TrackTrace Rx

FDA Publishes Guidance On Suspect Product & Notification

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In response to the increasing threat of illegitimate and counterfeit drugs entering the U.S. pharma supply chain, the Food & Drug Administration (FDA) passed the Drug Supply Chain Security Act in 2013, obliging manufacturers to report suspicious drugs to the agency. The FDA was required to publish a guidance no later than 180 days after the enactment of the DSCSA, so the one released on December 8, 2016, is “a little” overdue, but welcome. It is an edit of the draft published back in 2014, with improved readability and a new section on “High Risk of Illegitimacy Notifications” that they seek comments for. You can find the FDA DSCSA Guidance on “Identification of Suspect Product and Notification” here.

Who Should Read It

Everyone in the drug supply chain.  From drug manufacturers, wholesalers, repackagers, & dispensers to online pharmacies, clinics, hospitals and individual practitioners.

The fact that its draft was published two years ago may prompt some companies to take it lightly – bad idea. The guidance is as important as escalating its provisions to every company standard operating procedures. Your employees, too, must be familiar with its provisions. Otherwise, you run the risk of violating the law without realizing it, so make sure you study the new guidance in depth to know your obligations and the procedures for investigating, reporting and terminating the notification of an illegitimate product.

Key Highlights

1. DSCSA requires that the trading partners that identify a suspect product quarantine it during the investigation. If the trading partner determines a product is illegitimate, they must notify their trading partners that might have received the product and the FDA. Illegitimate can be either of the following – stolen, diverted, counterfeit, the subject of a fraudulent transaction, intentionally diverted, or otherwise unfit for distribution.

The new section “for comments purposes” requires manufacturers to notify the FDA and their trading partners within 24 hours after identifying or receiving a notification from the FDA that a product poses a high risk of illegitimacy in the following cases:

a) the trading partner believes there is a high risk a product in an immediate trading partner’s possession is illegitimate;

b) there is a high risk of an illegitimate product entering the U.S. drug distribution & supply chain;

c) “other high risk” (pursuant to subsection 582(h)). A manufacturer is recommended, not required though, to notify FDA only.

The FDA describes specific examples for each of these scenarios and a list of circumstances that may lead to them. The agency points out manufacturers may learn about high-risk products from their employees, trading partners, the FDA itself or other regulatory authorities even “when a product may not be in the manufacturer’s possession or control.”

Therefore, the FDA obliges manufacturers to notify the agency of a high-risk product even if the manufacturer is not in possession or control of the product, and provides examples for such scenarios. This obligation is notable as it is significantly broader than other obligations of the trading partners that typically have to be in possession or control of the suspect product to initiate an investigation and notification process.

Third-party logistics providers are not defined as “a trading partner” by the guidance. Therefore, they are not required (but encouraged) to notify the FDA if a situation arises.

2. In order to help companies identify scenarios that increase the risk of a suspect product entering the U.S. supply chain, the guideline outlines several areas where trading partners must be particularly diligent. These include:

  • buying from new suppliers
  • purchasing from a source that previously engaged in suspicious activity
  • purchasing online from unknown sources
  • when receiving an unsolicited offer from an unknown source
  • when the price is too low for a specific product

and other common sense scenarios. Overall, a transaction that has an increased risk might involve suspiciously low prices, particularly high-in-demand products, drugs subject to a shortage, or those previously counterfeited or diverted, or have a questionable appearance.

3. The FDA recommends for the trading partners to share observations and concerns regarding a suspect product with their partners and seek law enforcement and regulatory authorities help. This is necessary to expedite identification of a suspect product and the following investigation.

Once the suspect product is determined to be illegitimate, a trading partner must notify the FDA and its immediate trading partners of the findings. The FDA will provide an online form on its web page for the companies to fill out.

Note: the guidance goes into detail describing the process of termination of the notification. Companies would have to go back to their submitted notification web form, describe the product & the notification they issued. The companies then need to describe the actions, or the new information, that justify the termination of the notification.

Of special note is that the FDA considers this procedure of termination of notification to be binding, and requires the trading partners to “provide the Agency with an opportunity to provide its expert views and advice.”

Therefore, a trading partner must first receive the response from the FDA to their termination request, and only then notify its trading partners of the termination. The agency sets a 10-business-day period it takes for responding. Only when the company receives a response from the FDA can it notify its trading partners of termination. FDA made minor changes to the Form FDA 3911 and edited the instructions for completing it.

