Gilbert Gutknecht: “None of the amounts made available in this act to the Food and Drug Administration may be used under Section 801 of the…”

“None of the amounts made available in this act to the Food and Drug Administration may be used under Section 801 of the Food and Drug and Cosmetic Act to prevent an individual who is not in the business of importing prescription drugs within the meaning of Section 801(g) from importing a prescription drug that, 1, appears to be FDA approved; 2, does not appear to be a controlled substance, or, number 3, and appears to be manufactured, prepared, propagated, compounded, or processed in an establishment registered pursuant to section 510 of such act. In other words, it has to be made in an FDA-approved plant. It has to be sold through FDA-approved channels. It has to be sold with a legal prescription. Again, simply put, this says the FDA cannot spend its resources chasing law-abiding citizens who are bringing in legal drugs with a legal prescription. That is all we are saying in this amendment. We are not talking about bulk reimportation.”