In the pharmaceutical industry, state licensing requirements can change at a moment’s notice. Though no central “hub” exists listing all licensing updates for each state, our team of experts works with state boards on a routine basis to track all license requirement updates.
Recently, we’ve notified our clients and partners of changes that affect virtual manufacturers specifically in Arizona, Vermont, and New Hampshire.
Government agencies in these states have implemented a new requirement that Contract Manufacturer Organizations (CMO) must hold their own license in these states. This is a prerequisite for virtual manufacturers to obtain a new and/or renew a current license in these states. Let us help you determine how these, or other licensing changes, affect you.
Effective in 2019, the Arizona Board of Pharmacy has amended their qualification requirements for Virtual Manufacturers. A CMO located in the United States must hold a Manufacturer License with the Arizona Board of Pharmacy. If a CMO is located outside of the country, they will be required to provide an unredacted FDA inspection report dated within the last 2 years.
The New Hampshire Board of Pharmacy has recently moved to require licensure of all the following entities: “Virtual Manufacturers, Virtual Distributors, Contract Manufacturers (repackager/relabelers), and Brokers/Intermediaries.”
Effective for 2019, the Vermont Board of Pharmacy moved to require licensure of all entities that are engaged in the “dispensing, delivery, or distribution of prescription drugs.” Specifically, the board is now requiring CMOs located in the United States to hold a VT license. If a CMO is located outside of the United States, VT now requires an unredacted FDA inspection report dated within the last 2 years.
At Two Labs, keeping a pulse on these changes is at the core of our best-in-class service offering. We proactively monitor for changes in state regulations, government agency statue interpretations, and compliance requirements which affect manufacturers.
We work closely with our clients to not only update them on these changes, but to explain their impact on operations and provide detailed guidance on next steps.
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