Puerto Rico Eliminates Special Authorization Licensing Requirement for All Non-Resident Entities
Effective immediately, all Special Authorization licensing requirements for non-resident pharmaceutical entities have been repealed—streamlining access to product and controlled substance registrations.
Background
On June 17, 2025, the Puerto Rico Department of Health issued Administrative Order No. 612, officially repealing Administrative Order No. 564 and voiding prior guidance that had required non-resident pharmaceutical entities—such as virtual manufacturers and wholesale distributors—to obtain a Special Authorization License in order to register and operate in the territory.
This change represents a major regulatory update: all Special Authorization Licenses for non-resident entities have been eliminated, effectively removing a significant barrier to market access in Puerto Rico. The repeal comes after a formal review by the Secretariat for the Accreditation and Regulation of Public Health (SARPS), which concluded that the objectives of Order No. 564 could be met through existing legislation without the need for a separate authorization framework.
In a parallel move, the Department also repealed a related notice dated June 29, 2022, which specifically applied to non-resident wholesale distributors of prescription and non-prescription medicines, veterinary drugs, homeopathic products, nutritional supplements, and related artifacts.`
What This Means for Industry Stakeholders
With the repeal of the Special Authorization framework, non-resident pharmaceutical entities located in the United States no longer need to secure a separate license to register products or operate in Puerto Rico.
- Streamlined product registration for all prescription, OTC, veterinary, and homeopathic drugs, as well as nutritional supplements and medical artifacts.
- Elimination of duplicative licensing requirements for U.S.-based companies that are already licensed under their home jurisdictions.
- Faster, more predictable pathways to market for virtual manufacturers, wholesalers, and distributors.
A Breakthrough for Controlled Substance Virtual Manufacturers
One of the most significant outcomes of this repeal is its direct impact on Controlled Substance Virtual Manufacturers, who were previously unable to obtain a Controlled Substance Product Registration due to being stuck in the Special Authorization application bottleneck.
With the elimination of the Special Authorization License requirement, Controlled Substance Virtual Manufacturers may now proceed directly to obtain their Controlled Substance Product Registrations through the Department of Health’s existing licensing channels.
This regulatory change effectively:
- Unlocks access to the Controlled Substance market in Puerto Rico for non-resident virtual manufacturers.
- Removes a bureaucratic bottleneck that previously delayed or prevented product launches.
- Aligns controlled substance registration procedures with those applicable to other product categories, under existing law.
This long-awaited resolution is expected to benefit not only the companies directly affected but also the broader healthcare ecosystem in Puerto Rico by increasing product availability and competition.
Next Steps for Companies
Pharmaceutical stakeholders should take immediate action to align operations with the updated regulatory framework:
- Discontinue any pending or planned Special Authorization License filings, as they are no longer required.
- Update internal compliance protocols and documentation to reflect the repeal.
- Proceed with product and controlled substance registrations under the standard licensing provisions of Puerto Rico’s Department of Health.
- Engage with regulatory experts to ensure all filings are up to date and in compliance with the new structure.
Summary
The repeal of all Special Authorization Licenses for non-resident pharmaceutical entities is a positive and long-awaited regulatory advancement. It simplifies market access, reduces unnecessary administrative hurdles, and opens critical doors for companies in the controlled substance space.
LighthouseAI commends the Department of Health for taking this decisive step toward regulatory clarity and efficiency, and we stand ready to support clients as they navigate the updated landscape.
Documentation:
NOTIFICACIÓN ESPECIAL SOBRE AVISO DE DISTRIBUIDORES NO RESIDENTES
Assistance With Puerto Rico
Since 2018, LighthouseAI has maintained a full-time office in Puerto Rico, supporting hundreds of companies in establishing their operations throughout the territory.
For additional questions, or to inquire about our Puerto Rico consulting and regulatory services, please Contact Us.
Disclaimer: The information provided herein is for general informational purposes only and does not constitute legal advice. Always consult with a qualified professional for specific regulatory guidance.
