Tuesday, December 03, 2013
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.
To get signed up for the industry stakeholder list for future FDA communications, send an email with contact information to firstname.lastname@example.org.
To listen to the recorded stakeholder call: (866) 431-2898 (US), +1 (203) 369-0950 (International) Passcode: TRACE
Monday, November 18, 2013
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!
Tuesday, November 12, 2013
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!
Saturday, September 28, 2013
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..
Wednesday, August 28, 2013
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.
Friday, July 26, 2013
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!
Sunday, July 14, 2013
Over 200 life science industry leaders attended our second Live Q&A with Virginia Herold, Executive Officer of the California Board of Pharmacy, demonstrating that California ePedigree and Serialization is still top of mind for many in the pharmaceutical supply chain.
Over the course of 2 hours, Virginia discussed California laws, rules and interpretations covering a wide range of topics:
- ePedigree creation in CMO/CPO and other business relationships
- Inference, certification, drop shipments and other developing rules
- Documenting the "50 percent", grandfathered and exempted products
- 3PL ePedigree and serialization expectations
- Serialization data management and product packaging changes
- Importation of products and dozens of other questions!
View the on-demand replay of the webinar event and download a complete transcript of the discussion by clicking here.
If you have any follow-up questions for Virginia that you would like us to submit to her anonymously or if you would like to discuss the key takeaways from the event, just contact us!
Monday, July 01, 2013
The United States Senate has just introduced the amended pharmaceutical track and trace bill in preparation for the upcoming full Senate floor debate of the measure.
Entitled the "Pharmaceutical Quality, Security, and Accountability Act", this bill is the result of the merging of the compounding and drug security bills which were passed earlier in June by the Senate HELP committee.
The new consolidated bill includes certain amendments to the drug security bill previous passed by the HELP committee. Highlights include:
- Provisions for Manufacturers to provide transaction history, information and statements in a single document, paper or electronic, to downstream trading partners
- Verification procedures for Manufacturers, Wholesale Distributors and Dispensers in the event of potentially suspect product that should specifically include the standardized numerical identifier when verifying the package starting on or after the respective serialization deadlines for each industry segment
Debate on the bill in the full Senate is expected the week of July 8th. If the bill passes, it will have to be reconciled with the House drug security bill that differs on a few key components.
To hear a detailed breakdown of the serialization, transaction 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!
Thursday, May 23, 2013
China’s updated National Essential Drug Lists (NEDL) were published on March 15th, 2013 and came into force on May 1st 2013. The 2012 version of the NEDL includes 520 drug molecules on it, including 317 chemical drugs and biological products with 850 dosage forms. Oncology drugs, human insulin products and drugs for blood diseases are some of the new medicines added to the 2012 NEDL.
On May 9th, the China Food and Drug Administration (CFDA) announced the new drug serialization and traceability reporting deadlines for these added medicines. They include:
- November 30, 2013: 2012 NEDL drug products that are domestically packaged (i.e. w/in China) need to be serialized and reported upon to the CFDA.
- March 31, 2014: 2012 NEDL drug products that are packaged outside of China and imported into the country will need to be serialized and reported upon to the CFDA.
The new NEDL products, like the 2009 NEDL list drugs and the Provincial Essential Drug List medicines which have deadlines throughout 2013, all have similar requirements for acquiring serial numbers from the CFDA, applying the serial numbers at the case and unit package level and reporting on various commissioning and inventory movement transactions across the supply chain.
TraceLink and special guest David Colombo of Eli Lilly recently gave a detailed explanation of the deadlines and the operational and technical requirements for companies in the supply chain with respect to China serialization and traceability reporting compliance.
You can watch a streaming replay here: China Serialization Webinar
Tuesday, April 09, 2013
The Director General of Foreign Trade (DGFT) in India has announced that India has deferred primary level (e.g. blister pack) barcoding for track and trace of exported pharmaceuticals one year to July 1, 2014. The original date of implementation for this requirement was to have been July 1, 2013.
This was the third phase of serialization and barcoding of pharmaceuticals manufactured/packaged in India and destined for export. The previous two phases for tertiary and secondary (unit or package) level serialization were implemented in 2012.
The DGFT described the change in the public notice no. 54(RE-2012) published on April 5th. Link to the notice. Navigate to the Public Notices section, Public Notices 2012-2013 and click on the link for notice 54(RE-2012)/ 2009-2014,
- FDA Drug Quality and Security Act Stakeholder Discussion Notes
- H.R. 3204 Passes Senate, Drug Quality and Security Act to Become Law
- H.R. 3204 Drug Quality and Security Act Readied for Senate Vote
- US Federal Serialization, Track and Trace Legislation Passes U.S. House
- Amazon AWS Issue Highlights Need for Well-Designed Cloud Software
- Senate Posts New Pharma Serialization, Drug Traceability Draft
- California ePedigree and Serialization Q&A w/ Board of Pharmacy Draws 200
- US Senate Posts Amended Pharma Serialization and Traceability Bill
- China Serialization Deadlines for 2012 National Essential Drug List & Webinar
- India Delays Primary-Level Barcoding for Exported Pharmaceuticals