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 follows 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: 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 product 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.
The 7 steps to get a Mississippi Drug Facility Permit.
Fill out an application for your drug facility permit. Include a brief description of the services your business offers, along with the type of drug facility permit you require.
Step 2: Submit background information.
Submit a completed fingerprint card, verification form, background questionnaire and a notarized affidavit for the designated representative.
Step 3: List all trading partners your business provides services for.
If your business is a third party logistics provider or a virtual entity, you must include a list of third party logistics or contract manufacturers you conduct business with or plan to conduct business with in the future.
Step 4: Get a surety bond.
You are required to have a surety bond in the amount of $100,000 (or $25,000 if your business had annual gross receipts totaling $10,000,000 or less from the previous tax year). The surety bond is your guarantee to the state that you will follow all the Mississippi Board of Pharmacy’s rules and regulations. If a claim is made against your bond and the surety finds the claim to be valid, the surety will pay out to the claimant up to the total bond amount. It will be your responsibility to pay the surety back in full in this instance.
In lieu of a surety bond, a letter of credit or other equivalent means of security is acceptable.
Step 5: Include the following documents with your application.
- A copy of your current home state license or home state permit.
- Your most recent inspection report. (If your state doesn’t perform inspections on your type of facility, please include documentation from your home state detailing this information.)
- A list of all states you have licenses, permits or registrations with.
- A copy of your DEA registration (if applicable).
- Documentation of current FDA registration if your business type is a manufacturer or re-packager.
- A detailed standard operating procedure or training narrative.
Step 6: Pay all the required fees.
- $500 – Application fee
- $50 – Controlled substances permit fee (If applicable)
- $40 – Background check fee for designated representative
Checks are to be made payable to “Mississippi Board of Pharmacy”. You may write the checks out separately or cumulatively. A $250 late fee is added if an application is received after December 31.
Step 7: Submit your application and documents.
Mail your application, fingerprint card and all other documents to the address below.
MISSISSIPPI BOARD OF PHARMACY
Attention: AliceClaire Scott, Licensing Division
6360 I-55 North, Suite 400
Jackson, Mississippi 39211
If you have any questions regarding the Mississippi Drug Facility permit, please email the Mississippi Board of Pharmacy at email@example.com or call 601.899.8880.
The Mississippi Board of Pharmacy requires drug facility permit holders have a surety bond.
How much does a Drug Facility Permit Bond cost?
You will need either a $25,000 or $100,000 surety bond to get a drug facility permit. If your business’ annual gross last year was more than $10,000,000, you will need a $100,000 surety bond. The cost of the surety bond depends on the credit of everyone who has 10% or more ownership in the business. Personal and business financials are also required for the $100,000 bond amount. We issue MS Drug Facility Permit Bonds starting as low as 1% of the bond amount.
If you have any questions about the bond, give us a call at 866.722.9239 or email firstname.lastname@example.org to speak to one of our bond experts. Fill out our online application to get quotes for your Drug Facility Permit Bond today!