Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment

摘要

The Food and Drug Administration (FDA) is proposing to remove a section of the Prescription Drug Marketing Act (PDMA) regulations requiring that prior to the completion of any wholesale distribution of a prescription drug, an unauthorized distributor must provide to the purchaser "a statement identifying each prior sale, purchase, or trade of such drug," starting with the manufacturer, and that the identifying statement (also known as the "pedigree") must include certain information about the drug and each prior sale, purchase, or trade. This action is being taken in response to longstanding issues, including an injunction currently in effect, regarding the application of and compliance with this requirement. FDA is also announcing that it intends to exercise enforcement discretion with respect to certain requirements of the regulation while the rulemaking is pending and with respect to the statutory pedigree requirements of the PDMA, as long as the pedigree identifies the names and addresses of the last authorized distributor of record that handled the drug and the associated dates of transactions involving that last authorized distributor of record and the drug, as well as the na