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When companies think about “national” compliance, the mind usually jumps to the 50 states, spanning California to New York. But the United States has several territories with their own boards, their own rules, and their own fees.
The fun part is that each territory, like the 50 states, approaches pharmacy and wholesale oversight a little differently – and the requirements are real, enforceable, and often surprising for companies that assume U.S. territories operate like the 50 states.
Below is a guided tour of the big three: the Commonwealth of the Northern Mariana Islands (CNMI), the U.S. Virgin Islands (USVI), and Guam.
The CNMI Health Care Professions Licensing Board regulates pharmacies, wholesalers, manufacturers, and anyone distributing drugs into the Commonwealth. The law is straightforward.
If you are located in CNMI and handling drugs, you need a license. If you are located outside CNMI and providing services to patients inside CNMI, you also need a license.
Application:
Fees are substantial. A new pharmacy, wholesale, or mail-order application costs $500 dollars; renewals cost $400 dollars; late renewals cost $1,000 dollars plus the renewal fee.
CNMI also requires non-resident businesses to maintain a registered agent on the islands.
The U.S. Virgin Islands uses a layered process that begins with a Certificate of Need (CON).
Before the Board of Pharmacy will even look at a pharmacy application, the applicant must file a letter of intent, submit a CON application with a $200 dollar fee, and provide the original plus three copies.
Only after the Department of Health approves the CON can a company apply to the Board of Pharmacy for a pharmacy, wholesaler, distributor, 3PL, or centralized services license.
Application:
USVI Guidelines: Registration is biennial and currently costs $1,872 dollars. Companies should not underestimate the CON; itis a real gatekeeper and often the slowest part of the process.
Guam’s system is the closest analog to mainland U.S. state boards. Non-resident wholesalers and pharmacies must file separate applications, qualify as a foreign entity in Guam, and appoint a registered agent located on the island.
Applications:
Guam Guidelines: Guam’s definition of “drug” is broad and tracks federal language, so nearly all therapeutic products fall under the regulated umbrella.
While CNMI, USVI, and Guam differ in style, nearly all territorial regimes share a few consistent themes:
Even though the population is small, the regulatory expectations are not.
US Territory compliance is one of the most common blind spots in national licensing programs. Companies expand their U.S. distribution footprint, ship to a few customers in Guam or CNMI, and only later discover that the respective Boards consider their activity fully in-scope.
The practical takeaway is simple. A modern compliance program must account for all fifty-five U.S. jurisdictions, not just the fifty states. Remote fulfillment, mail-order models, and multi-state 3PL networks make territorial rules relevant to almost everyone.
Covering the territories is not about volume or revenue. Itis about eliminating preventable regulatory risk. Whether you automate the workflow or manage it through internal tracking, giving the territories equal weight helps avoid costly surprises, board inquiries, and forced operational pauses.
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