Finally, beginning November 2017, pharmaceutical manufacturers must mark their produce with a National Drug Code (NDC), expiration date, serial number, lot number in the machine- and human-readable formats.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

GS1 DSCSA EPCIS Version 1.2 Helps Companies Prepare for Item-Level Traceability

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The Drug Supply Chain Security Act (DSCSA) requires that starting November 2017 manufacturers mark their products in human- and machine-readable format with a National Drug Code (NDC), serial and lot numbers and an expiration date. Serialization deadlines differ depending on where a company is in the supply chain – November 2017 for manufacturers, November 2018 for repackagers, November 2019 for distributors.

In an effort to help companies prepare for the deadlines, several U.S. trade associations, 11 drug manufacturers and repackagers, 13 solution providers, 4 wholesalers and several individual industry consultants spent two years working on a second edit of the GS1 US guideline, released in early-November this year. Providing a detailed breakdown of the item-level traceability and lot-level management, the implementation suite dwells on the use of the Electronic Product Code Information Services, the EPCIS.

GS1 US is the U.S. part of the global GS1 organization, which pushes forward the use of product identification and tracking throughout the pharma industry worldwide. Its requirements have been accepted by the FDA as a base for the implementation of the DSCSA goals. These procedures are already used in other industries in at least 40 countries. So, the update to the EPCIS standard (EPCIS and Core Business Vocabulary (CBV) released in September 2016) along with the new implementation guideline, mark the next milestone for the pharma and healthcare tracking systems update.

Who Should Read It

Primarily, the solution providers. Any solution provider building platforms to facilitate DSCSA compliance for the companies in the drug supply chain must read the guideline.

Drug manufacturers that need to meet the requirements of the wholesalers to provide serial number information, so the wholesalers can meet their saleable returns verification deadline in 2019, also need to read it to facilitate interoperability.

As for other participants of the drug supply chain, it is best if they have at least a couple of technically-savvy people in the organization who understand the concepts outlined in the guideline.

GS1 US DSCSA Implementation Suite

The 600+ page suite consists of four documents, the main Implementation Guideline, and three addenda, offering information and examples on serialization, pedigree and track-and-trace obligations of the industry as a whole, and also explaining how particular businesses can apply the standards to comply with the DSCSA.

Besides improved readability and document formatting as compared to version 1.1, the version 1.2 brings some important changes. Here are the highlights:

Since EPCIS and CBV have been updated in September to the version 1.2, the guideline accounts for the changes, as the previous edit only used EPCIS 1.1 and CBV 1.1 plus custom extensions. Lot-level management-related EPCIS event specifications have been updated with regard to EPCIS 1.2 and CBV 1.2.

Serialized item traceability-related EPCIS event specifications are updated to cover all DSCSA data requirements, featuring new EPCIS 1.2 and CBV 1.2. The previous 1.1 guideline used EPCIS 1.1, CBV 1.1, custom extensions, and was based on 2015 California drug pedigree law.

Special attention goes to the expiration dates. The guideline recommends manufacturers should always include a day of the month and highlights the importance of synchronization of the expiration dates printed on the label, reported in EPCIS and encoded in the barcode.

“Application of EPCIS for Serialized Item-Level Traceability” (Implementation Guideline, part III) is new, and dwells on using EPCIS serial numbers when implementing item-level traceability. DSCSA deadline for this is 2023, but manufacturers that need to comply with the wholesalers’ requirements will need to implement it sooner, by 2018. The wholesalers’ deadline for the saleable returns verification is in 2019, so manufacturers will need to provide them with serial number information to ensure interoperability. So, even if manufacturers are not rushed by the DSCSA, wholesalers will enforce a faster implementation on the manufacturers anyway.

The version 1.2 gives more EPCIS event times clarification, as well as a guidance on notifying trading partners of an exception condition. In this regard, “Diagrams and XML Examples for Serialized Exceptions Processing” addendum is a must-read. When November 2023 comes, and EPCIS is implemented in compliance with the DSCSA, errors, inevitable in documenting product shipments at the serial number-level in EPCIS events, must be corrected. That’s where the scenarios covered in the addendum provide guidance. Termed as “exception processing,” these scenarios (total of 16) show how to fix possible errors, including the IT-related errors and cases involving damage to the product. These are complex processes, so you want to understand the concepts.

The changes introduced in version 1.2 explain the details in the formatting and recording supply chain events to ensure the item-level data is handled properly. According to Peter Sturtevant, senior director at GS1 US, the exceptions fall into four categories, when:

  • a trading partner receives no EPCIS record with the shipment;
  • the trading partner receives the EPCIS record, but not the physical shipment;
  • the barcode identification must be changed;
  • there are errors on both ends, the shipping, and the receiving.

