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Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

FDA Delays Enforcement of DSCSA Saleable Returns Requirement

Note: For the latest industry reaction to the FDA’s announcement, read our update here.

In a policy document published on October 23, the U.S. Food and Drug Administration (FDA) announced it was delaying enforcement of key aspects of the Drug Supply Chain Security Act (DSCSA) that will affect wholesale distributors and dispensers. The regulations were due to go into effect on November 27 of this year; now they won’t be enforced until November 27, 2023.

The delay, the second since 2019, pertains to the requirement to verify saleable returns under the DSCSA law. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Here are the details.

Wholesale distributors: product identifiers

The FDA announced that it did “not intend to take action against” wholesale distributors that did not verify product identifiers before further distributing returned products as required under the DSCSA.

It explained that wholesale distributors, other trading partners, and stakeholders had expressed concern about industry readiness to implement the Saleable Returns Verification Requirement since the delay in November 2019. Specifically:

  • Challenges developing interoperable, electronic systems to enable verification and achieve interoperability between networks
  • More time needed to test verification systems using real-time volumes of returned product with all trading partners
  • Significant delays testing verification systems due to the COVID-19 pandemic, especially because logistics and supply chain experts were reassigned from DSCSA preparation to responding to the pandemic

Wholesale distributors: transaction statements

The FDA also addressed transaction statements under the FD&C Act. This is a little complicated, so we’ll take it one step at a time.

Section 582 of the FD&C Act requires manufacturers, repackagers, wholesale distributors, and dispensers to exchange transaction information, transaction history, and a transaction statement — known collectively as “T3 information” — for transactions involving certain prescription drugs.

Section 581 of the FD&C Act requires transaction statements to include a statement that the entity transferring ownership — wholesale distributors in this case — had systems and processes in place to comply with verification requirements under Section 582.

Now, “prior to November 27, 2023, [the] FDA does not intend to take action against” wholesale distributors whose transaction statements do not include the statement required under Section 581. See pp. 7–8 of today’s announcement for full details about this change.

Distributors: product identifiers for suspect/illegitimate products

Distributors have also received a 3-year reprieve concerning requirements for product identifiers. The FDA said it did “not intend to take action against” dispensers that did not verify the statutorily designated portion of product identifiers of suspect or illegitimate product before November 27, 2023.” Section 582 of the FD&C Act stipulates how dispensers must investigate suspect and illegitimate products.

Final thoughts

If you’re a wholesale distributor or dispenser and have questions about these changes to the saleable returns verification requirement — or anything else about the DSCSA — we can help. rfxcel is the industry thought leader in DSCSA compliance, including the Verification Router Service (VRS), and we are ready to help you make the most of this extra time.

Contact us today and our supply chain experts will show you how our award-winning rfxcel Traceability System will fully prepare you for the DSCSA. We’ll answer your questions, address your concerns, and customize a solution that will ensure you’re compliant. The extra breathing room is nice, but the time to act is now.

DSCSA 2020: November Is Coming & It’s Time to Comply

Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid.  You can call any VRS provider to verify if a PI is valid, but if they do not manage the PI in question, they will automatically route your verification request to the provider that does. All of this happens in real time, and VRS ensures that information is accurate and up to date.

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.

The L1-L5 Solution Providers, Explained

Jargon. For better or for worse, it’s a fact of life — more so for people like us who work in the highly technical field of supply chain management. From ANSI to XML, an alphabet soup of shop talk can rain down upon us without warning, often leaving us scratching our heads (or at least searching online). L1-L5 solution provider? What does that mean?

And if we say rfxcel is an L4 and L5 solution provider, what does that mean? With as little jargon as possible, let’s find out. (Hint: It has nothing to do with alleviating back pain.)

What does the “L” stand for in L1-L5 solution provider?

The “L” in “L1-L5 solution provider” stands for “level,” as in the level of serialization in a supply chain. To put a finer point on it, it means the level of serialization and information management in a supply chain. And if you hadn’t guessed, there are five levels:

  • Level 1: Device
  • Level 2: Packaging
  • Level 3: Site
  • Level 4: Enterprise
  • Level 5: Network

The list above progresses from the smallest or most localized level, the L1 device level, to the most expansive and all-encompassing level, the L5 network level. Generally, L1, L2, and L3 are grouped together because they’re happening where products are created and packaged; L4 and L5 are paired together in the realm where those products enter the greater supply chain to make their way to their final destinations.

