On August 21st, large portions of the United States and other places will experience a total eclipse of the sun by the moon. On November 27th, the serialization and verification delay of the Drug Supply Chain Security Act (DSCSA) contained within the FDA’s recent draft compliance policy (see “FDA Delays Enforcement of DSCSA November Deadline: What It Means”) will eclipse the grandfathering guidance that hasn’t even been published yet. In fact, the overdue grandfathering guidance should be easy for the FDA to write now (see “Who Is Being Harmed By Four Overdue FDA DSCSA Guidances?”). Grandfathering probably just won’t exist. Here’s why. Continue reading DSCSA Serialization Delay Eclipses Grandfathering
I recently wrote about several letters sent to the FDA by the Pharmaceutical Distribution Security Alliance (PDSA) regarding the overdue guidance documents (see “In Absence Of FDA Guidance, Follow PDSA Recommendations”). I highly recommend that you read those letters. But there was one letter from the PDSA to the FDA that I did not reference in that essay because it is not related to missing guidance. Instead, it’s about PDSA’s fear about the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019. To be exact, the type of verification they are worried about is the kind that will be based on a drug’s Standardized Numerical Identifier (SNI). Continue reading Will Manufacturers Have Trouble Verifying Some Drugs Next Year?
The Pharmaceutical Distribution Security Alliance (PDSA) is a coalition of companies and organizations dedicated to the safety and integrity of the U.S. pharmaceutical supply chain. When the Drug Supply Chain Security Act (DSCSA) went into effect on November 27, 2013 the PDSA began to serve as a voice for its members in communications with the U.S. FDA. Their preferred way of communication is through formal letters signed by their legal advisor, Vince Ventimiglia. PDSA letters to the FDA are really interesting because they do an excellent job of providing recommendations for the FDA to consider as they prepared to publish the four guidance documents that were due back on November 27, 2015. The FDA has still not published those documents. Continue reading In Absence Of FDA Guidance, Follow PDSA Recommendations
President-elect Donald Trump has made no secret of his interest in eliminating regulations that burden businesses unnecessarily. And he may take a particular interest in those that were newly imposed under President Obama. He has vowed to use his first 100 days to repeal “Obamacare”, the Affordable Care Act (ACA) and his plans include “… cutting the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Could the Drug Supply Chain Security Act (DSCSA) get caught up in that vow and also be repealed? There are three obvious possibilities. Continue reading Will President Trump Eliminate The DSCSA?
The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA). We are now operating under the first major phase. Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for each shipment they receive. Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”). But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license. Those and other requirements of the DSCSA were not delayed by the FDA.
The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now. That is, between now and Continue reading The Coming Battle Over Decommissioning At The Pharmacy
Last Friday a new committee formed by Rx-360 held their first meeting of parties interested in identifying architectures—or at least “conceptual models”—useful for efficiently meeting the full diversity of pharmaceutical track and trace regulations around the globe. Rx-360 is a non-profit organization “…formed in 2009 to support an industry-wide commitment to ensure patient safety by enhancing quality and authenticity throughout the pharmaceutical supply chain”, according to their press releases.
The new committee is called the “Traceability Data Exchange Architecture Work Group” and it seeks Continue reading Pharma Supply Chain Companies Organize To Establish Global Traceability Data Exchange Architecture
Are you a pharmaceutical manufacturer who is acting as a wholesale distributor, as defined by the U.S. Drug Supply Chain Security Act (DSCSA), for some of your products? This might occur if you are buying pre-packaged drugs from the New Drug Application (NDA)-holder or Abbreviated New Drug Application (ANDA)-holder and offering them for sale to U.S. wholesale distributors. If you cannot justifiably fit into the DSCSA definitions of either a “co-licensed partner”, or an “exclusive distributor” for those drugs, you might as well remove them from your catalog because the “Big-3” wholesale distributors—AmerisourceBergen, Cardinal Health and McKesson—probably will not be willing to buy them anymore as of next January.
That’s because the DSCSA, which begins to take effect at that time, will most likely consider you as a Continue reading DSCSA: Special Privileges For The “Big-3” Wholesale Distributors, Part 1
Congress should have mandated randomization of drug serial numbers, but they did not, so it is up to each manufacturer to recognize the importance it would bring to the protection of their brands and of the supply chain. Let me explain.
The text of the Drug Supply Chain Security Act (DSCSA) was developed last year by Congressional staff in consultation/negotiation with various lobbying organizations—primarily the Prescription Drug Security Alliance (PDSA). The effect of the legislation is to create a way of protecting the U.S. pharmaceutical supply chain that relies primarily on product identifier authentication (PIA) (see “Product Identifier Authentication” and “The Aggregation Hoax and PIA”) for at least the first 10 years and possibly beyond. Continue reading DSCSA: Congress Should Have Mandated Randomization