International online pharmacies are not permitted to ship Brixadi 8/0.16 MG internationally.

According to PharmacyChecker International Pharmacy Verification Program (IPVP) standards, pharmacies located outside the United States “may not market, sell, process and/or dispense prescription orders for controlled substances, as defined U.S. law, federal and/or state, to patients in the U.S. Pharmacies located within the U.S. marketing, selling, processing and/or dispensing prescription orders for controlled substances must possess a valid U.S. DEA Registration.”.

The U.S. Controlled Substance Act places all substances that are, in some manner, regulated under existing federal law into one of five schedules (i.e., I – V). This placement is based upon a substance’s medical use, potential for abuse, and safety or dependence liability.

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 amended the U.S. Controlled Substances Act to prohibit the delivery, distribution, or dispensing of a controlled substance that is a prescription drug over the Internet without a valid prescription.

More information about PharmacyChecker restrictions on controlled substances can be found in the PC IPVP Accreditation Standards & Guide.

International online pharmacies are not permitted to ship Brixadi 8/0.16 MG internationally.

The United States (U.S.) Food and Drug Administration (FDA) has identified Brixadi as a medication with additional ETASU requirements related to dispensing, such as restricted distribution or pharmacy registration.

According to PharmacyChecker International Pharmacy Verification Program standards, international online pharmacies “must not market, sell, process or dispense internationally medications identified by the U.S. FDA as Risk Evaluation and Mitigation Strategy (REMS) medications with additional “Elements to Assure Safe Use” (ETASU) requirements related to dispensing, such as restricted distribution or pharmacy registration, as international pharmacies are not recognized as participants by the U.S. FDA.”

For other REMS medicines without ETASU, “the pharmacist processing and/or dispensing internationally a medication that has been identified by the U.S. FDA as a REMS medication must ensure that the patient receives a copy of the most current version of the U.S. FDA approved Medication Guide (MedGuide) each time the medication is dispensed.”

More information about the REMS program can be found on the FDA website: Approved Risk Evaluation and Mitigation Strategies (REMS)