When talking about L1-L5, let’s work backwards from largest to smallest. This way, we can “zoom in on” the details and put everything in a more vivid context.

Level 5: Network

L5 is where rfxcel has its roots and where we built our reputation for supply chain excellence. The network level is where all serialization and regulatory data is managed, including with your trading partners, regulatory authorities and their repositories, and customers. It ensures you’re communicating with partners and complying with regulations.

Level 4: Enterprise

rfxcel’s roots also run deep in L4, which manages and verifies all your serialization and regulatory data/compliance reporting before sending it to L5. It also generates your serial numbers and manages all your business processes. When you design your solutions for L1, L2, and L3, you must decide how they will integrate with your L4 solution.

Level 3: Site

This is where we enter your actual manufacturing facilities and processes. L3 manages the line systems (i.e., L2) at your site to ensure that they are working optimally. L3 is optional; if present, it serves as the “middle man” between L4 and L2, requesting serial numbers from the former and allocating them to the latter.  L3 will also verify the L2 data before it is submitted to L4.

Level 2: Packaging

L2 systems control the L1 hardware and manage the serial numbers which are printed and applied on packages by L1 devices. L2 systems will communicate with the L4 (or L3,f present) to send/receive serial numbers as needed.

Level 1: Device

L1 comprises devices on a packaging line that enable serial numbers to be affixed to packaging and products, such as barcode printers, label printers, and labelers. It also includes cameras and scanners used for quality control, such as visual inspections of products and labeling.

rfxcel is an L4 and L5 solution provider that integrates with L2 and L3

As we said above, we’ve built a reputation for excellence for L4 and L5, the enterprise and network levels. This is our business: Creating innovative software solutions that optimize key supply chain requirements and functions — from the nuts and bolts of serialization and regulatory compliance to environmental monitoring and data analytics — and bring true end-to-end track and trace capabilities to any supply chain.

Our solutions ensure you’re communicating with all your trading partners, all regulatory bodies and their repositories, and your customers. We’ll help keep your lines running smoothly. We’ll yield rich, actionable data that you can use to improve your operations, connect with your customers, and build consumer trust and brand reputation.

We create one uniform, harmonized supply chain that takes care of everything from unit-level serialization and global compliance network needs to closing the last mile all the way to the person buying your product.

Final thoughts

All levels are important. They rely on one another to make things work. When you’re planning a serialization solution, you have to think very carefully about how they’ll interact and communicate.

rfxcel makes sure your data is accurate, travels quickly between and among levels, and meets the requirements of your partners and government authorities — no matter what systems you have in place now or will get in the future. Interconnectivity and interoperability are the cornerstones of all our implementations.

If you have questions about L1-L5, are looking to build a solution, or are considering switching solution providers, contact us today to talk with one of our supply chain experts and see what our award-winning rfxcel Traceability System can do.

DSCSA Saleable Returns Verification Requirement: Just the Facts

Note: On October 23, 2020, the FDA delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The Drug Supply Chain Security Act (DSCSA) is transforming every aspect of the U.S. pharmaceutical supply chain. The law has many parts, but today we’re focusing on the DSCSA saleable returns verification requirement, one of its key mandates. Let’s jump right in.

First, what is the DSCSA?

The DSCSA went into effect on November 27, 2013. It is actually Title II of the Drug Quality and Security Act (DQSA) and calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies).

The goal of the DSCSA is to facilitate product tracing in the pharmaceutical supply chain and, ultimately, promote patient and consumer safety and ensure the authenticity of products. Non-compliance is “prohibited … and subject to enforcement action under the [Federal Food, Drug, and Cosmetic Act].” In a nutshell, if you’re out of compliance, you’re out of business.

What is the DSCSA saleable returns verification requirement?

Millions of pharmaceutical products are returned for resale every year in the United States. These are known as “saleable returns.” Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. In other words, every returned drug has to be vetted — declared as safe and legitimate — before it can be sold again. This is accomplished by verifying the drug’s PI, which has four components: a Global Trade Item Number (GTIN), a unique serial number, a lot ID, and an expiration date.

