TrackTrace Rx

Learn About the Trading Partner Changes in the DSCSA

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As guidelines for the Drug Supply Chain Security Act (DSCSA) continue to come out, various questions have been raised as to the Food and Drug Administration’s (FDA) definitions of “trading partners.”

The DSCSA will require that trading partners in the drug supply chain – which include repackagers, wholesale distributors, manufacturers, and dispensers – be able to provide certain product tracing information in order to become authorized to operate in the industry. There has been a substantial amount of confusion as to how the definitions of trading partners have changed due to the DSCSA, however. In addition, confusion exists about whether or not the DSCSA regulations will apply to various types of professions like brokers, solution providers, and certain types of contractors.

In response to the confusion, the FDA released a supplemental document to clarify the definitions.

According to the FDA, an entity is considered to be under the jurisdiction of the DSCSA if it “meets the statutory definition of a particular trading partner that would trigger the applicable requirements depends on the activities in which it engages.”

Let’s take a closer look at what these mean for each of the five trading partners discussed in the guidance document.

Manufacturers as Trading Partners

The DSCSA’s definition of a manufacturer as a trading partner can be found in section 581(10) of the Federal Food, Drug, and Cosmetic Act (FD&C), which defines a manufacturer as any entity that holds an approved application or license to manufacture drug products.

The FDA argues that the confusion over the definition of manufacturers stems from that fact that entities that have drug approvals – like co-licensed partners and affiliates of entities defined as a manufacturer under section 581(10) – are required to register under section 510 to be seen as “authorized.”

The FDA has since clarified that manufacturing establishments refer to, with limited exceptions, any person or group which prepares, manufactures, compounds, propagates or processes drugs. Such entities much register under section 510. This also applies to any affiliates of manufacturers, but only if the affiliate legally controls or is controlled by a manufacturer, either directly or indirectly.

Repackagers as Trading Partners

Repackagers are now defined as “a person who owns or operates an establishment that repacks and relabels a product or package for – (A) further sale; or (B) distribution without a further transaction” in the DSCSA.

The FDA has also said that the definition of trading partner, which is found in section 581, includes repackagers, and that all repackagers must comply with section 510 to be recognized as legitimate trading partners.

In addition, the FDA expanded upon these definitions and clarified that dispensers that are solely involved with the labeling and packaging of drug products will not be classified as a repackagers, and are therefore not subject to the requirements found in section 582(e) of the FD&C Act.

Third-Party Logistics Providers as Trading Partners

Third Party Logistics Providers (3PL) are now considered new entities in the drug supply chain.  Since they only provide logistical services and don’t actually take ownership of drugs or products, however, they are regulated differently than other trading partners. What this means is that 3PL facilities must be separately licensed and regulated from wholesale distributors.

The new guidance released by the FDA states that 3PLs that:

  • Don’t accept shipments or in any way shift the possession of products
  • Aren’t considered trading partners
  • Do not have to adhere to the authorized trading partner provisions of section 582 of the FD&C Act when engaging with other entities.

However, 3PLs are prohibited from engaging in any activity in any state unless their facilities are licensed by the state from which the 3PL distributes the drug, and in certain circumstances the 3PL must get a license from the state which they are distributing the drug to. They must also deliver certain types of information to the FDA, including information about their state licensure.

Wholesale Distributors as Trading Partners

The new DSCSA definitions defined wholesale distributors as entities that distribute a drug or product to a person other than the direct consumer or patient for whom the drug intended. This is a change from how the FD&C Act previously defined wholesale distributors. Due to the new definition for wholesale distributors, many companies that were previously defined as wholesale distributors are now considered 3PLs. In addition, the FDA has clarified that a manufacturer cannot be considered a wholesale distributor, because they are distributing their own drug and not another entity’s drug.

If an entity distributes a drug to someone other than a customer or patient, and is not covered in the above exceptions or the exceptions found in section 503(e)(4), it is subject to all wholesale distributor requirements of the DSCSA.

Dispensers as Trading Partners

The FD&C defines a dispenser as a pharmacy, or any other entity authorized to dispense or administer prescription drugs for humans, which doesn’t function as a wholesale distributor. This definition categorizes distribution centers and dispenser-affiliated warehouses as dispensers, which is a big change considering they were previously not classified as such.

According to the new published guidelines, dispensers are not required to provide information regarding product tracing at the time of a transaction or prior to it, as long as the transaction is only dispensing a product to a patient.  The same holds true if one dispenser is selling to another dispenser for patient-related needs.

The changes to the five trading partner categories have been somewhat confusing, but hopefully the new guidance document will help you make sense of the changes. Even with the added clarification given by the FDA, however, it’s important to thoroughly review the literature regarding the new DSCSA requirements to make sure your company is in compliance.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

The Innovative Abilities Of Blockchain In Meeting DSCSA

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There’s been a great deal of recent interest in the use of Blockchain technology to tackle challenges in the healthcare field, especially when it comes to maintaining compliance with the DSCSA. Beginning in November of 2023, pharmaceutical supply companies will be required to maintain accurate information that will let drugs be traced along the supply chain. The pharmaceutical industry has a huge challenge ahead of it to meet these standards, and Blockchain technology may be one of the solutions.

To understand whether or not Blockchain represents a valid solution to the issue of supply chain tracking, some background on it is necessary.

