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Egypt Pharmaceutical Supply Chain: News and Regulations

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If you follow our blog (and we know you do), you’ve probably detected a theme over the last few days: global pharma compliance. We’ve written about Russia Chestny ZNAK, United Arab Emirates Tatmeen, Uzbekistan ASL BELGISI, and our rfxcel DSCSA Compliance Library. Today, we’re looking at the Egypt pharmaceutical supply chain. Let’s get started.

Notable news about the Egypt pharmaceutical supply chain

Last August, Egyptian Prime Minister Mostafa Madbouli told a gathering of government officials that the country would prioritize the “localization” of the pharma industry. He said President Abdel Fattah al-Sisi had tasked the government with developing an executive plan to this end.

It seems to be working: the Egypt pharmaceutical supply chain is enjoying strong growth. Last month, Egyptian Drug Authority (EDA) Director Dr. Tamer Essam said the country’s pharma exports had risen to 35 percent, an all-time high. “There is no medicine in the world or vaccine that is not manufactured in Egypt,” he said. In February 2021, the EDA announced it was launching an export subsidy initiative and had begun reviewing and updating all export procedures to ensure they complied with global regulatory requirements.

In April 2021, the head of the General Division of Drug Traders at the Federation of Egyptian Chambers of Commerce (FEDCOC), Ali Auf, said Egypt produced about 85 percent of its pharmaceutical needs domestically (and imported only 15 percent).

Auf made these statements two days after President Sisi inaugurated Gypto Pharma City, which embodies Egypt’s drive for pharmaceutical self-sufficiency. Situated on roughly 44.5 acres in Khanka, about 20 miles from Cairo, it’s one of the largest “medicine cities” in the region. It has facilities for production, administration, industrial services, and networks.

Egypt envisions Gypto Pharma City as a regional hub for the international pharmaceutical and vaccine industries, calling it “one of the most important national projects … with the aim of possessing the modern technological and industrial capacity in this vital field.”

The Egyptian Pharmaceutical Track & Trace System

The goal of the Egyptian Pharmaceutical Track & Trace System (EPTTS) is end-to-end traceability and product authentication across the Egypt pharmaceutical supply chain to reduce counterfeits, increase efficiency, and protect consumers. Appropriately, this dovetails into what the government has said about Gypto Pharma City — that it will “help citizens obtain high-quality and safe pharmacological treatment, end monopolistic practices, and control the prices of medicines.”

At first, the Ministry of Health and Population managed EPTTS; however, Law No. 151 of August 2019 essentially transferred those duties to the newly formed EDA. (It also created another organization, the Egyptian Authority for Unified Drug Procurement, a “centralized procurement and supply interface.”) The EDA was initially affiliated to the prime minister, but Presidential Decree 18/2020 of January 2020 gave it more autonomy.

The EDA “inherited” three organizations from the Ministry of Health and Population:

    • The Central Administration of Pharmaceutical Affairs (CAPA) registers pharma products, issues licenses for the establishment of pharma entities, and licenses the import and export of pharma products. It’s also responsible for regulating prices and evaluating clinical trials and studies of drugs.
    • The National Organization for Drug Control and Research (NODCAR) works to ensure the quality, safety, and effectiveness of pharma products, cosmetics, and insecticides. NODCAR must certify every pharmaceutical product before it can be registered, marketed, advertised, distributed, imported, or exported.
    • The National Organization for Research and Control of Biologicals (NORCB) monitors, inspects, and releases all biological products for human or animal use, such as vaccines.

Like most countries, the Egypt pharmaceutical supply chain follows GS1 labeling standards, characterized by Global Trade Item Numbers (GTINs), Serialized Global Trade Item Numbers (SGTINs), 2D DataMatrix codes, GS1-128 barcodes, serial shipping container codes (SSCCs), and Global Location Numbers (GLNs). It is also using GS1’s Electronic Product Code Information Services (EPCIS) standard.

Secondary packaging must be marked with a 2D DataMatrix code with the GTIN, expiry date, batch number, and a randomized serial number. EPTTS’ original plan was to require these data points to be presented in a specific sequence, but this was nixed. Cases and pallets must have a GS1-128 barcode or a DataMatrix code with the SSCC.

EPTTS requires aggregation, including maintaining the parent-child relationship, but has yet to provide details. We’re also waiting for specifics about some aspects of serialization, including if serial numbers can be reused.

For data and compliance reporting, supply chain actors are required to submit data to a GS1 Global Data Synchronization Network (GDSN) database. They must upload photos — as many as six of them — that clearly show the product packaging and other details, including the GTIN, brand name, storage instructions, country of origin, product name, and any warning statement. To date, however, the government hasn’t published specifications for communicating with the EPTTS database.

A pilot to test EPTTS was held from December 1, 2019, to January 12, 2020. Participants have shared feedback, but there hasn’t been much movement since. GS1 Egypt and the EDA are apparently still working on the implementation guidelines, which are now in their third iteration.

Final thoughts

The Egypt pharmaceutical supply chain regulations are a work in progress, and we’ll continue to follow developments and share updates when there’s concrete news.

But as we said in our overview of UAE Tatmeen, the global push for pharmaceutical traceability and serialization is continuing at a furious pace. If you’re a manufacturer, a distributor, a third-party logistics provider, a dispenser — any actor in the supply chain — waiting for Egypt or any other country to formalize their regulations is not a wise strategy. You have to have a solution now, preferably one that will work in every country.

That’s what our Traceability System does. Our supply chain experts can demonstrate in a few minutes how it automates compliance and optimizes just about every other aspect of your operations. Contact us today to see it in action. And continue following our blog. We’ll be writing more about global pharma regulations in the coming weeks (and months and years).  For example:

UAE Pharmaceutical Traceability: Ensuring Transparency with the “Tatmeen” Platform

Posted on by rfxadmin

The global push for pharmaceutical traceability and serialization continues at a furious pace. Today, we’re looking at the United Arab Emirates (UAE), whose Ministry of Health and Prevention (MOHAP) in June 2021 announced the “Tatmeen” platform for UAE pharmaceutical products traceability. There are key deadlines this year, so let’s take a look.

