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DSCSA

What Happens to DSCSA Requirements in the Event of a Public Health Emergency?

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The purpose of the DSCSA, more formally known as the Drug Supply Chain Security Act, is to create a system that makes it easier to track and trace prescription medications along the drug supply chain in the United States. Initiated in 2013, the DSCSA regulates transactions along the supply chain, including manufacturers, repackager, distributors, pharmacies and other dispensers. The process of fully enacting the DSCSA is scheduled to take place over a 10 year period, illustrating that the requirements under the act are significant and complex.

With this in mind, one of the main questions surrounding full implementation of the DSCSA is what will happen in the event of a public health emergency. If we’re facing a situation where speed becomes crucial in the manufacture and distribution of pharmaceuticals, will the requirements of the DSCSA negatively impact our ability to navigate a public health crisis effectively? It’s important that anyone working within the drug supply chain understand if and how the DSCSA requirements will affect a public health crisis.

Defining a Public Health Crisis

The event of a true, serious public health crisis is relatively rare in the United States. We’re fortunate enough that advancements in technology have made it easier to recognize a significant public health threat so that it can be addressed before it becomes a widespread issue. However, we are not completely immune. In fact, we need not look much further than recent history to illustrate this point.

For example, the AIDS epidemic posed a significant public health crisis in parts of Africa during the 1980s. More recently, we’ve experienced close calls with threats to public health, such as MRSA, SARS, and H5N1, also known as the bird flu. The simple fact is that people are traveling around the world in massive numbers, and this exponentially increases the risk of a public health crisis. For reference, the Federal Aviation Administration claims that 2.5 million passengers fly daily in and out of United States airports alone.

While we’ve seen some smaller scale threats to public health in recent years, a true public health crisis can be defined as a health related event that has a geographically widespread effect on the general public with the potential to have devastating consequences on not only the health of the citizens but also on social and economical levels. A significant public health crisis has the capacity to destroy lives, communities and our economic structure. This means that the ability to respond quickly is key to managing a crisis and mitigating any potential damage.

The DSCSA and Public Health Emergencies

The implementation of serialization and tracing standards within the DSCSA is a time consuming process to say the least. Even once the final deadline is reached in 2023, we’re still looking at processes that could potentially slow down the ability to produce and supply the public with necessary medication in the event of a public health emergency.

Considering that this is a question that many people in the drug supply chain industries have asked, the FDA has included provisions about how the DSCSA requirements will be handled during the event of a public health crisis.

The Secretary of Health and Human Services has the ability to declare a public health emergency under section 319 o0f the Public Health Service Act. This can occur when it’s agreed upon that a disease presents a public health emergency or that a public health emergency, to include both infectious diseases or bioterrorist attacks, exists. In such an event, there may exist a need to expedite the production and distribution of pharmaceuticals as the emergency situation dictates. The FDA wants to assure both the public and members of the drug supply chain that no part of the DSCSA is designed to impede upon this process.

The DSCSA considers a public health emergency as sufficient reason to automatically exclude certain requirements for a period of time. According to the FDA, product distribution for public health emergencies is excluded from the act’s definition of wholesale distribution and transaction. Meaning, that any requirements related to tracing and wholesale distribution don’t apply to any trading partner that works to address a public health emergency. In such a case, the other requirements set forth in the DSCSA still apply.

Additionally, any entity that is engaged in distribution activities during a public health emergency should maintain all security aspects of the supply chain as medications are distributed to meet the pressing public health need. Once the expiration of the public health emergency is declared, any exceptions made under the DSCSA for the term also expire and standard requirements apply. Generally speaking, the term of the public health emergency will last until the Secretary states the emergency is no longer a threat to public health or 90 days after the declaration of the emergency was first issued, whichever of the two occurs first. If necessary, the Secretary may elect to extend the term beyond the initial 90 days.

It’s also important to note that there’s a designation between a true public health emergency and a general shortage of a particular medication. If a shortage of medication is not directly related to a public health emergency, then the manufacturer is expected to comply according to all stated guidelines.

Navigating Public Health Emergencies

While we all have the sincere hope that there won’t be the need to test the DSCSA requirements during a public health crisis, it’s important to acknowledge that the risk exists and to be prepared in the event that an emergency is issued by the Secretary. If we’re faced with a public health emergency, members of the drug supply chain will need to know how to react in accordance of the DSCSA requirements.

The best plan of action requires being proactive and preparing your drug supply chain business with the best in serialization software. A great software system doesn’t handle just one component of the serialization process but helps to guide you effectively through the challenges along the way. If you’re tired of the stress of the serialization process, then we have a solution for you. Contact TrackTraceRX today to learn more.

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

 

New Draft Guidance Outlines the Waiver Process Under DSCSA

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The FDA recently released draft guidance to better help trading partners in the pharmaceutical drug supply chain understand exactly how the waiver process, including exemptions from the DSCSA of 2013, will operate.

The goal of the DSCSA has been to build a system that identifies and traces the pharmaceutical distribution process in the United States. This is also set to establish the process for which a distributor, manufacturer or repackaging facility can request a waiver from applicable laws. Considering that every aspect of the DSCSA is scheduled to be complete and fully implemented by 2023, addressing concerns on the waiver process now helps to facilitate a smoother transition for the trading partners and vendors that are directly affected.

What Appears in the New Draft Guidance?

