Abbott said in the opinion that Sections 36 through 43 of SB 410 violate the Federal Food, Drug, and Cosmetic Act, which makes it illegal to import prescription drugs and to “cause” the importation of prohibited medications. The executive director of the Texas State Board of Pharmacy had requested the opinion after US Food and Drug Administration (FDA) objected to the law ( Lone Star State Pharmacy Officials Request Legal Clarification ).
The legislation, approved by lawmakers in May and then signed into law by Governor Rick Perry, required the Texas pharmacy board to designate between one and 10 Canadian pharmacies to ship, mail, or deliver to Texas residents prescriptions dispensed under a prescription drug order. Each pharmacy had to be inspected by the board and supervised by a pharmacist licensed by the Canadian government. The measure also allowed Texas pharmacies to order consumers’ prescription drugs from the designated Canadian pharmacies.
Abbott pointed out that Sections 36 through 43 of the new Texas statute are in direct opposition to the federal Food, Drug, and Cosmetic Act, which makes it illegal to import prescription drugs and to “cause” the importation of prohibited medications, the opinion said.
“Importation of prescription drugs that are manufactured outside the United States violates the federal FDCA unless the drugs have been approved by the FDA and covered either under an ‘approved application’ for new drugs or under an ‘investigational new drug’ exemption,” Abbott wrote.
FDA raised a number of concerns about the safety of prescription drugs from Canadian pharmacies (See FDA Warns TX About Bill to License Canadian Pharmacies ).
The Abbott opinion is here .
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