What Is Blockchain?

Blockchain technology is essentially a method of encapsulating data or information within a layered data structure so that multiple parties can trust in the accuracy of the source of information. You can think of it like a digital ledger that tracks transactions and lets multiple parties see those transactions, with an added layer of security.

The most famous use of Blockchain is to track the transactions of cryptocurrencies like Bitcoin, but it has applications for the healthcare field including anti-counterfeiting and supply chain regulatory compliance.

How Can Blockchain Be Used To Assist In DSCSA Compliance?

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After November 27, 2023, US companies in the pharmaceutical supply chain will no longer have to give transaction histories to their customers, instead they will have to retain “…systems and processes necessary to promptly facilitate gathering the information necessary to produce the transaction information for each transaction going back to the manufacturer”.

Gathering all the documents related to transaction information would be necessary only when there is an investigation into possibly illegitimate products. This poses a problem under the new system, as many questions will be raised regarding the authenticity of the party asking for the transaction information.

If a hospital needs to gather transaction information for a drug going all the way back to the manufacturer, you can easily imagine the manufacturer asking a series of questions to see if the hospital can be trusted.

“Do you actually own the drug you’re asking for info about?” “Are you actually a trusted member of the supply chain?”

Considering what is at stake for the manufacturer, it makes sense that they would not respond to people asking for this information unless they can prove that they are trustworthy. This is a time intensive and frustrating process, and the law allows only so much time to provide the required transaction information.

This is where Blockchain comes in as a possible solution to this problem. Blockchain introduces a way of ensuring that the party making a request for information can be trusted, that their reason for requesting the information is legitimate, and that they own the product they are asking about.

Let’s take a closer look at the key features of Blockchain and the difficulties in implementing the DSCSA.

Why Is Blockchain So Helpful In Meeting DSCSA Challenges?

The Center for Supply Chain Studies (C4SCS) is an organization created to assist different industries in evaluating the impact of changes in regulatory, business, or technological areas. A team from the C4SCS conducted an in-depth investigation of the challenges in industry compliance with the new DSCSA standards, and if Blockchain could assist in solving these issues.

Here’s a rundown on the challenges of meeting compliance for DSCSA, as identified by the C4SCS:

  • There’s a distributed environment with a wide variety of companies and parties in the industry
  • There’s a need to share data with unknown participants in the supply chain
  • A massive amount of data exists to be collected and stored
  • Current proposed solutions to DSCSA compliance are expensive and intrusive, largely relying on adequate funding and governance to ensure compliance

And here are some of the key features of Blockchain that make it attractive:

  • Blockchain is distributed, with no central authority
  • Blockchain is also anonymous, and anyone can participate in it at any time
  • There’s a single point of entry involved in Blockchain, which makes connection easy. It’s also private, and you don’t need everyone to know when you’ve entered Blockchain
  • It’s safe and trustworthy
  • Blockchain is self-funded, it generates income for the parties which perform the services necessary

It’s easy to see that the features of Blockchain align nicely with the DSCSA and provide possible solutions to its issues. The problem of a distributed environment is handled by the fact that Blockchain itself is also distributed, yet secure and trustworthy. Blockchain gives people a way of trusting other parties without needing a central repository or governing agency to oversee everything and would work whether or not a distributed or centralized architecture was used.

Blockchain’s Adoption Problems

The C4SCS team is convinced that Blockchain represents a viable solution to the problems posed by the new DSCSA standards. However, there are issues preventing widespread adoption of Blockchain.

Blockchain is still a rather new technology and lacks the technical standards that would encourage wide acceptance of the platform. For this reason, many industry observers feel that it is still too early to pursue commercial applications for Blockchain. That said, there is an intense interest and energy around Blockchain that will spur further development of the technology and of its standards, so it is possible that by 2023 the technology will have advanced far enough to make Blockchain the obvious solution to the DSCSA’s compliance issues.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

 

Will You Be Affected by the DSCSA?

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The Drug Supply Chain Security Act (DSCSA) was signed back in 2013 and aims to give the Federal Drug Administration (FDA) more power to regulate drugs and protect patients from counterfeit, contaminated, or otherwise dangerous drugs.

The World Health Organization (WHO) says that between 1% and 10% of all medical drugs sold throughout the world are counterfeit, and some countries have a counterfeit rate as high as 50%. To combat this problem and protect patients of these drugs, manufacturers, distributors, repackagers, and dispensers will be required to comply with the provisions of the act, which include providing transaction information on sales of certain prescription drugs

Which companies will be impacted by the DSCSA?

How do you know if your company will be affected?

It would be tempting to say that any company that handles pharmaceutical-grade drugs must abide by DSCSA regulations, but in practice, it’s more difficult to get an exact answer. There are exemptions to the requirements for certain products and transactions, however, and state laws regarding the handling of certain drugs may conflict with how the DSCSA classifies them.

As a general rule of thumb, if a company is a defined by the act as a trading partner, and it deals in prescription drugs not exempted from DSCSA regulations, it’s probably under the jurisdiction of the DSCSA.

Defining Prescription Drugs and Exemptions

It’s important to understand what classifies as a prescription drug under the DSCSA. Section 503(b)(1) of the Food, Drug, and Cosmetics Act defines a “prescription drug” as a drug intended for human use and the DSCSA says the drug must be in “finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution).”

