Protect Patients Enable Health Ensure Compliance

The FDA has posted their current activity plan and deadline timelines for developing guidance, holding meetings and working with stakeholders on implementation of the various provisions of the Drug Quality and Security Act.

The timeline covers project activity phases and target deadlines:

  • Guidance development and publication
  • Public meetings (target dates tbd)
  • Licensure regulations and databases
  • Additional regulations supporting unit-level tracing and other DQSA provisions

Various industry stakeholders have stated a desire to work with the FDA to accelerate the development and completion of the TH/TI/TS data exchange as soon as possible even though the FDA isn't required to complete this until November 2014.

The timeline document is available here.

To provide direct feedback to the FDA, here is the preferred email dropbox: drugtrackandtrace@fda.hhs.gov

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

The FDA has announced a DQSA Request for Information related to data exchange methods and information standards to be used for compliance with the Drug Quality and Security Act.

Published on February 20th and available on the FDA website, this RFI is part of the FDA's process seeking information from industry stakeholders on ways to facilitate the creation and exchange of transaction information, history and statement. Public comments on the public docket are due within 60 days (April 21st).

In summary, the RFI's purpose:

  • We are seeking information from drug manufacturers, repackagers, wholesale distributors, dispensers (primarily pharmacies) and other drug supply chain stakeholders and interested parties, including standards organizations, State and Federal Agencies, and solution providers.
  • In particular, stakeholders and other interested parties are requested to comment about the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format, for each transfer of product in which a change of ownership occurs.

Since DQSA went into law on Nov 27, 2013, the industry has been looking at various approaches for managing, exchanging, archiving and analyzing the compliance data mandated by DQSA. EPCIS event-based approaches and modifications to existing ASN data methods are two of the options being reviewed by industry stakeholders and standards bodies such as GS1.

The FDA has until November of 2014 to publish official guidance for DQSA data exchange but recent comments by the FDA and feedback from industry has suggested that the FDA will want to information as soon as practical to help industry efficiently implement DQSA compliance solutions.

TraceLink held a recent webinar looking at some of the DQSA data management and data exchange issues facing industry as companies put into place solutions to meet the product tracing and product and transaction verification regulations of DQSA.

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

Brazil's ANVISA, the Brazilian Health Surveillance Agency, has published the first public hearing to discuss the creation and implementation of the National Drug Control System to use for meeting the new resolution mandating pharmaceutical serialization and drug tracking to be phased between 2015 to 2016.

The meeting is set for January 23, 2014 from 9am to 12pm at ANVISA headquarters in Brasilia, Brazil. Here is a link to more information.

The National System of Drug Control framework published on December 10th, 2013 provides for unit-level serialization and supply chain-wide drug tracking from manufacture to dispensation where each node in the supply chain maintains their own database of drug product and downstream transaction tracking data.

Our recent webinar on the regulation detailed specifics on the new regulation from serialization requirements to drug tracking capabilities that companies need to implement by December 10, 2015.

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

Brazil's ANVISA, the Brazilian Health Surveillance Agency, has adopted a new resolution mandating pharmaceutical serialization and drug tracking to be phased between 2015 to 2016.

The National System of Drug Control framework published on December 10th, 2013 provides for unit-level serialization and supply chain-wide drug tracking from manufacture to dispensation where each node in the supply chain maintains their own database of drug product and downstream transaction tracking data. Reporting of this data back to ANVISA is also envisioned in the regulation although details are scarce on the core requirements.

Phase 1 deadline:  December 10, 2015  (serialization and tracking data for 3 batches of product)
Phase 2 deadline:  December 10, 2016  (serialization and tracking for all pharmaceuticals)

TraceLink will be holding an educational webinar on January 7th, 2014 to discuss the provisions of the regulation and implications for members of the pharmaceutical supply chain. Join us to learn more!

Key Provisions

  • Serialization: Unit-level serialization, using a 2D DataMatrix barcode, which includes a 13-digit ANVISA drug registration number, unique randomized serial number, expiration date and lot number. These combine to form the ANVISA Unique Identifier of Medicines (IUM). The requirement to tie case-level transport packaging to the unit-level IUMs within implies that aggregation is required.
  • Supply Chain Tracking: Tracking and capture of drug product transactions from point of manufacture to point of dispensation at pharmacy, including reverse logistics. This includes tracking of transportation activities.
  • Manufacturer: Maintain a real-time database of all transactions down to dispensation containing: IUM, identification number (CNPJ) of drug recipients, identification number (CNPJ) of transport companies, date/type of drug transaction, transport packaging (case) identifier.
  • Distributor: Provide serialized product transaction data back to the Manufacturer. Maintain a real-time database of all transactions managed containing: IUM, identification number (CNPJ) of companies selling to or receiving drugs from the distributor, identification number (CNPJ) of transport companies, date/type of drug transaction, transport packaging (case) identifier.
  • Dispenser / Pharmacy: Provide serialized product transaction data back to the Manufacturer and Distributor. Maintain a real-time database of all transactions managed containing: IUM, identification number (CNPJ) of companies selling to or receiving drugs from the dispenser, identification number (CNPJ) of transport companies, date/type of drug transaction, transport packaging (case) identifier.
  • Data Archival: One (1) year after the expiration date of the drug product.