The document, titled “Waivers, Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food, Drug and Cosmetic Act Guidance for Industry” is only 8 pages long, but clearly outlines when waivers and exemptions are allowed under the law, and the process for submission and review.

The draft notes that under Section 582(a)(3)(A) of the FD& C Act that the FDA is required to issue a guidance that the United States Secretary of Health and Human Services can grant waivers if the requirements of the DSCSA “would result in an undue economic hardship or for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act.”

The guidance outlines the three types of waiver requests that will be accepted by trading partners.

  • A waiver of the section 582 requirements is warranted because compliance would foreseeably result in undue economic hardship or is deemed to be appropriate for medical reasons.
  • An exception to section 582 requirements may be requested when the container or packaging is accepted as being too small to allow labeling with sufficient space for all the proper identifying criteria and information necessary for compliance.
  • An exemption to the products or transactions regarding section 582 requirements if it is seen as necessary for maintaining public health or is determined to be otherwise appropriate.

Additionally, we see that the document also states that the FDA has the authority to establish exceptions and exemptions from the stated requirements of section 582 as it sees fit. Trade partners who have been uneasy about the full implementation of the DSCSA will appreciate the fact that the FDA can use this authority at any point that it feels it is necessary to address unforeseen and widespread issues that affect a large segment of the industry as a whole.

This authority is especially advantageous from the perspective of the FDA, considering the time and resources that can be saved by preventing the domino affect of waiver and exemption requests that could accompany a change in the industry that has a major impact on all players.

What’s Needed to Request a Waiver?

Any authorized wholesale distributor, manufacturer, dispenser or repackaging facility can request a waiver or exemption from the section 582 requirements. The draft guidance serves as resource for agencies who qualify for these exemptions by providing details of the complete process and what information must be presented at the time of the request. Having this information now will help streamline the potentially time-consuming exemption process and help to ensure that claims are not denied based on incomplete or inaccurate details at the time of submission.

When submitting a request for a waiver, here is the information that will be required to make a determination.

  • The complete identity of the trading partner that would be included in the waiver or exemption, including the agencies full name and complete contact information for one individual that will serve as a point of contact between the agency and the FDA should questions or other matters arise.
  • A complete description, including the national drug code number, of the products and/or activities that will be covered under the waiver or exemption.
  • Which requirements of section 582 the agency is seeking a waiver or exemption from.
  • The effective date range of the requested waiver or exemption.
  • A clearly composed statement that outlines the valid reasons why the FDA should consider the request. When submitting this request, keep in mind that only 1 waiver or exemption is permitted per supporting document. Additional requests will need to be filed independently.

How the New Draft Guidance Helps Define the Waiver Process for the Future of the DSCSA

While we still have a few years until complete implementation, the new draft guidance provides a solid foundational understanding of the waiver and exemption process as it stands today. In this industry, we all know that things change and that the waiver process as it’s defined today may or may not prove effective for the future of the industry.

To help streamline the waiver and exemption process and keep the focus on the core principles of the DSCSA, the FDA says that it intends to review waivers and exemptions that currently stand and are valid on a schedule of every 2 years. This includes waivers that are valid “until further notice” and those that have an expiration date that is 2 or more years past the initial effective date and renew them as applicable. This commitment by the FDA helps to lessen the burden of requesting follow up reviews on agencies.

With information about the waiver process, how a request should be initiated and the process for determination and follow up being so clearly outlined, hopefully this draft guidance serves as reference and answers many of the questions that those in the industry have about section 582 requirements and under what circumstances a waiver or exemption stands as a valid request.

With these standards set in place, one of the biggest hurdles in the final implementation of the DSCSA has been addressed. From here, the next few years that bring us closer to complete implementation should be smooth sailing.

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

Integrity Issues In the Drug Supply Chain

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The Drug Supply Chain Security Act (DSCSA) was created to address integrity issues within the drug supply chain. What exactly are the issues the DSCSA was created to tackle? Most of the issues the DSCSA seeks to solve involve preventing the distribution of unsafe or ineffective drugs within US borders. Many drugs within the country are counterfeit, tainted, or otherwise unsafe which can greatly harm the health of people who use them.

Fighting Drug Counterfeiting

Getting anywhere close to an exact number regarding the amount of counterfeit drugs in the US is difficult, precisely because counterfeit drugs aren’t labeled and tracked like legitimate drugs are. Yet the World Health Organization estimates that approximately 1% of all drugs in developed countries could be counterfeit, with this percentage being much higher in other countries.

Known examples of drugs that have suffered from counterfeiting in the US include Lipitor (a medication to lower cholesterol), Procrit (stimulates the growth of red blood cells) and Alli (an over-the-counter drug used for weight-loss). These counterfeit drugs often contain the wrong ingredients for treating a condition or inactive ingredients, and as such counterfeit drugs can cause a variety of unexpected and dangerous side effects or be utterly ineffective in their treatment of a condition.

The production and distribution of counterfeit, tainted, or low-quality drugs can even harm people who haven’t taken the drug. Low-quality drugs – drugs that do not contain enough active ingredient to be effective – can end up contributing to the development of drug-resistant diseases and the outbreak of diseases in a population. If a drug contains an insufficient dose of an ingredient to kill off all of the bacteria, the remaining bacteria can become resistant to it. In addition, if a drug fails to kill off the bacteria in one host, that host can propagate it to other people.