In general, over-the-counter drugs, medical devices, and drugs for animals are exempt from the act. Drugs which require a pharmacist to dispense it typically fall under the act, but not always. While a drug may require a pharmacist to dispense it, that doesn’t mean the FDA classifies it as a prescription drug, since state laws might require certain drugs to be handled by a pharmacist though the FDA doesn’t classify it as a prescription drug.

Other products exempted from DSCSA regulations include:

  • Blood for transfusions
  • Radioactive drugs or radioactive biological products
  • Medical gases
  • Compounded drugs
  • Imaging drugs
  • Intravenous products intended to replenish fluids or electrolytes
  • Drugs intended for irrigation or sterile water

Defining Trading Partners

Let’s go back to trading partners. How are trading partners defined under the DSCSA?

A trading partner is any company, organization, or entity such as a dispenser, manufacturer, repackager, logistics provider, or wholesaler distributor.

A dispenser is defined as any hospital, retailer, pharmacy, or group of pharmacies under common ownership and control (which don’t act as a wholesaler distributor), or any other person who is authorized to administer or dispense prescription drugs. The associated warehouses or distribution centers of authorized people or groups (which don’t act as a wholesale distributor) are also impacted by the regulations.

Manufacturers are classified as a person who has an approved application under Section 505 or a license issued to them under Section 351 of the Public Health Service Act.

A repackager is a company that relabels and repackages drugs for distribution or sale, including repackaging departments, which are actually a part of most hospitals.

Wholesale distributors are groups who are involved in the wholesale distribution of a prescription drug to any person or group other than the patient. This doesn’t include manufacturers, third-party logistics providers, or repackagers.

A third-party logistics provider refers to an entity that provides logistical support for a drug for other organizations, but does not own the product. The other mentioned categories take direct ownership of the drug.

Transaction Exemptions

So a company must adhere to DSCSA regulations if they’re classified as a trading partner and dealing with prescription drugs, right? Is that all there is to it? Unfortunately no, it’s a bit more complicated than that. As it turns out even if a particular drug is not exempt, a company may still be exempt from many DSCSA provisions when it’s conducting certain kinds of transactions. To put that another way, a product would need to follow the DSCSA under other transactions, but in these specific transactions, they do not.

The list of exempt transactions include:

  • Intra-company distribution of products within a single manufacturer, or between members of an affiliate.
  • Distribution of samples of a product by a licensed wholesale distributor or manufacturer
  • Distribution of “medical convenience kits”, collections of finished medical devices which might include drug products or biological products and are packaged in kits for the convenience of the user, if:
  • The kit is assembled in an establishment registered by the FDA as a device manufacturer, the kit doesn’t contain a controlled substance, and the manufacturer of the kit purchased the product contained in the kit directly from the manufacturer or from a wholesale distributor that purchased it directly from the manufacturer.
  • The label on the primary container of the drug or biologic product in the kit is not altered and the product in the kit is one of the following:
    • A vasopressor, a sympathomimetic, an anesthetic, an anticoagulant, an intravenous solution intended for the replenishment of fluids and electrolytes, a product intended to maintain the equilibrium of water and minerals in the body, or a product intended for irrigation or reconstitution.

The upcoming DSCSA deadline is November 27, 2017, and it will require manufacturers to label each product with a unique product identifier. While it was rumored that DSCSA enforcement has been delayed, in reality, the law has not been delayed. The FDA will merely be exercising discretion and giving companies a little more leeway when it comes to penalties for non-compliance.

The list of DSCSA provisions and exemptions requires close reading because in the end, you are the only person who can decide if your company and product falls under the act. Only with a careful reading of the provisions and an intimate knowledge of your product can you arrive at that crucial decision.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

3 Things About Serialization Planning You Need to Know

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Even though compliance is the primary reason most pharma companies are implementing serialization, there is a wealth of business value beyond it. DSCSA compliance opens a window of opportunities for businesses, and forward-thinking leaders are exploring them now.

As of November 2017, prescription drugs sold on the US market must be serialized. This means pharma companies must have an operational serialization solution by that time. By 2023, the industry must enable data exchange and full unit-level traceability.

The Drug Supply Chain Security Act creates significant roadblocks for businesses, as it takes a large-scale strategy to reach full compliance. Planning, implementation, mitigating disruptions across the enterprise and the pharmaceutical supply chain are just the formal tip of the iceberg. Below, there is the significant investment in a myriad of solutions and adjustments. From software and hardware to staff training, and development of new processes that ensure compliant reporting, and serialization.

#1. Capturing Data

Even though DSCSA-mandated labeling and reporting requirements are top of mind, there are opportunities pharma companies can explore to optimize processes and boost revenue. Assessing short-term compliance goals and long-term ones such as scalability, rich data, and its value for business intelligence can drive substantial business value.

The captured data holds the key to the future value generation that goes beyond DSCSA compliance and reporting to your partners in the supply chain. You can use it to support an investigation in case the supply chain gets compromised. You can tap into it to simplify processing of ad-hoc queries, and to support your routine operations. You can use it to analyze which lines perform the best, and replicate those efficiencies across the operations.