Reporting of drug serialization and supply chain tracking data back to ANVISA systems is mentioned although no procedures or transmission methodologies are documented at this point.

Here is the official ANVISA announcement link.

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

The FDA held its first public stakeholder call this morning (Dec. 3rd, 2013) to discuss the new Drug Quality and Security Act law. This is the first of a series of public engagements that the FDA will hold as the various provisions of DQSA are phased in starting Jan. 1, 2015 and continuing over the next 10 years.

The call, led by Dr. Ilisa Bernstein and Cara Tenenbaum of the FDA, didn't contain much in the way of hard specifics on rules, regulations and licensure. The FDA is still developing its go-forward plans and communication processes.

Call highlights - FDA intro:

Dr. Bernstein gave a brief summary of the goals of the law (enabling verification of the legitimacy of drug products, enhancing detection of illegitimate products, enabling more efficient recalls, improving immediate removal from the supply chain of illegitimate products, etc.).

Dr. Bernstein then summarized the key provisions of the law (product tracing, product identification, product verification, detection, response and notification of suspect and illegitimate product, interoperable electronic system for unit-level drug tracing, etc.).

Dr. Bernstein concluded with initial thoughts on how the FDA and industry stakeholders will work together throughout the 10 year period to facilitate adoption across the supply chain of the various provisions of the law. In particular, the FDA is very mindful of the short readiness time window for the Jan 1, 2015 dates and is actively working on its industry communication and engagement plan for near-term guidance in the coming months.

Call highlights - Q&A:

  • FDA is working on the whole guidance process for 2014, including bi-directional communication plan, publication/comment process, potential public meetings or workshops. Although nothing confirmed, I expect that the FDA will call at least one full face-to-face meeting to discuss interoperable data exchange for 2015 compliance. More details soon. 
  • FDA will also publish information that summarizes key milestones of the law and related FDA activities.
  • PDMA compliance guidance for the interim period until 2015 will be forthcoming.
  • Information about any requirements on documentation of systems and processes put into place for 2015 compliance will be part of the forthcoming FDA implementation plan and guidance.
  • Unique identifier requirements are being looked at closely by the FDA. The FDA will review the existing Standardized Numerical Identifier (SNI) guidance, the "barcode rule" and labeling requirements to determine if any adjustments need to be made. The FDA will work closely with industry on this to understand current best practices, industry capabilities, etc.
  • Product imported into the US will have to comply with the regulations.The FDA doesn't seem to feel there will be any material impact on the customs process or issues with importers.
  • Licensure guidance will be forthcoming on how to determine state v. federal license compliance processes, how to meet documentation requirements, information on new federal licensing program for 3PLs, etc.

There were no additional specifics provided, beyond those already stated in the law, w/r/t questions posed around product exemptions, 3PL provisions and minimum pharmacy distribution quantities.

Overall, it was very clear that the FDA is promoting a vigorous, engaged collaboration with industry stakeholders to ensure DQSA adoption and success for 2015 and beyond. 

Learn More:

To get signed up for the industry stakeholder list for future FDA communications, send an email with contact information to cara.tenenbaum@fda.hhs.gov.

To listen to the recorded stakeholder call:  (866) 431-2898 (US), +1 (203) 369-0950 (International)  Passcode: TRACE

To learn about the new DQSA regulations and compliance requirements for all segments of the supply chain, watch these webinars.

To understand the data management and supply network data exchange requirements for DQSA, join this webinar.

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

H.R. 3204, the Drug Quality and Security Act, has passed the US Senate. The bill was approved this afternoon (Nov. 18) by voice vote and now goes to the President for signature.

The bill passed with all amendments withdrawn by Majority Leader Reid.

UPDATE: H.R. 3204 was signed into law by President Obama on November 27, 2013.

Law Text: Here is a link to the text of H.R. 3204 as was signed by the President.

Educational Webinars: TraceLink held a 5-part Drug Quality and Security Act educational webinar series from Oct 4th to Nov 1st detailing the regulations, definitions, data management and business process requirements for the pharma supply chain (manufacturers, wholesale distributors, dispensers and more). You can watch streaming replays of all five events. Learn More

Keep an eye out for follow-on webinars on how to prepare your company and your supply network for compliance with H.R. 3204 requirements which start January 1, 2015.

