Joe Barton: “Section 535 of the conference report included a provision that will allow individuals to import into the U.S. from…”

“Section 535 of the conference report included a provision that will allow individuals to import into the U.S. from Canada a 90-day supply of a prescription drug, on their person, for their personal use. The provision specifically exempts controlled substances and biological products. As the Chairman of the authorizing Committee with jurisdiction over the regulation of drugs and biological products, it is important for me to clarify what the language in this section means in regards to biologic products. The exemption applies to biological products, as that term is defined in Section 351 of the Public Health Service Act. The legislation does not confine the exception of only to those products licensed under Section 351 of the PHSA. This is an important distinction. To be clear, the language exempts biologic products licensed under the Public Health Service Act and those approved under the Federal Food, Drug and Cosmetic Act.”