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Drug Supply Chain Security Act (DSCSA) Pharmacy Responsibilities

Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock continues to count down to the final compliance deadline.

On August 25, 2023, the U.S. Food and Drug Administration (FDA) 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. Read our blog post here for all the details.

If you want to ensure that your business processes comply with DSCSA pharmacy regulations, the first step is to familiarize yourself with the nuances of the law. With that in mind, 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 will culminate next year 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.

As the final link in the pharmaceutical supply chain, pharmacies are the last safeguard between suspect products and patients. They are responsible for gathering transaction information and reviewing supply chain data to verify the legitimacy of products (more on that below).

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. The DSCSA pharmacy requirements apply only to dispensers that provide medication to patients or end-users. If your pharmacy is providing medications to another dispenser or another member of the pharmaceutical supply chain, it is acting as a distributor, which means other DSCSA requirements would apply.

How to comply with the DSCSA

Compliance is mandatory if you are a dispenser under DSCSA pharmacy requirements. Failure to comply will raise flags with the FDA and open your organization to penalties, including fines.

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 only until the November 27, 2024, deadline.

Under DSCSA pharmacy requirements, you have to obtain and exchange this data for every transaction. The purpose of these traceability requirements is to promote drug distribution security and to identify potential discrepancies in the supply chain records. If a product cannot be traced back to a legitimate source, it is considered “suspect.”

Adhering to these transaction requirements will help pharmacies protect their consumers from illegitimate drug products. Traceability standards also help the FDA ensure that suspect prescription drugs do not enter the supply chain in the first place.

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.

If the FDA conducts a DSCSA pharmacy audit, it can examine records dating back six years. If information is missing, you will be found in violation of the DSCSA and could face substantial penalties.

Providing product traceability information is another important part of DSCSA pharmacy requirements, as pharmacies frequently send inventory to other companies within their healthcare networks. When you engage in these activities, you are acting as a distributor and must adhere to all relevant standards regarding the creation of lot numbers and product-level tracing.

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.

For now, we will provide a brief recap of what constitutes an ATP under the DSCSA guidelines. The FDA states that an authorized partner is:

  • A manufacturer or repackager that has a valid registration with the FDA
  • A wholesale distributor that has a valid license under state law
  • A third-party logistics provider (3PL) that has a valid license in accordance with state law
  • A dispenser that has a valid license in accordance with state law

The FDA defines a trading partner as:

  • An entity (i.e., manufacturer, distributor, repackager, or dispenser) that accepts director ownership of a product from a manufacturer
  • An entity that transfers direct ownership of a product
  • A 3PL that accepts or transfers products to another entity in the supply chain

In other words, an ATP is an entity that is appropriately licensed and accepts or transfers direct ownership of a regulated pharmaceutical product. Before a pharmacy does business with a repackager, wholesaler, or distributor, it must verify the organization’s ATP status.

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.

Identifying illegitimate products is one of the most important roles of pharmacists under DSCSA requirements. It is also one of the most challenging tasks, as each pharmacist and pharmacy technician must be trained on how to identify illegitimate or suspect products. All pharmacies should train their employees about the DSCSA requirements (e.g., abnormalities in transaction information) and other methods to identify suspect products.

You must authenticate and verify drugs

This is what’s coming in 2024. 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.

EPCIS is a standard from GS1, an international organization responsible for creating and maintaining operational standards for key industries, including healthcare. EPCIS is a means to electronically share the “what, when, where, why, and how” information about pharmaceutical products, promoting end-to-end traceability and interoperability among supply chain actors.

Final thoughts

Navigating complex compliance requirements and adapting to new standards can present challenges. Fortunately, you have options — like partnering with rfxcel to help you meet DSCSA pharmacy requirements.

Even though the enforcement deadline has been extended until November 2024, the time to act is now. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA pharmacy compliance solutions, which include robust traceability tools, data management solutions, and more. As an rfxcel partner, you’ll tap into the expertise of our DSCSA pharmacy compliance experts, who will collaborate with you to design a solution to ensure you meet all DSCSA requirements and remain compliant forever.

We also invite you to download our DSCSA compliance 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. Also bookmark our DSCSA compliance library, which has all our resources about the law.

Dairy Traceability in 2021: The FDA, the Industry, and the Future

It’s June, and it’s definitely ice cream season! It was 96°F (35°C) at our headquarters in Reno, Nevada, yesterday. Naturally, when we think of ice cream, we think about dairy traceability. Dairy traceability ensures consumer safety and keeps vital supply chains moving.

Most of our readers can probably assume that their food was manufactured, processed, transported, and stored safely and in accordance with quality standards and safety regulations. But the World Health Organization estimates that 600 million people are sickened from contaminated food products every year — and as many as 420,000 die. Dairy products are among the biggest culprits, as they can carry pathogens that cause foodborne illnesses.