The data about a product’s critical tracking events is money – you just have to convert it into efficiencies, and improvements. That said, consider capturing the data in the full format. The serial numbers, the date and time complete with the time zone, the location, and the business context. The latter can include any relevant details, such as product condition, or associated transactions.

Beyond the DSCSA-mandated commissioning, packing, and shipping, consider capturing sampling, inspection, exception processing, reverse logistics, unpacking, and repacking. In other words, consider where you could benefit from greater visibility into the processes.

#2. Providing Data

Drug manufacturers, distributors, contract manufacturers, third-party logistics providers and repackagers – all must contribute their share to ensuring the products they operate are traceable. Each one of the trading partners expects to receive tracking events data from the manufacturers, which in its turn needs data from a supplier.

So, the goal here is to have a clear idea of what data each partner needs. The roadblock could be that not all of your partners may have a good idea of their data requirements. Regardless, make sure to get the details that will save you a headache in the future. You may want to inquire with your partners about:

  • The critical tracking-event data they need – ensure you capture it; if not, adjust accordingly.
  • The master data they need you to sync with their systems – item attributes such as name, dose, and dosage form, required party, location, etc.
  • Shared use of the same identifiers for product identification and party/location identification– i.e. SGTIN, GLN.

#3. Interoperability

Providing your partners with the right data, and receiving the data you need, is by far not the only focus area you need to clear with your trading partners. Technical issues usually tend to be the most expensive to troubleshoot, and interoperability of your solution and your partners’ solution is paramount. With the deadline impending, there is little time left to test and ensure your IT systems and those of your partners can inter-operate reliably when DSCSA prime time comes.

When you need to interface with multiple partners, there must be a consistent acceptance of industry standards in some critical aspects, such as:

  • The format of data your partners will send and expect to receive (GS1 EPCIS and the GS1 US guideline for EPCIS).
  • The data exchange mechanism your partners intend to use and their security requirements (Secure File Transfer Protocol, Applicability Statement 2), their advantages and disadvantages for your operations.

Choosing Vendors

Determining vendor evaluation criteria is key to addressing your business requirements. For example, will the vendor ensure to provide the right data based on your business processes, and if yes, have they done so for other companies? Does the vendor comply with the GS1 US guideline for the use of EPCIS in the US drug supply chain?

Now that everyone is pressed for time with their serialization implementation, you need to ensure the vendor has sufficient resources (support, technical, engineering capacity) to cater to your specific needs adequately. In other words, are their resources stretched thin? Of note is whether the vendor is already working with any of your trading partners, and the interoperability level they can ensure.

Final Words

The right serialization and traceability solution offers a wealth of benefits beyond DSCSA compliance. According to a recent KPMG survey, more than 70% of polled companies “plan to use serialization data to enhance business processes.”

While companies are investing tens and even hundreds of millions of dollars to reach end-to-end traceability of drugs within the US supply chain by 2023, it makes all the sense to focus on the long-term value potential of all their implemented solutions.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

5 Things You Should Know About DSCSA Enforcement Delay

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The nearest DSCSA deadline kicks in on November 27, 2017. It requires the manufacturers to imprint or affix a unique product identifier – at the package level and secondary homogenous case level before sending it down the supply chain. Manufacturers must verify the serialized product at package level should they receive a request from their trading partner to assist in an investigation of a suspect product, when verifying saleable returns or when receiving a verification request from the FDA.

In July 2017, the FDA has published a draft guidance document that, when final, will delay the enforcement of the DSCSA for the manufacturers for one year until November 26, 2018. All participants of the drug supply chain – especially the manufacturers – should be careful when interpreting the meaning of the delay, and its consequences.

1. Why The Delay?

The industry is not ready for the November 2017 deadline. Since last year, many drug manufacturers, their trading partners down the supply chain, and industry surveys have expressed concern about the serialization readiness of the industry to meet the November deadline. The FDA heard you, and to avoid the potential disruptions in the drug supply chain, the agency is willing to look away for now.

2. What Is and What Isn’t Delayed

The DSCSA law has not been delayed. The one-year delay of the DSCSA enforcement will come into effect on November 27, 2017, and last through November 26, 2018. During this period, the FDA will exercise “enforcement discretion” regarding the product identifiers requirements.

The penalties under the DSCSA have not been delayed. It means you can still get penalized during the discretion period for noncompliance. However, during the discretion period the FDA will not inspect and penalize companies for no particular reason, that is just for the sake of identifying the non-compliant companies.

On the other hand, the agency can still apply penalties if an investigation into an incident in the supply chain should indicate that a company’s negligence to comply with the DSCSA caused or contributed to the incident, and/or had a negative impact on patient safety. So, in the event of an incident, you can still be investigated by the agency, and face subsequent liabilities for noncompliance.

3. Manufacturers

If the draft guidance makes it to the final version more or less unchanged, the FDA will not inspect manufacturers’ operations randomly during the enforcement discretion period, until November 26, 2018. The FDA will not penalize a manufacturer during this period if the manufacturer:

  • introduces a product into the supply chain without affixing or imprinting a product identifier on each package of homogenous case
  • does not perform suspect products verification when receiving a verification request
  • does not verify when receiving a request from the trading partner
  • does not perform verification of a saleable return

However, some DSCSA manufacturer requirements will be fully enforced starting November 27, 2017. Namely, manufacturers still have to provide the transaction information, transaction history and transaction statement in electronic format. Exceptions apply if you sell to a licensed healthcare practitioner directly and under the State law, and the practitioner is authorized to prescribe medication. See Section 582 (b)(1)© for more details.

