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Managing the Business of Science™
Spectrum MMC resolves thorny problems

Project:  The U.S. affiliate of a foreign manufacturer was asked to provide a State pharmacy license in order to continue shipping FDA approved product to hospitals in that State. The affiliate could not meet the requirements as outlined for non-resident wholesaler license and the costs associated with this issue were prohibitive.

Details:  Current practice by State government and professional regulatory agencies is to refer applicants to websites, but it is difficult to locate specific information or resolve issues in a clear and timely fashion. Some regulatory agencies respond to voice messages or email only one day per week, and some are currently one or more months behind. Spectrum MMC reviewed U.S. Federal and State distribution and licensing requirements and then embarked on a verbal communication program. Over a period of several days, communication was established with Federal and State government officials and Federal and State professional regulatory agency officials.

Result:  Direct voice contact with a State Board of Pharmacy official confirmed that, under circumstances applicable to this instance, this company is exempt from licensing requirements.

Client was able to commercialize its products in a timely manner at no additional costs.
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