Regulation and Solution Briefing: If you have questions about H.R. 3204 or would like to know about the software solutions that TraceLink is developing to meet all the product tracing, product/transaction verification, serialization and other requirements of the proposed law, contact us

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

H.R. 3204, the Drug Quality and Security Act, is now ready to be taken up by the United States Senate after clearing a number of procedural hurdles. The motion to invoke cloture (limiting Senate debate) was overwhelmingly passed Tuesday night (Nov 12th) by a 97-1 margin.

Majority Leader Reid has now placed time on the Senate calendar for Wednesday morning, Nov 13th to allow Senators to voice opinions on the bill preparatory to a final vote. Sen. Reid has stated his intention to quickly pass H.R. 3204 by either unanimous consent or voice vote.

Bill Text: Here is a link to the text of H.R. 3204 as was officially placed on the Senate calendar.

Educational Webinars: TraceLink held a 5-part Drug Quality and Security Act educational webinar series from Oct 4th to Nov 1st detailing the regulations, definitions, data management and business process requirements for Pharmaceutical Companies and other supply chain members. You can watch streaming replays of all five events. Learn More

Keep an eye out for follow-on webinars on how to prepare your company and your supply network for compliance with H.R. 3204 requirements which start January 1, 2015.

If you have questions about H.R. 3204 or would like to know about the software solutions that TraceLink is developing to meet all the product tracing, product/transaction verification, serialization and other requirements of the proposed law, contact us

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

Both the U.S. Senate (HELP Committee) and U.S. House (Energy and Commerce Committee) announced on Sept. 25th that agreement had been reached on bipartisan, bicameral legislation (H.R. 3204 - "Drug Quality and Security Act") for compounding and track and trace. The draft bill includes expected elements of pharmaceutical serialization and drug traceability across the supply chain from point of manufacture to point of dispensation. 

Update: On September 28th, the U.S. House passed the bill by voice vote. A copy of the bill is available here.

Webinar: TraceLink is holding a 5-part Drug Quality and Security Act webinar series starting Friday, Oct. 4th. Learn More

Here is the press release announcement: (link)

Key elements of the proposed bill follow fairly closely to that of the Senate draft proposal which TraceLink reviewed in detail in June during our Federal legislation webinar (link). 

This proposed law, which would preempt state-level ePedigree regulations like those being finalized by the California Board of Pharmacy, covers all segments of the supply chain from pharmaceutical companies, repackagers and 3PLs to wholesale distributors and pharmacies. 

The bill sponsors intend to introduce the draft legislation onto both the Senate and House floor soon for vote. Key highlights of the draft legislation following a quick analysis include:

  • Serialization: Beginning 4 years from enactment, manufacturers shall serialize each package and homogeneous case of prescription drug product distributed within the United States. Wholesale distributors may not accept product unless it has been serialized starting in 6 years, dispensers starting 7 yrs. from enactment.
  • Lot traceability: Beginning Jan 1, 2015 (manufacturers) through July 2015 (dispensers), prior to or at the same time as product changes ownership, companies need to provide or receive transaction information, history and statements for products in a single document (paper or electronic), Beginning 4 years from enactment, this information needs to be exchanged electronically.
  • Item-level track and trace: Beginning 10 years from enactment, transaction information and statements shall be exchanged starting at point of manufacture, in a secure, interoperable electronic manner, for all products at the unit level including the standardized numerical identifier.
  • Verification: Beginning Jan 1, 2015, manufacturers shall have systems in place to verify potentially illegitimate product, including validation of applicable transaction histories and information.
  • Requests for Information: Manufacturers shall provide transaction information, history and statements for potentially suspect or illegitimate product that is subject to an investigation or recall initiated by a Federal or State official not later than 1 business day or 48 hours total elapsed time after receiving the request.

The bill also includes details on federal regulation of drug compounding companies and wholesale distribution licensing.

Note, the above is a high-level summary. There are specific nuances or exemptions that affect companies in different ways depending on segment, product, etc. The above summary is meant to provide high-level context for the draft bill.

Keep an eye out for our upcoming webinar with a detailed analysis of this key legislation, what it means for all segments of the supply chain and considerations for how to prepare for it given other global pharmaceutical serialization and pharmaceutical traceability / reporting regulations..

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

Well-designed Cloud-based applications need to be resilient, anticipating potential infrastructure failures to ensure continuous access by users and internal systems.

The wisdom of this was highlighted this week as companies such as Instagram and Vine reported service problems due to issues with an Amazon AWS Cloud data center in Virginia. Failure of a networking device at the center caused user access problems for some well-known services.

