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Uzbekistan ASL BELGISI Update: Deadline for Pharma Serialization Extended

Posted on by rfxadmin

On February 7, 2022 — just 10 days after we posted our Uzbekistan ASL BELGISI update — the country’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” of pharmaceutical products.

The requirements were originally scheduled to take effect on February 1.

The extension was announced in a letter signed by Mubin Mirzaev, the first deputy chairman of the State Tax Committee. A new deadline was not stipulated, so the country’s serialization scheme for pharmaceuticals is effectively on hold until further notice. The letter did not mention 2022 deadlines for other regulated product categories (e.g., tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; and water and soft drinks).

Delay or not, we expect the serialization and labeling requirements, which are based on Russia’s Chestny ZNAK system, to remain the same. Read our Uzbekistan ASL BELGISI update for more details about the regulations.

More provisions for Uzbekistan ASL BELGISI from the State Tax Committee

Deputy Chairman Mirzaev’s letter outlined two provisions:

      • A provision to instruct the State Tax Committee and CRPT Turon, which operates Uzbekistan ASL BELGISI, to submit proposals to the country’s Cabinet of Ministers for a system to recognize marking codes from other countries, “primarily markings applied [in] the territory of the Russian Federation.”
      • A provision to “implement a mechanism for electronic registration of non-resident foreign manufacturers of pharmaceutical products with the tax authorities.” Manufacturers would be assigned a non-resident taxpayer identification number (TIN) and would have to obtain a non-resident electronic digital signature (EDS).

The letter also said that the “norms for amending the Technical Regulations for the production of pharmaceutical products were transferred from the project for labeling ‘household appliances’ to the project for mandatory digital labeling of pharmaceutical products.”

As we wrote in our Uzbekistan ASL BELGISI update, a pilot for appliances began on July 1, 2021, and 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.

Final thoughts

The Uzbekistan ASL BELGISI delay illustrates a truth about supply chain regulations: Deadlines change. All the time. Announcements like the one we talked about today should never come as a surprise or catch you off guard.

The good news is that deadline changes are not the end of the world. What’s important is for you to have a supply chain solution that meets established standards, such as the world-leading GS1 standard. If your solution is fast, flexible, scalable, and automated — like our Traceability System — you will be ready to comply and keep your supply chain moving. All the time.

We’ll continue to monitor Uzbekistan ASL BELGISI as we do with other supply chain regulations. In just the last two weeks or so, we’ve written about the Africa supply chain (first of a two-part series), Egypt’s pharmaceutical regulations, Russia Chestny ZNAK requirements for beer and dietary supplements, the United Arab Emirates’ “Tatmeen” platform, and the U.S. Drug Supply Chain Security Act (DSCSA). Count on us to keep you informed about regulations around the world.

And contact us if you have any questions or want to see our solutions in action. Our digital supply chain experts are always here to listen to you, help you evaluate your needs, and work directly with you to design a solution customized for your business.

UAE Pharmaceutical Products Traceability Requirements for 2022: “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: Our DSCSA Resources in One Place

Posted on by rfxadmin

Welcome to the rfxcel DSCSA Compliance Library. It’s a collection of our DSCSA resources (as of September 2022). As we move toward the November 2023 deadline, we thought it would be a good idea to make this information available in one convenient location.

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. Rest assured that the contents of the rfxcel DSCSA Compliance Library are up to date.

If you want to see how we’ve followed the evolution of the DSCSA in our blog or track down other news we shared over the years, look around our “Resources” page. You’ll probably find some other things that interest you too.

­­Our top DSCSA webinars
The DSCSA in our blog
DSCSA compliance white papers + global compliance resources
Our top DSCSA news items
The DSCSA timeline

DSCSA 2023 Serialization Timeline

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

Posted on by rfxadmin

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.

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

Posted on by rfxadmin

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

The Drug Supply Chain Security Act (DSCSA) represents the most significant change to pharmaceutical distribution and manufacturing processes in decades.
When the act was originally passed, DSCSA implementation was supposed to occur at a much faster pace. However, the FDA had to push back the deadline on two separate occasions, as manufacturers and distributors simply weren’t ready to adapt to the changes.

We’ve written extensively about the legislation, which was passed on November 27, 2013. But with the deadline for full compliance quickly approaching, we thought a quick overview was in order. So let’s answer the question, What is the Drug Supply Chain Security Act?