Combating counterfeit or tainted drugs is difficult because not only must the FDA account for drugs produced within the country, but many drugs and medical devices are manufactured outside of the country as well. These drugs and medical devices are imported into the country, but many of the imported drugs are unapproved.

The importation of drugs also allows criminals a chance to steal drug cargo and resell them on a black market, where the distribution of the drugs is not monitored for safety. Drug heists aren’t extremely common, but when drugs do get stolen millions of dollars worth of drugs can quickly disappear. Cargo thefts that occur in the pharmaceutical industry cost around 4 million dollars per theft on average.

The Supply Chain Security Toolkit

One of the ways the FDA is dealing with drugs coming from other countries is by creating a “Supply Chain Security Toolkit”. This toolkit is supposed to be useable by drug supply chain authorities in other countries, including countries that are part of the Asia-Pacific Economic Cooperation (APEC) group, as well as non-APEC countries, academics, and non-governmental organizations (NGO)s.

The toolkit provides comprehensive information relating to every aspect of the drug supply chain and advises people on things like counterfeit detection technology, track and trace procedures, and internet sales tracking.  The toolkit covers things like the raw materials used in manufacturing to the information provided to patients about best use practices. It is hoped that regulators and stakeholders alike will implement its tools and advice to adopt better safety practices and standards, with the ultimate goal of reducing counterfeit or substandard drugs and protecting consumers.

Regarding the drug supply chain in the US, the DSCSA was created to help protect the integrity of the drug supply chain as a whole. It has provisions in it that mandate the creation of a system for tracking drugs through the entire supply chain, from manufacturers to distributors, repackagers and dispensers.

The Role of the DSCSA

The hope is that through the creation of a system that labels and tracks all drugs within a system, verifying the authenticity and safety of a drug will be much easier and quicker. One of the ways that the DSCSA is seeking to ensure a drug can be traced through the supply chain is with product identifiers, a unique label that has information relevant to that batch of drugs on the packaging or case. The identifiers will enable people to look up the specific case of drugs in a database and see their entire history, from manufacturer down the entire drug supply chain.

Not all medical substances must fall under the purview of the DSCSA. Some exemptions from the DSCSA include blood for transfusion, radioactive biological products, medical gases, and products for sterilizing water. Compounds like these are often more difficult to counterfeit and they are not considered DSCSA products, so trading partners dealing only with these substances do not have to abide by DSCSA regulations.

FDA Education Initiatives

In addition to the creation of the DSCSA, the FDA has launched multiple initiatives to help combat substandard or counterfeit drugs and protect consumers. The FDA has a campaign referred to as BeSafeRx, which is intended to alert the public about the dangers associated with purchasing medication through uncontrolled online pharmacies. The FDA tells consumers not to buy drugs from these sites.

The FDA also has a program called Know Your Source. While BeSafeRx is an educational program for the general public, the Know Your Source program is designed to target healthcare professionals. The program aims to educate healthcare professionals about potential sources and warning signs of unsafe drugs so they can avoid passing them on to their patients. Finally, the FDA sends out letters to health care providers, with the goal of advising them that they might have unintentionally purchased drugs from dangerous and unregulated sources.

There are many integrity issues with the drug supply chain that pose substantial risks to the health of society. This makes the DSCSA necessary to protecting the health of patients and consumers across the United States.

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

What Will Happen In The Next Phase Of The DSCSA?

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This year will see the end of the Drug Supply Chain Security Act (DSCSA)’s midterm goals. The DSCSA will hit its second milestone and proceed into the third phase of the Act. What does the transition into the third phase of the DSCSA mean for trading partners involved in the drug supply chain?

The Different Phases Of The DSCSA

Seeing how the third phase of the DSCSA will impact trading partners requires laying the groundwork for the DSCSA. The DSCSA was created to give the FDA more ability to regulate drugs involved in the drug supply chain. Many drugs that move through the drug supply chain are illegitimate or dangerous. They can be counterfeit, contaminated, stolen, or otherwise hazardous. To combat these hazardous drugs, the DSCSA’s goal is to allow the tracking of specific drugs from the manufacturer all the way down to the consumer. The fact that every time the drug changes hands it is logged means that it is much easier for regulatory bodies to find out where a problem occurred if something goes wrong.

The transition from the current system of tracking drugs to the advanced traceability system of the DSCSA couldn’t happen overnight. Members of the drug supply chain had to have time to transition to the new requirements. Because of this fact, the DSCSA was broken up into different phases with different milestones.

The phases of the DSCSA are as follows:

  1. Lot-level Management
  2. Item Serialization
  3. Serialized Traceability

The Previous Phases Of The DSCSA:

Lot-Level Management

The DSCSA’s first phase dealt with lot-level management. It started on January 1st, 2015 and applied to manufacturers, repackagers, and wholesalers. It started applying to pharmacies on July 1st of that year. The lot-level management system was intended to kick off the transition between monitoring lots and batches of drugs to the monitoring of individual items. Lots and batches refer to specific groups of prescription drugs manufactured or packaged at a specific location. The way these batches and lots were tracked involved the compilation of three different datasets.

Transaction Information, Transaction History, and Transaction Statements all had to be included along with a transaction. Transaction information contained things like the number of containers, the lot number of the product, the strength and dosage of the product, and the transaction date. The history of the transaction was a statement that contained all previous transaction information going back to the manufacturer. The transaction statement is a statement acknowledging that the product has changed hands to another trading partner.

