Drug and medical device state licensing regulations are complicated and no two states regulate alike. Complying with state licensing regulations is critical to pharmaceutical companies both seeking to acquire new trading partners and to maintain existing licensing programs in compliance with ever-changing regulations.
Complete Compliance Solutions assists companies with assessing their pharmaceutical state licensing requirements. Contact us to learn more about our state licensing services.
Meet your Drug and Device License Needs With Our State Licensing Services
Why You Need a Partner to Assess Your State Licensing Needs
Pharmaceutical licensing requirements for manufacturers, wholesale distributors, 3PLs, and retailers vary considerably across state lines. States may regulate pharmaceutical companies if they distribute or sell products into their state, even if the company is not physically located in the state. As a result, a comprehensive review of every state licensing requirement should be conducted to ensure compliance.
Pharmaceutical companies attempting to navigate the complex patchwork of state licensing regulations on their own can expend much time and money and risk overlooking required professional and facility licenses or applying for licenses they don’t need. Further, state board of pharmacy licensing regulations are ever-changing and companies risk falling into non-compliance if they fail to continually monitor changes in state licensing regulations.
Let Complete Compliance Solutions ease this time-consuming burden. Our experts conduct a complete regulatory assessment of a company's pharmaceutical state licensing needs based on its unique supply chain model. We review current state pharmacy statutes, pharmacy laws, policy and guidance documents, and state agency website content to identify state pharmacy licensing requirements.
I'm a paragraph. Click here to add your own text and edit me. It's easy.
How We Help Companies With Our State Licensing Services
We support clients with the following state licensing assessment needs:
Pre-Launch State Licensing Process Assessment
Our experts assist companies working to launch a new product line or open a new pharmaceutical-related business to assess their state licensing requirements based on their planned supply chain model and pharmacy product portfolio.
We advise clients on required state license type, anticipated fee costs, and estimated timelines for obtaining the licenses so they can be positioned to launch their new project or new business in compliance with state board of pharmacy licensing regulations.
Licenses to Support New Customer Acquisition
Manufacturers, wholesale distributors, and 3PLs vying for new customers are likely to be asked to provide proof of state licensure as part of the due diligence process. State licensing regulations require current license holders verify supply chain trading partners are appropriately licensed in order to engage in drug and medical device trading activities. Further, companies adding new product lines or distribution models on behalf of a new customer may require additional state pharmacy licenses.
We support companies with assessing their state pharmacy and facility licensing obligations so they can be confident that their operations are legally compliant and that they are well-equipped to serve future professional customers.
Gap Analysis and Program Health Assessment
Maintaining ongoing compliance with the ever-changing patchwork of state facility and professional licensing regulations is challenging for pharmaceutical companies. Companies managing in-house compliance programs must remain vigilant to changing regulations or changes in product lines and business operations or risk overlooking requirements for new state board pharmacy licenses. Often, a thorough gap analysis can uncover needed or unnecessary licenses.
Our experts review a company's existing state licensing program to evaluate potential gaps and recommend solutions to resolve these gaps.
When a company is ready to apply for needed licenses or decides to engage an expert company in managing its licensing compliance program, Complete Compliance Solutions is ready to partner. We provide comprehensive state licensing services to include securing new licenses and managing license renewals.
State Licensing FAQ
How do you check if a state requires a drug or medical device license?
States board of pharmacy responsible for regulating pharmacy and professional licensing publish information on their agency website. Some states provide FAQs and information clearly identifying licensing requirements for pharmaceutical companies throughout the pharmacy supply chain. Other states simply provide links to pharmaceutical application forms, pharmacy laws, and regulations, requiring companies undertake greater effort to determine licensing requirements.
Where can I find a website link to every state licensing agency?
The regulation of drug and device licensing is performed at the state level. Every state board of pharmacy maintains their own agency website with information on state licensing requirements. A comprehensive list with links to every state licensing agency can be found here.
How can I contact a state licensing agency?
Information on how to contact state board of pharmacy licensing agencies for questions or assistance is provided on agency websites. Most agencies provide email links to a general help mailbox, while a few agencies provide personal email contacts. With the recent trend to remote work, email has become the preferred method for professional communication over telephone contact.