The DSCSA saleable returns verification requirement for distributors was originally scheduled to take effect on November 27, 2019; however, as we discussed in a previous blog post, the FDA in late September 2019 announced that it did “not intend to take action against” wholesalers that did not meet the requirement before November 27, 2020. This 1-year postponement gave pharma supply chain stakeholders more time to prepare to comply.

Of course, November 27, 2020, is only a few months away. Are you going to be ready? More on that below.

How does the DSCSA saleable returns requirement work?

The easiest way to understand the DSCSA saleable returns requirement is to think of the U.S. pharma supply chain as having only two members: wholesalers and manufacturers. And the law requires them to talk with one another about returned drugs. Here’s what we mean.

To meet the DSCSA saleable returns verification requirement, a wholesaler must initiate a verification request (to a manufacturer) to verify the returned products before it can resell them. The manufacturer that receives that request must provide a verification response within 24 hours. This is why wholesalers are called requestors and manufacturers are called responders.

The 24-hour deadline, however, doesn’t meet business realities. Why? Because, as we mentioned above, millions and millions of drugs are returned every year. The volume is just too great. Therefore, wholesalers need manufacturers to provide verification responses almost instantaneously — at the sub-second level, not in a few minutes, let alone an entire day.

Enter the Verification Router Service (VRS).

The VRS and the DSCSA saleable returns verification requirement

VRS is a huge topic, and to get into the details is outside the scope of what we’re talking about today. Put simply, the VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement.

The Healthcare Distribution Alliance (HDA) is the driving force behind the VRS, which facilitates the “talk” between wholesalers (requestors) and manufacturers (responders) to verify every drug. Here, a third member joins the DSCSA saleable returns “family”: A solution provider that enables the verification requests to be routed between wholesalers and manufacturers.

The VRS is an automated service that verifies if a PI is valid. There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid. A wholesaler can call any VRS provider to verify if a PI is valid. If a provider does not manage that particular PI, it will automatically route the verification request to the appropriate provider. All of this happens in real time, and the VRS ensures that information is accurate and up to date.

Final thoughts

rfxcel is the industry thought leader in the DSCSA saleable returns verification requirement and the VRS. Not only did we extend testing of VRS, we implemented a VRS pilot program for the Food and Drug Administration. We’re applying our expertise in supply chain track and trace, serialization, and compliance solutions to help the pharma industry prepare for November.

And we can help you too. Contact us today to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the DSCSA saleable returns verification requirement — and meet all your other supply chain needs.

CONTACT US TO SEE THE VRS SOLUTION AND FDA TEST RESULTS:


India Pharma News: FDA Recalls, COVID-19 Vaccine & Ideas Summit 2020

The last time we checked in on the India pharma supply chain, the country had announced restrictions on the export of active pharmaceutical ingredients and medicines, launched its national iVEDA portal for drug authentication and track and trace, and changed a deadline for regulations concerning drug exports.

There have been some India pharma headlines in the last week or two, so let’s do a summer roundup.

FDA Recall of India Pharma Products

The U.S. Food and Drug Administration (FDA) and the Indian government work together on pharma supply chain issues. From January 28–30, 2020, for example, a joint action called Operation Broadsword prevented approximately 500 shipments of illegal and unapproved prescription drugs and medical devices from reaching U.S. consumers.

Now, two Indian pharma companies are voluntarily recalling lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis revealed they could contain nitrosodimethylamine (NDMA), a known carcinogen, above the acceptable limit. The recall affects both 500mg and 1000mg tablets. Metformin is commonly used to treat type 2 diabetes. A complete list of all metformin products being recalled is available on the FDA website.

There are two other FDA recalls affecting Indian pharma companies. About 1,500 bottles of Clozapine are being recalled after 50mg tablets were found in bottles of 100mg tablets, and one lot of Aripiprazole tablets are being recalled because bottles labeled as containing 30 2mg tablets actually contain 100 5mg tablets. Clozapine is used to treat mood/mental disorders and Aripiprazole is used to treat schizophrenia and bipolar disorder.

