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DSCSA Saleable Returns: Enhancing Efficiency in Pharmaceutical Product Returns

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Note about DSCSA saleable returns: 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

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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

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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. 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?

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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

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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

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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.

New GS1 Guidance for Product Identifiers in the DSCSA Saleable Returns Verification Requirement

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On March 31, GS1 released new guidance concerning product identifiers (PIs) in the DSCSA Saleable Returns Verification Requirement. The 60-page document describes different scenarios for how pharma supply chain stakeholders can treat the PI status of a returned serialized product in the Verification Router Service (VRS).

Let’s take a look at what new GS1 guidance says about dealing with PIs.

The Basics of the DSCSA Saleable Returns Verification Requirement

The DSCSA Saleable Returns Verification Requirement says that wholesale distributors must verify the PIs on sealed homogeneous cases or packages before they can resell a returned product. This went into effect on November 27, 2019. However, as we reported last September, the FDA delayed enforcement by one year to allow additional time for industry readiness.

The PI contains a Global Trade Item Number (GTIN), a serial number, a lot ID, and an expiration date (for the lot).

In a nutshell, the VRS has requestors and responders. A requestor, often a wholesale distributor, sends a verification request to a responder, usually a manufacturer. The VRS routes the request to the appropriate responder for verification of the PI against its repository. The responder returns the following values:

    • Response status: Do all four components of the PI match?
    • Failure reason: If they don’t match, why?
    • Other information about the PI status: This can be used to identify concerns about the product (e.g., if it has been recalled or is suspect).

A strict interpretation of the DSCSA provides a verification “pass” or “fail” based only on matching all four PI elements. In other words, the DSCSA does not require a responder to consider the PI status as part of its verification. However, many manufacturers believe the PI status must be considered. This is why GS1 developed its new guidance for PIs in the DSCSA Saleable Returns Verification Requirement.

What the GS1 Guidance Says

The guidance describes seven scenarios for saleable return responses, summarized below. For full details, contact us and review the GS1 guidance.

SCENARIO A: The PI matches the manufacturer’s repository and there is no information to indicate that the product is unfit for distribution. The product is verified for resale.

SCENARIO B1: The PI matches. However, the manufacturer has reason to believe the product is recalled/withdrawn or expired. The product DOES pass verification for resale (based on the manufacturer’s internal policy) and the manufacturer provides “Recalled” or “Expired” as additional information in the Output Response.

SCENARIO B2: Same as B1, but the product DOES NOT pass verification for resale (based on the manufacturer’s internal policy) and the manufacturer provides “Recalled” or “Expired” as additional information in the Output Response.

SCENARIO C1: The PI matches, but the manufacturer has reason to believe the product is suspect. The product DOES NOT pass verification for resale and the manufacturer provides “Not_for_re-distribution” as a reason for the failure with “Suspect” as additional information in the Output Response.

SCENARIO C2: The PI matches, but the manufacturer has reason to believe the product is unfit for distribution. The product DOES NOT pass verification for resale and the manufacturer provides “Manufacturer_policy” as a reason for the failure without additional information in the Output Response.

SCENARIO D: The PI DOES NOT match. The product DOES NOT pass verification for resale and the manufacturer provides “No_reason_provided” as a reason for the failure.

SCENARIO E: The PI DOES NOT match. The product DOES NOT pass verification for resale. In addition to “No_reason_provided,” there are four other possible reasons the manufacturer can give for the PI mismatch in the Output Response:

    1. “No_match_GTIN_Serial”
    2. “No_match_GTIN_Serial_Lot_Expiry”
    3. “No_match_GTIN_Serial_Lot”
    4. “No_match_GTIN_Serial_Expiry”

Final thoughts

As of May 6, 2020, rfxcel is the only VRS provider to comply with the updated GS1 specifications and fully support all of its scenarios and response options. We also implemented the FDA’s VRS pilot. When you work with us, you’ll know you’re working with the industry’s foremost authority on VRS and the DSCSA Saleable Returns Verification Requirement.

Contact us today to speak with one of our supply chain experts. We can help you understand the intricacies of VRS and the DSCSA, how they might affect your business, and how to be fully prepared for compliance now and always.

FDA DSCSA Guidance Update: Transaction and Distribution Activities During COVID-19 Emergency

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On April 30, the U.S. Food and Drug Administration (FDA) issued guidance for “flexibility” pertaining to certain transaction and wholesale distribution activities under the Drug Supply Chain Security Act (DSCSA). This was a direct response to the COVID-19 public health emergency. Here’s what the FDA DSCSA guidance says.