Of note is that fact that the enforcement delay does not apply to serialized product introduced into the supply chain between November 27, 2017, and November 26, 2018. The new compliance policy does not affect the verification provisions, Section 582 (b)(4).

So, when dealing with already serialized products, manufacturers and downstream trading partners must use their serial numbers in verification.

4. Trading Partners

Under DSCSA, the downstream trading partners (repackagers – starting November 2018, wholesale distributors – 2019, and dispensers – 2020) must only engage in transactions with the drugs that come with the DSCSA-mandated serial number on it. They must verify the drugs with the manufacturer when investigating suspect products and saleable returns relying on the SNI, the standardized numerical identifier.

So, how does the period of enforcement discretion affect these downstream trading partners? When you deal with the products without a serial number introduced into the supply chain by the manufacturer during this enforcement discretion period, the FDA will not penalize you. The FDA will not take action against you if you do not use a serial number to verify a non-serialized product introduced by the manufacturer during this period.

The enforcement discretion during this year means that non-serialized products get a pass into the supply chain until November 26, 2018. And as long as they continue to circulate in the supply chain, they will continue to avoid penalties for not having a serial number.

However, the FDA leaves it to the trading partners to determine if the non-serialized drug they are investigating, returning, or buying/selling was introduced into the supply chain during this enforcement discretion period.

When the respective 2018, 2019 and 2020 deadlines kick in, the trading partners dealing with a non-serialized product that entered the supply chain before or after the enforcement discretion period:

  • should not buy it
  • should not return it for saleable inventory
  • should consider labeling it as illegitimate if it’s under investigation

So, how do the trading partners determine if the non-serialized product entered the supply chain during the enforcement discretion period, and not before or after it? The FDA suggests two methods:

  • Using the Transaction Information documents in the Transaction History to identify the date the product was first introduced into the supply chain by the manufacturer.
  • Using non-DSCSA documentation like commercial and shipping invoices, or bills of lading that indicate when the manufacturer introduced the drug into the supply chain.

Therefore, once their respective DSCSA deadlines kick in, the downstream trading partners will have to determine if non-serialized products they intend to buy are in compliance (i.e. introduced in the supply chain during the enforcement discretion period).

5. Grandfathering

Recognizing the complexity of managing the grandfathered product and the effect of the enforcement delay on it, the FDA intends to publish an additional mandated grandfathering guidance. Hopefully, sooner rather than later.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

 

Preparing for Serialization – Focal Points

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The Drug Supply Chain Security Act (DSCSA) November 2017 deadline is approaching fast, perhaps too fast for some companies. Even if the largest players have prepared and tested their serialization solutions ahead of time, the industry as a whole is far from being ready on time. Some reports suggest many companies need 12-24 months more to implement serialization; a fraction of the market has not started yet. The latter believe the FDA would postpone the deadline. Should the deadline be postponed or not, serialization implementation is an endeavor of an extraordinary magnitude.

Most serialization projects start out as DSCSA compliance initiatives, but the thing is serialization goes far beyond that. You need a significant budget, personnel and time, new equipment, new IT systems, and new processes. Each of these requires massive investments, but when combined, these ingredients may create a hog in your budget. That is why implementing serialization requires time, from nine months and up, to plan, test, and troubleshoot before the prime time. Inevitably, glitches and setbacks will occur. Preparing right when choosing the serialization solution, as well as working in close coordination with your partners, CMOs, and 3PLs will help you get there.

Data

Careful planning from a forward-thinking perspective will let your serialization solution optimize your operations and even increase revenue. So, the first thing on your agenda should be evaluating in the long-term and short-term perspective your:

  • Compliance needs
  • Scalability capacity
  • Rich data

It is the data that holds the largest potential for boosting your operations, especially the tracking events of a product as it moves down the supply chain. For your data to have value beyond compliance, it must provide tangible benefits, such as your ability to query it and use it for reporting to partners (for DSCSA compliance), facilitating an investigation when the need arises, and solving ad hoc issues in your routine operations.

It is highly recommended to capture all critical tracking events and include the serial numbers involved in the event – the date and time complete with the time zone, location and the operational context (condition of the product, and associated transactions).

The captured pool of data should include:

  • Data needed specifically for the DSCSA compliance (applying the serial number, packing, shipping).
  • Processing of exceptions.
  • Processes that are critical – sampling, repacking, inspection, and others.

CMOs

The ultimate responsibility of serialization under the DSCSA is on the shoulders of the manufacturers, but if contract manufacturers (CMOs) lag with their serialization efforts, the manufacturers are at risk. In other words, CMO lag is manufacturer’s lag, so keeping a close communication loop with your CMO is important. You need to put in place the agreements that cover the key DSCSA responsibilities between your companies. You must have a voice in enforcing your CMOs serialization initiatives, and advising on packaging optimization and supply chain processes.