India pharma company anticipates COVID-19 vaccine early next year

The chairman of Ahmedabad-based Zydus Cadila says he expects phase 1 and phase 2 studies of its novel coronavirus vaccine to be completed in three months. It is currently testing the vaccine, ZyCoV-D, for safety and efficacy. It will be compared with placebo.

As reported in the Hindu Times, Chairman Pankaj Patel said the vaccine could be ready in “about seven or a little more than seven months … provided the data is encouraging and the vaccine is proven to be effective during the trials.” He said Cadila might be able to produce up to 100 million doses a year.

Zydus Cadila is also planning to produce remdesivir, which is being used worldwide to treat COVID-19. Patel the company could produce up to 400,000 doses of the medicine in the first month after it wins regulatory approval to manufacture it in India.

India Ideas Summit 2020

The United States India Business Council (USIBC) is holding its 45th annual meeting next week. Together with the U.S. Chamber of Commerce, it will host the Ideas Summit, also an annual event, from July 21-22. It will be a virtual gathering, naturally.

This year’s theme is “Building a Better Future.” Looking to a “post-COVID world,” diplomats, scholars, senior business executives, think tanks, and other thought leaders will discuss topics ranging from geopolitics and equitable growth to the future of healthcare and digitization and technology trends.

They will also focus on global supply chains. This month, the USIBC released a white paper entitled “Positioning India to Capture Global Supply Chains & Grow Economic Opportunity.” The 22-page paper is of interest to anyone who follows supply chains and recognizes India’s position in global markets. It touches on the work of the USIBC Task Force on Supply Chain Standards and Practices and how the country is working to attract new supply chains. Read the white paper here.

Final thoughts

India will undoubtedly continue to cultivate its position in the global pharmaceutical industry. It’s actively modernizing its supply chain. For example, in April it replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal.

We’ve worked in the India pharma market for many years and understand its complexities, challenges, and benefits. Our signature rfxcel Traceability System (rTS) and rfxcel Compliance Management (rCM) solution have helped our customers keep up with India’s regulations and remain competitive.

Contact us today to see how we can maximize your impact in India.

rfxcel Continues Winning Streak in Russian Serialization, Track and Trace

Once again, Russia’s Center for Research in Perspective Technologies (CRPT) has named rfxcel an official partner, this time for software and integration for dairy, bottled water, footwear, wheelchairs, tires, perfumes, bicycles, and light industry. We’re pretty excited about this. We had already been named an official software, integration, and tested solutions partner for medications. Our team in Moscow has worked hard to make us the leader in Russian serialization and track and trace for all industries; you should contact them if you have any questions about doing business in Russia.

The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Our rfxcel Traceability System (rTS) works seamlessly with the system, including a Russian-language user interface that makes integration and startup much quicker.

Let’s take a quick look at what’s going on with the dairy and bottled water industries in Russia, and why we’re leading in Russian serialization and track and trace.

The CRPT and Russian Serialization/ChestnyZNAK “Experiments”

The CRPT follows best practices by conducting “experiments” — what we would call pilots — for products before the officially enter the ChestnyZNAK system. The pilot for dairy ran from July 15, 2019, to February 29, 2020; for bottled water, the pilot began April 1, 2030, and is scheduled to end March 1, 2021.

A pilot for bicycles wrapped at the end of May 2020, and a current one for wheelchairs is  expected to end June 1, 2021. Pilots for children’s goods (e.g., baby food, clothing, toys, and games) and medical devices will apparently be announced soon.

Requirements for Dairy and Bottled Water

Russia’s supply chain regulations are notoriously strict. This is one reason being named an official CRPT partner is a feather in our cap: We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the requirements and ensure companies stay compliant.

We’re currently working on some other materials about the regulations for dairy and bottled water (and tires and other products), so check back soon to see those. In the meantime, however, here’s some basic information to tide you over.

Dairy

All products must be labeled with a DataMatrix code. The code must contain the following:

  • The goods code (14 numerical digits)
  • An individual serial number (13 digits) generated by the CRPT or a company’s economic agent
  • A verification key provided by the CRPT (4 digits)

According to the language in the regulations, companies may include an expiration date (6 characters for non-perishables, 10 for perishables), but that is not mandatory.

Product packaging mush have a 15×15 mm space for the codes. If a product has a cap, such milk in a PET bottle, the material and surface texture must be able to accommodate printing (e.g., ink or laser).

