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distributors were supposed to begin exchanging those documents on January 1^st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1^st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).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 →

FDA Guidance

FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1

December 26, 2014 Dirk Rodgers 3 Comments

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’s DSCSA Guidance in 2014

December 15, 2014 Dirk Rodgers

When Congress penned the Drug Supply Chain Security Act (DSCSA) last year it laid out specific dates and subjects for which it expected the FDA to publish guidance on. So far in 2014, the FDA has kept up with that schedule by holding a public meeting, publishing multiple draft guidances and setting up a website to collect information from wholesale distributors and third-party logistics providers.

The public meeting was held on May 8th and 9th to collect ideas for the standards that FDA should support for the interoperable exchange of transaction data in paper and electronic form, starting with manufacturers, repackagers and wholesale distributors on January 1, 2015 and dispensers on July 1, 2015 (see “The 2014 FDA DSCSA Workshop“). During the workshop, the attendees raised Continue reading FDA’s DSCSA Guidance in 2014 →

FDA Guidance

FDA Posts Guidance For Wholesale Distributor and 3PL Annual Reporting

December 10, 2014 Dirk Rodgers

The 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 →

RxTrace Traceability Survey

What will happen next? The 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz

December 8, 2014 Dirk Rodgers

For the second year in a row RxTrace is partnering with Frequentz to conduct a survey about U.S. Pharma Traceability. This year the survey has been improved with separate sets of questions for each segment of the supply chain and also for companies who are not actual supply chain members. The survey asks questions about the readiness of companies for the 2015 requirements of the DSCSA as well as preparations for the 2017 serialization requirements. A few of the questions are the same as last year so we can track any change in thinking.

Click here to take the 2015 survey.

The answers you provide Continue reading What will happen next? The 2015 RxTrace U.S. Pharma Traceability Survey, Sponsored by Frequentz →

…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance