; phone 605-773-3356. Download application form.
  • Due Process – Out -of-state drug wholesaler distributors shall designate a resident agent in South Dakota for service of process (ARSD 20:67:07:01). Information regarding South Dakota registered agents is located at https://sdsos.gov/business-services/corporations/corporate-forms/commercial-registered-agents.aspx