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.”

The law has been rolled out in phases since it was passed nearly 10 years ago. Implementation culminates on November 27, 2023, at which time the U.S. pharmaceutical supply chain will be fully serialized.

DSCSA Compliance

In the buildup to the rollout of DSCSA’s final layer of regulations, the FDA has partnered with numerous industry leaders to discuss various aspects of the Drug Supply Chain Security Act.

These discussions cover DSCSA compliance topics, technical requirements, and mechanisms for requesting information from pharmaceutical manufacturers. Stakeholder experiences during the implementation process are also considered.

Additionally, the FDA published another round of DSCSA guidance documents in March of 2023. These documents provide concrete definitions for terms like “illegitimate product” and “suspect product,” along with other key information.

Pharmacies, healthcare organizations, and other members of the pharmacological supply chain can use these definitions to analyze the authenticity of drug products and protect consumers.

You can find more information about DSCSA 2023 implementation and overall readiness by visiting the FDA’s website.

Key Requirements of the Drug Supply Chain Security Act

Formerly known as the Drug Quality and Security Act (DQSA), the DSCSA sets forth sweeping labeling and tracing requirements for the pharmaceutical industry.

By providing comprehensive FDA guidance, the act facilitates the accurate tracing of products from the point of production to distribution to health systems and beyond. However, product tracing is only a single component of the DSCSA.

When structuring the act, the FDA grouped DSCSA requirements into the following categories:

1. Product identification/serialization

A unique product identifier (PI), such as a bar code, must be placed on certain prescription drug packages.

2. Product tracing

Stakeholders must provide information about a drug and who handled it each time it’s sold. This includes transaction information (TI), a transaction statement (TS), and a transaction history (TH), collectively known as “T3” information. Read our “Dispensers and DSCSA 2023” white paper for more about T3 information.

While all aspects of the DSCSA are important, its product tracing provisions will likely have the most significant impact on the pharmaceutical supply chain. Pharmacists, dispensers, distributors, and all other members of the supply network can leverage traceability data to ensure product authenticity and protect consumers from the dangers of counterfeits.

3. Product verification

Stakeholders must establish systems and processes to verify PIs for certain prescription drugs packages. The Verification Router Service (VRS) enables a rapid, secure exchange of data to do this. See more about VRS below.

4. 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.

5. Licensing

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

Looking Forward: DSCA 2023

The FDA has delayed the rollout of the DSCSA two times, giving the industry extra time to prepare. However, an FDA official recently said there will be no more delays. November 27, 2023, is a done deal.

In terms of what’s next, take a look at our “DSCSA 2023: The Future of Pharmaceutical Traceability in the United States” blog post. This gets into the granular details of the transformation that’s going to happen in 2023, but here are the basics of what to expect:

Serialization

Serialization relies on product identifiers (the “PIs” we mentioned above), which include serial numbers and expiration dates. For 2023, all transaction information (the “TI” we mentioned above) must include the PI. TI includes the following:

  • The product name
  • The product’s strength and dosage form
  • The product’s National Drug Code
  • The container size and number of containers
  • The lot number
  • The transaction date
  • The shipment date
  • The name and address of the businesses from which and to which ownership is being transferred

Authorized trading partners

Put simply, the DSCSA says that if you’re not an authorized trading partner (ATP), your access to the U.S. pharma supply chain will be severely restricted or denied altogether. All manufacturers, wholesale distributors, repackagers, third-party logistics providers, and dispensers and their trading partners must be ATPs. Learn more about ATPs in our DSCSA Authorized Trading Partners guide.

Verifying drugs

The DSCSA’s saleable returns verification requirement stipulates that wholesalers must verify all returned drugs before they can be reintroduced to the supply chain. This is done by verifying a drug’s PI. A wholesaler must initiate a verification request to the drug’s manufacturer, then the manufacturer must provide a verification response within 24 hours. The Verification Router Service — the VRS — is what enables the rapid, secure exchange of data between these parties. 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.

Final thoughts

What is the Drug Supply Chain Security Act? The DSCSA makes pharma stakeholders responsible for securing 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.

A fully serialized pharma supply chain is just two years away. It’s important to use this time to get your systems in place. We have almost 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 and want to see a short demo of our solutions — or just want to know more about your responsibilities — contact us today. Our DSCSA experts will work directly with you to design a solution that meets your specific needs, no matter your role in the supply chain.

