Drug manufacturers must be licensed in any state that regulates drug manufacturing companies. Failure to obtain required licenses can result in substantial financial and administrative penalties, including prohibition of the product’s shipment into the state. In addition to regulatory action, companies risk losing partners in the drug supply chain who are unable to distribute or purchase products from a manufacturer lacking appropriate state licensure.
Complete Compliance Solutions works with drug manufacturers to secure their OTC and Rx drug manufacturing licensing needs.
Secure Your OTC and Rx State Drug Manufacturing Licensing Needs Today
Why You Need a State Licensing Partner As a Drug Manufacturer
Regulation of OTC and Rx drug manufacturing companies differs across every state. Navigating every state’s pharmaceutical regulation to determine state licensing requirements is time consuming. Companies risk overlooking required licenses or applying for unnecessary licenses.
Once licensing obligations are identified, the license application process is challenging, with each state requiring detailed and unique information to complete the application. Drug manufacturing companies must carefully track each application status and promptly respond to state licensing agency requests for additional information to facilitate timely issuance of licenses.
And, the work doesn’t end when state drug licenses are issued. License expiration dates vary by state. Companies must track license renewal requirements to ensure timely submission of renewal applications or risk a cancelled drug license if they fail to renew the license in time.
Complete Compliance Solutions partners with pharmaceutical manufacturers to understand their state drug licensing obligations, apply for and work with state agencies through issuance of the drug license, submit business operation change notifications, and manage state drug license renewals. As specialists in state pharmaceutical licensing, we take ownership over our clients’ state drug licensing needs so companies can focus on growing their core business.
We Help Companies with Rx and OTC State Drug Manufacturing Licensing
Our Clients Include:
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Own-Product Manufacturers distributing drug products directly or through another distributor into a regulated state
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Virtual manufacturers who own the drug product, but contract with a manufacturer
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Contract Development and Manufacturing Organizations (CDMO) contracted to manufacture drugs on behalf of another company
Our clients range from leading OTC consumer goods and pharmaceutical firms to start-up companies launching new drug products.
How Complete Compliance Solutions Helps Your Business with Drug Manufacturing License Compliance
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Why Drug Manufacturers Need to Obtain a State Drug License
Drug product manufacturers are regulated by both Federal and state laws. Every state is authorized to regulate both OTC and Rx drug manufacturers and regulations vary state by state.
Unlicensed shipment or sale of drug products into regulated states can result in substantial financial and administrative penalties, including prohibition of the drug product’s shipment into the state. And, increasingly, state agencies require license holders and applicants provide proof that their trading partners are appropriately licensed before the product can be shipped into the state. As a result, a supplier or customer may ask any regulated company in the supply chain to confirm the facility holds appropriate licenses in all regulated states.
Companies often overlook state drug manufacturer licensing requirements because they are unaware their drug product is regulated or their manufacturing facility operations require a license. To avoid business disruptions and enforcement actions, it is critical companies understand their drug manufacturer licensing requirements and maintain appropriate licensure for their drug products.
Interested in assessing your company's drug manufacturing licensing needs?
State Drug Manufacturing Licensing FAQ
How long does it take to secure state drug manufacturing licenses?
Depending on the state agency, licenses can take 2 weeks to upwards of 12 weeks from the date the application is submitted. Understanding each state’s licensing application process is critical to avoiding unnecessary delay in being issued a license.
Which states require a manufacturer drug license to sell a product in the state?
State licensing requirements vary by state. Nearly all states require Rx drug manufacturers to hold a license when the facility is located in the state and most states require Rx drug manufacturers to hold a license if their product will be sold in the state. A smaller number of states regulate OTC drug manufacturers located in a regulated state and selling product into the regulated state.
When do manufacturer drug licenses expire?
License expiration dates vary by states. Some state drug licenses expire at a defined date for all holders of a specific license type. In other instances, the license expiration is linked to the date the license was issued. Most states require drug licenses be renewed annually while other states require renewal every two years.