When a problem occurs, a wholesaler must quarantine the product until the issue is resolved, but wholesalers are averse to spending the time on exception management. EPCIS will help automate and speed up the exception management, something that is difficult to perform when using the ASN communications via EDI standards.

More exception scenarios complete with XML examples and flowcharts are added for the lot-level management and serialized item traceability. (Application of EPCIS for Lot-Level Management, part II of the Implementation Guideline).

More EPCIS event specifications are added, covering the exception scenarios for the lot-level management and serialized item traceability.

EPCIS event specification for a Transformation event covers repackaging scenarios under DSCSA lot-level management requirement.

The next guide edition, according to Sturtevant, might come in the foreseeable future. The eyes of the industry are still on the FDA that is behind on its own implementation guidelines for the DSCSA compliance.

On a lighter note, the TrackTraceRx team posted pictures of our event at the ASHP Show in Las vegas. You can see the pictures here!

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Launching our new Feature at the ASHP Vegas Show: Pharmacy Marketplace Integration

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After a very successful launch at the HDA Seminar in Washington D.C., TrackTraceRx is excited to be sponsoring our next event: The ASHP MIDYEAR 2016 Clinical Meeting & Exhibition in Vegas December 4-8. Not only will we be showing our TrackTraceRx Suite but we are also announcing that the TrackTraceRx Suite will be fully integrated with the TRXADE Pharmacy Marketplace. The TRXADE Marketplace is one of the most trusted marketplace for pharmacies and wholesalers with over 6000 members. Our TrackTraceRx Suite will be fully integrated with the TRXADE Marketplace right out of the box. By being a TrackTraceRx Suite customer, you will automatically be integrated to the TRXADE Marketplace saving you thousands of dollars in integration fees. Please stop by our booth #577 to see a demonstration.

For more information please contact us at http://www.tracktracesuite.com

Here are some photos of the event:

TrackTraceRx at conference

TrackTraceRx Team

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Registration and checkin was a breeze!

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Grand Conference! The ASHP has done it again!

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Vicente our ERP engineer hard at work! Or at least pretending to! 😉

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The social media photo op!

Big Three Wholesalers Outline Their Requirements on DSCSA Compliance to Manufacturers

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In the 80s Metallica, Anthrax, Slayer and Megadeth were referred to as the “The Big 4” and “The Four Horsemen”. In the Internet world today, Facebook, Google, Apple and Amazon dominate the Internet and are also crowned “The Four Horsemen”. I’m sure in every industry you can certainly pick four big companies that monopolizes and you can easily token them as the “The Four Horsemen”. In the pharmaceutical world though, it’s the “Three Horsemen” or as they are famously coined “The Big Three”…Amerisource Bergen, Cardinal and McKesson.

But here is the problem – decades of acquisitions and mergers have shaped the patchwork quilt of an industry that is highly fragmented. The Big Three actors – McKesson, AmerisourceBergen and Cardinal Health – account for up to 85-90% of total sales for many U.S. drug manufacturers. The rest are smaller distributors that mostly follow suit, so when we talk about a unified, more streamlined approach we want to know where the Big Three stand on serialization and aggregation requirements. What they decide, is that we will follow. Like the the 80s rock bands that rocked the nation, and how Facebook, Google, Apple and Amazon command the Internet.

As the Drug Supply Chain Security Act deadlines approach, serialization and aggregation coordination efforts come to the fore. Manufacturers need to know if they will be required to develop different processes to meet unique wholesaler DSCSA compliance guidelines, or if there is a path towards a more streamlined and unified approach. The one that will let manufacturers develop once and then scale out. Again they turn to the Big 3 for guidance.

Further fragmentation is ensured by the fact that each wholesale distributor dictates its own requirements for the manufacturers to follow so that the wholesaler can comply with their DSCSA requirements.

There is hope…

Earlier this year, all three major drug wholesalers communicated their serialization and aggregation guidelines to manufacturers.

McKesson 

McKesson sent a letter to its suppliers, outlining its requirements for drug manufacturers. Here are its highlights:

GS1 EPCIS format is to be used for the serialized DSCSA information exchange.
Aggregating product from item to pack/bundle level, when applicable.
Pack/bundle level to case level, case to pallet/container level utilizing the GTIN and SSCC labeling formats.
HDMA Advance Ship Notice (ASN 865) is to be used unchanged until the Lot Level Traceability is due in 2023.

