Managing Diverse State Licensing Requirements

In addition to registering with the Food and Drug Administration (FDA) twice annually, a drug manufacturing license is required at the state level, including for virtual manufacturers.  State licensing requirements vary by state and can change frequently.

  • In what states does your organization need to be licensed?
  • How often does licensing need to be renewed?
  • What are the state requirements?
  • What exemptions, if any, should your organization request?
  • What changes in my organization require me to re-submit information for licensing?
  • We are a virtual manufacturer. Are state licensing requirements different for us?

These questions and more can quickly add months to a product launch, especially for pre-commercial and emerging pharma organizations with limited human and financial resources. And the frequent changes in state requirements challenge even established pharmaceutical manufacturers with identifying, tracking and reacting to changes swiftly.

State Licensing Requirements 101

Explaining all state licensing requirements in a short article is impossible, so here are some basics you should know:

  1. A drug manufacturing license is required at the state level.
  2. Depending on the state, a manufacturer license, wholesale distributor license, and/or pharmacy facility license may be required.
  3. In some states, virtual manufacturers are subject to the same licensing requirements as wholesale distributors.
  4. If controlled substances are manufactured, separate state licensing and permit requirements exist.
  5. Before issuing a license, the state may require a facility inspection.
  6. When applying for a drug manufacturing license, at a minimum, the following will be required:
    • Proof of FDA drug establishment registration
    • Corporate documents
    • Certificate of Good Standing
    • Proof of registered agent
    • Facility plans or construction drawings
    • Description of security system and security measures in place
    • Facility manager information
    • Self-inspection report
    • List of drugs to be manufactured/repackaged
    • Copy of VAWD certificate
    • Lease/zoning statement
    • Certificate of insurance

The following require state licensing action:

  • New applications
  • Renewals
  • Change of Ownership
  • Change of officer, address, or designated representative
  • Merger and acquisition activity

Managing State Licensing

State licensing is not a “one and done” process.  It is an ongoing, time-consuming process that, if not managed with flawless attention to detail and timing can delay a product launch and interrupt sales and distribution.  For that reason, most pharmaceutical manufacturers either have a team dedicated to managing the state licensing process or hire a third party expert, like UNITE Pharma trade advisors, to manage the process for them from start to finish.

A third party expert takes the burden off your team, so you can focus your resources on what you do best- developing and manufacturing pharmaceutical products.  When selecting a third party to manage state licensing, you should require they have demonstrated expertise in and manage the following for you:

  • Filling out and submitting the required application(s)
  • Advising you on required documentation needed by the state to submit with the application
  • Managing renewals
  • Tracking state licensing requirement changes and proactively supporting your organization in addressing them, as needed