3PLs

Engage your third-party logistics providers (3PLs) to leverage their serialization capabilities:

  • Define responsibilities, rules and accountability in your mutual serialization efforts.
  • Provide access to master data (GTIN, GLN, and attributes), as it is crucial to identify the key events accurately.
  • Put in place clear governance standards to preserve the integrity and accuracy of master data, especially as it is updated over the course of time.
  • Data requirements must be clear, especially with the current mix of standards. GS1 EPCIS 1.0 of 2007, 1.1 of 2014, or 1.2 of 2016 – the industry is relying on three active versions of the GS1 EPCIS standard. Agree on the data format requirements down to the specific EPCIS versions for data interoperability, especially when interfacing with multiple partners.
  • Work on integrating systems to achieve maximum supply chain visibility. 3PLs’ shipments affect manufacturer’s revenue and inventory directly. Manufacturers need data from 3PLs to send ASNs and invoices, so integrating to their systems lets manufacturers receive timely alerts and act on them, minimizing the wait times. API-enabled technologies grant systems interoperability without time-consuming programming.

Know Your Partner’s Requirements

Drug manufacturers, CMOs, re-packagers, and 3PLs all have their share of responsibility to ensure drug traceability within the supply chain. Every actor will expect to receive tracking events data from their trading partners. Some may be still at the early stages of identifying their data requirements. So, knowing what kind of data is required by your trading partner will save everyone the hassle when the deadline is due. Ask your trading partners about:

  • Specifically what tracking event data they need, and how it compares and scales down to the data you intend to capture. Adjust.
  • What master data you need to synchronize with each of your trading partners (drug name, dose, dosage form, and so forth).
  • What identifiers you and your partner use for product identification and party and location identification (SGTIN, GLN?)
  • What cybersecurity and data protection mechanisms are required by each of your trading partners.
  • What mechanisms you will use to transmit/receive data (to know if you need to support legacy protocols such as SFTP, AS2).
  • What roadblocks can hamper interoperability?

Conclusion

Finally, assess your vendor. See if the vendor is compliant with the GS1 EPCIS standards, or if/how they can ensure the collected data is used effectively to get business insights and optimize your operations. Do they have enough bandwidth (support, engineering capacity) to meet the deadline? Do they work with any of your trading partners (if not, can they interface with your trading partners’ systems)?

You can not go solo in your serialization project. Every actor of the drug supply chain is responsible for their share of the requirements. Manufacturers, CMOs, 3PLs, wholesalers, and serialization solution vendors must collaborate to get it done right. Then it’s good business.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Top Challenges for Serialization

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Once the Drug Supply Chain Security Act (DSCSA) is fully implemented in 2023, the industry and the consumers will be able to harness the benefits of a safer supply chain. The patients will benefit because it will be easier to identify counterfeit products in the supply chain and remove them. Drug manufacturers will benefit from the detailed data they can use to support sales or marketing campaigns, optimize supply chain management, enhance performance by CMOs, improve management of the cold chain, minimize losses stemming from product diversions or losses, issue returns credits at original prices, or assess product availability. Other supply chain partners will benefit from serialization, too. To make that happen, however, manufacturers, wholesalers, dispensers, repackagers and other participants must live up to their DSCSA responsibilities.

One of the recent IQPS reports gives an insight into the complexities and roadblocks the pharmaceutical industry faces with regards to serialization compliance. The bad news is serialization endeavors look intimidating, but the good news is there exist solutions that help companies implement serialization as smoothly as possible.

Deadlines

Recently, we reported on a serialization readiness survey that found a part of stakeholders would require another 12-24 months to complete their pilot programs and troubleshoot issues. Some companies have not even started, yet, because they are confident the FDA will postpone the November 2017 deadline. This gives a false sense of security.

The serialization requirements for the November 2017 deadline are clear. In 2015, the FDA granted a six-months grace period for manufacturers failing to meet the January 2015 lot-level traceability requirement. Perhaps, it is for this reason that some companies believe the agency would grant another grace period for the November 2017 serialization deadline. However, the agency might not be so inclined to do it this time because we have known about the deadline for four years now, which is enough time to prepare.

What if you are late?

The more there are companies trying to speed up their serialization implementation at the same time (months before the November deadline), the more solution vendors’ resources will be stretched thin. Some vendors reject new clients, others expand their bandwidth by hiring new staff. The new personnel needs the training and experience to be at par with the more experienced peers.

Needless to say what happens when complex strategies are rushed, and serialization is a complex endeavor. Rushed solutions often lack in the planning part. Hurried planning may not account and future-proof for the otherwise predictable future needs, addressing the nearest goals only. Rushed communication may lead to misunderstandings among your internal staff as much as with your partners. Your internal staff needs ample space and time for training and testing your serialization solution. In other words, if you have not started, yet, you need to do it now and maintain a reasonable pace to avoid these hurdles.

Aggregation

Unit-level serialization is clear, but aggregation is an implied requirement. The lack of an unambiguous aggregation requirement in the DSCSA led some companies to believe they do not need to implement it before 2023, which is the deadline for electronic tracking and traceability.

Even if they are right in theory, they are wrong in practice, given the three largest drug wholesalers (the Big 3) demand aggregation as early as 2018-2019. For them, to make serialization feasible they need aggregation information for trading partner sales.