McKesson makes it clear it’s time to plan for and implement aggregation. While some manufacturers are already working on serialization, aggregation could be a more difficult task. Unlike serialization that has been a buzzing word for quite some time now, aggregation has been an unexplored territory. Based on serial number packaging hierarchy, aggregation might already be partially in place with some manufacturers, though. If your company has serial numbers on some package levels or shipping containers, you have aggregation data, at least partially.

Cardinal

Cardinal Health published its Technical Requirements for Serialization (requirements for barcodes, EPCIS serialized data exchange and master data), Upcoming Drug Supply Chain Security Act manufacturer requirements, and sent two communications earlier this year. Here are some key highlights from Cardinal serialization requirements:

Manufacturers must meet the serialization deadline in 2017, re-packagers in 2018, as wholesalers must meet the deadline in 2019 for verification of re-saleable products.
Serialized data exchange might be required by Cardinal as early as January 2019, as the company is waiting for the results of the HDA 2019 Saleable Returns Verification pilot.
Manufacturers must aggregate data from individual units to case level.
Manufacturers must use GS1 standards for product identifiers and adhere to HDMA guidelines. Manufacturers must use GTINs and GLNs in GS1 standard.

Cardinal 3PL clients will start testing serialized data exchange in June 2016.
Those Cardinal 3PL clients that seek a solution for data verification/retention requirements will be able to receive data reporting service starting September 2016.

The Technical Guide offers information for the companies interested in participating in pilot, and stresses one important detail – “Cardinal Health will not incorporate automated SGTIN validation as part of our Receiving process at this time <…> for piloting purposes our EPCIS system will be decoupled from our production receiving processes, and we will conduct pilots using our EPCIS repository in a manual and highly controlled fashion, providing feedback on labeling, aggregation quality and DSCSA content (if applicable) for each Manufacturer who participates.”

We can assume this means that during the testing Cardinal will accept your shipment even if your serialization information is not 100% accurate.

AmerisourceBergen

AmerisourceBergen (ABC) published its Serialization Labeling Guidelines and Requirements, backed by a supplier letter:

Manufacturers must follow GS1 standards and HDA guidelines for labeling on case and unit level products.
Should there be any labeling issues, ABC will provide assistance on correcting them until November 2017.
ABC will receive lot-level data via electronic ASN or via GS1 EPCIS format.
Starting early 2018, manufacturers must provide “EPCIS electronic serialized transactions and a list of standardized product identifiers for the cases & units” to ensure returns verification database accuracy.
Manufacturers must aggregate “units to homogenous cases, units to non-homogenous cases, & cases to pallets” to “meet the 2019 saleable returns obligation.”
Manufacturers must convert the NDC (National Drug Code) number to GTIN (Global Trade Item Number).

Summary

The good news is the Big Three do have a few things in common in their serialization guidelines for manufacturers:

Use of ASN format for sending lot-level DSCSA information.
Serialization of units and cases.
Use of GS1 standards for product identifiers.
Use of GS1 standards to serialize prescription drug products before November 2017.
Cardinal requires manufacturers to aggregate units- to case-level while McKesson and AmerisourceBergen require all levels of aggregation.

McKesson did not provide a set date for serialized data exchange while AmerisourceBergen set a time frame at early-2018, and Cardinal at early-2019.

Aggregation and serialization are mandated by the DSCSA with the due date in 2023, but the Big Three deadlines are set earlier. Why? The 2019 saleable returns verification deadline must be the reason. Without aggregation and serialization from manufacturers, it is logistically über-challenging to verify saleable returns. Without aggregation and serialization, verifying saleable returns would require for the wholesalers to manually open all the returns and verify each serial number with the manufacturer via phone.

HDA Pilot Study for Saleable Returns and Manufacturer Serialization Readiness Survey

(TrackTraceRx was one of the sponsors at the HDA Traceability Education Seminar in November. If you get a chance, please read our recap of the Seminar Here.)

All three stress the importance of the HDA pilot (formerly HDMA), as they expect its final report to fine-tune their aggregation requirements and enable the verification of the serialized saleable returns by November 2019.

In early-November, 2016, HDA published the results of the Pilot Study for Saleable Returns and recommended two “cost-effective and viable” scenarios to help manufacturers and wholesalers comply with the DSCSA requirements.

The first scenario suggests “a manufacturer sends aggregated product identifier only for the products purchased to each individual distributor.” When the wholesaler needs to process a saleable return, it references an internal database to verify the product identifier information from the manufacturer.

The second scenario implies there is a third-party verification router service. The manufacturer, in this case, stores all its product identifier information locally, with the database synchronized with a third-party routing service. When a wholesaler receives a saleable return, it captures the product data, sends it to the third-party router service, which, in its turn, routes the query to the manufacturer’s database.