Item Serialization

We are currently in the middle of the midterm portion of the DSCSA. This period runs until November of 2019 and it mandates that re-packagers and manufacturers of drugs must serialize the individual packages with a unique product identifier.

The product identifier that the DSCSA requires is a combination of several different systems previously used to track drugs. These include systems like the national drug code established by the FDA, barcodes which are part of the GS1 Global Trade Item Number system, individual serial numbers, lot numbers, and expiration dates. These various forms of information are to be combined into a single label that can be applied to an individual drug package. This product information is put into a 2-D DataMatrix that enables the product to be (with some effort) tracked back through the system by a human or computer. Product packages cannot change hands in between trading partners without the included product identifier.

Tracing Products At The Item Level

By November 2023 the FDA expects that all trading partners involved in the drug supply chain will be utilizing product identifiers and have a system capable of tracking these product identifiers all the way through the chain. Whereas previous levels of the DSCSA mandated that packages of drugs must be trackable, by this point individual items must be traceable as well.

The product identifier information must be entered into some kind of system that allows an individual item to be traced in between trading partners. Currently, members of the drug supply chain are experimenting with possible solutions to the drug tracing problem. Various pilot programs are being tested out by different companies, and solutions like blockchain and other communal databases are being explored. December of last year saw the FDA released statements regarding their standards for data exchange, data architecture, and data aggregation. These standards must be taken into account by companies and pilot programs moving forward.

So to recap, what exactly will happen in the next phase of the DSCSA? As the next milestone for the DSCSA comes ever closer, the companies involved in the drug supply chain will not only need to implement serialization at the item level of the supply chain, they will also need to create a method of storing serialization information and allowing the FDA or other authorities to trace products all across the supply chain. The task may be daunting, but the benefits for consumer health and safety will be worth it.

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

TrackTraceRx Launches their new Serialization solution for Manufacturers

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Our very own Andre Caprio is at at booth #107 at the  #HDADMC @HDAconnect please stop by and say hi and find out how we can help you with your #serialization project! #DSCSA…

TrackTraceRx will be launching our new Serialization solution for manufacturers at the HDADMC conference. Due to the complexity of serialization, TrackTraceRx will only be accepting a limited amount of new sign ups. Please contact us to book your demo.

 

 

 

 

 

A Breakdown of the Draft Guidance for The DSCSA’s Grandfathering Policy

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When the Drug Supply Chain Security Act was initially passed back in 2013, it was required that the FDA put out guidance information regarding the grandfathering of specific product identifiers for certain prescription drug packages. The DSCSA requires every package of drugs as well as homogenous cases of products in the drug supply chain to be equipped with some kind of identifier. It was likely that packages of prescription drugs which were already in finished dosage form would be considered to be grandfathered in, yet only this past month did the FDA get around to releasing information about their grandfathering policy.

All comments on the new guidance draft are due by January 26th of next year, and in the meantime the guidance specifies the circumstances under which a homogenous case of product not equipped with identifying information, as defined by Section 582(a)(5)(A) of the DSCSA, will be grandfathered (exempted) from the identification requirements.

The FDA explains that certain product identifier requirements are considered exempt from the act if the homogenous cases of drugs are “in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of [section 582 of the DSCSA].”

What does the mean exactly? It essentially means that a drug package or homogenous packages or case of drug products is considered already in the pharmaceutical supply, and thus exempt from DSCSA standards, if the manufacturer of the product packaged the product before the 27th of November, 2018.

The Product Identifier Delay

You may be wondering why the date for exemptions is so late, but the FDA has stated that their new guidance should be considered with regard to their earlier draft guidance that discussed product identifiers.

In their earlier guidance called “Product Identifier Requirements Under the Drug Supply Chain Security Act” the FDA announced that it would be delaying the serialization deadline for one year. This meant that while the original intended deadline for serialization was November 27th of this year, manufacturers now have another year to be in compliance with the new serialization rules. The FDA is exercising their enforcement discretion for manufacturers who haven’t added product identifiers to drug packages yet. It’s hard to say exactly that the reasoning behind this decision was, but the failure to get the grandfathering guidance out by their initial deadline may have played some role in the decision.

It’s important to note that manufacturers can’t merely claim that they packaged a case before November 27, 2018. There must be documentation supporting this claim. According to the FDA if a drug package or homogenous case isn’t labeled with a product identifier, and yet is accompanied by the requisite transaction history or transaction information, then it is reasonable for a trading partner to conclude that the product had been packaged before the deadline. Yet if the transaction history or transaction information doesn’t display a sale or handling prior to the November deadline, then the transaction statement should be used as an indication of the product being in the supply chain before the deadline, assuming there are no other signs that the product is illegitimate.

The FDA communication goes on to discuss how trading partners should handle grandfathering exceptions. The draft guidance specifically addresses manufacturers, repackagers, distributors and dispensers who are exempt from the two Section 582 requirements.

Manufacturers:

When manufacturers investigate an unserialized product to determine its legitimacy, the manufacturer does not have to use the product identifier for purposes of verification. The manufacturer must still make use of the transaction information and transaction history data to determine legitimacy.

If an authorized trading partner has the product request verification from the manufacturer then said manufacturer is not required to use a product identifier, yet they must still abide by the other standards referenced in Section 582(b)(4)(C) which gives information on how to determine a product’s legitimacy.

