Tag Archives: FDA

DSCSA, Interoperability

Interoperability And The DSCSA

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Divi-Divi tree Aruba. Click image to enlarge.
Divi-Divi tree in Aruba. Click image to enlarge.

I just arrived home from a vacation in Aruba so I missed out on the winter weather many of you experienced last week.  Here are a few pictures to help warm you up!

While I was in Aruba I spent some time thinking about interoperability as it applies to the provisions of the U.S. Drug Supply Chain Security Act (DSCSA).  The text of the law uses the term “interoperable” multiple times with regard to the exchange of data between trading partners, but interestingly, it does not define the term.  That leaves the definition of the term up to the FDA.

Before we look at the FDA’s definition of “interoperable”, let’s Continue reading Interoperability And The DSCSA →

Healthcare Legislation

RAPS Explains The 21st Century Cures Act

House Engergy and Commerce CommitteeAlexander Gaffney, RAC, Manager, Regulatory Intelligence at the Regulatory Affairs Professionals Society (RAPS) is right on top of any new proposed legislation related to FDA and other health-related federal government agencies.  Last week he reported on the contents of a discussion draft of the “21st Century Cures” Act that was made public by the House of Representatives Energy and Commerce Committee (see Gaffney’s “Regulatory Explainer: The 21st Century Cures Act”).

At 393 pages, the draft bill, if enacted in its current form, would Continue reading RAPS Explains The 21st Century Cures Act →

Exception Handling

DSCSA Exception Handling: A Preview of Your Next Surprise Headache

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HDMA ASN Exception GuidelinesCompanies that participate in the U.S. pharma supply chain and are subject to the U.S. Drug Supply Chain Security Act (DSCSA) are preparing to meet the FDA’s 2015 deadlines for exchanging Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for every shipment.  Those preparations include integrating the generation, transmission, confirmation, storage and retrieval (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”) of these documents into their existing supply chain and regulatory compliance processes.  It is a big deal and it affects a large number of companies. Continue reading DSCSA Exception Handling: A Preview of Your Next Surprise Headache →

Decommissioning

The Coming Battle Over Decommissioning At The Pharmacy

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Certificate of Serial Number Death
Certificate of Serial Number Death

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 →

serialization

Pharma Industry Attention Returns to Serialization

FDA sNDC example plus lot and expiry as a GS1 DataMatrix symbolBefore the passage of the Drug Supply Chain Security Act (DSCSA) on November 27, 2013, the pharma industry was focused pretty well on getting the California-mandated serial numbers on 50% of their drug packages by last Thursday (January 1, 2015), and the remainder of their products by next January.  But that mandate evaporated by federal preemption as soon as the Federal bill was signed into law.  From that moment on, everyone turned their sights toward meeting the data exchange requirements of the DSCSA by last Thursday (see “DQSA: How Should Transaction Data Be Exchanged?”).  Of course, just before Christmas, the FDA pushed that effective date out to May 1, 2015 (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

That extension in enforcement is a blessing to a few Continue reading Pharma Industry Attention Returns to Serialization →

DSCSA Web Portals

A Closer Look At Web Portals for DSCSA Transaction Data Exchange

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???????????????These are the last few days of 2014.  During the rush up to Christmas, the FDA gave the industry a gift by announcing that they will not enforce the transaction data exchange requirements of the Drug Supply Chain Security Act (DSCSA) until May 1, 2015—a four month delay (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1” for details).  So things are likely to be quieter this week than they otherwise might have been.  And if you are one of those who are working this week, why not fill out the 2015 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz?  It will be closed soon so make sure you click here to fill it out now.

One of the approaches that the FDA mentioned in their data exchange guidance, published on November 26, is the use of secure web portals (see “FDA Publishes Draft Guidance For DSCSA Data Exchange”).  Some companies are Continue reading A Closer Look At Web Portals for DSCSA Transaction Data Exchange →

FDA Guidance

FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

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?????????????????In a direct response to concerns expressed by the Healthcare Distribution Management Association (HDMA) and others (see “HDMA Expresses Concerns About Industry Readiness for DSCSA” and “Will The DSCSA Cause Drug Shortages After January 1?”), the FDA posted new guidance that states their intention to postpone enforcement of just the requirements for manufacturers, wholesale distributors and repackagers to provide and capture Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS).  That requirement was to Continue reading FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1 →

FDA Guidance

FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting

Annual Reporting Draft GuidanceThe FDA posted new draft guidance for pharma wholesale distributors and third-party logistics providers to follow to meet their obligation to register their licensing information annually.  The new requirement is from the Drug Supply Chain Security Act (DSCSA) that was enacted last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law“).  The draft guidance explains who, what, when and how companies must report.  The FDA will make the data reported available to the public through a web site at some point in the future.

The information the FDA will collect as part of the report from both wholesale distributors and 3PLs include facility location and contact information, a unique facility identifier, license information for each State–including expiration dates–and any significant disciplinary action Continue reading FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting →