Tag Archives: TH

Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

SteadyState.2015.to.2023The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA).  The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).

Although not everything has worked out Continue reading Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?

InBrief: HDMA Updates DSCSA Q&A

HDMA LogoThe Healthcare Distribution Management Association (HDMA) recently updated their “HDMA Qs and As on the Drug Supply Chain Security Act (DSCSA)” to version 2.0.  This is a very well thought through document that will help companies understand how wholesale distributors are interpreting confusing or ambiguous sections of the law.  The document leans heavily toward questions about how wholesale distributors will need to react in various situations, but it will also be a resource that manufacturers, repackagers and dispensers will want to obtain and review.  What is really needed is for someone to do the same kind of analysis for questions that mainly affect those other supply chain entities.   Continue reading InBrief: HDMA Updates DSCSA Q&A

Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

??????????????We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI)Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”).  Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).

Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).  In fact, the vast majority of companies have Continue reading Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?

DSCSA Exception Handling: A Preview of Your Next Surprise Headache

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

The Coming Battle Over Decommissioning At The Pharmacy

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

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

A Closer Look At Web Portals for DSCSA Transaction Data Exchange

???????????????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 Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

?????????????????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