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DSCSA Saleable Returns: Enhancing Efficiency in Pharmaceutical Product Returns

Posted on by rfxadmin

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

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

First, what is the DSCSA?

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

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

What is the DSCSA saleable returns verification requirement?

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

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

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

How does the DSCSA saleable returns requirement work?

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

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

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

Enter the Verification Router Service (VRS).

The VRS and the DSCSA saleable returns verification requirement

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

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

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

Final thoughts

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

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

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


DSCSA: Preparing for the Full Serialization of the U.S. Pharmaceutical Supply Chain

Posted on by rfxadmin

The U.S. Drug Supply Chain Security Act (DSCSA) will fundamentally change how pharmaceutical companies do business in the United States. Though the U.S. Food and Drug Administration on August 25, 2023, announced an extended stabilization period that will be in effect until November 27, 2024, giving the industry more time to comply, the key takeaway is, Don’t stop preparing.

This paper gets into the specifics of the DSCSA and what all actors in the U.S. pharmaceutical supply chain must do to comply. If you’re a manufacturer, wholesale distributor, dispenser (i.e., pharmacy or healthcare system), repackager, or third-party logistics provider (3PL), download it today and contact us to discuss your needs for DSCSA compliance.

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

Posted on by rfxadmin

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

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

The Basics of the DSCSA Saleable Returns Verification Requirement

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

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

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

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

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

What the GS1 Guidance Says

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

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

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

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

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

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

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

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

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

Final thoughts

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

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

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

Posted on by rfxadmin

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

Legal Basis for the FDA DSCSA Guidance

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

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

What the FDA DSCSA Guidance Says

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

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

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

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

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

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

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

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

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

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

Final thoughts

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

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

 

What Do Pharma Dispensers Have to Do for the DSCSA?

Posted on by rfxadmin

If you’re a pharma dispenser, the Drug Supply Chain Security Act (DSCSA) is going to fundamentally change how you do business. What do pharma dispensers have to do for the DSCSA, you ask? There’s a big deadline coming up this November, but let’s take things in order. Here we go!

First things first: What is the DSCSA?

The DSCSA was created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013. It’s 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.

The DSCSA is being rolled out in two phases:

    • Phase I (2015–2023) addresses lot-level traceability. This means exchanging information about every package of medication so supply chain stakeholders can see exactly where it has been.
    • Phase II (2023) is 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.

Are you considered a dispenser under the DSCSA?

According to the DSCSA, a dispenser is “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.

2016-present: What do pharma dispensers have to do for the DSCSA?

Here’s a no-frills answer to our question, What do pharma dispensers have to do for the DSCSA? This is everything you must be doing right now.

Exchange “T3” information. Dispensers must be able to exchange “T3” information about every drug they buy and who handled it each time it changes ownership in the United States. This “product tracing information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. TH is required until the final November 27, 2023, deadline.

Confirm trading partners are licensed or registered. If you can’t confirm your partners are licensed or registered, you can’t do business with them. There’s an FDA database to check the registration of manufacturers and repackagers and the licensing of wholesale distributors and third-party logistics providers. For dispenser-to-dispenser transactions, you must check licensing through state authorities.

Receive, store, and provide product tracing documentation. This is all about the T3 information. You must accept only prescription drugs with proper T3 information. You must store the T3 information for six years. And you must generate and provide all T3 information when you sell a prescription drug to a trading partner.

Investigate and properly handle suspect and illegitimate drugs. As you might imagine, this is a big part of the answer to our question, What do pharma dispensers have to do for the DSCSA? Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.

As a pharma dispenser, you must quarantine and investigate these drugs to determine if they are fake. If they are determined to be fake, you should work with the manufacturer and take specific action to ensure they do not reach patients/consumers. You must also notify the FDA and trading partners (i.e., those they bought the drug from and those they sold it to) about the compromised drug.

November 2020 deadline: What do pharma dispensers have to do for the DSCSA?

The DSCSA deadline for pharma dispensers is November 27, and it’s about authenticating and verifying drugs. You’ll have to be able to authenticate and verify all the medicines you buy before selling them. This comes down to two key requirements:

    1. You may buy and sell only products encoded with product identifiers (PIs). A PI is a standardized graphic with three elements: the product’s standardized numerical identifier (SNI), which comprises the National Drug Code plus a unique alphanumeric serial number); a lot number; and an expiration date. PIs must be in human- and machine-readable formats.
    2. You must verify every product at the package level, including the SNI. The FDA defines a package as “the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product.”

