Complete Compliance Solutions

State Board of Pharmacy OTC Drug Licensing

We provide streamlined solutions to managing multiple state licensing requirements for regulated health care products.

Companies that manufacture over the counter (OTC) drug products and medical devices or distribute those products into multiple states must secure and manage numerous state licenses. While OTC drug products are most commonly recognized as non-prescription medicines, vitamins and dietary supplements, they also include common consumer products such as cosmetics with UV protection, medicated shampoos, antiperspirants, toothpastes and mouthwashes. 

To sell OTC drug products and devices into certain states, companies must sort through multiple state regulations, complete and file complex forms, and track the application status for with each state Board of Pharmacy to ensure they obtain the required licenses. Further, changes in business operations such as a company name change, business location change or change in corporate officers, require license amendments. 

States license a variety of OTC product distribution models, including:

  • Manufacturers distributing into a regulated state
  • Own-label and private label distributors selling into a regulated state
  • Third-party logistic providers managing distribution on behalf of a manufacturer into a regulated state
  • Brick-and-mortar and e-retailers selling into a regulated state.

Our Services

We understand that as companies work to bring new OTC products to market or expand their manufacturing and distribution operations, they often struggle to manage this complex patchwork of multi-state licensing requirements. We offer our clients a streamlined, cost-effective process to secure and manage these numerous licenses.

Our team works with manufactures, distributors and retailers to identify licensing requirements based on their business model. Our consultants prepare and file required applications and work closely with state agencies to secure timely processing of licenses. Additionally, because the renewal process and timeline for each license varies by state, we assist with the renewal process to ensure licenses remain current. If business operations change, we work with state agencies to update business licenses