“There is no ‘one-size-fits-all-situation’ to meeting this compliance deadline. Each company is different and will need to determine, based on their needs, which scenario or combination of scenarios work best for their company,” said Perry Fri, Executive VP of Industry Relations, Membership and Education, HDA; and COO of the HDA Research Foundation.

HDA also announced the results of its Manufacturer Serialization Readiness Survey, which surveyed 73 manufacturers that account for 71% of drugs produced in the U.S. The survey found that 89% of manufacturers were ready to ship serialized products before the DSCSA-set deadline in November 2017. 67.1% expressed commitment to aggregate, and 27.4% are waiting for the FDA guidance to decide whether to aggregate. The next big event is for the FDA to publish its DSCSA aggregation guidance.

I know this is a lot to take in. For any further questions, please feel free to contact one of our DSCSA experts for a free evaluation of your process and procedures. To Book a free evaluation visit the TrackTraceRx web site.

-Chris

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

 

Will Donald Trump Repeal The DSCSA Law?

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As one of the strangest and most ferocious election cycles in the U.S. has come to an end, and Donald Trump was named President-elect,industry experts are unboxing their crystal balls to try and predict what the future holds for the fate of existing regulation red tapes and one of its parts, the Drug Supply Chain Security Act (DSCSA). Even though we have yet to see the new administration in action, there is some evidence we can analyze to answer the question that keeps the industry tense – will Donald Trump eliminate the DSCSA?

Enacted in 2013, DSCSA is considered a heavy burden by many companies in the pharma supply chain. So some might think that there is a possibility the new administration would scrutinize it since Trump promised to “cut the red tape at the FDA: there are over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.”

Again, just as a full repeal of the ACA is unlikely, we assume the same could be true for the DSCSA mainly because of the preemption clause. Eliminating the DSCSA in its entirety would also remove the preemption clause, which prevents states from passing more restrictive regulations than the ones in the DSCSA, such as the one in California. Elimination of the preemptive clause is very likely to cause much distress to the industry and be counter to Trump’s advocating of “cutting the red tape.” So, with the industry in opposition to the full DSCSA repeal, the Congress might not want to tread in those waters.

Let’s really think about this… A repeal of the DSCSA and removing a standardized federal law applied nationwide would allow States like Florida and California to once again enact their own laws. This takes us back to a fragmented track and trace disaster that the industry begged Congress to change in 2013, hence why the DSCSA was created.

So, if there is a change for the DSCSA on the table, it will most likely keep the preemption clause. Could some parts be eliminated? Some say yes, the ones that have not been applied by the companies in the supply chain by now – serialization and aggregation.

There is, of course, a chance for the DSCSA to fall under the category of the regulations that both parties “like” alongside coverage for patients with pre-existing conditions and plans that allow children to remain on their parents’ plans for extended time. We might assume, with the workload that the ACA repeal and replacement will be, the Congress might leave the smaller regulations like the DSCSA untouched.

In any case, the odds are in favor of President Trump signing the bills that would ease the regulatory pressure on businesses, but all direction points that with regards to the DSCSA, it will probably be an exception.

-Chris

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

 

HDA Traceability Seminar Recap – FDA Update

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Hello Everyone,

The TrackTraceRx team spent last week at the HDA Traceability Seminar in Washington D.C. and found it very informative and beneficial. Thank you everyone who stopped by our booth and signed up to see our launch of the TrackTraceRx Suite. The demand has been amazing as companies see the benefits of having a fully integrated solution versus a single service solution.

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About the Conference

The HDA Traceability Seminar had a record breaking registered attendee of 450 (WOW!)… an amazing turnout. The HDA also covered their salable returns pilots and issued their report here:

http://www.hdmanet.org/~/media/pdfs/industry-relations/hda-pilots-scenario-brochure.ashx

The report covers different scenarios of handling how distributors must process serialized saleable pharmaceutical returns from customers.  According to an HDA member survey, saleable pharmaceutical returns comprise 2 to 3 percent — or nearly 59 million units — of total sales annually.

Out of the nine different scenarios in the report, two of the live pilot scenarios were determined to be the most cost-effective and viable approaches to achieving compliance. In the first recommended option, a manufacturer sends aggregated product identifier information only for the products purchased to each individual distributor; when the distributor processes a saleable return, the distributor references an internal database to verify the product identifier information from the manufacturer.

