Assessments


licensing

 

 

State Licensing Assessment

This assessment condenses licensing requirements for virtual manufacturers across 51 jurisdictions. This breakdown helps to categorize these jurisdictions based on their licensing requirements to create a more streamlined licensing process. Click here to learn more.

disciplinary action

Notification of Disciplinary Action

Upon discovery of misconduct, a facility is required to report disciplinary action to the Boards of Pharmacy for states in which business is conducted. The form which these reports must take in terms of deadlines, type of communication, and follow-up procedures hinge on the severity of the offense or oversight. This assessment outlines state-specific steps and details for this type of reporting for the following states: Arizona, Colorado, Nevada, New Mexico, Rhode Island, Arkansas, Florida, Kansas, Minnesota, Montana, Ohio, Oregon, Vermont, New York, Connecticut, Mississippi, North Carolina, Oklahoma, South Carolina, South Dakota, and Utah. Click here to learn more.

manufacturer assessment

OTC Distributor & Manufacturer Assessment

For the manufacture and distribution of over-the-counter products, required licensure varies across states. Some states require out-of-state manufacturer/wholesaler licenses, while others require a specific license designation for over-the-counter products if these are to be distributed. This assessment covers information about who must be licensed, which type of license they must have, and circumstances under which special designations are required based on certain products. Click here to learn more.

Wholesale Distributor Controlled Substance Assessment

Regarding the distribution of controlled substances, over half of the US states require specific licensure. Because of the variability of different states’ state licensing applications, some applications for wholesale distribution include a section on controlled substances, some states require a separate application, and some don’t require anything more than a wholesale distribution license. This assessment covers these details on a state-by-state basis, in addition to information about the variable required presence of a notary, application fees, and additional required documentation. Click here to learn more.

officer assessment

Change of Officer Assessment

When the leadership structure of a company participating in the pharmaceutical supply chain is shifted, the Boards of Pharmacy must be notified. This notification looks different depending on the company’s resident state, the states in which the company conducts business and the type of leadership alteration. This assessment outlines the proper notification practices based on these specific differences. Click here to learn more.

503B Assessment

Companies with a 503B designation are subject to different licensing requirements on a state-by-state basis. Licensure required to conduct business in across a group of five states, for example, may require the attainment of five different types of licenses, or may simply be covered with the possession of a single wholesale distribution license. This assessment covers these details in addition to the inclusion of legal research notes and specifics about communication with the Boards of Pharmacy. Click here to learn more.

 

 

Foreign CMO Assessment

When a company involves a foreign CMO in business proceedings across the United States, additional regulatory licensure is required. These requirements vary depending on a company’s state of incorporation and the states in which that company conducts business. This assessment addresses these topics on a state-by-state basis, and includes additional notes about this process within each state as the processes and requirements in each state are unique. Click here to learn more.

 

 

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