In the meantime, you can hear directly from our experts in our “Plan for DSCSA Readiness” webinar and our DSCSA 2023 webinar series. These are great resources to help you better understand the law.

Drug Supply Chain Security Act Pharmacy Responsibilities

Posted on by rfxadmin

Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock is ticking to be ready for the November 27, 2023, deadline. Let’s do a quick recap for pharmacies.

What is the U.S. Drug Supply Chain Security Act?

The U.S. Drug Supply Chain Security Act, enacted on November 27, 2013, establishes a system to track and trace prescription drugs in a fully serialized supply chain. It calls for end-to-end traceability and electronic interoperability to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. supply chain.

So far, the DSCSA has mostly focused on lot-level traceability — exchanging information about every package of medication so stakeholders can see exactly where it has been. Enactment culminates in November 2023, with complete unit-level serialization of the U.S. drug supply chain. This means stakeholders will have to electronically track products at the individual package level.

Drug Supply Chain Security Act pharmacy responsibilities: definitions

Pharmacies are referred to as “dispensers” in the DSCSA. The legislation defines a dispenser as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”

If you dispense only products to be used in animals, you are not a dispenser under the DSCSA.

How to comply with the DSCSA

As we said above, the Drug Supply Chain Security Act pharmacy responsibilities are complex. Let’s break them down into easy-to-understand pieces.

You must exchange information about every drug you buy and who handled it each time it changes ownership in the United States.

The DSCSA calls this “product tracing information,” and it has three components, collectively referred to as “T3 information”:

  1. Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form)
  2. Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership.
  3. Transaction history (TH), an electronic statement with the TI for every transaction going back to the manufacturer. TH is required until the November 27, 2023, deadline.
You must receive, store, and provide product tracing documentation

You can accept prescription drugs only if they have proper tracing information, and you must store the information for six years. You must also generate and provide all information when you sell a prescription drug to a trading partner.

You can only do business with authorized trading partners (ATPs)

And speaking of trading partners, if you can’t confirm your they’re licensed or registered, you can’t do business with them. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series for all the details.

You must investigate and properly handle suspect and illegitimate drugs

Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution — the problem the DSCSA was designed to eliminate. Pharmacies must quarantine and investigate these drugs to determine if they are fake. If you make this determination, the next step is to work with the manufacturer and take specific action to ensure the bad drug does not reach patients/consumers. You must also notify the FDA and your trading partners about the drug.

You must authenticate and verify drugs

This is what’s coming in 2023. You’ll have to be able to authenticate and verify all the medicines you buy before you can sell them. The fundamental requirement is that TI (transaction information) must include a product identifier (PI), which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) is likely to be the standard the industry will use to enable this exchange.

Final Thoughts

We’re writing this on November 24, 2021. Yes, it’s the day before Thanksgiving. (Happy Thanksgiving!) It’s also almost exactly two years from the DSCSA implementation deadline. That may seem like a long time, but …

It is definitely not a long time. There’s a lot to do to ensure you’ll comply with your Drug Supply Chain Security Act pharmacy responsibilities. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA solutions. Our team of supply chain experts will design a solution to ensure you meet all DSCSA requirements and remain compliant forever.

And if you’re looking for something to read over the Thanksgiving holiday, download our “Dispensers and DSCSA 2023” white paper. It drills down into what we talked about today and is a great reference tool to have on hand as you prepare for the full serialization of the U.S. pharma supply chain.

Happy Thanksgiving!

What Are the Two Parts of the Drug Quality and Security Act?

Posted on by rfxadmin

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013, to address gaps and oversights in the way compound medications — medications that are customized by combining, mixing, or altering two or more drugs to meet the needs of a specific patient — are prepared and distributed. It was a response to the inadvertent distribution of contaminated steroidal injections that killed 64 people and caused infections in 793 patients.

The DQSA comprises two pieces of legislation: The Compounding Quality Act and the Drug Supply Chain Security Act (DSCSA). Here’s a quick overview of each.

DQSA Part 1: The Compounding Quality Act

The goal of the Compounding Quality Act is to make compounded medicines safer for patients.  It established a registration system for pharmaceutical industry stakeholders that create sterile drugs (e.g., manufacturers and pharmacies). It also reinstated Section 503A of the Food, Drug, and Cosmetic Act (FD&C Act), parts of which the Supreme Court in 2002 ruled unconstitutional.