Repackagers:

Product repackagers are classified as “partially exempt” when in possession of a product without serialization after November 27th, 2018, if the product lacking an identifier was accepted after that date. If the repackager were to hand over the product to another trading partner after Novermber 27, 2018, the repackager must add a product identifier.

Similar to the other trading partners, repackagers may refer to both transaction history and transaction information data to determine the legitimacy of a product lacking an identifier.

While a repackager who repackages and/or sells unserialized products before the November deadline are considered exempted from the mandate to use a product identifier to determine authenticity, the repackager must still abide by any other relevant requirements.

Wholesale Distributors:

Wholesale distributors are considered to be exempt from the statue, which requires they distribute only serialized products after November 27, 2019. They aren’t required to verify the legitimacy of products utilizing the product identifier starting on November 27, 2019, but they are required to use all available transaction data, such as transaction history and transaction information, to assess the legitimacy of the product.

Dispensers:

Dispensers are classified as exempt from the provisions of Section 582(d)(2). This means that they don’t have to only engage with serialized products after November 2020. Wholesale distributors also don’t have to verify products using the product identifier, much like the other trading partners. Starting November 27, 2020 they have to use all available transaction data to determine the legitimacy of a product.

No Sunset Deadline?

If you are surprised that there’s no hard deadline regarding when trading partners must stop dealing in products without an identifier, it is because grandfathered products can be used in transaction until those products expire. The FDA expects that there will be very few drug products still within date by November 27, 2023.

Though the guidance comes two years late, it is still helpful. By clarifying their policy on the grandfathering of drugs without an identifier, the FDA will hopefully reduce confusion on the topic and allow trading partners to rest at ease regarding grandfathered products.

Comparing the DSCSA and the EU/FMD

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Over the next six years, the drug supply chain in the United States will undergo a series of changes in order to conform to new standards created by the federal government. The Drug Supply Chain Security Act (DSCSA) mandates the development and implementation of standards for tracing drug products, with these standards to be phased in by 2023.

The drug supply chain in the United States isn’t the only pharmaceutical landscape to see new standards though, as the European Union (EU) will also be enforcing new standards for tracking drugs via the Falsified Medicines Directive (FMD) and its associated Delegated Regulation (DR). How do the DSCSA and the FMD/DR compare? What is similar about the two different sets of standards? What is different about them? To answer these questions, it is important to take a close look at the structure of both the DSCSA and FMD/DR

Overview of the DSCSA

The DSCSA was signed into law in 2013, and it was created to facilitate verifying the legitimacy of drugs, making recalls easier, and increasing the overall traceability of the supply chain. The DSCSA’s Title II creates new serialization standards as well as requirements for the handling of electronic transaction data.

The establishment of the DSCSA is multi-phased. The rollout of the new standards began in 2015, and the industry is expected to be in full compliance by 2023, so there are eight years of transition between the old standards and the new standards. The transition began with lot-level management, or changes at the local level for manufacturers, repackagers and wholesalers. These companies were expected to start exchanging lot-based documentation for drugs in 2015.

The middle phase of DSCSA implementation concerns item serialization, and will take place from 2017 to 2019. Repackagers and manufacturers will have to begin adding unique product identifiers like GS1 Global Trade Item Numbers, as well as expiration dates and lot numbers to each product. The final phase of implementation involves serialized item-level traceability. The item-level traceability will make information that allows supply chain partners to trace the ownership of a product back to the original repackager or manufacturer available.

Overview of the FMD/DR

Similar to the DSCSA, the EU’s Falsified Medicines Directive lays out the legal justification for combating falsified drugs and medicines, and then directs member states of the EU to take action to protect the drug supply chain from counterfeit drugs. The 28 member states of the EU as well as a few other countries like Iceland, Norway and Switzerland will be participating in the FMD.

The FMD itself is relatively short, only 14 pages, but it has powerful implications for the more than 30 countries that will abide by the directive. The FMD mandates the passing of a “delegated act” which would require that safety features and information be included on the packaging of prescription drugs sold in the EU. The safety features were intended to “allow verification of the authenticity and identification of individual packs, and provide evidence of tampering.” The specifications for the mandated safety features would be provided during the passage of the Delegated Regulation.

During February of 2015 the DR was passed, explaining that there should be two safety features on every drug package. One of the safety features is the inclusion of anti-tamper devices, while the other is the inclusion of a unique product identifier (composed of various elements like serial numbers, product codes, and batch numbers). The act also specifies what companies or entities must abide by the new regulations as well as what the responsibilities of said entities are. The entities that are subject to the FMD/DR include manufacturers, wholesalers, repackagers, parallel traders, and dispensers or pharmacies.

All entities subject to the FMD/DR are expected to be in compliance with the new standards and regulations by February 9th of 2019, so pharmaceutical companies will have to be including anti-tamper features and product identifiers in all their products by this date, in addition to complying with any other mandates of the FMD/DR.

Comparing the DSCSA and FMD/DR

One of the most prominent differences between the DSCSA and the FMD/DR is that the rollout periods for the two systems are vastly different. The DSCSA is essentially made up of a series of milestones, with the final milestone being full compliance in 2023. The FMD/DR only has one real milestone, full compliance by February 9, 2019 after the DR was adopted in 2015.

While the DSCSA and FMD/DR both require that repackagers and manufacturers label every lot with different serial numbers for the purposes of verification and recordkeeping, the two directives differ in the type of information they mandate the collection of.