Final Thoughts

Traceability and serialization technology is the cornerstone of the DSCSA — it is also the cornerstone of our business. rfxcel has been developing leading-edge track and trace and serialization solutions since 2003. Our supply chain experts have the DSCSA in their DNA. What do pharma dispensers have to do for the DSCSA? Let us go beyond the basics we’ve explained here and help you be compliant forever.

Contact us today to learn more about how we can help you with the DSCSA and your other supply chain needs. ANd be sure to download our “Dispensers and the DSCSA white paper.”

 

 

Dispensers and DSCSA: Key Points for 2020 with rfxcel

Posted on by rfxadmin

Between 2015 and 2019, manufacturers, repackagers, wholesale distributors, and dispensers (i.e., pharmacies in hospitals, clinics, supermarkets, or elsewhere) have had to meet different compliance requirements of the Drug Supply Chain Security Act (DSCSA). Now, in 2020, another deadline is looming for dispensers: On November 27, they must be able to authenticate and verify the drugs they sell to consumers.

The DSCSA was enacted on November 27, 2013, as a means to secure the U.S. supply of medications. Phased rollout of regulations began in January 2015 and is scheduled to conclude on November 27, 2023. In a nutshell, the law mandates product serialization and traceability to stop harmful drugs from entering the supply chain, spot them if they do get in, and facilitate rapid response if any are detected.

Let’s take a quick look at how the DSCSA has affected dispensers to date — and what’s coming up in November.

Are you a dispenser?

As we noted above, dispensers are pharmacies. However, to make sure we’re all on the same page (and that you know if the law applies to you), here’s how the DSCSA defines “dispenser”:

    • 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.
    • Does not include a person who dispenses only products to be used in animals.

The first DSCSA deadline for dispensers

The first important deadline for dispensers was July 1, 2015, when they had to begin exchanging “T3” information about every drug they bought and who handled it each time it changed ownership in the United States. (Manufacturers, repackagers, and wholesale distributors had to do this starting January 1, 2015). For every transaction, they’re required to exchange “product tracing information” that includes three things:

1. Transaction Information (TI) about a product:

    • Proprietary or established name or names
    • Strength and dosage form
    • National Drug Code number
    • Container size
    • Number of containers
    • Lot number (certain wholesale distributor transactions were excluded from this requirement)
    • Transaction date
    • Shipment date (if more than 24 hours after the transaction date)
    • Transfer of ownership (the name and addresses of the business/person from whom and to whom ownership is being transferred)

2. Transaction History (TH): An electronic statement with the TI for every transaction going back to the manufacturer. TH is is required until the November 27, 2023, deadline.

3. Transaction Statement (TS): An electronic statement confirming the entity transferring ownership:

    • Is authorized as required under DSCSA
    • Received the product from a person that is authorized as required under DSCSA
    • Received TI and a TS from the prior owner of the product, as required under the law
    • Did not knowingly ship a suspect or illegitimate product
    • Had systems and processes in place to comply with verification requirements under the law
    • Did not knowingly provide false TI or alter the transaction history.

2016-2019 milestones

There were three key requirements for dispensers between 2016 and 2019:

1. They must confirm their trading partners are licensed or registered.

2. They must receive, store, and provide product tracing documentation.

    • Accept only prescription drugs with proper T3 information.
    • Store the T3 information for six years.
    • Generate and provide all T3 information when they sell a prescription drug to a trading partner.

3. They must investigate and properly handle suspect and illegitimate drugs

    • This includes drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution.
    • Quarantine and investigate suspect drugs to determine if they are fake. If they are determined to be fake, dispensers should work with the manufacturer and take specific action to ensure they do not reach patients/consumers. Pharmacies must also notify the FDA and relevant trading partners (i.e., those they bought the drug from and those they sold it to) about the compromised drug.

Preparing for November 2020

The next phase of DSCSA implementation for dispensers concerns authenticating and verifying drugs. They will have to have processes in place to authenticate and verify all the medicines they buy before selling them to consumers. (Wholesale distributors have been required to do this since November 2019.) This boils down to two key requirements:

1. Dispensers may buy and sell only products encoded with product identifiers (PIs).

    • A PI is a standardized graphic with three elements: the product’s standardized numerical identifier (SNI), which comprises the National Drug Code plus a unique alphanumeric serial number); a lot number; and an expiration date. PIs must be in human- and machine-readable formats.

