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Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Puerto Rico Implements Licensure Requirement for Non-Resident Wholesalers & Manufacturers

While the vast majority of states require non-resident wholesale distributors and manufacturers that ship prescription drugs into their states to obtain a non-resident license, Puerto Rico had been one of the few that did not...more

Federal Court Deals Blow to FDA’s Compounding MOU

On September 21, 2021, D.C. District Court Judge Christopher Cooper gave an initial victory to the seven compounding pharmacies (“the pharmacies”) challenging Food and Drug Administration’s (“FDA”) final standard Memorandum...more

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