Companies can register as an official outsourcing facility if they meet a specific set of criteria. Outsourcing facilities are usually larger companies that supply compounds to healthcare facilities such as pharmacies, hospitals, and clinics. The key requirements for outsourcing facilities under the Compounding Quality Act include the following:

  • They must report adverse events to the FDA twice a year.
  • They must submit reports about all compounded medications to the FDA twice a year
  • They must meet product labeling requirements.
  • They must agree to FDA inspections (according to a “risk-based schedule” and pay fees for any re-inspections.
  • They must pay a registration fee to the FDA.

Outsourcing facilities are also subject to increased quality standards and can be penalized for certain actions, including intentionally falsifying prescriptions for compounded medicines, failing to report adverse events or compounded medications to the FDA, making false claims about compounded medicines (i.e., false advertising), and selling medications with “not for resale” warnings.

All this said, it’s important to note that the FDA does not approve compounded drugs. The Agency does not verify their safety or effectiveness. Furthermore, compounded drugs do not have an FDA finding of manufacturing quality before they are marketed.

DQSA Part 2: The Drug Supply Chain Security Act

The DSCSA is a wide-ranging piece of legislation designed to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. pharmaceutical supply chain. It affects virtually every industry stakeholder, from manufacturers, distributors, and wholesalers to repackagers, logistics providers, and dispensers (i.e., pharmacies). It is

Enacted in November 2013 and culminating with the November 2023 deadline, the ultimate goal of the DSCSA is a fully serialized pharmaceutical supply chain with full electronic operability. There are four core requirements:

  1. Product serialization
  2. Product tracing
  3. Verification (of product identifiers)
  4. Authorized trading partners

If you follow our blog, you know we’ve been writing about the DSCSA for years. For a longer summary, check out “Countdown to DSCSA 2023 Serialization: The Deadline Is Two Years Away.” For an in-depth look at what’s in store for 2023, read “DSCSA 2023: The Future of Pharmaceutical Traceability in the USA.”

Final thoughts

rfxcel has been the leading provider of regulatory and compliance software for the pharmaceutical industry for almost 20 years. We’ve also been a thought leader on the DQSA and DSCSA compliance. Our goal is to keep all stakeholders informed and work with them to ensure they’re ready to meet all the requirements in 2023.

Below are a few of our most recent resources to help bring you up to speed. Take a look, and if you have any questions or want to see a short demo of our DQSA and DSCSA solutions, contact us today. Our supply chain experts know the legislation inside and out and will work with you to design a solution that’s right for you.

Countdown to DSCSA 2023 Serialization: The Deadline Is Just Two Years Away

Posted on by rfxadmin

November 27, 2023 — the date the pharmaceutical industry has had its sights on since the U.S. Drug Supply Chain Security Act (DSCSA) was enacted eight years ago. With only two years until the deadline, we thought it was a good time to recap what’s in store for DSCSA 2023 serialization.

The DSCSA Timeline

As our timeline shows, November 27, 2023, will be the 10th anniversary of the DSCSA. Per Section 582(g)(1) of the DSCSA (Title II of the Drug Quality and Security Act), “On the date that is 10 years after the date of enactment of the Drug Supply Chain Security Act … interoperable, electronic tracing of product at the package level requirements shall go into effect.” In other words, DSCSA 2023 serialization.

DSCSA 2023 Serialization Timeline

DSCSA 2023 serialization: recent developments

No more delays. On August 9, 2021, the FDA signaled that the DSCSA 2023 deadline for interoperability would not change. Leigh Verbois, the director of the FDA’s Office of Drug Security, Integrity, and Response, made the comments during a webinar hosted by the Healthcare Distribution Alliance (HDA).

Draft and final guidance on product identifiers (PIs) and more. On June 3, 2021, the FDA published “new guidance to further enhance the security of prescription drugs in the U.S. supply chain.” Guidance was released for PIs, suspect and illegitimate products, and enhanced drug distribution security.

Full serialization

For DSCSA 2023 serialization, transaction information (TI) must include the PI, which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) appears to be the standard the industry will use to enable this exchange. Right now, TI and transaction statements (TS) are being electronically exchanged at the lot level, which is usually done with an advance ship notice (ASN). The transition from ASN to EPCIS is a cornerstone of DSCSA 2023 serialization.

