“Pedigree Nouveau” Must Be Uncorked January 1

July 30, 2014

By Douglas B. Farquhar

While Wikipedia tells us that this year’s Beaujolais Nouveau will best be consumed during a flexible time period beginning November 21, drug manufacturers and drug wholesalers should be warned that there is less flexibility in an important deadline for the “pedigree nouveau” that must be distributed with each package of prescription drugs.  You must start sending out three separate transaction forms with each shipment of drugs on or before January 1, 2015.

This deadline is set by one of the little publicized provisions in the Drug Quality and Security Act, which was enacted in late November 2013 (see our previous posts herehere and here).  One section of the Act, entitled the Drug Supply Chain Security Act (the DSCSA), requires manufacturers of prescription drugs (including contract manufacturers) and wholesalers to provide a “transaction history,” “transaction information,” and a “transaction statement” each time they sell prescription drugs.  Because many manufacturers and wholesalers have not historically provided the “drug pedigrees” that were required under some circumstances under prior federal law and regulation, they may not be aware of the new requirements.

In the old days, wholesalers could qualify as “Authorized Distributors of Record,” and were not required to provide prior transaction history.  That is no longer the case, effective January 1, 2015.  Each time they engage in a transaction relating to prescription drugs, they will be required to provide a “transaction history” to their customers.  The transaction history must provide evidence about each transaction back to the manufacturer.  But the transaction history is not the only document that must be provided.  Manufacturers and wholesalers must provide, with each transaction, “transaction information” (defined as information about the drug, including lot number and quantities in “package;” the dates of transactions and the parties to the prior transactions) and a “transaction statement” (basically confirming compliance with applicable laws).

The DSCSA also defines manufacturers as including what it calls “co-licensed partners.”  If the distributor/marketer of a drug can meet the requirements of a “co-licensed partner” with the holder of the drug application (Abbreviated New Drug Application or New Drug Application), or with a person or entity who manufactures a drug that is not the subject of an ANDA or NDA, that entity does not have to list any transactions before the distributor/marketer’s  sale.  The term “co-licensed partner” is not defined by federal law or regulations.  Yet.

Also, third-party logistics companies, defined in the DSCSA as “an entity that provides or coordinates warehousing, or other logistics services of a product . . . on behalf of a manufacturer . . . but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product,” generally do not have to provide any transaction history, statement, or “transaction information.”

So, instead of – or in addition to – tasting a fresh French wine in late November or early December, wholesalers and manufacturers need to uncork their pedigrees nouveaux before January 1.