Taking Care of Your OTC and Rx Pharmaceutical State Licensing Needs
Are you concerned about regulatory gaps in your current state licensing program?
Does your company risk facing business interruptions because you need to show proof of state licensure to manufacture, distribute, or sell a drug or device?
Are you looking for cost-effective options for managing your current state licensing program?
For businesses engaged in the drug and medical device supply chain, there’s no shortage of OTC and Rx drug and device state licensing requirements. And many of these businesses just don’t have the time or personnel to keep up-to-date on numerous and complex regulations, much less fill out complicated forms.
Our expert team of consultants is dedicated to helping companies navigate the complex licensing landscape with ease.
Our Pharma State Licensing Services
OTC & Rx State Drug Manufacturing Licensing
Drug manufacturing models include physical manufacturers, contract manufacturing organizations (CMOs), and virtual manufacturers. State pharmaceutical licensing requirements depend on the unique manufacturing model and drug product category (OTC vs Rx) .
Complete Compliance Solutions partners with OTC and Rx drug manufacturers to identify and secure state licenses appropriate for their unique manufacturing model and manage license renewals.
OTC & Rx State Drug Distribution Licensing
Distribution models vary based on whether the company distributes their own pharmaceutical products, distributes products manufactured by other companies, or distributes products under the direction of a distributor or manufacturer. State agencies regulate distributors differently depending on their unique distribution model and drug product category (OTC vs Rx).
Complete Compliance Solutions assists OTC and Rx drug distributors with identifying the appropriate license type, securing required licenses, and managing license renewals.
OTC & Rx State Medical Device Manufacturer and Distributor Licensing
Medical device manufacturers and distributors are regulated by state agencies based on their unique business model and medical device category (OTC vs Rx). Device manufacturing models include own-product manufacturers, contract manufacturing organizations (CMOs), and virtual manufacturers.
Complete Compliance Solutions manages state licensing for OTC and Rx medical device manufacturing and distribution companies.
Each State Has Different Licensing Requirements
Partner with Complete Compliance Solutions to Ensure Your Business is Compliant
Every state has the authority to regulate OTC and Rx drugs and medical devices in their state. Unlike a single pharmaceutical establishment registration required by the Food and Drug Administration (FDA), several state licenses may be required to legally manufacture, distribute, and sell pharmaceuticals in the United States. And, each state regulates the supply chain differently.
The challenge facing pharma companies is matching their unique business model to each state regulation to determine necessary licenses. Once required licenses are identified, companies can be overwhelmed by the complicated application process unique to every state.
Compliance does not end when licenses are issued. Each license requires renewal, with expiration dates and renewal requirements differing by state.
And, state licensing regulations change. These changes can be difficult to locate and stakeholders are often unaware of changes.
Click the link below for a directory to each state’s licensing agency.
Complete Compliance Solutions takes ownership over our client's state licensing needs. We help clients with determining their licensing needs, applying for and securing licenses, and maintaining updated license information when business operations change. We manage license renewals to ensure important renewal deadlines aren't missed. Our experts routinely monitor changes in regulations and communicate when our client's licenses are affected.
Our clients range from leading consumer goods and pharmaceutical firms to start-up firms launching new products. Our clients include:
Drug manufacturers (own product, virtual, and contract manufacturing organizations (CMOs)
Medical device manufacturers (own product, virtual, and CMOs)
Medical device distributors
Medical device wholesalers
Third party logistics providers (3PLs).
Complete Compliance Solutions partners with companies to secure and manage OTC and Rx drug and medical device state licenses so companies can focus on growing their core business while minimizing risk.
Are Your Products Regulated by State Licensure?
States regulate combinations of different product categories. Most states regulate the manufacturing and distribution of Rx drugs and Rx medical devices in their state. While the regulation of Rx drugs and medical devices by states is widely understood by pharmaceutical companies, companies may be unaware that approximately 20 states regulate the manufacturing and distribution OTC drug and medical device products in their state.
To add to the confusion, states regulate differently based on the distribution model (manufacturer, virtual manufacturer, contract manufacturing organization (CMO), wholesale distributor, third party logistics provider (3PL).
In some cases, state licenses may be required even if the manufacturer or wholesale distributor is not located in the state where the product is sold.