UAE Pharmaceutical Products Traceability and the Tatmeen System

MOHAP established Tatmeen, which means “assurance” in Arabic, in Ministerial Decree No. 73 on June 14, 2021. Described as a “central command center,” it’s a GS1-based platform for UAE pharmaceutical products traceability. MOHAP’s partners include the Dubai Health Authority (DHA), Department of Health (Abu Dhabi), and EVOTEQ, a “digital transformation catalyst” based in the UAE, and GS1 UAE.

Tatmeen’s goals should sound familiar:

    • Fight counterfeits and illegal and substandard medications
    • Eliminate unauthorized imports
    • Improve recall management
    • Ensure expired and about-to-expire drugs don’t reach consumers
    • Forecast demand and avoid shortages
    • Move drugs where they’re needed quickly and safely
    • Protect pharma companies, including their intellectual property rights

These other aspects should also sound familiar:

    • Products are scanned at every node of the supply chain
    • Product information is reported into to a central repository (in this case GS1’s BrandSync platform)
    • Scanning captures and verifies data in real time and reports information into a central database
    • Hospitals and pharmacies scan when drugs arrive at their facility and when they’re dispensed
    • Patients and consumers can scan with mobile devices to validate products, report expired products, fakes, and suspected gray market activity

Tatmeen will integrate with the DHA’s electronic medical record system, Salama (incorrectly identified as “Salam” in some industry sources). It will also utilize DHA’s Tarmeez, a paperless drug and medical supplies management system that gives authorized users access to a centralized electronic catalog of all available inventory.

Tatmeen labeling and reporting requirements

All conventional medicines sold, distributed, or stored in the UAE are regulated and must be serialized. These products are exempt:

    • Free samples
    • Products imported for personal use only
    • Medical devices and supplies
    • General sales list (GSL) products

And —surprise, surprise — UAE pharmaceutical products traceability requirements should sound familiar. Secondary packaging must contain four data points in a GS1 DataMatrix code and in human-readable form:

    1. Global Trade Item Number (GTIN)
    2. Randomized serial number (up to 20 characters)
    3. Expiry date (in YYMMDD format)
    4. Batch or lot number

This example is adapted from the MOHAP’s serialization guide:

UAE DataMatrix Code

Aggregation requirements should also ring a bell: All logistic units must be aggregated and labeled with a GS1-128 barcode encoded with a serial shipping container code (SSCC). Manufacturers are responsible for aggregation.

If a brand owner regards an item as a trade item, “it may additionally be identified with a GTIN.” Distributors, wholesalers, and health facilities that unpack and re-pack products to deliver to points of dispensing are required to aggregate the logistic units using their own SSCC codes.

Marketing authorization holders (MAHs), brand owners, manufacturers, or their subsidiaries must register and upload the mandated product master data into the BrandSync platform.

Domestic and foreign manufacturers, third-party logistics providers, batch releasers, contract manufacturing organizations, distributors, licensing agents, and MAHs are responsible for collecting serialized product item traceability records and reporting them to Tatmeen.

UAE pharmaceutical products traceability rollout and 2022 deadline

There was a 6-month “status adjustment” period after Tatmeen was announced for manufacturers and marketing authorization holders to register with the BrandSync platform and begin using 2D DataMatrix codes. This deadline passed on December 13, 2021.

The next major deadline is December 13, 2022. By that date, all supply chain actors in the UAE must obtain a Global Location Number (GLN) from GS1 UAE to identify their organization, where it’s located, and other required information. Relevant stakeholders must also begin reporting serial numbers to Tatmeen and begin aggregation with GS1-128 barcodes and SSCCs.

Final thoughts

We noted a few times that parts of the Tatmeen regulations should sound familiar. If you follow our blog and read our articles about pharmaceutical regulations in other countries — DSCSA in the United States, Chestny ZNAK in Russia, ANVISA in Brazil, ASL BELGISI in Uzbekistan, and so on — everything about UAE pharmaceutical products traceability should ring a bell.

As we said right at the start today, the global push for pharmaceutical traceability and serialization continues at a furious pace. Requirements may vary from country to country, but their essence is the same (e.g., protecting consumers, serialization, traceability, electronic reporting, central repositories, GS1 standards). Tatmeen is just one more example in a very large regulatory ocean.

It’s easy to feel swept up in this current. And, truth be told, if you’re not complying now or preparing to comply by published deadlines, you’re putting your business in jeopardy. If you have questions about Tatmeen or complying with pharmaceutical serialization and traceability regulations in any country, contact us today. In just a few minutes, our supply chain specialists can demonstrate how our award-winning Traceability System ensures you’re compliant in any country, today, tomorrow — always.

For even more information, check out our Global Compliance Page, download our Worldwide Pharmaceutical Compliance Requirements white paper, and catch up on other pharma news in our blog:

DSCSA Compliance Library: Comprehensive DSCSA Information in One Location

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Welcome to the rfxcel DSCSA Compliance Library. It’s a collection of our key DSCSA resources (as of September 2023) and is a convenient place to get information as the industry navigates the “extended stabilization period” until FDA enforcement begins on November 27, 2024.

We will, of course, continue writing about the DSCSA and providing the best supply chain solutions to ensure manufacturers, wholesalers, dispensers, repackagers, third-party logistics providers — all pharmaceutical stakeholders — meet the requirements and remain compliant forever.

So bookmark this page and our blog. You can also subscribe to our newsletter to make sure you don’t miss anything about the DSCSA and other important developments in the pharma industry. Just fill out the short form at the bottom of any page on our website.

And of course, contact us today with your questions about the DSCSA or anything else about the pharma supply chain. Our experts are here to help.

A note about the rfxcel DSCSA Compliance Library

Please note that that we haven’t included everything we’ve written or presented about the DSCSA. Deadlines and requirements have changed since the law was enacted in November 2013, so some of our earlier pieces are, logically, outdated.