Legal Basis for the FDA DSCSA Guidance

Public health emergencies in the United States are provided for under Section 319 of the Public Health Service Act (PHS Act). When an emergency is declared, two statutory provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) are automatically triggered:

    1. The exemption of certain product distribution activities from the definition of transaction under the FD&C Act section 581(24)
    2. The exclusion of certain product distribution activities from the definition of wholesale distribution under the FD&C Act section 503(e)(4)

What the FDA DSCSA Guidance Says

The transaction exemption and wholesale distribution exclusion provisions mean that two DSCSA requirements do not apply to some distribution activities during the COVID-19 public health emergency:

1. Distribution of “covered COVID-19 products” to address the public health emergency. The transaction exemption and wholesale distribution exclusion apply to the following:

    • The distribution of prescription drug products that have been issued an Emergency Use Authorization (EAU) by the FDA. To date, this includes hydroxychloroquine sulfate, chloroquine phosphate, and, as of today, May 1, remdesivir. An EAU designation does not mean the FDA has approved a drug for a specific use; to date, the FDA has not approved any product to treat COVID-19.
    • FDA-approved products to diagnose, cure, mitigate, treat, or prevent COVID-19. According to the FDA website, this includes in vitro diagnostic products; high complexity molecular-based laboratory developed tests; personal protective equipment and related devices; ventilators and other medical devices; and therapeutics.

The FDA says that companies involved in the distribution of covered COVID-19 products should “maintain the security of the supply chain as these products are distributed to address the urgent public health need.” If possible, companies should continue to fully comply with the DSCSA regulations if doing so isn’t “a barrier to timely distribution of covered COVID-19 products.”

2. Distribution of other products affected by the COVID-19 public health emergency. The transaction exemption and wholesale distribution exclusion also extend to the distribution of “other affected products in certain circumstances.” For COVID-19, these circumstances exist when:

    • The distribution activities are directly affected by the COVID-19 public health emergency.
    • The distribution activities are for emergency medical reasons, such as treating symptoms of COVID-19.

The FDA gives three examples of when the COVID-19 public health emergency could directly affect distribution of these other products:

    • Distribution to an area where product availability is limited and there is higher demand.
    • Distribution by an authorized trading partner that needs to establish a new, temporary facility for distribution.
    • Dispenser-to-dispenser transfers of products that are needed, regardless of whether there is a specific patient need.

3. There are a few other parameters for the FDA DSCSA Guidance: 

    • They apply only to products distributed to address the COVID-19 public health emergency.
    • They apply to products that were already in the supply chain when the COVID-19 public health emergency was first declared.
    • They do not apply to a drug shortage unless it is caused by the public health emergency.
    • They are in effect only as long as the COVID-19 public health emergency is in effect.

Final thoughts

For the record, the U.S. COVID-19 public health emergency first went into effect on January 27, 2020. A 90-day renewal took effect on April 26. And as we all know, it’s had a huge impact on people’s lives and the global economy.

rfxcel is committed to being part of the solution. We recently released our Accurate Immunization Management Solution (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain — including potential COVID-19 vaccines. We’ve joined the COVID-19 Healthcare Coalition. We are open and operating at full capacity. Contact us today if you have any questions about our supply chain visibility solutions or our work during the COVID-19 public health emergency.

 

Exploring the Latest Updates to China Pharma Regulations: Reporting, Coding & Printing

Posted on by rfxadmin

China’s pharma regulations can be confusing. However, the Chinese National Medical Products Administration (NMPA) published a set of documents last year that clarified the country’s new serialization code. Released on April 28, 2019, the documents cover regulations for pharma ranging from coding requirements to guidelines for event reporting.

These documents are a valuable resource to help understand China’s complicated regulations. For example, they state that manufacturing authorization holders must build a traceability system, which they can create themselves or through a third party. In order to trade at an item level, issuing agencies must create a serial number generation strategy to ensure one-of-a-kind traceability codes.

Let’s discuss a few critical points of the regulatory requirements for pharma in China.

Chinese Pharma Reporting

Previous Chinese pharma regulations had strict reporting guidelines. Under the new regulations, pharma companies are not required to request or receive serial numbers from a central or state-controlled source as long as the number schemes are compliant with set standards. This allows manufacturers more control over which software solutions they can use.

Companies must also exchange all the information they generate and report with their supply chain partners — who, in turn, must also report their own data to the government.

Chinese Pharmaceutical Coding Requirements

The NMPA advises that China’s drug traceability strategy should incorporate current and future manufacturing and production needs. For coding, China requires a drug traceability code, a drug identification code, and a product identification code.