Bottled water

The regulations recognize six categories of bottled water. In addition to three unexplained “other” categories, these include:

  • Waters, including natural or artificial mineral, carbonated, free from sugar or other sweetening or flavoring substances. (The regulations also mention “ice and snow” under this category.)
  • Mineral and carbonated waters, including natural mineral waters:
  • Non-carbonated waters

The DataMatrix code must contain the same information as the codes for dairy. And like dairy, companies have the option to include other information, such as an expiration date or a minimum retail price.

Final thoughts

Our success with the CRPT is due to a lot of hard work and our commitment to designing the best solutions for Russian serialization, track and trace, aggregation, and compliance.

When Chestny ZNAK was enacted into law on December 29, 2017, we began honing our operations in Russia. About this time last year, we reported that we had doubled the size of our team in Russia; since then, it’s tripled in size. We’re one of very few supply chain solution providers with active implementations in Russia, and we’re working with more and more companies as our reputation grows.

Our continued success with the CRPT, ChestnyZNAK, and Russian serialization boils down to the quality of our solutions and the knowledge and skill of our people, who have expertise in key areas of supply chain management and technology. They all speak Russian, of course, and they know the regulations inside and out. They understand how to meet our customers’ needs while ensuring they’re fully compliant with Russian serialization, aggregation, and supply chain compliance requirements.

Contact us today learn more about how rfxcel can help you with Russian serialization and the ChestnyZNAK regulations. Also, download our white papers about Russia’s requirements for consumer goods and pharmaceuticals. These are great resources that will help you understand what you need to do to succeed in Russia’s lucrative markets.

And be sure to ask about our other track and trace and compliance solutions. Sure, we’re the leader in Russian serialization, aggregation, track and trace, and supply chain compliance solutions, but we can optimize any supply chain anywhere in the world. Ask us how!

What Is Pharma Supply Chain Aggregation?

We all want to know that the medicines we buy at our pharmacy are what they say they are. This is one of the main reasons why these products are strictly tracked and monitored, including serialization and pharma supply chain aggregation. From the very first step of production, all ingredients are tracked as a medicine moves down the manufacturing chain. This means every bottle of pills that is in your medicine cabinet can be traced back to the date and time of manufacture. You can even find out who was mixing the ingredients.

This is the level of tracking many countries require by law in the pharma supply chain, and many governments have imposed strict serialization regulations over the last few years. These laws are designed to combat  counterfeits and ensure consumer safety.

Serialization has many facets, including the use of Global Trade Item Numbers (GTINs), 2D barcodes, and aggregation processes. Aggregation is a crucial component of serialization in the pharma supply chain. It helps track products from the moment they’re packaged to the time they reach consumers. Aggregation contributes to the safety and efficiency of the global pharmaceutical industry.

As more and more countries update their aggregation requirements, it’s vital to understand what this process is. Let’s take a closer look at aggregation, including how it’s defined, how it works, and the different types.

What is pharma supply chain aggregation?

Pharmaceutical products have different packaging levels, and they all need to be serialized and traced. The basic levels include the unit or single case, bundle pack, case, and pallet. Aggregation creates and maintains a so-called parent-child relationship among the packaging levels and the product owner’s information. Each data aggregate is saved in a database before a product moves to the next participant in the supply chain. Here is the basic mapping of aggregation:

  • Unit-level pack aggregations (lowest level) → bundle pack aggregation → case aggregation → pallet aggregation (highest level).

How does pharma supply chain aggregation work?

Aggregation is achieved by associating serial numbers with the different packaging levels. It also entails scanning barcodes to associate/link supply chain participants with one another.

Aggregation begins with unit-level serialization, by which serial numbers are applied to the container of medicine, such as a bottle or a blister pack. This packaging is then associated with the case its shipped in, which is also given a unique serial number. When the cases are packed on a pallet, that gets its own serial number to associate it with the cases. The parent-child relationship is complete.

Why is aggregation necessary in supply chain management?

Aggregation is a necessary to make the pharm supply chain safe and secure. It facilitates traceability and transparency, and enables efficient returns management. It also eliminates the need to scan individual units. And because it makes the pharma supply chain flow more smoothly, warehouses and storage facilities save time and money. For example, with a single scan of a  barcode, workers can decommission damaged pallets, and companies can process recalls and returns more quickly and accurately.