The implications are significant. And they illustrate why dairy traceability is so important. Let’s take a look at where we are with dairy traceability in 2021.

Dairy traceability: the industry perspective

Dairy traceability has been on the industry’s radar for quite some time. For example, the Innovation Center for U.S. Dairy has been an advocate since at least 2009, when its Globalization Report noted that traceability was, in so many words, the future of the dairy supply chain.

In 2013, the Center published Guidance for Dairy Product Enhanced Traceability. Now in its third iteration (July 2020), it addresses much of what the FDA wants, including establishing and maintaining records with key data elements (KDEs) associated with critical tracking events (CTEs). There’s also a 21-point Dairy Traceability Checklist that manufacturers can use to evaluate if they follow enhanced dairy traceability best practices.

Last, the Center created the U.S. Dairy Traceability Commitment, “designed by processors, for processors, to increase global competitiveness, help satisfy future requirements of the Food Safety Modernization Act (FSMA) and, in the rare event of a safety issue, quickly isolate products to protect public health and prevent brand damage.”

Dairy traceability: the FDA perspective

Traceability — including dairy traceability — and modernization have also been on the FDA’s radar. We’ve written about this before, so we won’t drill down into the details today. In a nutshell:

The new requirements, also known as the Food Traceability Proposed Rule, apply to many popular cheeses, including brie, camembert, feta, mozzarella, Monterey Jack, cottage cheese, ricotta, and queso fresco.

Dairy traceability in 2021

Just about a year after the FDA announced its New Era of Smarter Food Safety Blueprint and the Innovation Center for U.S. Dairy updated its Guidance for Dairy Product Enhanced Traceability, it’s clear the dairy industry and the FDA are trying to get on the same page.

Generally, the industry has been receptive to the FDA’s efforts. The International Dairy Foods Association, for example, supports the New Era of Smarter Food Safety Blueprint. Still, many in the industry say the Food Traceability Proposed Rule isn’t necessary because supply chain stakeholders have been modernizing and building traceability systems without a government mandate.

With that in mind, the International Dairy Foods Association submitted comments to the FDA asking it to revise the recordkeeping requirements, arguing that doing so would support more widespread adoption of dairy traceability across the industry, to the ultimate benefit of the public. The Association is also working with the FDA to ensure dairy manufacturers have the proper direction and tools that support more efficient food safety practices and dairy traceability protocols.

Final thoughts

This quick sketch of dairy traceability makes two things clear. First, the FDA is all-in on modernization and traceability. Second, the industry understands the need for dairy traceability and has shown its willingness to commit to maintaining a modern, traceable supply chain.

In this environment, rfxcel’s traceability solutions will help dairy companies in any market modernize their food safety protocols, facilitate end-to-end traceability in a digital supply chain, comply with evolving regulations, and maintain trust with customers. Contact us for more information about how we can help, and check back soon for more about traceability in the food supply chain.


rfxcel Ready to Help Dairy Industry Comply with Russia’s 2021 Serialization Regulations

rfxcel’s track and trace solutions ensure companies operating in Russia’s dairy market can comply with dairy serialization regulations being rolled out in 2021

Reno, Nevada (Feb. 11, 2021). rfxcel, the global leader in digital supply chain traceability solutions, today announced that it was prepared to ensure companies operating in Russia’s dairy market could comply with serialization regulations being rolled out in 2021.

Mandatory serialization of cheeses and cottage cheese and ice cream and food ice is set to begin on June 1, 2021. These are the first dairy products required to be serialized in Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Companies were allowed to begin labeling these goods as early as January 20, but the regulations will not go into full effect until June.

Furthermore, dairy products with a shelf life of more than 40 days and fewer than 40 days are required to be serialized beginning September 1 and  December 1, respectively. The regulations apply to several product categories, including milk and cream, buttermilk and fermented milk products, and dairy products for baby food.

rfxcel CEO Glenn Abood said the company had been preparing for the dairy regulations since an industry pilot was announced in 2019. “The long and short of it is that we’re always prepared to help companies in any industry navigate Russia’s strict and complex regulations,” he said. “We committed ourselves to being the leader in Chestny ZNAK compliance when the system was created a little more than four years ago, and our team in Moscow has followed its rollout, the evolution of the regulations, and the pilots for different industries, including dairy. We knew what was coming, so we’re ready to go.”

The dairy pilot ran between July 2019 and the end of 2020. During that time rfxcel earned official partner status in 10 of the 11 industries for which the Center for Research in Perspective Technologies (CRPT), which operates Chestny ZNAK, had chosen partners. It also tripled the size of its Moscow-based team and continues to be one of only a few solutions providers with active implementations in Russia.

