While the vast majority of states require nonresident wholesale distributors and manufacturers who ship prescription drugs to their states to obtain a nonresident license, Puerto Rico was one of the few that did not have such a requirement. . That has now changed. Effective July 1, 2022, Puerto Rico began requiring all non-resident wholesalers and manufacturers who ship prescription and over-the-counter human and veterinary drugs, medical devices, and homeopathic and nutritional supplements within the Commonwealth to obtain a license of non-resident. , called “special authorization”. The Puerto Rico Auxiliary Secretariat for Health Facility Regulation and Accreditation (“SARAFS”), the agency responsible for issuing the special permits, has not yet provided guidance on whether third-party logistics providers are also subject to this new authorization requirement.
SARAFS published a notification regarding this new requirement on June 29, 2022, which summarizes the regulatory basis for the authorization requirement and details the application process. The notice directs previously identified non-resident facilities to complete the application process through the online renewal portal, which can be found here. When submitting the online application, each applicant must also complete and upload the following forms, which are available on the portal: Self-certification of compliance; Clear the criminal records of non-resident distributors; Certification of compliance with drug registration; and Certificate of guarantee. The special authorization will be valid for two years, after which it may be renewed.
Although the new regulations went into effect on July 1, 2022, SARAFS indicated that non-resident wholesalers and manufacturers who currently ship products to Puerto Rico can continue to do so until they receive their new special authorization. ; however, facilities not yet shipping to Puerto Rico must first obtain special authorization before beginning distributions. After receiving special authorization, licensees must ensure compliance with the provisions of the Puerto Rico Pharmacy Law, 20 LPRA § 410 and following, and its applicable regulations, including those relating to storage, handling, record keeping, personnel and annual reporting. If the Drugs and Pharmacy Division of SARAFS finds that a non-resident facility is not operating in accordance with these regulations, SARAFS may also inspect the facility at the facility’s expense. In the event of non-compliance, SARAFS may impose fines, revoke the special authorization or execute the required bond.
This new non-resident licensing requirement does not replace the existing requirement for wholesale distributors and non-resident manufacturers to register certain products shipped to Puerto Rico, but rather complements this requirement. In fact, SARAFS issued a second notice regarding a change in the process for nonresident wholesale distributors, manufacturers, and their agents to register products shipped to Puerto Rico. According to the notice, a new portal allowing wholesale distributors, manufacturers and their agents to register the products they ship to the Commonwealth was originally due to launch on June 30, 2022. However, there have been delays with the portal and the launch date has been pushed back to August 15, 2022.
Mainly, non-resident pharmacies are still not required to obtain a non-resident license or special authorization, or register products shipped to a patient in Puerto Rico pursuant to a valid prescription. See National Pharmacies, Inc. v. Feliciano-de-Melecio, 221 F.3d 235, 242 (2000); Regulations of the Secretaria de Salud Núm. 156, section 3.03(a).