2. Verify every product at the package level, including the SNI.

    • The FDA defines a package as “the smallest unit placed into interstate commerce by the manufacturer or the repackager that is intended by that manufacturer or repackager, as applicable, for individual sale to the pharmacy or other dispenser of the drug product.”

Final thoughts

We know: It can be confusing. That’s why you have to work with a supply chain solution provider that knows the DSCSA inside and out and can help you navigate the deadlines and unexpected changes or delays.

rfxcel has the DSCSA in its DNA. The solutions in our signature platform have DSCSA compliance built in. Our supply chain experts will, ahem, dispense their knowledge when you need it. They will advise, guide, and support you as you grow your business while safeguarding your customers. Contact us today to learn more about how we can help you with the DSCSA and your other supply chain needs.

FDA Delays Enforcement of DSCSA Saleable Returns Verification Requirement

Posted on by rfxadmin

September 23, 2019: In a policy document released today, the FDA announced that it did “not intend to take action against wholesale distributors” that do not meet the Drug Supply Chain Security Act (DSCSA) Salable Returns Verification Requirement before November 27, 2020.

This is a 1-year delay; the original deadline for wholesale distributors to verify a product identifier before further distributing a returned product was November 27, 2019 — barely two months away.

Why the FDA Delayed the Saleable Returns Verification Requirement

The FDA has received comments and feedback from wholesale distributors and other stakeholders “expressing concern with industry-wide readiness for implementation of the verification of saleable returned product requirement for wholesale distributors.” Specifically, stakeholders were concerned about the following:

    • Large volume: Verification of saleable returns will involve “very large volume of saleable returned product requiring verification.” This statement points to the need to ensure testing with higher volumes across all VRS participants (see next bullet).
    • More testing: More testing is required with higher volumes “during actual production.” The specific FDA language identifies the “need to refine and test verification systems during actual production using real-time volumes of saleable returned product rather than simply in pilots.”
    • Interoperability readiness: This highlights the “the complexities of building an interoperable … system … amid immature technologies.” In short, the VRS is new and there are multiple participants that must be tested together.

More Time to Comply but Don’t Delay

The FDA has essentially granted a 1-year grace period, recognizing that some wholesale distributors — as well as their trading partners — simply won’t be ready to verify returned products by the original November 2019 deadline. This is good news for the industry, but efforts to implement VRS must not be delayed.

The FDA’s decision for the enforcement delay gives the industry time for more testing “during actual production using real-time volumes.” The implied understanding is that the industry will use the extra time to test more production-like scenarios. Companies that continue with their planned implementation efforts will benefit from the continued testing; companies that wait will not benefit from the extended test cycles and (like previous delays in enforcement) will end up competing for limited resources when the new deadline approaches.

The FDA announcement also indicated it was “aware that several pilot participants are in the early stages of developing and testing interoperable, electronic systems to enable verification and achieve interoperability between networks.” rfxcel is a key driver in the FDA pilots and has been approved to run a pilot to quantify the readiness of the VRS ecosystem. Our commitment to the industry to ensure readiness remains steadfast, and we will use this time to step up our testing efforts with our customers and the industry.

DSCSA Requirements That Are Not Affected by Today’s Announcement

The FDA made it clear that wholesale distributors and other stakeholders must still meet other DSCSA requirements:

    1. Wholesale distributors must still have verification systems in place to determine if a returned product is a “suspect product.”
    2. Beginning November 27, 2019, wholesale distributors must still ensure that the products they deal with are encoded with a product identifier.
    3. Manufacturers must still fulfill their verification obligations when they receive a verification request from a wholesale distributor.
    4. Beginning November 27, 2019, wholesale distributors can accept a returned product from a dispenser or repackager only if it can associate the product with its specific transaction information and transaction statement.

Furthermore, the revised policy does not apply to “returns of saleable packages and sealed homogeneous cases of product without product identifiers that were in the pharmaceutical distribution supply chain before November 27, 2018.”

Be sure to check back for more news and updates. rfxcel is the pharma industry’s thought leader on VRS and the longest-tenured track and trace provider in the life sciences. You can trust us to give you expert guidance on what to expect with the VRS, as well as all aspects of DSCSA compliance.

