Navigating Puerto Rico’s New Licensing Standards for Pharmaceutical Wholesale Distributors

The Puerto Rico Department of Health has recently implemented a significant change to its licensing standards. These changes primarily affect non-resident wholesale distributors aiming to ship prescription and over-the-counter drugs, medical devices, and supplements into the Commonwealth.  

The key update? A new requirement for distributors to obtain a non-resident license, known as a “Special Authorization.” 

What This Means for Non-Resident Distributors 

It’s important to note that this new non-resident licensure requirement does not replace the existing requirement for non-resident wholesale distributors to register products shipped into Puerto Rico but is instead an addition to that requirement. 

Special Authorization Application Process 

The online application process includes the completion of the following forms, which are available on the portal: Self-Certification of Compliance; Clear Criminal History Record of Non-Resident Distributors; Certification of Compliance with Drugs Registration; and Certification of Bond. The special authorization will be valid for two years, after which it can be renewed. 

How Are Third-Party Logistics Providers Affected 

The Puerto Rico Secretary of Auxiliary Regulation of Public Health(“SARSP”), the agency responsible for issuing the special authorizations, has not yet provided guidance as to whether third-party logistics providers are also subject to this new licensure requirement. 

What This Means for Non-Resident Pharmacies 

Interestingly, while wholesale distributors face these new requirements, non-resident pharmacies are exempt from obtaining such licenses. They also remain exempt from registering products shipped to patients in Puerto Rico for valid prescriptions. 

Assistance with the New Requirement Changes 

For businesses navigating these changes, understanding the nuances of compliance is crucial. Should you have inquiries or require assistance with the latest licensing updates in Puerto Rico, don’t hesitate to reach out to us at hello@lighthouseai.com. 

If you are an existing client of LighthouseAI or Pharma Solutions, you may contact your existing Project Manager for updates or questions.