The DSCSA in our blog

DSCSA compliance white papers

Our top DSCSA news items

­­Our top DSCSA webinars

The DSCSA timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

Uzbekistan Traceability: Advancing Supply Chain Transparency and Safety

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Note about Uzbekistan traceability: On February 7, 2022 — just 10 days after we posted this article — Uzbekistan’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” for pharmaceutical products. The February 1 deadline is longer in effect for this product category. Read the details here.

 

On February 1, 2022, Uzbekistan traceability requirements for medicines and medical devices will go into effect. It’s the latest compliance deadline in the country’s push for serialization and digital marking regulations that will affect an array of industries. Here’s a breakdown of the law and the latest Uzbekistan traceability updates.

The Uzbekistan Traceability System: ASL BELGISI

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

On November 20, 2020, the Uzbekistan government published Decree PKM-737, “Establishment of Obligatory Digital Labeling.” It mandates serialization for tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks.

Furthermore, it requires supply chain participants to register with a national catalog of labeled goods; when an application is approved, the participant receives an account and is granted access to the system.

According to the CRPT Turon website, the “main task” of ASL BELGISI “is to guarantee consumers the authenticity and declared quality of the purchased products.” Like Chestny ZNAK, consumers can download a mobile app to scan products, report suspect products, and provide feedback about the system.

Marking requirements

Uzbekistan traceability requirements mirror those mandated in Chestny ZNAK. All domestically produced and imported goods must be marked with DataMatrix codes that are traced across the supply chain through a four-step process:

    1. CPRT Turon assigns a unique DataMatrix code to each product and the manufacturer or importer places it on the packaging.
    2. The product’s movements are traced throughout the supply chain, from the factory or point of importation to the consumer, via scanning of the DataMatrix code.
    3. Retailers scan the codes when products are stocked and sold.
    4. Consumers can use the ASL BELGISI app to check a product’s legitimacy (i.e., confirm that it’s not a counterfeit) and access product information.

To get DataMatrix codes, participants must be registered with ASL BELGISI, describe the goods in a national catalog of labeled goods, then formally order the codes and apply them to the products. The codes must be applied to packaging or a product label according to the ISO/IEC 16022-2008 “Automatic identification and data capture techniques – Data Matrix bar code symbology” specification. At present, each DataMatrix code costs 68 som (excluding VAT), which is quite literally a fraction of a U.S. dollar: $0.0063.

Like its Russian counterpart, ASL BELGISI uses “verification keys” and “verification codes.” These are also commonly known as crypto codes. CRPT Turon generates these codes.

Generally, the DataMatrix codes for products in every regulated industry must include four data points:

    • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
    • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
    • A four-character verification key generated by CRPT Turon
    • A 44-character verification code generated by CRPT Turon

For aggregation, a Serial Shipping Container Code (SSCC) number must be provided in a one-dimensional barcode following the ISO 15394:2009 “Packaging – Barcode and two-dimensional symbols for shipping, transport and receiving labels” specification.

Regulated industries and key dates/requirements

Uzbekistan traceability regulations currently apply to five product categories: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks. Below, we list the latest information about each category.

Filter cigarettes

    • January 1, 2021: only labeled products may be produced and imported
    • July 1, 2021: manufacturers may ship only labeled products to wholesalers
    • October 1, 2021: distributors may ship only labeled products to retailers
    • January 1, 2022: sale of unmarked cigarettes is prohibited
    • October 1, 2022: mandatory labeling for all types of tobacco products

Alcohol

    • January 1, 2021: only labeled products, including wine and wine products, may be produced and imported
    • December 1, 2021: alcoholic beverages packaged in metal containers, including aluminum containers, must be labeled
    • December 1, 2021: aggregation required for alcoholic beverages, including wine and wine products
    • November 1, 2022: aggregation required for alcoholic beverages packaged in metal containers, including aluminum containers

Beer and brewing products

Mandatory labeling began on April 1, 2021.

Appliances

A pilot for appliances began on July 1, 2021. Mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Medicines and medical devices

    • June 1, 2021: 6-month pilot for medicines and medical devices begins
    • January 28, 2022: CRPT Turon announces that the pilot is officially closed
    • February 1, 2022: only labeled products may be produced and imported

CRPT Turon reported that, during the pilot, all participants successfully registered with ASL BELGISI and registered agreed-upon product in the national catalog of labeled goods. They also successfully installed marking equipment on production lines, trained employees to use the equipment, and released batches of properly labeled, serialized products.

More about the requirements for medicines and medical devices

In addition to a DataMatrix code that includes a 14-digit product code (i.e., GTIN), a 13-character randomized serial number, a 4-character verification key, and a 44-character verification code, packaging must have a human-readable GTIN, lot number, expiration date, manufacturing date, and serial number.

Digital marking must be applied directly to packaging on the production line in a “specially designated place” and not be larger than 10×10 millimeters. The codes must be affixed in a way that prevents them from being separated from packaging during the entire shelf life of the product. Codes may not be printed on external packaging material, including transparent film/wraps, and my not be obscured by other information.

Water and soft drinks

This product category includes bottled water, soft drinks, and fruit and vegetable juices.

    • June 1, 2021: pilot for water and soft drinks begins
    • March 1, 2022: only labeled products may be produced and imported

Final thoughts

In June 2021, CRPT Turon announced that it had issued more than 350 million codes, including more than 200 million for tobacco products, almost 130 million for alcohol products, and approximately 20 million for beer products.

As of today (January 28, 2022), it reports that it has issued nearly 583 million codes for tobacco products, more than 300 million for alcohol products, almost 143 million for beer products.

These figures illustrate a simple fact: Strict serialization and traceability regulations are here to stay in Uzbekistan. Russia has led the way with Chestny ZNAK, which arguably has the world’s toughest supply chain requirements, and we should watch the regulatory landscape in the other Newly Independent States (NIS) — Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Ukraine.