 

Comprehensive DSCSA Timeline: Prepping for DSCSA Compliance

Posted on by rfxadmin

Created as Title II of the Drug Quality and Security Act (DQSA), the Drug Supply Chain Security Act (DSCSA) is designed to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. The DSCSA timeline has established requirements and deadlines to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country.

In August 2023, the FDA announced a “stabilization period” that postponed enforcement of key requirements until November 27, 2024, giving pharma companies an extra year to prepare, get their systems running, and be ready for full compliance.

With this in mind, here’s a recap of the DSCSA timeline.

Understanding the DSCSA Timeline

The “end game” for the Drug Supply Chain Security Act is full interoperable electronic unit-level traceability (serialization) of every regulated drug in the United States. Key dates of the DSCSA timeline include the following:

      • November 27, 2013: DSCSA enacted
      • November 27, 2014: Third-party logistics providers (3PLs) must report licensure information to FDA annually
      • November 27, 2015: Manufacturers must print lot numbers on packaging
      • November 27, 2017: Manufacturers must serialize and verify products
      • November 27, 2018: Repackagers must serialize products
      • September 23, 2019: FDA delays enforcement of saleable returns requirement for wholesalers
      • November 27, 2019: Wholesalers/distributors can only receive and distribute serialized products
      • August 25, 2023: FDA announces extended stabilization period, postponing enforcement for one year
      • November 27, 2024: Full interoperable electronic unit-level traceability for all stakeholders

So, by November 27, 2024, manufacturers, wholesale distributors, dispensers (i.e., pharmacies, healthcare systems), repackagers, and 3PLs must have interoperable systems in place to share and verify package-level product identifier data electronically.

DSCSA Compliance Requirements

DSCSA compliance requirements vary by stakeholder, but it’s important to know how the regulations will affect both you and your trading partners.

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 because they require these stakeholders to have specific systems in place to be fully compliant. These are what we’ve been calling 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 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 transfer-ring ownership of the product that it has com-plied with the DSCSA.

Verification

Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drugs packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS).

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.

Strategies for Compliance

Preparing for DSCSA compliance requires a lot of work, but it’s manageable with the right strategies and technologies. Start by understanding your role in the pharma supply chain and the specific requirements you’re expected to meet. Create a checklist for each requirement and make sure you have the resources needed to meet those standards.

The FDA made it clear that the stabilization period is not an excuse for pharma stakeholders to take a break from preparing. It’s quite the opposite, in fact: The Agency said the stabilization period was “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.”

You can read the FDA’s official document about the stabilization period here.

Technology and DSCSA Compliance

Technology is your greatest ally when it comes to achieving and maintaining DSCSA compliance. During the stabilization period, companies need to assess their readiness and implement and test serialization and data-exchange solutions. Your solution must be capable of verifying product identifiers (serialized data), aggregation, and electronic data exchange.

Resources for Ongoing Compliance

There are numerous FDA and third-party resources that can assist with your compliance efforts.

This FDA webinar, entitled “Implementing DSCSA: Stabilization Period and Expectations,” is a good place to begin. The FDA’s main DSCSA page also includes numerous resources, as well as a link to sign up for email updates.

We also highly recommend our own DSCSA Compliance Library. It has links to our articles, webinars, white papers, and other resources that will help you better understand the DSCSA requirements.

Navigate the DSCSA Timeline with rfxcel

As the DSCSA timeline leads the industry to November 27, 2024, you’ll need to ensure that your organization is ready. That’s where we can help.

If you have questions about the DSCSA timeline and your obligations or are concerned that your current provider may not have the tools you need to comply, we encourage you to contact us today to speak with one of our DSCSA experts. We can provide you with the latest information and the solutions to protect consumers, identify suspect products, and maintain compliance.

DSCSA T3 Data Requirements: Track and Trace Software Solutions

Posted on by rfxadmin

Under the Drug Supply Chain Security Act (DSCSA), the T3 data for most medicines must be exchanged at change of ownership. The T3 data requirements includes the sending the Transaction history (TH), the Transaction information (TI), and the Transaction statement (TS).

Transaction History is a statement that details all information on all transactions for a product starting with the manufacturer. It is required until the final November 27, 2023, deadline.