No TraceLink customers were affected by the issue.

This incident reinforces the critical importance of “Designing for the Cloud” rather than just throwing traditional software up into a Cloud-hosted environment and risking single points of failure.

How does “Designing for the Cloud” help TraceLink create a highly available and reliable Cloud-based software platform and why is it beneficial for our customers?

  • Distributed Architecture. The TraceLink Life Sciences Cloud is redundantly deployed within and across multiple Amazon AWS data centers. So the failure of a system, group of systems, or even entire data center is absorbed while continuing to meet our SLA for our customers.
  • Data Protection. Our customers’ data is critical to their operations. We protect this data from system failures by distributing it across multiple physical locations.
  • Automated Management and Monitoring. We continuously monitor all areas of the TraceLink Life Sciences Cloud. This immediately alerts us to potential issues and permits us to automatically provision and recover resources due to failures or changes in customer demand.
  • Elasticity. With a loosely-coupled, distributed architecture, increases in performance and scalability requirements are accommodated by provisioning additional capacity in the service layer requiring it when needed. Planned growth is cost-effectively delivered while unplanned market opportunities can be quickly addressed.
  • Utility Pricing. Contrasted with traditional enterprise architectures and approaches to redundancy requiring considerable up-front and ongoing costs, “Designing for the Cloud” means you provision only what you need and only pay for what you use. World-class reliability is now affordable.

Oddly enough, this incident also reinforces a key argument for using well-designed Cloud platforms to manage mission-critical operations. Amazon has over 30 global data centers and hundreds of thousands of machines to leverage for a redundant distributed architecture. Many companies are lucky to have the IT budget to create a single internal IT infrastructure to meet their needs much less develop a fully redundant setup.

All IT infrastructures have components that will fail at some point in time: disks, motherboards, power supplies, fans; the list goes on. The more components you have, the more likely that something will fail. A hardware failure like the one that affected the Amazon data center could have completely shut down user access to an internal IT system. The AWS Cloud enables TraceLink to deploy our solution with a level of availability and reliability far beyond what a company can afford to invest in internally to protect against these failures.

As Benjamin Franklin said: “Failing to plan is planning to fail”. This has always been a guiding principle for TraceLink as we designed the Life Sciences Cloud for mission-critical operations.

Posted by Peter Spellman | Comments (0) | Trackback (0) | Permalink

On July 25th, the sponsors of the "Pharmaceutical Quality, Security, and Accountability Act" introduced a new update to the consolidated pharmaceutical compounding and drug track and trace bill. The changes continue the process of working with stakeholders to gain agreement as the bill is prepared for full Senate debate on the floor.

Compared to the previous bill published on June 19th, this new version includes relatively minor changes and technical clean-up. Most of the modifications come in the compounding provisions. Highlights on the changes specific to the track and trace language include:

  • Manufacturers:  Must provide the Transaction History, Product Information and Statements in electronic form to supply chain partners starting four (4) years from enactment. Prior to this, Manufacturers must provide such data in a single paper or electronic document. In previous versions, Manufacturers had the option of providing this information in a single paper or electronic document starting one (1) year from enactment all the way until the unit-level traceability provisions kick in ten (10) years from enactment.
  • Manufacturers:  Have a small change to information requirements. Now, Manufacturers must provide Transaction data to 3PLs only when both change of ownership and change of possession occur. Previously, the draft required that Transaction data needed to be provided to the 3PL if they received the product from the Manufacturer even if no change of ownership occurred.
  • Dispensers:  Gain a special provision for responding to Requests for Information in the case of suspect product investigations. Starting with the one (1) year after enactment and extending until four (4) years after enactment, Dispensers shall have additional time to respond to these Requests in supplying any lot level information that was provided to the Dispenser in paper format.
  • Repackagers:  May now return saleable or nonsaleable product back to the company from whom the product was received without providing the Transaction data on behalf of the hospital or other entity that took ownership from the repackager.

Debate on the bill in the full Senate was expected in early July. Now, as appropriations bills, the Student Loan Act and presidential nominees have taken center stage, it looks increasingly unlikely that the Senate will take up the bill before August recess. This would mean the Congress has 9 days in September to vote on the Senate bill, call a conference committee to reconcile the Senate and House track and trace bills, then bring a reconciled bill up for vote in both chambers.

To hear a detailed breakdown of the drug serialization,supply chain traceability, product verification and other provisions of both the Senate and House bills, you can watch a streaming replay of our analysis here: Federal Pharmaceutical Serialization and Traceability Webinar. Or, drop us a note and we'd love to discuss what the potential national legislation would mean to your business!

Posted by Brian Daleiden | Comments (0) | Trackback (0) | Permalink

Awards and Recognition

view all