As we said above, ASL BELGISI, the Uzbekistan traceability system, mirrors Russia’s Chestny ZNAK. rfxcel is an undisputed leader in Chestny ZNAK compliance. Consider these facts:

  • We’re an official CRPT partner for medications, bottled drinking water, tobacco, footwear, tires, light industry, perfumes, dairy, bicycles, and wheelchairs.
  • We’ve demonstrated to the CRPT that our solutions for traceability and compliance meet its stringent requirements.
  • We’re accredited as an IT company by Russia’s Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia (e.g., major global consumer goods and pharmaceutical companies).
  • We have an ever-growing Moscow-based team that knows the regulations and brings expertise in key areas of supply chain management and technology.
  • We’ve led the way in thought leadership with white papers and industry updates and information. (See the list below for a sample.)

We’ve also developed end-to-end traceability and compliance hubs for governments that want to lock down their supply chains with the best digital technologies and solutions. Read more about those here and here.

Contact us today to learn more about our traceability and compliance solutions. Our digital supply chain experts will share a short demo of our award-winning Traceability System and show you how to remain compliant and agile no matter where you do business.

A sample of our Chestny ZNAK coverage:

 

Who Investigates Counterfeit Cosmetics Products?

Posted on by rfxadmin

In our last blog post, we talked about the global problem of counterfeit cosmetics. Today, we’re talking about who investigates counterfeit cosmetics products, starting with how cosmetics are regulated in the United States and the EU.

Regulation of cosmetics products varies greatly from country to country, so our discussion today should not be taken as an overview of what to expect everywhere cosmetics are sold. Enforcement of laws and the actions authorities take to target counterfeits also vary.

What is universal, however, is that the cosmetics industry faces unique challenges with consumer safety, increased consumer demand for transparency, and being targeted by counterfeiters. It’s good to know who investigates counterfeit cosmetics products and what measures you can take to be part of the solution.

Who investigates counterfeit cosmetics products: USA and EU

Counterfeit cosmetics are dangerous because the criminals who make them don’t follow regulations or standards for production. Fakes are often contaminated with “stuff” you really don’t want to think about, let alone put on your face, such as bacteria, animal and human feces, arsenic, and mercury. So, regulators keep an eye on cosmetics.

United States

In the United States, the Food and Drug Administration (FDA) is the governing body for cosmetic regulations. Cosmetics products do not require FDA approval — but they are regulated. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) explain the FDA’s requirements, restrictions, and disciplinary actions regarding cosmetics.

The FDA focuses on preventing adulteration and misbranding, mislabeling, and harmful ingredients or drugs. Adulteration refers to products or product ingredients that are not in line with FDA regulations or that have been contaminated. A misbranded product is “improperly labelled or deceptively packaged,” which could include counterfeit cosmetics products. The FDA prohibits 11 chemicals from being used in cosmetics products.

Additionally, the FDA reserves the authority to request recalls and work with the Department of Justice, Federal Bureau of Investigation (FBI), and Border Customs if any violations are found. It maintains a “Cosmetics Recalls & Alerts” page and has a searchable “Enforcement Report” database of recalled products.

The European Union

Cosmetics products manufactured in and imported to Europe are regulated under the EU Cosmetic Regulation. Like the FDA, the EU regulates ingredients and labeling; generally, however, the regulations are broader and more precisely defined.

For example, more than 1,300 substances (e.g., chemicals, colorants, and preservatives) are banned from cosmetic use, and hundreds more are permitted only under certain conditions. The regulations also mandate Good Manufacturing Practices (GMP), whereas the FDA only suggests GMP as “guidelines for effective self-inspection.”

Furthermore, the EU requires significant product documentation. Every cosmetics company must have a “responsible person” for every product they make. This person is responsible for ensuring products are safe and comply with regulations, and must submit a cosmetics product notification through an online portal before a product can be sold.

The responsible person must also create a product information file that includes the name, description, and nature of the product; description of the manufacturing methods; statement of compliance with regulations and GMP; a product safety report; and data about animal testing, if any. They must also assemble a product safety report that contains product safety information and a product safety assessment.

Do consumers have a role?

Yes, and it begins with vigilance with prices, packaging, and product quality:

      • Prices: If the price is too good to be true or just noticeably cheaper than the last time you bought it, there’s a good chance it’s a fake.
      • Packaging: The printing might look shoddy or the colors might seem off. There might not be a barcode. There might not be packaging at all, and the products might be offered in bulk.
      • Product: If the consistency or texture seem different, it’s likely a fake

In the United States, consumers can “report suspicions concerning the manufacture or sale of counterfeit or pirated goods” to the FBI. For suspected counterfeit cosmetics products seen online, consumers can contact the FBI Internet Fraud Complaint Center. The FBI has also partnered with the National Intellectual Property Rights Coordination Center to create a tip line where consumers can report products they suspect to be fake.

In the EU, consumers are encouraged to contact their local authorities about counterfeit cosmetics products. Depending on the nature of the situation, the authorities might investigate themselves or contact the appropriate investigative body, which could include Europol. The United Kingdom has Action Fraud, an online reporting tool for fraud and cybercrime.

Consumers should also be aware of what brands are doing to combat counterfeits and consumer engagement programs that encourage people to report suspicious products.

Final thoughts

If you really want to drill down into the U.S. and EU regulations, download our “Global Cosmetics Market” white paper today. It also has a section about regulations in Singapore, plus more information about counterfeit cosmetics products.

In “Top Supply Chain Trends of 2021,” we posed some important questions companies should ask themselves as we move toward what is likely to be another challenging year for supply chains. Many of those questions, listed below, fit perfectly with what we talked about today — regulations, counterfeits, brand protection, consumer engagement.

Your supply chain is where all of these concerns converge. Which is why you should schedule a short demo of our solutions. In about 15 minutes, we can show you the basics of our Traceability System and how it transforms your supply chain into a strategic asset that will improve and protect every facet of your business.

 

  • Are you keeping up with supply chain trends?
  • Are there gaps and blind spots in your supply chain?
  • Are counterfeits a problem in your industry?
  • Are you doing everything you can to protect your brand?
  • Are you actively reaching out to your customers to bring them closer to your brand?
  • Are there compliance deadlines on the horizon?
  • Are you certain your current supply chain solutions are truly optimal?
  • Are you using your supply chain as a strategic asset?