Transaction Information includes the established name or names of the product, the strength and dosage form of the product, the national drug codes, the container, the number of containers, the lot number of the product, the date of the transaction, the date of the shipment. If more than 24 hours after the date of the transaction, the business names and address of the person from whom ownership is being transferred, and the business name and address of the person to whom ownership is being transferred.

Transaction Statement is a statement, in paper or electronic format, that states the partner is authorized to transfer ownership, received the product from an authorized entity, received the TI and  TS from the prior owner of the product, did not knowingly ship a suspect or counterfeit product, had systems and processes in place to comply with verification requirements, did not knowingly provide false TI, and did not knowingly alter the TH.

What do the T3 data requirements mean for me?

Manufacturers need to start the T3 data requirements process by providing all necessary information to the new owner in a electronic format. Wholesale distributors, repackagers, and even dispensers selling products to other dispensers without the medication going to a distinct patient, must continue to produce and transfer this T3 information as they exchange ownership. At the same time, wholesale distributors, repackagers, and dispensers cannot accept ownership of a product unless they are provided with associated T3 data. The T3 data requirements mandate all parties who have ownership of a product need to keep that product’s T3 data for 6 years.

For any member of the supply chain, if a product is thought suspect, or is found to be counterfeit, the product needs to be quarantined and investigated. The product’s ownership cannot be exchanged during the time that it is quarantined or investigated. If an FDA official requests information in relation to any drug recall, the member of the supply chain needs to be able to produce the T3 data, and in most circumstances, give it to the official within 48 hours.

Dispensers have separate regulations. Dispensers are currently required to accept and maintain transactional data for 6 years. By 2020 the DSCSA will require dispensers to verify the product identifier printed on at least 3 units or 10% of all units (whichever one is bigger), and match them to the recorded T3 data – if there are less than 3 packages, then all must be checked. By November 27, 2023, all pharmacies must have an electronic, interoperable system in place trace products at the package level.

Other Insights

Dispensers may enter into agreements with 3rd parties, where the 3rd party would store all T3 data. However, the dispenser is still responsible for producing all T3 data if a regulatory body makes a request. Relying on another partner, whose system is out of the dispenser’s control, may not be ideal. Many of these agreements only cover the products that 3rd party interacts with, requiring the dispenser to still track all T3 data for items that it received directly from a manufacturer or secondary wholesaler. Also, in 2020 dispensers will be required to check lot numbers regardless.

How rfxcel can help

rfxcel has been a leading traceability provider since 2003. Our expertise helps hundreds of customers achieve full regulatory compliance with the DSCSA. Our traceability system allows seamless integration with partner systems and provides no delays to your day-to-day business operations.

With DSCSA looming around the corner it is important to find a solutions provider who focuses on data integrity and flexibility. rfxcel’s system provides over a hundred data checks to ensure that there is no garbage data going in or going out, and with thousands of T3 data reports being created every day, ensuring that data is correct is top priority.

To learn more about the DSCSA, and how rfxcel can help you achieve compliance, click here.

Exploring Track and Trace for Pharmaceuticals: A Complete Guide

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Track and trace for pharmaceuticals lets you pinpoint any item’s current and past locations in your supply chain in real time. It’s a powerful tool that no pharma company can do without, especially as more and more regulations mandate track and trace capabilities and specific requirements for recording and sharing supply chain data.

We’ve been doing track and trace for pharmaceuticals for 20 years, longer than any other solution provider serving the industry, and we thought now was a good time to revisit the fundamentals as part of our ongoing discussion about the pharma supply chain, evolving technologies, and regulatory compliance. Let’s take a look.

What is track and trace?

Track and trace is the ability to see everything in your supply chain.

Tracking means you’re able to see where something is now and where it is heading (e.g., a factory, a warehouse, a pharmacy or hospital). That “something” can be a pallet of items, individual boxes on that pallet, and the individual items inside each box.

Tracing means you’re able to see where an item has been and who has handled it (e.g., the date and time it arrived at a warehouse and when it was shipped to its final destination).

What is a track and trace system for?

A track and trace system comprises components that work together to ensure efficient product identification, data management, and communication. These components are crucial for accurate, real-time visibility and effective management throughout the supply chain. A track and trace system usually utilizes specialized software combined with product labeling, particularly barcodes (e.g., 2D DataMatrix codes) as unique identifiers, to achieve these capabilities.

