The US Food and Drug Administration (FDA) is responsible for ensuring the safety of our nation's drug supply. The FDA regulates pharmaceutical trading partners along the supply chain, including wholesale drug distributors. Drug distributors purchase pharmaceuticals from manufacturers and sell to dispensers, such as pharmacies, hospitals, and retailers. Wholesale drug distributors are responsible for moving a majority of drugs in the supply chain. These companies range in size from top 10 Forbes companies to small businesses, with several millions of distributors in operation today.
C urrent FDA regulations require prescription drug wholesale distributors be licensed by each state in which they distribute products. Federal regulations establish minimum licensing standards to be adopted by state licensing agencies. However, states are permitted to adopt stricter standards and a majority of states have elected to implement more onerous licensing requirements.
The lack of uniform drug distributor licensing standards has resulted in a confusing patchwork of state regulations with different licensing requirements. For instance, some states require fingerprinting and criminal background checks for key personnel.
And, some states have expanded regulation of drug products to include regulation of OTC drug distributors shipping product into their state. So, distributors of consumer products classified as OTC drugs must secure drug distributor licenses if operating in regulated states.
States regulate distributors differently based on their unique distribution model. Distribution models and licensing obligations vary based on whether the company manufacturers and distributes their own or another company's drug products, distributes products but never physically possesses the product, or distributes products under the direction of a distributor or manufacturer (3PL).
U n derstanding state drug licensing obligations is complicated and time-consuming. CCS takes ownership over your drug distributor licensing needs. We manage the details of applying for and securing required licenses, freeing up your company resources to focus on your business goals.
Pharmaceutical firms risk formal disciplinary action and fines for the distribution of drugs into a regulated state without the required wholesale drug distributor permit. Companies doubtful of rigid agency regulation of pharmaceutical companies are encouraged to review the Kansas Board of Pharmacy website listing multiple facility disciplinary orders issued to both in-state and out-of-state facilities for violations of Board rules. Once disciplinary orders are connected with a company, these orders most certainly will need to be disclosed to other state agencies when applying for or renewing a license.
Increasingly, state agencies are requiring wholesale drug distributors provide state licensing details on their trading partners as a requirement to obtain or renew their license. Failure to confirm their trading partners hold appropriate state registrations risks putting the distributor's license in jeopardy. Companies risk losing partners in the supply chain who are unable to distribute or purchase products from a partner lacking appropriate state licensure.
The process and timeline for renewing each state drug license varies by state. To avoid risk of operating with an expired license, renewal deadlines and procedures for each state license must be managed carefully.
About half of state drug wholesaler licenses are renewed annually, while the remaining state licenses are renewed every two or three years. And expiration dates vary by state. License expiration dates are linked to the date the license was issued or are based on a defined date for all holders of a specific drug permit type.
Each state regulates the renewal process for their state distributor licenses. With increased staffing challenges causing delays in processing license renewal applications, it is important companies submit permit renewal applications well in advance of drug distributor license renewal deadlines. How far in advance state agencies allow submission of renewal applications vary by state.
State agencies communicate renewal instructions differently, with some states mailing paper renewal applications and other states emailing online renewal instructions. Maintaining correct contact information on file with agencies is important for ensuring important renewal instructions aren't missed. Once renewal applications are submitted, companies must carefully track each application to confirm license renewal.
Tracking multiple license renewal requirements is time-consuming and companies risk an expired license if important deadlines are missed. CCS manages our client's drug licensing portfolio by tracking license renewal deadlines, submitting renewal applications, and tracking receipt of renewed licenses.