Addressing the Concern: The Threat of Counterfeit Cosmetics

Posted on by rfxadmin

Counterfeit cosmetics have boomed during the pandemic. Not that they’ve ever not been in fashion among the criminal set. But recent research shows a renaissance, a proliferation of often dangerous fakes readily available to more people and through newer channels.

We just published a white paper about the global cosmetics market. It has a section about counterfeit cosmetics, and now we want to keep the conversation going with more information about this global problem. Here we go.

The statistics reveal “a worrying threat”

In “Global Trade in Fakes: A Worrying Threat” (June 2021), the Organisation for Economic Co-operation and Development (OECD) reported that the global value of counterfeits and pirated goods amounted to as much as $464 billion in 2019, or 2.5 percent of world trade.

Worldwide, there were “consistently” more than 130,000 customs seizures of counterfeit and pirated goods annually in 2017, 2018, and 2019. “Overall,” the report continues, “the unified database on customs seizures of IP-infringing goods includes almost half [a] million observations.”

In 2017 and 2018, counterfeit cosmetics and perfumery products accounted for about 4 percent of all customs seizures. That rose to just under 10 percent in 2019 — a considerable jump in a very short time. Furthermore, cosmetics and perfumery products were among the Top 5 products “targeted by counterfeiters” every year from 2011 to 2019. (The others were articles of leather, clothing, footwear, and watches.)

What toll do counterfeit cosmetics take on the industry’s fiscal health? One report shows that annual sales losses from counterfeiting in cosmetics and personal care products sector amounted to 4.7 billion euros, or about $5.3 billion.

Our brand protection series talks more about counterfeits. It’s a real problem that every industry, some more than others, must contend with.

Counterfeit cosmetics in a huge global market

According to a Fortune Business Insights report published in September, the cosmetics market was worth $277.67 billion in 2020. Despite an overall decline in sales during the pandemic, the market is projected to grow to $415.29 billion by 2028.

The market has responded to consumer demand for a wider variety of products, and online shopping has added an ease of access. Online shopping will drive the market and, according to industry watchers, could account for nearly 30 percent of global beauty sales by 2026.

However, the dramatic shift from in-person to online purchasing during the pandemic has emboldened criminals to churn out more and more counterfeit cosmetic products. As OECD put in its “Global Trade in Fakes” report, “Under confinement, consumers turn to online markets to [fulfill] their needs, driving significant growth in the online supply of a wide range of counterfeits.”

Research from the U.S. Department of Homeland Security supports this finding. Its “Combating Trafficking in Counterfeit and Pirated Goods” report (January 2020) noted that “Selling counterfeit and pirated goods through e-commerce platforms and related online third-party marketplaces is a highly profitable venture.”

The threat to businesses and consumers

Counterfeit cosmetic products are a real threat to manufacturers and consumers. The bogus goods mimic the original, undercutting company sales. They bypass quality control processes and regulatory oversight, which means they can contain harmful “ingredients.”

For example, in 2018 authorities in the United Kingdom recovered counterfeit cosmetics that were found to contain mercury and high levels of hydroquinone, a skin-whitening agent. UK Police have also warned consumers about fake products containing “rat droppings, human urine, and arsenic.” Police in Los Angeles found counterfeits with bacteria and animal waste.

With the surge in online orders, shipping has become important to the counterfeit industry. The OECD reported that between 2017 and 2019, 64 percent of global seizures were postal shipments and 13 percent involved express couriers. In the same period, 77 percent of all counterfeits seized by authorities were discovered during the shipping period.

Final thoughts

Counterfeit cosmetics — counterfeit anything — threaten consumer safety and brand reputations.

Your supply chain is your first line of defense. With the right solution for end-to-end traceability, like our rfxcel Traceability System, you can leverage data and lock down your supply chain guard to against counterfeits and help mitigate other risks.

You’ll also be able to meet consumer demand for transparency. You can tell them with certainty that your products are what you say they are. You’ll ensure product safety and protect your brand.

If you have questions, we can help. Take a look at our solutions for brand protection and download our white paper about the global cosmetics market. And contact us today to arrange a short demo of our Traceability System. In about 15 minutes, our supply chain experts can show how our solutions will turn your supply chain into your most valuable strategic asset.

Top Supply Chain Trends of 2021

Posted on by rfxadmin

The supply chain has been grabbing headlines since the pandemic began, but this year was especially newsworthy. From flotilla-like bottlenecks at major U.S. ports to warnings about counterfeit toys in Santa’s sleigh, it’s been a challenging time for supply chain stakeholders and consumers alike. So, as the year winds down, we thought we’d take a look at some of the top supply chain trends of 2021.

The year’s supply chain trends

Before we start, please note that this isn’t a ranked list or a “countdown” to the No. 1 supply chain trend of the year. It’s just a collection of trends that have occurred in different industries and that have made industry news as we’ve worked our way through the year. That said, without further ado, here are the top supply chain trends of 2021.

Automation

Automation includes robotics, machine learning, artificial intelligence, process mining, drones, and driverless delivery systems. This trend dates back to the first half of 2019, when companies in North America spent $869 million on more than 16,000 robots. This year, the World Robotics 2021 Industrial Robots report said there were 3 million industrial robots operating in factories globally, a record number and an increase of 10 percent. The report also said sales of new robots grew 0.5 percent, with 384,000 units shipped globally in 2020.

Blockchain

Blockchain has been a buzzword for years, and worldwide spending on the technology has been predicted to reach more than $11 billion by 2022. In regard to supply chain management, blockchain has great potential for traceability because it allows the provenance of any product to be easily demonstrated with and supported by immutable, tamper-proof data. It’s a big topic, so download our “Blockchain-Based Supply Chain Traceability” white paper to learn more.

