Non-Resident U.S. Distributors Required to Obtain Special Authorization to Distribute Medications and Medical Devices in Puerto Rico
Wholesale Distributor Requirements
Requirements for Special Wholesale Distributor Authorization - Non-Resident (Initial Application)
- Copy of the (veterinary or human prescription drug/nutritional supplement/non-prescription drug/medical device) distributor license or permit issued by the Board of Pharmacy of the State where the Distribution Center is physically located.
- Copy of the license or permit for the distributor of (veterinary or human prescription drug/nutritional supplement/non-prescription drug/medical device) for sale outside the state and issued by the Board of Pharmacy of the State where the Distribution Center is physically located, if applicable.
- Valid Certificate of Compliance (Good Standing) issued by the Pharmacy Board where the Distribution Center is physically located.
- Copy of the Federal Tax Identification Number (FEID#).
- Name of the person designated as the representative of the Distribution Center for purposes of this application, including contact information with telephone number and email. Also, include a list of four people with names, positions, ranks, and decision-making power in case the designated person is not available to attend to any matter that arises, including contact information.
- Certification of compliance with the Puerto Rico Drug Registration requirements (download document and complete).
- Downloaded document: Certification of Compliance with Drugs Registration
- Negative Criminal Conduct Certification (download document and complete).
- List of clients located in PR (Specify the type of facility).
- Certification of compliance with the Annual Sales Report for facilities with a Triennial Registration Certificate. (download the document and complete it).
- Downloaded document: Certification of Bond
- Self-certification (download document and complete).
- Download document: Self-Certification of Compliance
- Index of the manual of written procedures (including procedures for the validation of current licenses of clients in Puerto Rico).
- Copy of the Bond for $75,000 where the Division of Medicines and Pharmacy of SARAFS is included as beneficiary.
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