“As a wholesaling community, we have ~58MM saleable returns a year; if we can’t get data, how will we execute the verification of those products?” says Matt Sample of AmerisourceBergen. Based on average estimates, aggregation implementation takes 30% longer to execute.

Manufacturers that have not included aggregation in their 2017 unit-level serialization compliance plan risk facing production disruptions and extra costs incurred by the wholesalers’ requirements to aggregate.

Challenges Beyond Compliance

The unique serialization codes present another challenge. Creating, managing and coordinating the unique serialization codes for individual drug products across the organization (and during each stage of the production process) requires a standard, interoperable and centrally configurable solution.

Integrating different coding formats is a resource-hungry necessity. So is the integration of your serialization solution with your existing enterprise and legacy systems, as well making it work with your third-party partners such as CFAs, 3PLs, and CMOs.

Pharma companies face the challenges of customer connectivity and significantly larger data volumes, which may have an operational impact. Serialization equipment and implementation of software were the initial concerns of many manufacturers. Now that many companies have made progress in this area, the next roadblock is transforming your serialization pilot into an ongoing business operation. When data exchange is implemented on the packaging unit, we face serial number level challenges between trading partners because the manufacturers have many-fold relationships with others in the supply chain.

Therefore, manufacturers should already be in the process of implementing the following:

  • deploying the necessary systems to create, randomize, and commission serial numbers
  • imprinting serial numbers on unit-level packages
  • transmitting Transaction History, Transaction Information, and Statements
  • planning for incorporation of warehouse operations to record serial numbers during packing and shipping

The packaging line equipment and systems, serial number repositories and control systems, scanning systems and hardware need interoperable interfaces, so there is the technical and financial challenge.

Training staff and establishing operations that include serialization responsibilities is a formidable organizational challenge.

Challenges Beyond The 2017 Deadline

EPCIS data exchange will continue to be an issue because it is new to the pharmaceutical systems and their business processes. Thorough testing of data exchange ensues. Technical, labeling and data related exceptions might persist past the deadline, says Sample.

Serialization Challenges Facing Contract Partners

Contract partners face mainly IT integration testing challenges that imply artwork change in development and qualification, says Christopher Howell of Patheon. Best practices for the CMOs and pharma companies include early testing, frequent communication with all stakeholders and standardizing GS1 requirements.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Upcoming DSCSA Deadlines Explained

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The Drug Supply Chain Security Act mandates the prescription drugs be serialized by November 2017.  However, the DSCSA and other serialization regulations are complex and suggest far-reaching consequences and costly upgrades. To simplify the complexity to a certain extent, we can break down the deadlines in smaller milestones. The Food and Drug Administration program, when laid out in pieces, can help us identify these milestones, and perhaps, even see some hidden liabilities.

November 2017 – Serialization Deadline for the U.S.

Everyone in the U.S. drug supply chain knows about this one, and unless the current administration issues an administrative freeze, or the FDA grants a waiver or delays the deadline, all pharmaceutical companies and CMOs have to deploy serialization full-scale by the beginning of November 2017. Some industry actors rest assured the deadline will be delayed because the serialization readiness is far from complete industry-wide. Nonetheless, eight months from now all prescription medicines aka RX products must be serialized.

Note: all homogenous cases must be serialized, too.

November 2017 – Wholesalers Beware of Hidden Liability

DSCSA, as many complex regulations, has implicit and explicit requirements, and one of such hidden November 2017 deadlines affects wholesalers. Some regulations in the drug supply chain’s DSCSA may be addressed directly to manufacturers, and so manufacturers prepare. However, when we look at how the same regulation affects the wholesalers, we can see the wholesalers are liable just as much. Smaller wholesalers may easily overlook these less obvious deadlines. In the meantime, the said deadline is approaching, and unless you are one of the three big wholesalers you might have missed that one detail.

A case in point – wholesalers’ ability to receive the product tracing information, the so-called 3 Ts (transfers, transactions, and trading partners), in electronic format by November 2017.

The direct DSCSA mandate is for the manufacturers:

 ‘‘(C) ELECTRONIC FORMAT. —‘‘(i) IN GENERAL.—Beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, except as provided under clause (ii), a manufacturer shall provide the transaction information, transaction history, and transaction statement required under subparagraph (A)(i) in electronic format” 

Explicitly – for manufacturers, yet implying wholesalers because if manufacturers must send the product tracing in electronic format in 2017, wholesalers must be able to receive the Transaction History, Transaction Information and Transaction Statement in electronic format accordingly. Even though their respective deadline is 2019.

Most big wholesalers have already met this requirement, but the small- and medium-size businesses are still using the paper-based product tracing (packaging slips, invoices).  All pharma supply chain partners, including wholesalers big and small, are liable for failing to meet this requirement after November 2017. This requirement places distributors in a difficult position, and perhaps we might see some regulatory updates requiring full aggregation and transfer of aggregated data long before 2023.

Needless to say, wholesalers have busy compliance schedules ahead:

  • 2017 – electronic product tracing
  • 2019 – trade serialized Rx, verify suspect products by SN ID, returned SN products
  • 2023 – fully interoperable SN exchange, sunset transaction history

2023 – Data Exchange and Full Unit Traceability

By 2023, DSCSA mandates full unit level traceability and data exchange, wrapping up the long journey of DSCSA implementation. Even though the deadline is 2023, the impact on other participants in the drug supply chain can have effects before 2023, just like in the case with 3Ts liabilities.