Sustainability

There’s been a barrage of research about supply chain sustainability, particularly consumers’ expectations for transparency and environmentally friendly products and packaging. In one recent survey, 83 percent of respondents said it was “important or extremely important” for companies to design environmentally conscious products. Another found that 81 percent of shoppers say transparency is important or extremely important to them. In short, more companies are choosing to make their supply greener and more transparent.

Consumer engagement/customer experience

Consumer engagement and customer experience have always had a place in marketing and branding, but they’ve risen to a priority position over the last several years. (See a tidy summary of why here.) But what does your supply chain have to do with any of this?

The short answer: Your supply chain is a gold mine of information that can be leveraged for robust, innovative engagement/experience strategies. The basic building block is serialization. Read our two-part series to learn more. And definitely read our article about how supply chain traceability is building a “consumer kingdom.”

“The Trifecta”: Traceability, Visibility, Transparency

It should come as no surprise that we’re including these three “must-haves” on our list of the top supply chain trends in 2021. We’ve always maintained that visibility, transparency, and traceability are the key to a successful supply chain; however, the last two years have shown us that this trifecta is more important than ever and is the best way to optimize, safeguard, and leverage your supply chain for business value.

Visibility means using data to gain insight into how your supply chain is functioning and to take steps to make it run more efficiently. The goal is to see every ingredient/input, every product, every partner, every handoff … everything. Transparency means communicating supply chain knowledge internally and externally so all stakeholders, including consumers, can see how you operate. Traceability means you can follow a product to its point of origin and prove what it is and where it came from.

We have written extensively on these topics. Here’s a suggested reading list:

Internet of Things (IoT)

IoT is a network of physical objects that connects to the internet via sensors and software. It’s the basis of our Integrated Monitoring solution. It enables greater visibility and flexibility across your entire supply chain. For example, IoT-enabled sensors placed in a shipment of vaccines will send a real-time alert if a problem arises, such as a temperature excursion or route diversion. We’ve written about IoT in the food and beverage industry, and rfxcel CEO Glenn Abood wrote a great article about real-time monitoring in the pharma cold chain. We also have a great video about it.

Digitization

If we were ranking the 2021′ supply chain trends, we’d make digitization No. 1. A supply chain that isn’t digitized cannot function efficiently. It cannot give consumers what they demand. It cannot comply with regulations. It cannot compete. It cannot make your business better.

Final thoughts

As we move toward the New Year, it’s a good time to think about the future of your supply chain. Ask yourself some basic questions:

    • Are you keeping up with the trends we talked about today?
    • Are there gaps and blind spots in your supply chain?
    • Are counterfeits a problem in your industry?
    • Are you doing everything you can to protect your brand?
    • Are you actively reaching out to your customers to bring them closer to your brand?
    • Are there compliance deadlines on the horizon?
    • Are you certain your current supply chain solutions are truly optimal?
    • Are you using your supply chain as a strategic asset?

The next step is to contact us. Our digital supply chain experts can share a short demo of our award-winning Traceability System that will clearly show why it’s the best solution for any business, under any circumstances.

Antares Vision Group, Through rfxcel, Announces EPCIS Center of Excellence to Enable DSCSA Serialization Requirements by 2023

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The Center of Excellence is a dedicated group of solution providers that will work with the industry to accelerate the rollout of serialized data in advance of the November 27, 2023, DSCSA deadline.

Reno, Nevada, Dec. 7, 2021 (EINPRESSWIRE). Antares Vision Group, through rfxcel, today announced an EPCIS Center of Excellence (COE) to help pharmaceutical stakeholders prepare for upcoming serialization requirements in the U.S. Drug Supply Chain Security Act (DSCSA). rfxcel first introduced the COE at a Healthcare Distribution Alliance (HDA) Quarterly Update on September 27.

Antares Vision Group is a global leader in creating end-to-end data connection ecosystems with solutions for quality, traceability, and data management for supply chains and digital factories. rfxcel is a global leader in digital supply chain traceability solutions and regulatory compliance.

DSCSA regulations will take effect on November 27, 2023, that require every supply chain partner to share unit-level product data electronically in a secure, interoperable manner. This data will include detailed transaction information and product identifiers, which include a unique serial number. At present, EPCIS — Electronic Product Code Information Services — is the most widely recognized international standard that will allow stakeholders to meet these requirements for transaction data connections.

rfxcel will coordinate with other recognized solution providers to develop processes to accelerate the rollout of EPCIS and ensure that serialized data is exchanged properly. rfxcel CEO Glenn Abood underlined that the COE is a group effort focused on the benefit all pharmaceutical supply chain participants.

“The EPCIS COE is an industry-wide undertaking that relies on the knowledge and expertise of every member,” Abood said. “The serialization deadline is just two years away, and rfxcel is excited to announce the COE and to be working with our peers to ensure the success of the DSCSA by meeting the requirements for accurate, high-quality data.”

rfxcel will provide regular updates about the COE’s activities and progress on its website. For more information, contact Vice President of Marketing and Strategic Initiatives Herb Wong at 925-791-3235 or hwong@rfxcel.com.

About Antares Vision Group

Antares Vision Group protects products, people, profits, and our planet with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021. In March 2021, Antares Vision acquired 100 percent of rfxcel Corporation, which specializes in software solutions for digitalization and supply chain transparency.

About rfxcel

Part of Antares Vision Group, rfxcel has a long history of providing leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States.

Understanding GS1 Barcodes in the Global Supply Chain

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Where would we be without standards? One thing’s certain: Your supply chain would be a lot messier, if not chaotic if you and your partners didn’t have a “common language” to process and exchange data. Standardized GS1 barcodes are one way we avoid this chaos.

GS1 barcodes keep everybody “on the same page.” They allow companies in virtually every industry to easily record, store, and transfer data. We’ve all seen them, and chances are your organization uses them — maybe even millions or billions of them. But let’s do a quick refresher course as another way to keep us all on the same page.

What is GS1, and why does everyone use GS1 barcodes?