Authorized trading partners

Under the DSCSA, authorized trading partners (ATPs) may engage in transactions only with other ATPs. In other words, all manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers and their trading partners must be ATPs. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series here.

Verification Router Service (VRS)

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI. A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products, and the manufacturer must provide a verification response within 24 hours. The VRS enables the rapid, secure exchange of data between these parties. Get more details here.

Final thoughts

We have been talking about and reporting on the DSCSA Day 1. We’ve been active in industry initiatives, particularly the VRS and the Open Credentialing Initiative (OCI) to meet ATP requirements. We’re ensuring the Ohio Department of Veterans Affairs is DSCSA-compliant. And we’ll soon be announcing another exciting initiative in the move toward full serialization of the U.S. pharma supply chain. Keep an eye out for that.

This year, we hosted a “Plan for DSCSA Readiness” webinar in March and a DSCSA 2023 webinar series in June that covered ATPs, EPCIS, and the VRS. We also published a “Dispensers and DSCSA 2023” white paper in May.

We’ve also been helping pharma companies and public-sector organizations comply with the DSCSA and other pharma regulations around the world. From our Serialization Processing and Compliance Management solutions to the full-scale power of our Traceability System, we ensure compliance no matter your role in the supply chain.

Take another look at our DSCSA timeline. A lot has happened since 2013 — and the pace will only intensify over the next two years. Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help and make sure you’re ready for 2023

 

FDA Official Says DSCSA 2023 Interoperability Deadline Will Not Change

Posted on by rfxadmin

The Food and Drug Administration (FDA) appears to be digging in its heels and insisting pharma stakeholders be ready to comply with interoperability requirements by November 27, 2023, the deadline mandated in the U.S. Drug Supply Chain Security Act (DSCSA).

Leigh Verbois, director of FDA’s Office of Drug Security, Integrity, and Response, indicated there would be no delays during a Healthcare Distribution Alliance (HDA) webinar on August 9.

As reported by Regulatory Focus, Verbois said, “It is FDA’s goal that we not extend the November deadline for interoperability … We have been working at a full tilt to make sure that we can make our goal of an interoperable system by 2023.”

Verbois also said that the FDA was continuing to develop a framework for interoperability, adding that the Agency knew there were “a number of important issues” to address and that regulators had been “working to understand the interplay between the elements that are necessary to build a system.”

Director Verbois’ comments at the HDA webinar come just two months after the FDA published draft and final guidance on key aspects of the DSCSA: product identifiers, suspect and illegitimate products, and enhanced drug distribution security.

  1. Product Identifiers under the Drug Supply Chain Security Act: Questions and Answers (final guidance)
  2. Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification Guidance for Industry (final guidance)
  3. Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry (revised draft guidance)
  4. Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (new draft guidance)

What are the DSCSA interoperability requirements?

The DSCSA requires pharma supply chain trading partners to exchange transaction information (TI) “in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”

Trading partners must provide TI and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” TI must “include the product identifier at the package level for each package included in the transaction.”

What’s changing in 2023?

Right now, TI and TS are being electronically exchanged at the lot-level, which is usually done with an advance ship notice (ASN).

In 2023, however, TI must include the product identifier, which includes serial numbers and expiration dates. This means the U.S. pharmaceutical supply chain will be fully serialized, and the Electronic Product Code Information Services (EPCIS) appears to be the standard the industry will use to enable this exchange.

The transition from ASN to EPCIS is one of the “four pillars” of the regulations that we talked about in our three-part DSCSA 2023 webinar series in June, which you can view and download here. We also hosted a “Plan for DSCSA Readiness” webinar in March that you can view here.

DSCSA 2023 Four Pillars

Final thoughts

As we reported in our blog, the FDA has twice delayed enforcement of the DSCSA Saleable Returns Requirement. Now, the table seems to be set for November 2023: No more delays, no more extensions.

The pace will only intensify. In just about two years, you’ll have to be up and running in a fully serialized U.S. pharmaceutical supply chain. Now, the question we’ve been asking for so long is even more critical: Will you be ready?

In terms of interoperability, ask yourself these questions:

  • Can you send and receive serialized data?
  • Can you send and receive aggregated data?
  • Do you have procedures and training in place to support serialized data exchange?

Contact us today if you need to know more. Our supply chain and DSCSA experts are here to help.

 

 

 

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