The second option employs a verification router service. In this scenario, the manufacturer stores all of its product identifier information locally, which is connected to a third-party routing service. Upon receiving a saleable return, the distributor captures the product data and sends the data to this third-party router service, which then routes the query to the appropriate manufacturer’s database.

FDA

Dr. Connie Jung from the FDA spoke about all respective DSCSA updates, and here is what we got:

The DSCSA text offers a grandfathering of current products clause for manufacturers and nothing for downstream trading partners. So the question remains on how downstream trading partners which receive products will handle grandfathering. It was implied that trading partners may possibly be able to take advantage of being able to grandfather these products also. TrackTraceRx will be able to confirm this as soon as the FDA releases more guidance on grandfathering products. When asked when this guidance would be issued all we got from the Dr. Connie Jung was “soon”.

Compounded drugs are exempt from the DSCSA.

The smallest saleable unit sold to the pharmacy must be serialized not the pill.

The FDA will not hold pilots but will look for the industry partner pilots.

Charitable organizations are not exempt from the DSCSA only company inter-transfer shipments are exempt.

All in all the event was amazing! Be sure that TrackTraceRx will be sponsoring the HDA’s next event as well at the: 2017 Distribution Management Conference and Expo (March 5-8). We hope to see you there!

-Chris

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

 

TrackTraceRx will be Sponsoring the 2016 HDA Traceability Seminar

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HDA - HDMA
We at TrackTraceRx will be sponsoring the 2016 HDMA now called the HDA – Traceability Seminar on November 9-11 in Washington D.C.. Connie Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity & Recalls, U.S. Food and Drug Administration (FDA) will be providing an update on the DSCSA implementation plan.

Implementation of the Drug Supply Chain Security Act (DSCSA) continues to transform the pharmaceutical supply chain. As the industry works toward the law’s 2023 finish line, HDA’s annual Traceability Seminar will bring together healthcare supply chain leaders to learn more about upcoming DSCSA implementation milestones as well as innovative approaches and lessons learned as distributors, manufacturers and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.

You can find out more about the event here: http://hda.org/events/2016-traceability-seminar

We look forward to seeing you there and stop by and say hi at our booth.

P.S. we will be having a big announcement soon. Look out for future emails to stay updated.

Cheers!

Drug Pedigree versus DSCSA T3s

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The question, “What is a drug pedigree?” is easily answered because the FDA itself has given us the definition: “A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.” To that we may add that there is also something called an e-pedigree, which is simply a pedigree in electronic form – that is, an electronic document that satisfies a pedigree requirement. The second question: “What difference does DSCSA make?” requires more discussion.

Before DSCSA came into force, the relevant legislation was the Prescription Drug Marketing Act of 1987 as amended in 1992 which placed pedigree requirements in 21 CFR Part 203. Every person engaged in the wholesale distribution of a prescription drug in interstate commerce who was not the manufacturer or an authorised distributor of record for that drug had to provide to the person who received the drug the pedigree for that drug. An authorised distributor of record was defined as “a distributor that has an ongoing relationship with a manufacturer to distribute that manufacturer’s drug products.” What qualified as an “ongoing relationship” was not at that time defined, but in 1999 FDA published regulations defining “ongoing relationship” to include a written agreement between manufacturer and distributor. The 1999 regulations also specified the fields of information that had to be included in the drug pedigree and stated that the information in the pedigree should be traceable back to the first sale by the manufacturer.

FDA did not seek to enforce the pedigree-related requirements in every case. In a guidance note, they set out the factors they would take into account in deciding whether enforcement measures were necessary.

These were as follows:

High Value in the US Market

FDA felt that experience showed that drug products with a high market value, high price or high sales volume or of which there was a shortage were more frequently counterfeited or stolen than others.

Prior Indicators

FDA finds that the same drugs are counterfeited or stolen again and again. In most cases, pedigrees are either falsified or not provided and this is an area where enforcement is almost automatic.

Reasonable Probability

In the case of new drugs that don’t have enough marketing history to qualify under the first two factors, FDA will take account of the reasonable probability that they may be earmarked for counterfeiting or diversion.

It should be stressed that these were the most frequent causes of enforcement but they were not the only ones; FDA also had a policy of taking action against wholesale distributors and others involved in the manufacture or distribution of counterfeit drugs and the type of drug involved would not enter into the calculation.

Passage of the DSCSA took us away from the previous regulatory environment and into a new one. The present regime is to be understood in relation to the requirement of the DSCSA that pharmaceutical manufacturers, repackagers, wholesale distributors, and drug dispensers who are not practitioners should notify FDA and certain trading partners of products identified as illegitimate within 24 hours of that determination being made. Products not so identified but suspect have to be quarantined while an investigation is conducted.

