Puerto Rico’s Regulation of the Drug Supply Chain: Past, Present and Future

Overview of Requirements

Puerto Rico became a U.S. territory over 100 years ago after the conclusion of the Spanish-American War. As a territory that is still citing laws passed as early as 1912 to regulate the pharmaceutical supply chain, there are many nuances to ensuring compliance when doing business on the island.

One significant similarity between Puerto Rico and state regulation is that they both differentiate between Title and Possession in a transaction involving prescription drugs. For example, when a Virtual Manufacturer sells to a customer on the island, they are transferring titles because they direct the sale of their product (who to sell it to and at what cost) but because their 3PL receives, stores and ships, they have possession.

Specifically, Puerto Rico has the following requirements for different business models:

• • Virtual Manufacturer requirements before doing business:
    • Engage a Representative Agent (a Pharma Solutions service)
    • Register with State and Treasury Departments (a Pharma Solutions service)
    • Register drug products with the Department of Health (a Pharma Solutions service)
    • If selling Controlled Substances, obtain a Controlled Substance license (a Pharma Solutions service)
    • Verify the customer is properly licensed (active facility license or prescriber’s license and DEA registration + Puerto Rico Controlled Substance registration, as applicable)
  • 3PL requirements before shipping to the island:
    • Ensure compliance with federal requirements (a Pharma Solutions service)
    • Ensure compliance with resident/domicile state requirements (a Pharma Solutions service)
  • Drug Distributor requirements before doing business:
    • Engage a Representative Agent (a Pharma Solutions service)
    • Register with State and Treasury Departments (a Pharma Solutions service)
    • Ensure drug products are registered with the Department of Health by asking the manufacturer for Product Registration Certificates
    • If selling Controlled Substances, obtain a Controlled Substance license (a Pharma Solutions service)
    • Verify the customer is properly licensed (active facility license or prescriber’s license and DEA registration + Puerto Rico Controlled Substance registration, as applicable)

Recent News – Division Director Resigns

In September, Lydia M. Santiago Candelario, RPh resigned her position as Coordinator (Director) of the Division of Medications and Pharmacy of SARAFS, the governmental organization tasked with licensing and accrediting health facilities. She served as a contract “Pharmaceutical Adviser” to the Division for a few years since at least 2016. The unexpected resignation only caused slight delays in processing applications/registrations.

Licensed Representative Agent

A Representative Agent varies significantly from a “Registered Agent” required when filing with various Secretaries of State on the mainland. Whereas a Registered Agent strictly provides an address for the company in case that company is sued, a Representative Agent does much more. A Representative Agent holds the seller’s order information, reports diversion, and maintains a controlled substance license locally if the seller ships controlled substances. A Representative Agent must be licensed with SARAFS to perform these services.

For manufacturers, the Licensed Representative Agent is also responsible for coordinating recalls/withdrawals, registering drug products, and maintaining the Controlled Substance license, as applicable.

Registering Products

A manufacturer, or their distributor, must ensure that every NDC shipped to the island is registered with the Department of Health. This includes:

• • Prescription drugs
  • OTC drugs
  • Combination products (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic)
  • List 1 chemicals
  • Herbal products and remedies
  • Cosmetics containing active Ingredients
  • Agricultural items, such as pesticides
  • Sampling/Complimentary drugs
  • Biologics/Tissue
  • Vitamins/Dietary supplements

Puerto Rico requires this registration because it ties a Representative Agent to each product which ultimately helps keep manufacturers accountable for the quality and integrity of their product should there be an adverse event, recall, or withdrawal.

Product Registrations, at this time, do not expire. Additionally, they are not tied to a specific Representative Agent so a company may change Representative Agents at any time.

Selling Controlled Substances

Any entity passing title to controlled substances to any customer on the island must be licensed by the Puerto Rico Department of Health, Office of Investigations (formally ASSMCA). A controlled substance license is tied to Representative Agents (see above), so entities doing business on the island must plan accordingly when changing Registered Agents.

For additional information on Puerto Rico compliance and our solutions, please reach out to us directly via email, hello@fiveriversrx.com, or via phone, (800) 962-8760.

About Us

Based just outside of Philadelphia, Pharma Solutions provides actionable guidance and excellent administrative services with a focus on client care across Compliance, Commercial, and Quality solutions. Our mission is to improve the health and welfare of the American public by providing solutions and implementing best practices for companies in the pharmaceutical supply chain.