The DSCSA mandates collection of the following data: Serial Number (no randomization required), the Lot Number where the product originated, the expiration date, and the National Drug Code (NDC) Number.

The FMD/DR requires the collection of the following data: Product Code, Drug Registration Number, Lot Number, Expiration Date, and the Randomized and Unique Serial Numbers.

The FMD/DR has standards for “commissioning”, or verifying received products and “decommissioning” or taking a serial number out of the supply chain. Decommissioning would only be done if the product was destroyed, stolen, or lost. The DSCSA currently doesn’t have any provisions in place that demand either the commissioning or decommissioning of individual drug products.

Neither the DSCSA nor the FMD/DR require the implementation of any specific serial number system. The DSCSA allows manufactures to add in unique serial numbers to a pre-existing National Drug Control System (NDS), which forms a serialized NDC. The problem with this format is that it can only be used for products within the US, which means that if a US company is going to export goods internationally it needs to use a different identification system, like the Electronic Product Event Data (UPCIS) system or the GS1’s Global Trade Item Numbers (GTIN). Countries adhering to the provisions established by the FMD/DR would presumably use one of these systems as well.

The biggest difference between how verification is handled between the US and EU systems is when and how often drugs are verified. In the EU every drug must be verified by before it is dispensed to the patient, whereas in the US only drugs being returned or seen as suspect will be verified.

Since neither the FMD/DR or the DSCSA give guidance for the implementation of any serial number systems or data collection systems, the decision is left primarily up to individual companies. This means that they will face similar challenges regarding the standardization of systems and the communication between companies. Different entities will be arguing for the implementation of their own preferred systems, and collaboration is difficult in any environment that has many different organizations.

No matter the differences between the two systems, both the DSCSA and the FMD/DR will have to deal with the challenges of applying universal standards to a wide variety of companies and entities. Despite the challenges, a safer drug supply chain is worth it.

DSCSA Requirements Updates by the Big Three – (Cardinal – ABC – McK)

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The Grand Alliance in the picture above (World War II), known as the “Big Three”: the Soviet Union, the United States, and the United Kingdom, or their leaders Joseph Stalin, Franklin Roosevelt and Winston Churchill. In the Pharmaceutical world we know them as Amerisource Bergen, Cardinal and McKesson.

As the date for the transition to the new DSCSA requirements approaches, a lot of attention is being paid to the actions of the “Big Three” pharmaceutical companies – AmerisourceBergen ,CardinalHealth, and McKesson. These three companies have a massive amount of influence over the rest of the pharmaceutical industry, so their decisions and announcements regarding DSCSA requirements carry implications for all other companies in the industry.

Updates from AmerisourceBergen on GTIN Repository

AmerisourceBergen and CardinalHealth issued statements this past April regarding serialization requirements. In terms of GTIN repository, AmerisourceBergen says that manufacturers must use the Healthcare Distribution Alliance’s official GTIN repository to handle master data for products as well as GTINS for all products covered by the DSCSA.  The company says that the decision that was born out of an industry need to establish “one source of truth” for GTINs and their attributed data. This was done in order to stop wholesalers and manufacturers from receiving repetitive data requests.

AmerisourceBergen also commented on the future of the Advanced Ship Notice. The company says they are willing to pilot, test, and potentially cut over to EPCIS for all Transaction Information deals prior to 2023, assuming manufacturing partners can send a serialized data through EPCIS 1.2 next year.

Updates from CardinalHealth on Verification Router Service

CardinalHealth released their communication about Verification Router Service. VRS is a solution to assist manufacturers in aggregating shipment data. It is hoped that the improved ease of aggregating data will convince more manufacturers to aggregate.

CardinalHealth’s statement says that manufacturers send aggregated data along with every shipment so that identifiers for products can be internally verified. VRS has manufacturers subscribe to a third party routing service which brokers the different requests for verification, allowing manufacturers to maintain their own databases of serial numbers.

AmerisourceBergen also supports VRS as a possible solution that lets wholesalers verify product information through a secure and connected network.

Updates from McKesson 

McKesson sent out a communication about six different topics: DSCSA suppliers, the conversion of NDC to GTIN, GS1 EPCIS Events Multiple PO, GS1 EPCIS Events Single PO, Supplier Serialization Piloting, and Quick Start for HDA Bar Code.

In terms of Data Exchange via EPCIS, McKesson expects to be utilizing EPCIS 1.2 or higher. The company expects to do Unit to Case aggregation as well as Case to Pallet Aggregation with a SSCC label for the pallet. McKesson plans to handle returns verification by sending data through EPCIS or VRS.

McKesson also clarified that they would be using HDA for case labels, and using the HDA New Product From for new Rx products. In terms of GTIN, McKesson will be using the US G1 Standard.

Comparing the Big Three

Let’s take a look at what we known about the position of each of the Big Three companies.

