Millions of Americans take prescription drugs every day while assuming that those drugs are what they purport to be, that they have not been tampered with, and certainly that they are not counterfeit. The validity of those assumptions is increasingly tested and challenged, if not undermined, by a drug supply chain that circles the globe and by the involvement of multiple parties standing between the manufacturer and the consumer. The 2013 Drug Supply Chain Security Act (DSCSA) amends the Federal Food, Drug, and Cosmetic Act and clarifies the obligations of the parties in this chain.
Supply chain integrity necessarily implies an ability to identify, track, and trace drugs. The current regulatory capacity to do this at scale, given the volume of products, is limited. The DSCSA outlines steps for building an electronic, interoperable system to increase this capacity over the next decade. In the meantime, however, and in pursuit of less heroic objectives, the Food and Drug Administration (FDA) published a draft guidance document on June 10, 2014 to implement the provisions of the DSCSA. The provisions require manufacturers, repackagers, wholesale distributors, or dispensers (all "trading partners" in DSCSA parlance) to identify "suspect" drug products and to notify FDA and their "trading partners" of these findings. Suspect drug products, as defined by the DSCSA, are those products "for which there is reason to believe" the product...
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Topics: DSCSA, FDA, FDCA, Manufacturers, Pharmaceutical, Prescription Drugs, Supply Chain
Published In: Administrative Agency Updates, General Business Updates, Consumer Protection Updates, Science, Computers & Technology Updates
DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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