Lexology January 9, 2024
On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval.[1]
Generally, there are three pathways to importing a prescription drug into the United States: personal importation, manufacturer imports of multi-market-approved products and the SIP pathway. Personal importation is when an individual imports prescription drugs for their own use and not for further sale or distribution. There is little enforcement by the FDA against personal importation. Practically, if individuals follow the FDA’s guidance on personal importation, then the FDA will allow a 90-day supply of drug products to be imported into the U.S. by an individual. Drug manufacturers may import FDA-approved drugs that are also authorized for sale in a...
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