Trading partners have had to develop secure electronic systems to ensure that these requirements can be met. The idea of the drug pedigree is now expanded to embrace the set of documentation laid down in the Act. We are speaking here not of Master Data but of Transactional or Instance Data, of which the most relevant example is the lot number attached to a specific batch at the factory and following it all the way to the point at which it is broken down for distribution to consumers. The data must not change at any point on the chain.

We should, then, think of the pedigree in DSCSA terms as the DSCSA Transaction History, Information and Statement or T3. What we now have is a specific form for the Drug Pedigree – but not, as yet, a specific format. That is something that is being hammered out in discussions between all stakeholders at the present time and those stakeholders (they know who they are) who are not taking an active part in these discussions will have to accept what the active majority decides they should have.

We have said this on this blog before in relation to pharmacists; in fact, it applies to everyone on the supply chain from manufacturer onwards. It will be essential, if only to protect themselves against FDA enforcement, that every party involved at every stage of drug distribution from beginning to end should ensure that every T3 that passes through their hands is correct for the product it purports to cover and contains the data elements that FDA through DSCSA has decreed that it should contain.

Finally, and for the avoidance of doubt, here are the items that MUST be included in the new-style drug pedigree:

  • The name of the drug (both proprietary and established);
  • Dosage;
  • Container size;
  • Number of containers;
  • The lot number(s);
  • The business name and address of all parties to each prior transaction involving the drug, starting with the manufacturer; and
  • The date of each previous transaction

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

DSCSA: The Special Role of the Third-Party Logistics Provider

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The role of the third-party logistics provider (3PL) is highlighted under the Drug Supply Chain Security Act (DSCSA). A 3PL is not a wholesale distributor. The difference is inherent in the way the pharmaceutical industry works and the level of security demanded by the DSCSA.

A lot of industry works on a Just in Time (JIT) basis: the end user or consumer calls for the parts, equipment or other product on the brink of the event that makes it necessary. The drug industry works like that at one end; pharmacies, hospitals and other drug dispensers will order replenishments in the quantities they find most convenient when their existing stock is just about to run out. At the other end of the process (the manufacturing end), though, things are somewhat different. Whereas manufacturers in an increasing number of industries are, like their customers, focusing on JIT and not making something until it’s been ordered, Pharma manufacturers make drugs in large batches (aka lots) which are held until called for by the customer.

The only concern faced by a company that makes confectionery in large batches is the money they will lose if the sweeties are not kept secure and are stolen. In the drug supply business, the penalties imposed by the DSCSA if the whereabouts of any drug cannot be accounted for are severe and there is a need to keep the “buffer stock” (that is, the drugs that have been manufactured and are being held until someone places an order for them) completely secure.

It is open to any drug manufacturer to store finished goods in its own distribution center and only release them to the wholesale distributor when they are ordered, but many manufacturers prefer instead to have someone else look after them. The argument is: our skill is in developing and manufacturing drugs. Storage should be taken care of by someone who is expert in that field.

Hence the development of the 3PL. A distributor takes the finished goods from the manufacturer and stores them until they are instructed by the manufacturer to deliver them in fulfilment of customer orders received by the manufacturer. It is important to keep that distinction clear: storage is on behalf of the manufacturer; orders are placed on the manufacturer and not on the 3PL; the 3PL has negotiated a contract with the manufacturer under which the 3PL agrees to store the goods in safe condition and deliver them to a specified place (which is likely to be a wholesale distributor) when asked.

Note that in this whole process ownership of the goods remains with the manufacturer and that does not change until it passes to whoever the 3PL delivers them to. This remains true even though all of the paperwork may originate at the 3PL because it is often the 3PL who invoices the wholesale distributor on behalf of the manufacturer. In some cases, the 3PL actually receives payment on behalf of the manufacturer.

This is significant because the DSCSA requires that changes of ownership (all changes of ownership; there are no exceptions) should be recorded with a Transaction Information (TI), Transaction History (TH) and a Transaction Statement (TS). But ownership never passes to the 3PL.

Because a 3PL never owns the goods, they are not in theory required to be involved in the passing of TI, TH or TS, but in practice they are. What they can’t do is take from the manufacturer the responsibility under the DSCSA for generating, storing and retrieving the documentation.

