Complying with Puerto Rico’s Regulation 156B Second Extension
Written-by: Deneen Fumich, RPh
April 1, 2022, was the effective date that Puerto Rico passed Regulation 156B requiring that manufacturers and wholesale distributors that sell and ship medication and devices into Puerto Rico must hold one or more of the 6 license types available for the products that are distributed into Puerto Rico. Unfortunately, although the Regulation passed, the online application system was not ready.
Department of Healths SARAF’s office gave till June 30, 2022, to apply and comply with the regulation. Unfortunately, the Department was not prepared for online submissions and extended the date till August 2022.
Finally, the online application system was ready in August and a second extension to apply and comply was issued. This newest extension gave manufacturers and wholesalers until December 31, 2022 to apply for one or more licenses. Licenses are issued on product types and therefore, multiple licenses may need to be obtained. The below lists the various licenses that a company can apply for:
- Wholesaler prescription drugs
- Wholesaler non-prescription drugs
- Wholesaler Homeopathic, Natural products, and/or Nutritional Supplements
- Medical Device Distributor (Rx and OTC) – per DOH if:
- Device is FDA Approved – no license required
- Device is not FDA Approved – license required
- Veterinary Wholesaler prescription Drugs
- Veterinary Wholesaler non-prescription drugs
There still is no pathway forward for virtual manufacturers or for 503B compounding facilities. It is our understanding that the Department is currently working on a pathway for virtual manufacturers; however, a time frame is unknown.
Further, we have been advised that 503B compounding facilities were not part of the new law or regulation; and therefore, 503B’s will not be considered for a future pathway. Final guidance from the Department is that 503B compounding facilities are considered pharmacies and must follow the Puerto Rico Pharmacy law.
If you have not yet applied and would like further information and assistance, please reach out to email@example.com
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