Who needs a drug facility permit?
The Mississippi Board of Pharmacy (MBP) requires all businesses participating in the wholesale distribution or selling of prescription drugs have a drug facility permit. This permit is renewed annually before the start of the new year. There are 5 types of drug facility permits available depending on the services your business offers. All permit types require the business to follow DSCSA regulations.
Business participating in the wholesale distribution or selling of prescription drugs in Mississippi are required to have a drug facility permit.
What are the different types of Drug Facility Permits?
Third-Party Logistics (3PL): This type of permit is required if your business ships pharmaceutical products for other companies. Your business doesn’t own the product; however, your business stores and controls product inventory. This includes the shipping/receiving records for other pharmaceutical companies.
Virtual: Your business does not receive products but is registered with the FDS to license/own products. Your business must be licensed in its home state and every state your product is shipped. Your product must be created by an FDA registered pharmaceutical company and shipped by an FDA registered third party logistics company. Your business must maintain the following:
- An office with at least 1 full-time employee.
- Records of your products.
- Standard operating procedures.
- Take care of product complaints and adverse events.
Re-Packager: The product is packaged for other companies through a contract or trade agreement. Your business must be registered with the FDA and not take ownership of the products.
Wholesale Drug Distributor (WDD): If your business owns, houses and ships their products in their name or a product licensed to them from a different company, you will need a wholesale drug distributor facility permit. Your business must be registered with the FDA and have state licenses in the business’ home state and each state product is shipped to. A business shipping control substance product must be registered with the DEA.
Manufacturer: Businesses manufacturing products for themselves or another company under a contract or trade agreement require a manufacturer drug facility permit. If your business is a manufacture, it must be registered with the FDA and licensed in its home state. Being registered with the DEA is only required if your business is producing a control substance product.