A wholesale distributor located elsewhere in the United States needs a Special Authorization from the Puerto Rico Department of Health to ship drugs or medical devices into Puerto Rico. Its application includes a Certification of Bond in an amount the Department sets; a specialist quotes it, usually within one business day.
















Your shipments into Puerto Rico wait on the Special Authorization, and the authorization waits on the bond certification. Here is the whole process:
Apply online with your company details, your home-state wholesale license, the product lines you will distribute into Puerto Rico, and the bond amount the Renovaciones Online checklist shows.
A specialist reviews the amount, your distribution history and compliance record, and your company’s credit and finances, then returns a quote along with any collateral requirement.
Once you bind, we issue the executed bond and certification so you can upload it on Renovaciones Online beside the Self-Certification of Compliance, the criminal-history certificate, and the drug-registration certification.
The Puerto Rico Pharmacy Law, Law 247-2004, and the Secretary of Health’s regulations under its Article 6.02(a) govern the manufacture, distribution, and dispensing of drugs on the island. Until 2022, distributors located in other U.S. jurisdictions had no proper authorization to wholesale into Puerto Rico. The Department of Health’s notice of June 29, 2022, issued by its Auxiliary Secretariat for Regulation and Health Facilities Accreditation (SARAFS), closed that gap.
The Special Authorization covers distributing prescription and non-prescription drugs, veterinary medicines, homeopathic and natural products, nutritional supplements or medical devices into Puerto Rico.
From July 1, 2022, the Department’s Drugs and Pharmacy Division issues Special Authorizations to Non-Resident Distributors. Applicants comply with the applicable regulations and the requirements on the Online Renewals portal (Portal de Renovaciones Online), uploading a Self-Certification of Compliance, a Clear Criminal History Record, a Certification of Compliance with Drugs Registration, and a Certification of Bond, among others. The authorization is renewed every two years.
The bond is the Department’s financial backstop. The notice warns that non-compliance with Law 247-2004 and its regulations can lead to sanctions, including fines and execution of the required bond. The Department may also inspect non-resident distributors, at the distributor’s cost.
The Department’s public notices do not state a bond amount or publish a bond form, so we work from the figure on your portal checklist. Distributors located on the island need the regular Department of Health distributor license instead and do not use this authorization. The bond is underwritten on your company’s credit, finances, and compliance history, and a surety can ask for collateral on a thin file.
These are the actual underwriting fields — your company, your home-state license, what you will distribute into Puerto Rico, the amount on your portal checklist, and your finances. Submit once and a surety specialist returns a quote, typically within one business day. Free until your bond is issued.
Start the application →Send us the amount your portal checklist requires, and a surety specialist sizes, underwrites, and quotes the bond — typically within one business day. Free until issued.