Final thoughts

rfxcel was founded 17 years ago because our CEO, Glenn Abood, realized that consumers didn’t have a way to verify the authenticity of the medicines they buy. Today, as the longest-tenured supply chain solutions provider in the pharma industry, we offer cutting-edge technology that makes serialization, including the aggregation process, automatic, accurate, and secure. Couple this with our industry-leading compliance solutions, and you will ensure your supply chain runs at peak performance, protects your products, and secures your brand reputation. Contact us today to learn more!

Saudi Pharma Compliance: New Aggregation Deadline & More

Things have been relatively quiet with Saudi pharma compliance. The country’s Food and Drug Authority (SFDA) established the Drug Track and Trace System (RSD) to track all human registered drugs that are manufactured in Saudi Arabia or imported. Regulations that took effect in January 2019 have changed how the Saudi drug supply chain operates.

The RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, the SFDA is working on similar requirements for medical devices and cosmetics.

The SFDA’s goal is to create a safer and more efficient pharmaceutical supply chain. To succeed in the Saudi market, companies that produce, distribute, and dispense pharmaceuticals must fully understand and comply with the regulations. Let’s take a look at what’s been happening.

New Aggregation Deadline

Aggregation has been a sticking point in the Saudi pharma compliance requirements, with many delays for enactment. Here’s a quick timeline:

  • July 2019: The SFDA published guidelines for barcodes that included details for packaging hierarchies. This included barcoding, serialization, and pallet-level aggregation.
  • August 2019: The SFDA published a reminder about an upcoming October aggregation deadline.
  • December 2019: The SFDA moved the aggregation deadline to March 31, 2020.
  • April 2020: The SFDA moved the aggregation deadline to June 30, 2020.
  • June 28, 2020: The SFDA once again moved the aggregation deadline, this time till August 20, 2020.

So, as of today, companies have a little more than a month to comply with the aggregation requirements. This means they’ll have to prepare their packaging lines, coordinate with their trading partners, and have systems that can capture and report data to the RSD.

Overview of Saudi Pharma Compliance

Here’s quick rundown of what’s required for Saudi pharma compliance.

Data Matrix barcodes

Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, a 14-digit Global Trade Identification Number (GTIN-14), a serial number, the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to the RSD, and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Saudi Drug Code

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Global Location Numbers

From March 2018, companies had to register the locations of their factories and warehouses using their Global Location Numbers (GLNs).

RSD Stakeholder Management and Operation Portals

Companies use the Stakeholder Management Portal for initial registration in the RSD. The Stakeholder Operation Portal is where companies and their stakeholders report movements of drugs inside the supply chain. This ensures that information about all shipments are reported to Saudi  authorities.

According to the SFDA website, after a company has integrated its system with the RSD, all drug movements will be recorded automatically; companies/stakeholders won’t have to log in to the Stakeholder Operation Portal manually or register transactions manually.

Final thoughts

Saudi pharma compliance is complex. Manufacturers, warehouses, and pharmacies have a lot to think about. Though the date for implementing aggregation requirements has changed a few times, you should assume the August 20 deadline will hold firm.

The time to start preparing is now. rfxcel can help you be ready for all Saudi pharma compliance requirements. Our signature rfxcel Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA requirements — or regulations in any country.

Contact us for more information. Our supply chain experts are ready to help!

Supply Chain Visibility Can Fight Fraud in the Time of COVID-19

Earlier this month, the U.S. Food and Drug Administration (FDA) posted an update about actions it’s taking to keep fraudulent COVID-19 treatments off the market. The examples of fraud the Agency gave illustrate why all industries — not just the pharmaceutical industry — need to embrace supply chain visibility. Let’s take a look at what the FDA said and why supply chain visibility is a panacea for the problem.

Consumer vulnerability, scammers, and unproven and potentially dangerous products

The FDA’s update addressed “the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.”

This statement reveals one reason fraud exists: consumer vulnerability. When people are confronted with a problem, especially one they feel they cannot control (such as a pandemic), some may tend to seek solutions without pausing to think them through. Peddlers of fake and substandard products are always ready to exploit this situation.