The drug traceability code will identify a sales package at the unit level. The code is a combination of numbers, letters, and symbols. To be compliant, the code must include 20 characters (seven of these are the drug identification code) and adhere to ISO standards.

The drug identification code identifies the license holder, generic drug name, manufacturer, formulation, dosage form, specifications, and package specifications. The product identification code contains manufacturing data.

Chinese Printing Requirements

All printed information must be readable by the human eye. But China’s regulatory requirements do establish some guidelines for machine-readable data. Companies can choose from a 2D matrix/RFID tag or a linear bar code. This data must include:

  • Batch and serial number
  • Production date
  • Pharmaceutical form
  • Information about the manufacturing authorization holder
  • Expiry date

Our Global Pharma Compliance Software Solutions

rfxcel has been developing innovative supply chain solutions and helping pharma companies with serialization, compliance, and traceability since 2003. We’re experts in global compliance and are here to answer your questions about regulations in any country, including China. To learn more about how you can stay compliant, no matter where you do business, contact us today!

Brazil’s SNCM and ANVISA Updates

Posted on by rfxadmin

Brazil is the largest economy in Latin America. In May 2022, it will join Russia, the EU, and many other counties in mandating serialization in its pharma supply chain. Pharmaceutical companies manufacturing in or importing into Brazil are required to follow the regulations set forth in the National Medicine Control System (SNCM), as described in Law No. 13.410.

The SNCM was signed into law by the Brazilian Health Regulatory Agency (ANVISA) on December 28, 2016; it is the first step toward serialization implementation.

Here’s a rundown of the approaching Brazil serialization deadlines, the responsibilities of the Brazilian supply chain, and all the latest updates.

Original Brazil serializations deadlines

Brazil’s serialization requirements are being implemented in three stages. Stage 1 went into effect in September 2017, which marked the beginning of a 1-year pilot phase. Stage 2, lasting from September 2018 through May 2019, included a pilot review and the finalization of technical guidelines. Stage 3 was initially set for May 2019 to May 2022 and included unit-level serialization implementation.

In November 2019, reports stated there would be changes to these deadlines, which we will address later on in this piece.

Supply chain responsibilities

As of May 2022, every supply chain actor importing to or manufacturing in Brazil is responsible for capturing, storing, and exchanging important events electronically. This initiative was put into place to protect Brazil’s 190 million citizens against common problems in the drug supply chain, including counterfeit drugs and cargo theft.

The SNCM requires unit-level serialization, tracking and tracing products, and monitoring environmental conditions as products move through the supply chain. These serialization requirements state that every item must be visible at the unit level, and all products must have a list of the following specifications:

  • GS1 2D data matrix bar code that houses a Global Trade Item Number (GTIN)
  • ANVISA Medicine Registry Number
  • Unique serial number
  • Expiration date
  • Lot/batch number

Latest updates to the SNCM

As we reported in another recent blog post, updates to the SNCM were suggested in November (2019), raising concerns about compliance. The proposed changes stipulate that every pharma stakeholder should be able to serialize 25 percent of its products by October 2020 — a full 18 months earlier than the original deadline. (Other deadlines didn’t change: 50 percent by April 2021, 75 percent by September 2021, and 100 percent serialization and reporting by April 2022.)

We’re not sure what the ramifications will be — a 45-day public review is currently underway — but our Latin America team is monitoring the situation.

Final thoughts: rfxcel’s role in Brazil serialization

For 15 years, rfxcel has deployed its experience to help companies from Latin America to Russia increase supply chain visibility. We have fine-tuned our traceability software to help manufacturers operating in the Brazilian market achieve compliance.

We are prioritizing assisting Brazilian companies to prepare for the May 2022 deadline. Vinicius “Vinnie” Bagnarolli, rfxcel’s Director of Commercial Operations in Latin America, warns that even though the deadline is still far in the future, companies should start preparing for the shift now:

“SNCM requires pharma companies to do a lot of new things and adopt new behaviors. This includes implementing unit-level serialization, tracking and tracing products, and monitoring environmental conditions as they move through the supply chain. Companies will also have to submit detailed transaction data to the government. We want companies, distributors, and dispensers to know that we have the technical expertise and experience in Brazil to help them transition to SNCM. We are on the ground in Brazil; we are here to help.”

If you have questions or concerns about the SNCM or any other aspects of the pharma supply chain in Latin America, you can email Vinnie directly at vbagnarolli@rfxcel.com or contact us to set up an appointment. Also, check back for details about a webinar about these and other issues that Vinnie will host in December!

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