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

February 16, 2015 Dirk Rodgers 4 Comments

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, Interoperability

Interoperability And The DSCSA

February 9, 2015 Dirk Rodgers 2 Comments

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

February 2, 2015 Dirk Rodgers

Alexander 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 “21^st 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

January 26, 2015 Dirk Rodgers 2 Comments

Companies 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 →

serialization

Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines

January 19, 2015 IQPC

RxTrace is pleased to announce a partnership with the Pharmaceutical Traceability Forum, taking place March 30-April 1 in Boston, MA. In line with the upcoming regulatory and compliance deadlines, the Pharmaceutical Traceability Forum is the #1 event bringing together the brightest minds in the industry to discuss personal experiences and best strategies for preparing your serialization programs for 2015 and beyond.

Download the event agenda or request a copy via e-mail.

The Forum program, created for Continue reading Pharmaceutical Traceability Forum Offers Strategic and Solution Focused Discussions to Prepare Organizations for the Upcoming Compliance Deadlines →

Decommissioning

The Coming Battle Over Decommissioning At The Pharmacy

January 12, 2015 Dirk Rodgers 3 Comments

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 1^st 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 1^st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1^st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”). But be aware that according to the DSCSA, as of January 1^st, 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

January 5, 2015 Dirk Rodgers

Before 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

December 29, 2014 Dirk Rodgers 3 Comments

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 →

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