For many life sciences companies, coordinating the tracking, monitoring and reviewing of each state's wholesale distribution laws is overwhelming. Even more cumbersome, is determining how each state enforces its laws.
All 51 jurisdictions within the US (50 states plus the District of Columbia) have some type of wholesale distribution licensing requirements, each with significant and unique challenges. In order for a company to both distribute and sell into a state, it must be aware of and compliant with all state licensure requirements.
As state licensing agencies often revise their requirements, it is difficult for life sciences companies to keep up and remain compliant.
States impose heavy fines against companies that do not comply with wholesale distribution laws. Some states will fine a company for each and every infraction or shipment that occurs while it is not properly licensed or non-compliant with the multitude of state requirements.
Many states have begun requiring medical device or durable medical equipment manufacturers and distributors to obtain licenses. States are also becoming more stringent with obligations for pharmaceutical company Designated Representatives, which may include undergoing a criminal background check or meeting experience criteria. Looking ahead, we anticipate many states will continue to revamp their laws in response to the passage of pertinent federal regulations. Impacted wholesale distributors and third-party logistics providers will in turn be required to meet more stringent minimum requirements.
How We Can Help
Porzio Life Sciences' Distribution Licensing Team caters to life sciences companies irrespective of business model or products sold or distributed. We handle initial licensing, renewal licensing and various ancillary licensing projects. For example, if your company has added a controlled substance to your existing product portfolio, we can help you obtain the additional registrations required. Similarly, we can procure licenses required due to changes in ownership, location or name.
Current licensing customers:
- Wholesale distributors and manufacturers of prescription drugs (controlled and non-controlled), over-the-counter drugs and devices
- Corporate headquarters
- Third party logistics providers of drugs and devices
- Durable medical equipment providers
- Medical device distributors and manufacturers
- Changes in company ownership, location and name
- Reporting changes in corporate officers or designated representatives
PorzioLS also handles all state agency follow-up during the application process to ensure the license is issued as expeditiously as possible. Over all the years, we have developed good working relationships with the representatives at the state licensing agencies. We often accelerate the licensing process due to our familiarity with agency processes and requirements that might not even be publicly available.