What is track and trace for pharmaceuticals?

When designed and implemented correctly, a track and trace system for pharmaceuticals does exactly what its name promises. It tracks a drug, a vaccine, a medical device — anything in any configuration — as it moves forward through the supply chain and traces backward to reveal where it has been in the supply chain, all the way back to the individual ingredients or components that combined to create it.

Tracking lets pharmaceutical manufacturers keep tabs on every item in their supply chains as they are distributed. Its many benefits include optimizing operational efficiency and speed in the manufacturing process. It also protects against theft and diversion; monitors products in transit to help ensure they remain safe and environmentally stable; and prevent counterfeit, adulterated, or expired medications from entering the supply chain.

Traceability lets you follow the trail of anything in your supply chain. It is a key component in supply chain visibility and transparency. Its many benefits include fast and accurate recall management capabilities, brand protection, accurate inventory management, and building consumer/patient confidence.

Serialization for track and trace pharma

Track and trace for pharmaceuticals relies on a deliberate combination of technologies and processes. Its “building block” is serialization, which endows a product with a unique identity that allows it to be tracked and traced 24/7 and authenticated at any time (e.g., prior to sale, at dispensing, upon return, or during a recall).

Serialization also lets pharma companies “configure” their products to meet government regulations, many of which specifically mandate track and trace capabilities and related data requirements.

For example, the U.S. Drug Supply Chain Security Act (DSCSA) will require full serialization of the U.S. pharma supply chain on November 27 of this year (2023). Among other things, the law stipulates that a unique product identifier (PI), such as a barcode, must be placed on certain prescription drug packages, and that pharma companies must provide detailed information about a drug and who handled it each time it’s sold. (See below and read more about these and other requirements here.)

In Europe, a product’s data points are aggregated into a master database, the European HUB (EU HUB), as well as country-specific databases called the National Medicines Verification System (NMVS). In Russia, it’s the National Track and Trace Digital System (Chestny ZNAK).

Are track and trace regulations as common as serialization requirements?

Not every country with serialization requirements has track and trace requirements; however, regulators in many countries are starting to pair track and trace with serialization to achieve their goals, which include combating counterfeit, stolen, or adulterated drugs.

For example, as we said above, the DSCSA will require pharmaceutical stakeholders provide detailed information — transaction information (TI) and transaction statements (TS) — about a drug and who handled it each time it’s sold. Stakeholders at every node of the supply chain — from wholesalers to repackagers and dispensers — must receive an electronic copy of this data. They must also produce and add to the data if they sell the product.

Note: The DSCSA currently requires a third piece of data called the transaction history (TH). This is an electronic statement with the TI for every transaction going back to the manufacturer. However, TH will not be required after the November 2023 deadline.

Global compliance for track and trace in pharmaceuticals

In the pharmaceutical industry, track and trace systems are crucial for maintaining product integrity, combating counterfeit medications, and ensuring patient safety. To address these concerns, regulatory authorities worldwide have implemented stringent compliance requirements for track and trace in pharmaceuticals. Key aspects of global compliance requirements include serialization, product identification/authentication, traceability, electronic reporting to regulators, and electronic data-sharing among trading partners.

For more information about what countries require for track and trace for pharmaceuticals, check out our Global Compliance page. The regulatory landscape is constantly changing, so it’s the wise company that takes the time to keep up with requirements, changes, and deadlines.

Final thoughts: track and trace for pharmaceuticals

Track and trace for pharmaceuticals is no longer an option: It is a requirement for companies wanting to do business in key markets such as the United States, Europe, Russia, Brazil, the Middle East, Asia — virtually everywhere in the world. Put simply, not having a modern track and trace system is a huge risk.

As we said in our introduction, we’ve been doing pharmaceutical track and trace for 20 years. We were founded on the principle of making the pharma supply chain safer and protecting consumers through track and trace.

Today, we offer the industry’s most powerful track and trace solution. And now, as part of Antares Vision Group, we are confident that we offer the world’s most comprehensive solution for end-to-end supply chain track and trace connectivity. From L1 to L5, we have the hardware and software solutions that deliver all the benefits of track and trace for pharmaceuticals — or any product category.

Contact us today to talk to one of our supply chain experts or to schedule a demo of our award-winning Traceability System for the pharmaceutical industry. We want to make your supply chain your most valuable business asset.

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