Which brings us to the scammers, many of whom use the internet to sell their bogus goods. Today, the FDA says, unscrupulous actors are claiming their products “mitigate, prevent, treat, diagnose, or cure COVID-19.” With the pandemic dominating headlines and weighing heavily on people’s minds, these quacks are only more than happy to offer unproven and potentially dangerous products.

What is the FDA doing, exactly?

The Agency has launched Operation Quack Hack to find and stop scammers. It’s located scores of phony products online, including fraudulent drugs, COVID-19 testing kits, and personal protective equipment. The FDA has issued 42 warning letters to companies making false COVID-19 claims and has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, most of which have voluntarily removed the offending product pages.

One of the warning letters went to an organization selling fraudulent chlorine dioxide products as a COVID-19 treatment. When it refused to cease and desist sales of its so-called Miracle Mineral Solution, or “MMS,” a federal court issued a preliminary injunction requiring it to immediately stop distributing the product. The FDA characterizes chlorine dioxide as the equivalent of industrial bleach and since 2010 has been warning consumers about MMS and other products with names such as Master Mineral Solution, Chlorine Dioxide Protocol, and Water Purification Solution (WPS).

The FDA also intercepted and investigated a case of mislabeled COVID-19 “treatment kits” that someone was trying to import into the United States. Also, an FDA investigation led to a U.S. Department of Justice criminal complaint against a British man “who sought to profit from [the] pandemic and jeopardize public health.”

How supply chain visibility can fight fraud

Visibility means using data to gain insight into how a supply chain is functioning and to take steps to make it run more efficiently. The goal is to see everything.

A company must have systems that can gather and report data from one end of the supply chain to the other. Data should be as “rich” as possible; today, that means a digital supply chain with real-time access to unit-level data about everything from ingredients to temperature.

Here’s a rundown of how supply chain visibility can fight fraud. We’re using the pharma industry in our example, but the tenets apply to any product in any industry.

    • You know the origin of your ingredients. Supply chain visibility allows a manufacturer to verify that all the ingredients of a drug are legitimate. It can track every ingredient up until the time they’re combined to make the drug.
    • You can follow the drug’s every move: Part 1. After the drug has been manufactured, bottled, and packed into cases, you can see everywhere those cases go after they leave the plant — warehouses, stores, pharmacies, hospitals, etc. — and you can track their movements in real time. With supply chain visibility, you can anticipate traffic bottlenecks and reroute the delivery vehicle, keeping the shipment on time. You’ll also know if the delivery vehicle has been diverted from its prescribed route, which could indicate theft.
    • You know if the drug has been harmed or compromised. Supply chain visibility means you’ll be alerted if there’s a problem with the shipment. For example, if there’s been a change in temperature, light, or humidity that can affect the drug’s efficacy, or if the cases have been dropped or jolted in a way that might have damaged the bottles, packets, or vials inside. And we’ve already mentioned route diversion and theft.
    • You can follow the drug’s every move: Part 2. When the cases are separated (e.g., taken off a pallet), you can follow each one; when a case is opened, supply chain visibility lets you follow the individual bottles or packets all the way to check-out at the cash register or stocking at a pharmacy or hospital.

Final thoughts

Supply chain visibility creates an “airtight” supply chain that leaves virtually no room for unproven, potentially dangerous, fake, or otherwise fraudulent products to sneak in. And if such a product does appear, supply chain visibility means you can remove it faster. After all, when you can see everything, it’s easier to spot imposters and get rid of them.

rfxcel can provide supply chain visibility in any industry. Our signature rfxcel Traceability System (rTS) is a full-stack visibility and track and trace platform that comprises solutions that empower end-to-end supply chain visibility, including:

    • rfxcel Integrated Monitoring (rIM) is an award-winning solution that uses Internet of Things (IoT)-enabled devices to provide real-time data about 12+ environmental conditions (e.g., location, temperature, shock) of products anywhere in the world.
    • rfxcel MobileTraceability brings the power of an rTS digital supply chain to your smartphone, tablet, or other mobile device.

As FDA Associate Commissioner for Regulatory Affairs Dr. Judy McMeekin said, “It is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health.” Supply chain visibility is the way to do this. Contact us today to find out how we can help you.