Abood said the CRPT designations and success of the Moscow team had solidified rfxcel’s status as the leader in Russian compliance. “We’ve taken our rfxcel Traceability System, which includes solutions for serialization and compliance, into Russia and enabled companies in the pharmaceutical and consumer goods spaces meet deadlines, adapt to changes, stay compliant, and keep their supply chains moving. It’s been quite exciting, actually, and we’re looking forward to helping dairy companies have the same kind of success.”

Enacted by Federal Law No. 425-FZ on December 29, 2017, Chestny ZNAK was designed to protect consumers by keeping fake and substandard products out of the market. As envisioned, by 2024 it will transform the Russian supply chain and affect virtually every industry, from pharmaceuticals to baby food.

To learn more about rfxcel’s operations in Russia and its solutions for dairy, pharma, consumer goods, and other industries, contact Vice President of Marketing and Strategic Initiatives Herb Wong at hwong@rfxcel.com and visit rfxcel.com.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

Russia Dairy Serialization Update: Mandatory Labeling for Cheese and Ice Cream

Some important updates to Russia dairy serialization were made public on January 13, 2021. The regulations pertain to cheese and ice cream products, as well as products with certain shelf lives.

Supply chain laws governing the country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, have been continually tweaked and refined since it was created a little more than three years ago. Let’s take a look at what’s new for the dairy industry.

New rules for Russia dairy serialization

The Russia dairy serialization regulations were put forth in Decree No. 2099 of December 15, 2020; they will go into effect for different products at different times.

The first products to fall under mandatory labeling are cheeses, ice cream, and other edible ice. Companies can begin labeling these goods and transferring data to the Government Information System for Marking (GIS MT), which catalogs all marked goods, as early as January 20, 2021, but they must be registered with Chestny ZNAK to do so.

Mandatory labeling begins for these cheese and ice cream products on June1, 2021. Only serialized products are allowed to be sold after this date. However, products produced or imported into Russia before June 1 may be sold until the product’s expiration date.

Deadlines for cheese and ice cream stakeholders

The Russia dairy serialization regulations for cheese and ice cream products apply to manufacturers, importers, wholesalers, and retailers. Here are the key dates:

  • June 1, 2021: Manufacturers and importers must begin labeling and transferring product data to GIS MIT.
  • December 1, 2021: All stakeholders must transmit information about the retail sale of goods to Chestny ZNAK. (This occurs via point-of-sale cash registers connected to the internet.)
  • September 1, 2022: Using Universal Transfer Documents (UTDs), stakeholders must transmit information on the turnover of goods (including wholesale sales) and the withdrawal of goods.
  • December 1, 2023: Unit-level serialization of products with a shelf life of more than 40 days begins. Each product’s unique identification code must be indicated in the UTD.

Labeling of other dairy products with a shelf life of more than/less than 40 days

Manufacturers, importers, wholesalers, and retailers must comply with the Russia dairy serialization regulations for these products, which include the following:

  1. Milk and cream
  2. Buttermilk, fermented milk products (e.g., curdled milk and cream, yogurt, kefir (a fermented milk drink)
  3. Butter and other fats and oils made from milk, milk pastes
  4. Milk whey and other dairy products not included in other groups
  5. Dairy products for baby food
  6. Drinks containing milk fats

Mandatory labeling of products with a shelf life of more than 40 days begins on September 1, 2021. Products with a shelf life of less than 40 days must be labeled beginning December 1, 2021. Only serialized products may be sold after these dates. However, products produced or imported into Russia before these dates may be sold until the product’s expiration date.

Furthermore, for both categories:

  • December 1, 2021: All stakeholders must transmit information about the retail sale of goods to Chestny ZNAK. (This occurs via point-of-sale cash registers connected to the internet.)
  • September 1, 2022: Using Universal Transfer Documents (UTDs), stakeholders must transmit information on the sale and withdrawal of goods.

And for products with a shelf life of more than 40 days:

  • December 1, 2023: Unit-level serialization Each product’s unique identification code must be indicated in the UTD.

Mandatory labeling will not apply to the following products:

  1. Baby food for children under 3 and specialized dietary therapeutic and preventive food
  2. Products packed in a non-industrial manner/method in retail organizations
  3. Products with a net weight of 30 grams or less
  4. Products produced or imported into Russia as advertising/marketing samples not intended for sale
  5. Products to be exported outside the EAEU
  6. Products for sale in duty-free shops
  7. Products being stored by manufacturers (i.e., not intended for distribution)
  8. Products acquired under a transaction, information about which constitutes a state secret

Final thoughts

As the leader in Russia dairy serialization solutions, rfxcel knows the regulations can be a challenge to decipher. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the requirements.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia dairy serialization is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia dairy serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia dairy serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia dairy serialization and Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures companies in any industry remain compliant with the complex regulations.