GS1 is an international not-for-profit organization that develops and maintains a broad set of global standards used by businesses the world over. Of the various standards created by the organization, the GS1 barcode is undoubtedly the most well-known. Everyone from Amazon to eBay follows GS1 barcode standards, as these regulations help them easily share additional information about products with consumers and retailers.

A group of U.S. grocery retailers founded GS1 in 1973. Simultaneously, they created the first barcode labels. Since its inception roughly 50 years ago, GS1 has established itself as the leading authority on product identification regulations.

While GS1 general specifications have evolved over the years, the mission behind GS1 has remained unchanged. The organization is committed to promoting operational efficiency and supporting the sharing of information. It does so by providing e-commerce businesses, distributors, manufacturers, and retailers with an easy-to-follow set of labeling standards.

In 2023, GS1 barcodes are contributing to the proliferation of the global commerce ecosystem. Standardized produce labels like barcodes transcend borders, language barriers, and currencies. They enable members of the supply chain to interact on a worldwide scale to the benefit of consumers everywhere.

Why are GS1 barcodes important?

The short answer is, as we said above, standardized GS1 barcodes allow us to maintain order and avoid chaos. Workflows become quicker and more efficient. The GS1 barcodes keep supply chains running by enabling companies to sell, ship, track, reorder, and return products, in most cases by scanning with a handheld device or a camera-based system.

GS1 barcodes also expedite communication, traceability, visibility, and transparency. It’s really all about sharing information quickly in order to know the source of ingredients/components and products, where they’ve been and where they’re going, and when they reach their final destination.

These capabilities not only make supply chains more efficient — they also increase product safety and protect consumers. If there’s a recall, for example, a company can locate its products quickly, make sure shipments are stopped, remove items from stores, and share data with regulators and even consumers.

GS1 barcodes also save money. Administrative costs come down when everybody uses the same standards and has the same expectations. And because GS1 barcodes facilitate digital supply chains, they increase speed and reduce paperwork.

The bottom line is that GS1 barcodes provide members of the supply chain with easy access to product data. In turn, distributors, carriers, and retailers use barcode graphics to trace products throughout the supply chain, optimize operational efficiency, and ensure that consumers are receiving safe and authentic products.

GSI Identification Keys

GS1 standards define a set of unique identification codes, known as identification keys. GS1 says its identification keys “refer unambiguously to a real-world entity,” such as a product, a logistics unit, a physical location, a document, a service relationship, or another entity.

In other words, the ID keys let you quickly and conveniently access information about items in your supply chain and share it with your partners. Only GS1 members can build ID keys, which must include a GS1 company prefix. There are 12 ID keys:

        1. Global Trade Item Number (GTIN): identifies products and services, such as food and clothing
        2. Global Location Number (GLN): identifies parties and locations, such as companies, warehouses, factories, and stores
        3. Serial Shipping Container Code (SSCC): identifies logistics units, such as parcels and palletized products
        4. Global Returnable Asset Identifier (GRAI): identifies returnable assets
        5. Global Individual Asset Identifier (GIAI): identifies assets, such as equipment used in manufacturing and transportation
        6. Global Service Relation Number (GSRN): identifies relationships between service providers and recipients, such as hospital staff and members of brand “loyalty” or rewards programs
        7. Global Document Type Identifier (GDTI): identifies documents, such as shipping paperwork
        8. Global Identification Number for Consignment (GINC): identifies consignments, such as logistics units being transported in a container on a ship or airplane
        9. Global Shipment Identification Number (GSIN): identifies shipments
        10. Global Coupon Number (GCN): identifies coupons
        11. Component/Part Identifier (CPID): identifies components and parts
        12. Global Model Number (GMN): identifies a product’s model number

The GS1 standards also encompass data capture, including definitions of barcode and radio-frequency identification (RFID) data carriers, that allow ID keys and other data to be affixed directly to an object. Data standards also address the hardware to read and produce barcodes (e.g., scanners and printers), and hardware and software to connect the barcodes and RFID tags to business applications.

The different types of GS1 barcodes

All GS1 barcodes are “containers” that can hold different amounts information, such as serial numbers, batch numbers, GTINs, and expiration dates. As the image below from GS1 shows, there are four types, or “families,” of barcodes: EAN/UPC, two-dimensional (2D), DataBar, and one-dimensional (1D).

GS1 barcodes

EAN/UPC family. GS1 says, rightly, that these “are printed on virtually every consumer product in the world.” They are characterized by a series of vertical lines and a horizontal row of numbers, and come in four types: UPC-A, EAN-13, UPC-E, and EAN-8.

These GS1 barcodes are designed to be used at the point of sale and can be read by omnidirectional scanners. None support attributes — they cannot contain product information such as an expiration date, a batch number, or item weight. UPC-A has 12 numbers and supports GTIN-12; EAN-13 has 13 numbers and supports GTIN-13; UPC-E has 12 numbers (the zeros are “suppressed) and supports GTIN-12; and EAN-8 has 8 numbers and supports GTIN-8.

2D barcodes. Like EAN/UPC barcodes, 2D barcodes are ubiquitous. They are incredibly robust, able to hold dense product information and remain legible at greatly reduced sizes or when they’re etched into a surface, such as a plastic bottle cap. There are two kinds of 2D barcodes:

      1. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 ID keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.
      2. GS1 QR codes are also omnidirectional and support attributes and all GS1 ID keys. They can hold 7,089 numbers or 4,296 alphanumeric characters.

DataBar family. There are seven members in the DataBar family. Generally, they’re divided into two groups: those designed for use at the point of sale (i.e., can be read by omnidirectional scanners) and those that are not.

The first group has four types: omnidirectional, stacked omnidirectional, expanded, and expanded stacked.

      • Omnidirectional and stacked omnidirectional have 14 numbers. They support GTINs and Global Coupon Numbers (GCNs) but do not support attributes.
      • Expanded and expanded stacked have a maximum capacity of 74 numeric and 41 alphabetic characters. They support GTINs and GCNs, but do support attributes.

There are three types of barcodes in the second group: truncated, limited, and stacked. These have 14 numbers and support GTINs, but do not support attributes. They are not designed for use at the point of sale, so they cannot be read by omnidirectional scanners.