  • EPCIS Data Exchange: McKesson will use 1.2 or higher, Amerisource will use 1.0, 1.1, and 1.2. Cardinal has not announced what EPCIS it will be using.
  • Transaction Statement/Transaction Information: McKesson will be using ASN until at least 2023, while Ameriscource will use either ASN or EPCIS 1.2. Cardinal has committed to going paperless.
  • Case to Pallet Aggregation: McKesson says it expects aggregation with pallet SSCC labels, the other two companies have not said how they will handle pallet aggregation.
  • Unit to Case Aggregation: McKesson expects to aggregate, while the other companies have not specified what they will do.
  • Returns Verification: All three companies have agreed to send data via EPCIS or Router Services.
  • Unit Label: Cardinal and Amerisource both plan to utilize GS1 and HDA, along with barcode testing.
  • Case Label: Once again, Cardinal and Amerisource both plan to utilize GS1 and HDA, along with barcode testing. However, McKesson only plans for HDA support right now.
  • GTIN embedded with NDC: McKesson and Cardinal have both agreed to use US and GS1 Standards.
  • Master Data: Amerisource has said they will make use of the HDA GTIN Repository, the other two companies have not stated their plans.
  • New Rx Products: McKesson says that HDA New Product Forms will be used for new products, while the other two companies out of the Big Three have not stated how they will handle new Rx products.
  • Expiry Date: McKesson has said it will not be using “00” dating for expiry dates. No communication from Amerisource or Cardinal on the topic yet.
  • Non-Serialized Products After 2017: Cardinal has agreed to non-serialized products after 2017 if they meet FDA criteria, while Amerisource has agreed generally. McKesson has not stated how their position on the topic.
  • Non-Serialized Products After 2019: Cardinal and Amerisource have said they will not support Non-Serialized Products After 2019, and McKesson hasn’t stated if they will or will not.

Serialization Implications

Essentially the Big Three distributors want two main things out of those grappling with the new DSCSA requirements. They want to ensure labels for all goods and products are correct and that the right serial data is sent to them. It remains to be seen how effective the EPCIS system will be when dealing with distributors, but hopefully the transition to the new requirements will occur with fewer problems now that the Big Three have clarified their positions on a few things.

Verification Router Service: How Will It Impact DSCSA Compliance?

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Verification Router Services DSCSALast year the Food and Drug Administration mandated new verification requirements for the drug supply chain, as part of the Drug Supply Chain Security Act (DSCSA). As the DSCSA verification requirements come ever closer, many different methods of handling verification requirements are being analyzed by the pharmaceutical industry.

Methods such as maintaining a central repository that aggregates all relevant data, providing each manufacturer with their own verification database, and having distributors scan outbound products have all been suggested. Not all suggested verification systems suggested are created equal though, and one system stands out as being more workable than the others.

At the end of last year, the Healthcare Distribution Alliance (HDA) completed an analysis of nine potential ways to ensure drug companies meet verification requirements. The HDA then held a workshop where they presented pilot versions of two of the most promising verification systems.

One approach was to have manufacturers aggregate product identifying information and send it to individual distributors, when the distributor needs to process a saleable return they simply reference an internal database to verify the identifier information. The other tactic discussed for was the use of a verification router service (VRS), where a third-party routing service stores all product identifier data locally.

VRS has the potential to make meeting verification requirements easy and convenient, regardless of how many companies it has to serve.

What Is Verification Router Service?

As defined by the HDA, verification router service refers to using a third-party routing system to send product information back and forth between distributors and manufacturers.

“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,” reads the HDA communication.

How Is Verification Router Service Structured?

HDA’s workshop on VRS did not specify a structure the VRS system would have, but it did provide an example of how a VRS system might operate.

The pilot example shared by the HDA consisted of five different steps, and was anchored by a GTIN-to-IP address table. A manufacturer would have to share their EPCIS repository IP address, as well as their GTINs (Global Trade Item Number), in order for the pilot VRS to function.

HDA’s proposed 5-step process is as follows:

  • Step 1. A wholesale distributor receives a saleable return. They then scan the DSCSA product identifier on either the whole case or the first unit, and acquire the serial number and GTIN for the product.
  • Step 2.  The wholesale distributor sends both the serial number and the GTIN to the VRS. The VRS will then utilize the GTIN to look up the manufacturer’s EPCIS IP address.
  • Step 3. The VRS sends the serial number and GTIN over to the EPCIS for the purposes of verification.
  • Step 4.  The manufacturer’s system responds to the request with the corresponding serial number and GTIN, or with the current status of the units in question.
  • Step 5. The VRS system sends the relevant information to the wholesale distributor who needs it for saleable returns purposes.

This is only one possible way that a VRS system could function. In a webinar from  another organization, an alternate system was proposed, which would see the VRS just providing a wholesale distributor with the EPCIS IP address, which would let them directly communicate with a manufacturer.

This is a less complex method of communication, rather than having the VRS itself communicate with the manufacturer’s EPCIS.

Fewer variables involved in the communication process means better performance, security, and scalability. If the direct communication method were to be used, it is likely that both wholesale distributors and manufacturers would need to employ a web service layer that enables the VRS communications.

What Are the Challenges of Verification Router Service? 

At the HDA workshop three major challenges were identified that must be overcome by a router service.

The first issue is that collaborating and communicating on a task is difficult in an environment that has many different organizations. There are logistical problems that inevitably arise when dealing with large amounts of people, and beyond that different companies in the supply chain will want to have their own frameworks in place that benefit them, meaning negotiation between companies might prove difficult.

The second challenge is that any issues with downtime, outages, or system connectivity issues must be dealt with in a timely and efficient manner. Any delays in the processing of one packet of information will have ripple effects and become amplified due to how interconnected the VRS system is. If a distributor cannot get information from a manufacturer in a timely manner, those who need the information from the distributor will also be inconvenienced.

