License Applications

This course will cover the information you need to complete a drug manufacturer license application which is needed in many Sates that Palmetto Pharmaceuticals Inc. ships to. 

Understanding Palmetto and How We Operate

Virtual Manufacturer

Palmetto is considered to be a Virtual Manufacturer... but what does that mean?

A virtual manufacturer is an entity that owns the label information on a drug, but they do not physically manufacturer the drug. They generally have a contract manufacturer (CMO) who will make the drug and then allows the virtual manufacturer to provide a label and ship the product to their customers.

Supply Chain

Who ships our product?

Palmetto utilizes a company called RxTPL, which is a third party logistics company (3PL), to ship the product from our CMO (West-Ward) to a contract wholesale distributor (i.e Cardinal, Mckesson, ABC). This is the point where Palmetto no longer assumes ownership of the drug. The wholesaler will then sell and ship the product to various drug outlets and pharmacies.

Who is our CMO?

  • Mckesson
  • Cardinal
  • RxTPL
  • 3PL
  • West-Ward

Who is our 3PL?

  • Mckesson
  • ABC
  • RxTPL
  • West-Ward
  • TPLS

Where To Begin

Do We Need A License

Before you start the process, it's best to determine which states need us to be licensed. This information can be obtained in a few ways.

  • From our 3PL and CMO
  • Calling the Sate Boards

Information should be collected from both of our contract parties and compared. If there are inconsistencies then call the state board for clarification. Be sure to keep log notes of your phone calls with the board for reference purposes (word, or notes).

Add this information to an excel spreadsheet to keep track of the states which need licenses.


Which Forms Do I Choose?

Choosing the correct forms can be challenging...

The applications that Palmetto need to apply for are not always intuitive. Some states don't place manufacturer and virtual manufacturers in different categories. Other sates place all drug facilities on one application. While other applications will say "wholesale distributor" or Drug Outlet", although we do not consider ourselves to be in one of these categories , the other state's definitions in their law book may. This can become confusing and tedious. The best practice, when the application is not definitive, is to call the state board. It can be helpful to look at past licenses and look for the name of the old license application. 

Download The Necessary Forms

As you can see, there are many options to choose from from the South Carolina board of Pharmacy. None of them say " Virtual Manufacturer". Click on the information "i" below.

Complete The Forms

The next step is to complete the forms...

Be careful as you go through the form to fill it out accurately and to attache all the necessary documentation. If applications are completed inaccurately or incompletely they will send the application back or send a deficiency letter. Some of the options on the forms are not intuitive and need additional counsel from your supervisor. Always be sure to fill in the correct answer, do not guess.

Check The Boxes

Click the appropriate boxes that would most closely match Palmetto. (Check only one for each category)

Completed Application

Once It Is Complete

Scan the documents along with the check fullfilling the filling fee and save to an appropriate folder on the comapny drive

Mail

Once everything is scanned and saved, mail the documents to the state board address provided on the application.