Navigating the Seas of State Licensing
Medical Devices and Pharmaceuticals
(09/16/10 - St. Petersburg, FL) From Maine to Florida, differences in the state licensing regulations are making it very complicated for companies to legally sell their drugs and devices. Besides the complexity and state to state differences in the licensing regulations and requirements, these regulations and requirements are constantly changing making it very difficult for companies to comply.
To maintain sanity (and sell in numerous US states), an organized and logical approach to licensing is a must. There are a few steps that should be taken to keep this process manageable and moving forward quickly. The process itself can be a long and difficult one, but with an organized approach it is possible to expedite the results which are, of course, obtaining a license to legally sell and ship drugs and devices from your facility.
The following seven steps recommended by
Advanced Biomedical Consulting (ABC), LLC are a quick reference as to how to approach state licensing and should be followed (in order), so as to quickly obtain each license desired:
1. Contact the agency within each state (e.g. Board of Pharmacy, Department of Health, etc.). Each state has a website which lists the specific requirements and regulations for that state.
2. Based on the regulations, decide which license is appropriate for your company. An example of one of the biggest differences among the states is that some states require a distributor's license for out of state manufacturers while others do not.
3. Obtain the application. Most forms can be downloaded, but some need to be obtained by contacting the state and then getting the application by email, fax or mail.
4. Review the application and its requirements and begin obtaining all the documentation necessary. Some states will require other applications to be obtained prior to sending in the license application itself (e.g. license verifications, certificate of authority, etc.). The recent trend and way of the future is for a company to be VAWD certified. At least 2 states require VAWD certification for a wholesale distributor's license (which can take 7 or 8 months to obtain).
5. Prepare a simple spreadsheet detailing what is required for each state so that as the steps are taken, the status can be easily tracked.
6. As the licenses get approved, keep track of the renewal dates. Some licenses are only valid for one year while others remain valid for 2 years. Some others must be renewed only in specific months.
7. Periodically review the state websites, so that you can stay abreast of the changing requirements for that state. Staying ahead of those requirements can save valuable time when the changes take affect.
For more information about how to quickly and effectively obtain state licensing for any or all 50 states, feel free to contact
ABC here for a no obligation quote to manage and complete this entire process for you and your organization. If you contact ABC
before 01OCT10 and mention this newsletter, ABC will offer
15% OFF our standard rates for
state registration services.
So, take advantage of this opportunity today to save your organization valuable dollars and still get the help you need!
Advanced Biomedical Consulting (ABC), LLC is a member of the ABC family of companies, a group of companies known for providing both cost-effective and extremely
high quality products and
services. ABC provides a wide range of consulting services to industries associated with the manufacturing and distribution of Food and Drug Administration (FDA) regulated products. With a diversified workforce made up of published technical and regulatory experts in the pharmaceutical, medical device/diagnostic, biopharmaceutical, cosmetic, food/seafood, and animal feed industries, ABC can provide cost effective solutions to nearly all issues encountered in FDA regulated industries.