It follows that the contract between the manufacturer and the 3PL is of high importance. In practice, the manufacturer will impose on the 3PL a contractual requirement to be responsible for the accuracy of all transaction paperwork and for the security of the goods while in the 3PL’s possession. The manufacturer cannot transfer to the 3PL the manufacturer’s own responsibility for security but can, will and does ensure that the penalties faced by the 3PL for any lapse in security are onerous in the extreme.

As will be seen, there are various ways to look at the 3PL’s position. It could be any of these:

  • Outsourced order fulfilment
  • High security warehousing
  • Shipping and invoicing documentation
  • Physical tracking, at present by lot/batch number but ultimately by package
  • Annual reporting to FDA

In fact, of course, it isn’t any of those; it’s all of them. Given the importance of keeping prescription drugs safe and the seriousness with which the FDA regards them, there should be careful checking of the 3PL’s competences and systems by the manufacturer before a contract is signed and then on a regular basis afterwards. 3PLs have to be licensed and the existence of a license will give confidence but the FDA’s stance is clear: the responsibility for ensuring that all goes well lies first with the 3PL and then with the manufacturer and cannot be passed off onto the FDA. The agency will simply not accept that.

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

How DSCSA Applies To Physicians

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The Drug Supply Chain Security Act (DSCSA) casts its tentacles widely. There are limits, though, and this post is intended to clarify where those limits are.

Two common and opposing ideas have grown up:

  • That physicians are exempt from the Act
  • That physicians have to comply with the Act to exactly the same extent as every other entity in the supply chain that stretches from manufacturer to patient.

Neither of these is correct. Only the first, though, will bring the physician grief; the second will merely inflict additional and unnecessary work.

It is not true that every physician practice that inventories drugs must accept and maintain transactional data. Buy-and-bill drugs that are administered by physician practices in the usual course of business are excluded from this requirement. The Drug Quality and Security Act, Title II says that, “notwithstanding any other provision of law, the requirements under paragraphs (1) and (4) shall not apply to licensed healthcare practitioners authorized to prescribe or administer medication under State law or other licensed individuals under the supervision or direction of such practitioners who dispense or administer product in the usual course of professional practice.”

Note that this does not apply to physician practices with in-office dispensing pharmacies; such practices ARE required to comply with transactional data requirements, though the need for compliance is restricted to the pharmacy in the office and does not apply to the practice side of the business.

So what is a dispenser? And, more relevantly, when is a pharmacist a dispenser?

The Act defines a dispenser as “a retail pharmacy, hospital pharmacy, group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.” (Our italics).

This definition, then, includes physicians who dispense and administer prescription drugs, but only if we ignore the exemption quoted above. The requirement for dispensers that relates to product tracing and verification does not apply to physicians and other licensed healthcare practitioners.

That does not mean that DSCSA places no requirement on physicians and other licensed healthcare practitioners. They will be required to use product identifiers when the use of product identifiers for dispensers comes into operation in 2020 and they are required now, and have been since 1st January 2015, to confirm that trading partners are authorized.

It follows that at this time the only requirement the Act lays on physicians who administer prescription drugs in the usual course of their medical practice is to ensure that entities they deal with are authorized trading partners within the terms of the Act; by 2020, they will also have to use product identifiers. Where physician practices have in-office dispensing pharmacies, though, they should also ensure that those dispensing pharmacies comply with all provisions relating to dispensers.

That raises the question: how to ensure that trading partners are authorized? In this connection, verbal confirmation by the trading partner is unlikely to be sufficient and physicians should ensure that the process they go through to confirm a partner’s authorization is documented and can be summoned from whatever archive it is held in when the physician is called on to show what steps they took to confirm authorization. The confirmation can be carried out directly with the trading partner but it must be documented.

Third-party confirmation, though, would be preferable. FDA maintains a database showing all manufacturers and repackagers who are registered. State authorities maintain a register of licensed wholesale distributors, third-party logistics providers and dispensers. There is also an FDA website at www.fda.gov/knowyoursource that lists entities able to confirm that trading partners are properly licensed or registered.

The legislation has teeth. It is a feature of 21st-century life that criminals are continually refining existing methods of deceit and inventing new ones, but FDA cannot be relied on always to assume that the physician who accepts illegal drugs is an innocent party. FDA has in the fairly recent past commenced enforcement actions against physicians and sent letters to physicians identifying those it believes “may have obtained counterfeit or unapproved drugs from a rogue distributor.” No one wants to be the target of one of those enforcement actions or the recipient of one of those letters. However long a physician may have dealt with the trading partner and however illustrious the trading partner’s name, the wise physician (and is there any other kind?) will obtain and document confirmation of registration or licensure.

Free DSCSA Evaluation

Contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.