There are also a variety of problems surrounding the proper scanning, encoding, and formatting of products and product information. It could be difficult to sync scanning equipment with VRS because of the inherent differences in the two forms of technology. A universal format for VRS related product information must also be established.

The pilot program was able to handle a verification request from a distributor to manufacturer in 0.7 seconds. It performed at sub-second speed, meaning that the program is probably able to handle requests in real world operating conditions, despite the fact that in 2019, operators will be required to scan a 2D matrix code before sending their verification request to a router service. This would further complicate the process, and if response times became longer than a second, the return transaction might cut off altogether.

The HDA decision to endorse verification router service as a possible solution to meeting verification requirements has implications for the entire industry. If VRS is successfully implemented, the transfer of verification data between wholesale distributors and manufacturers should be relatively painless and easy. For this to happen though, every company in the supply chain will have to collaborate in the creation of VRS.

Many different companies will be looking at the technology over the coming months and attempting to create their own VRS frameworks.

While settling on a specific framework could prove challenging, at least at the moment, despite all the complexities, VRS seems to present itself as a viable way to meet verification requirements.

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

How OPEN-SCS’ New Standards Will Impact Packaging Lines and Serial Number Bonding

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Just recently the Open Serialization Communication Standard Group (OPEN-SCS), announced that they will soon introduce their new serialization standard: Packaging Serialization Specification (PSS) 1.0.  OPEN-SCS is an amalgamation of different companies in the healthcare sector who are working together to create a standardized format for packaging line serialization.

The OPEN-SCS’ communication for standardized serialization include recommendations for how to best approach Serial Number Provisioning, Serialization Report Transmission, Unused Serial Number Return, Batch & Master Data Repository.

How Will OPEN-SCS Be Structured?

OPEN-SCS uses a layered approach to implementing serialization standards. The advantage of a layered approach is that it confers more flexibility, reliability, and durability to users and designers, and a layered model can be implemented much faster as well.

The International Society of Automation has laid out a four level model in their ISA-95 guidelines. These four levels can be thought of as levels of organization that go from least to most complex, and should be focused on in all proposed solutions.

  • Level 1 – Devices: includes conveyors, scanners, printers, vision components and scales
  • Level 2 – Line: covers line production at a single production or packaging line at any specific site
  • Level 3 – Site: means a single site at a CMO/CPO or corporation
  • Level 4 – Enterprise: refers to a corporation in its entirety

PSS 1.0 was created through a joint effort by GS1 Global, OPC Foundation, and the ISPE. It covers four use case examples for regular communication between levels 3 and 4 of the serialization process. This new standard will lay the foundation for PSS 2.0 that will provide guidance about nine use cases between Level 2 and Level 3 of the serialization infrastructure. The goal of the new OPEN-SCS standards is to enable smooth communications between layers in a standardized method.

What Does This Mean for Packaging Lines?

This new serialization standard has implications for the entire pharmaceutical industry around the world.  A lack of universally recognized standards for serialization has made communication difficult, even as various serialization deadlines draw ever nearer.

Packaging lines around the world should prepare to switch over to the new standards, as IT equipment and infrastructure must constantly be upgraded. Even if they already have their own serialization equipment, all of these customized models mean that costs are higher. One of the primary objectives of OPEN-SCCS is to make IT connections between systems easy and cheap, but to do this they won’t need to end all the various custom systems around the world.

Open-SCS will effectively let companies and packaging lines with their own solutions hold onto these investments when they acquire sites that utilize a different vendor’s solutions, so long as they have upgraded to the certified OPEN-SCS software. Drug manufacturers will be able to employ a standardized security method for the first time, minimizing the probability of ransomware or malware attacks that can move between systems, even in an environment with systems from different vendors.

Drug manufacturers, contract manufacturers, as well as repackagers should remain vigilant for whenever the OPEN-SCS interface is available as an option they can integrate into their next software updates. The next major updates for L3 and L4 components should come soon, and the updates for L2 and L3 components will happen in the second half of 2018.

Implications for Serial Number Bonding

Serial Number Bonding is a serialization model used by GS1. The way that GS1 categorizes different serialization functions is a problem, as it is often unclear. GS1’s standards often failed to effectively address the needs of those manufacturers who had to rely on implementing their own serialization for their products.

The reason for this is that GS1 breaks down their options into four groups: Identify, Capture, Share and Use. However, they don’t make “bonding” a GS1 identifier to a particular product very easy, which means that Commission events produced by the GS1 model are frequently unreliable. The problems with placing a GS1 identifier onto a particular entity or product mean that the necessary information from the “Use” and “Share” processes, such as supply chain data, that pharmaceutical companies rely on may be incomplete and inadequate.

Standardization is needed to facilitate the easiest possible compliance with the DSCSA and other regulations, but if the standards in question are confusing or hard to follow they won’t achieve their goal of enabling smooth communication and regulatory compliance.

It is hoped that the OPEN-SCS framework will enable GS1 standards to be more easily applied and maintained. Serial numbers and product identifiers relating to GS1 standards will be GS1-conformant, and data will be gathered throughout the process of bonding to ensure corporate databases and EPCIS commission events have all the relevant information. Hopefully the new OPEN-SCS and GS1 standards will mesh easily and assist pharmaceutical companies in placing unique product identifiers on their products, instead of inhibiting them.

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