1D barcodes. The two types of 1D barcodes — GS1-128 and ITF-14 — are used in retail distribution, healthcare, and logistics. GS1-128 barcodes can carry any GS1 ID key and up to 48 alphanumeric characters, including serial numbers, expiration dates, and other information that helps track products through a supply chain. More than one GS1-128 barcode can be used on a single item. ITF-14 barcodes can hold only GTINs; GS1 says it is suitable for printing on corrugated materials.

Final thoughts

This year was the 50th anniversary of the GTIN. As GS1 said, “It is no exaggeration to say that the development of the GTIN set the stage for global, digitalized commerce.” Indeed, labeling standards and barcode technologies have evolved and advanced since 1971 to the great benefit of businesses and consumers alike.

We have been talking about the advantages of end-to-end traceability in a digital supply chain for a long time. When your products, labeled with powerful identifiers such as 2D DataMatrix codes, move through a digital supply chain powered by our award-winning Traceability System, you can leverage rich, unit-level data for much more than compliance and operational efficiency: You can create genuine, tangible business value. For example:

That’s really just the beginning of what a digital supply chain can do. To learn more, contact us today to see a short demo of our solutions. Our supply chain experts will show you how our Traceability System transforms your supply into your most valuable strategic asset.

What is the Drug Supply Chain Security Act (DSCSA)?

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Today’s question: What is the Drug Supply Chain Security Act (DSCSA)?

The Drug Supply Chain Security Act (DSCSA) was passed on November 27, 2013. Envisioning a 10-year journey leading to the complete serialization of the U.S. pharma supply chain and electronic, interoperable exchange of product information, the law is scheduled to take effect on November 27, 2023.

We’ve written extensively about the legislation, but with the deadline for full compliance quickly approaching, we thought an overview was in order.

So let’s take a look at the DSCSA from top to bottom — milestones, requirements, highlights, expectations, and challenges — and answer the question, What is the Drug Supply Chain Security Act?

The Most Recent DSCSA Developments

As the timeline below shows, the FDA has adjusted DSCSA compliance deadlines during the rollout. The most recent — and arguably most significant — happened in August 2023, when the Agency announced that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

However, it’s vital that all supply chain actors understand that the original compliance deadline of November 27, 2023, still stands. The Agency has made it clear that the stabilization period is not a delay of the 2023 requirements: It expects companies to have implemented the mandated systems and work to ensure they are operating correctly, smoothly, etc.

In Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies, the FDA states:

This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.

So what’s the key takeaway: Don’t stop preparing for the DSCSA. If you have questions about the DSCSA stabilization period or are concerned that your current provider isn’t doing everything it can to set you up for success, we encourage you to contact us today to speak with one of our DSCSA experts. We are 100 percent committed to ensuring all of our customers meet DSCSA compliance.

DSCSA Timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

DSCSA at a Glance

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country. By providing comprehensive FDA guidance, the act facilitates the accurate tracing of products from the point of production to distribution to dispensation and beyond.

Understanding the Drug Supply Chain Security Act

If you’re a pharmaceutical company — a manufacturer, wholesaler, dispenser, repackager, or third-party logistics provider — you must comply with the Drug Supply Chain Security Act (DSCSA) if you want to do business in the United States.

The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” The Act “will enhance [the] FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”

As we said above, the law has been rolled out in phases since it was passed nearly 10 years ago. Even though enforcement was delayed until November 2024, the FDA expects all supply chain stakeholders to keep preparing.

Key Requirements of the Drug Supply Chain Security Act

The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. Each is important, but four are particularly vital to being ready for November 2023 because they require these stakeholders to have specific systems in place to be fully compliant. These are the “four cornerstones” of DSCSA compliance:

Product identification (serialization)

Manufacturers and repackagers must put a unique product identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically.

Product tracing

Manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about the drug and who handled it each time it’s sold:

      • Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred.
      • The transaction statement (TS) is a paper or electronic attestation by the business transferring ownership of the product that it has complied with the DSCSA.
      • A third type of information, Transaction history (TH), is an electronic statement with the TI for every transaction going back to the manufacturer. It is required before the November 27, 2023, deadline; it is not required after that date.

Verification

Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drug packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS). Like everything else in the DSCSA, we’ve written extensively about the VRS. Our “DSCSA Saleable Returns Verification Requirement: Just the Facts” article is a good place to start.

Authorized trading partners (ATPs)

All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs.

In broad terms, to be an ATP you must meet certain registration, licensing, and licensure reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and comply with state licensing requirements. The definitions of ATP also include language about accepting or transferring direct ownership or possession of products.

There are “four cornerstones” of DSCSA compliance requirements:

Other DSCSA Requirements to Consider

Detection and response + notification: Stakeholders must quarantine and promptly investigate suspect or illegitimate drugs. They must also notify the FDA and other interested parties when they find such drugs.

Licensing: Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.

Final thoughts

What is the Drug Supply Chain Security Act? The DSCSA requires pharma stakeholders to work together to secure the U.S. supply chain. It doesn’t matter if you’re a manufacturer, wholesaler, repackager, third-party logistics provider, or a dispenser — the law affects how you conduct business. Your compliance depends on making sure you can meet your responsibilities.

That’s where rfxcel comes in.

We have 20 years of experience providing the pharmaceutical industry with leading regulatory and compliance software. So if you aren’t sure if you’re going to be ready for DSCSA 2023–2024 or you’re wondering if your current solution provider is doing everything it can to prepare you for compliance, contact us today.

Our DSCSA experts can show you a short demo of our solutions, clarify what your responsibilities are, and answer questions about your needs and how to meet them, no matter your role in the supply chain.

In the meantime, check out some of our other DSCSA resources, including our DSCSA: Preparing for the Full Serialization of the U.S. Pharmaceutical Supply Chain white paper and our DSCSA 2023 webinar series. These are great resources to help you better understand the law. You can click on those links or jump right to our DSCSA Compliance Library, a clearinghouse of all our information about the law.

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