A Moving Target

In a recent serialization readiness survey, one participant said global serialization compliance is a moving target referring to changing regulations in some countries. The U.S. regulatory climate might spell change regarding DSCSA, too, because the FDA has scheduled to release nine guidance documents. Hence, we might expect some clarifications that might accelerate certain deadlines, or affect trading partners in some other way. Here are the scheduled FDA guidance documents:

  • Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (for pharmaceuticals without product identifiers that are in the supply chain after the serialization deadline is due).
  • Identifying Trading Partners under DSCSA.
  • Product Identifier Requirements under DSCSA – Compliance Policy.
  • The Product Identifier for Human, Finished, Prescription Drugs (questions and answers regarding SNI and other serialization data, as well as barcode carriers).
  • Standardization of Data and Documentation Practices for Product Tracing.
  • Verification Systems under DSCSA for Certain Prescription Drugs.
  • Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate.
  • Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.
  • Fees Incurred Under the DSCSA.
  • Repackaging of certain drug products by pharmacies and outsourcing facilities.

Four of these were due in November 2015, and when published, they could have a serious impact on how some manufacturers approach the full serialization of prescription drugs deadline in November 2017. The industry is looking forward to these documents. Yet, the FDA has not been overly active since President Trump took office. It could be that the new administration is taking its time to appoint the new FDA Commissioner, but it could also have something to do with the Executive Order enacted by President Trump recently. The agencies now need to eliminate two regulations for every new one. A 60-day freeze was ordered on all new regulations. It could be the case that the FDA guidance documents we are waiting for might be viewed as “regulations,” so the FDA would need to repeal eight old guidelines before publishing at least four new ones.

Until any of these speculations are confirmed, and even if you hope the deadline will be delayed, the November 2017 requirements remain mandatory. Therefore, your serialization implementation strategy must be ready by now. You and your trading partners need to test the solution and have time for identifying issues and troubleshooting if DSCSA compliance is on your agenda.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

Serialization Readiness: Takeaways from 2016 Pharmaceutical Serialization & Traceability Report

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The International Quality and Productivity Center released its 2016 Pharmaceutical Serialization & Traceability report [PDF] aimed to assess the current serialization compliance readiness and the main challenges the pharmaceutical industry has yet to overcome, as seen by pharma and biotech professionals. Small to medium (SME) and large pharma and biotech manufacturers, distributors, logistic service providers, technology providers, hospitals, and training institutes took part in the survey.

Approaches to Planning

Companies adopt one of the four most common strategies to reach complete serialization:

  • 69% – Proactive deployment of global track and trace programs that would accommodate regulatory requirements for all relevant countries, future-proofing the system against compliance updates. Such companies rely on the efficient implementation ahead of time to preserve their market share, gain competitive advantage and profit from serialization through added supply chain visibility.
  • Localized, incremental deployment approach sees companies deploy their track and trace efforts by country due to resource limitations and/or strategic preferences that focus on localized decision making.
  • Many small and medium pharma and biotech manufacturers and virtual entities are just getting started to understand and/or plan for the regulatory compliance and related business requirements. About 24% of respondents are at the initial stages of their serialization projects, where companies outline the required infrastructure, evaluate partners and CMOs.  Some manufacturers in this category intent to outsource their serialization efforts.
  • Finally, the 6.3% minority of respondents report their companies have not started a formal serialization compliance program at all, yet. These companies plan to outsource the entirety of their serialization decision making. Some companies in this group believe the enforcement of serialization regulations will be delayed.

Serialization Implementation Progress

  • 25.7% of respondents said their companies had started serialization rollout across multiple sites globally.
  • 21.6% said their companies were currently looking for solution providers.
  • 20.3% replied their companies were in the early stages of planning for serialization.
  • 13.5% said their companies had started the pilot rollout in one site.
  • 13.5% of respondents said their companies have fully implemented serialization.
  • 5.4% have not started thinking about it, yet.

The late adopters, says the report, face a daunting amount of complex tasks they need to deliver in a short time, with no time for identifying or troubleshooting issues before the deadlines. A total of 47.3% of respondents has not deployed a pilot project, yet.

Challenging Regions

Asia is seen as one of the most challenging regions for planning the serialization strategies. Europe and the U.S. are perceived as the regions with harmonized regulations.  Overall, the number of regulations in different countries presents a major challenge. There are over forty regulations in different countries with varying deadlines from as early as 2017 to deadlines not set, yet. These local regulations are different in complexity and detail, and grasping it all requires significant resources.

Pressing Deadlines

The challenge for the EU and US regions is the highly pressured deadlines, which constitute one of the major roadblocks to serialization compliance. As November 2017 approaches, and the DSCSA requires that all manufacturers implement product serialization, many companies report being late.

11.8% report full readiness, 4.4% need less than six months, 20.6% need 6-12 months more to reach full serialization.

Approximately 40% of respondents need 18-24 months or longer to implement serialization fully, which means the majority of them will likely be late by DSCSA serialization deadline in November 2017.

The EU Falsified Medicines Directive (FMD) is perceived as an arduous process difficult to implement, requiring large, invasive and expensive packaging lines re-engineering. The EU FMD deadline is set for February 2019, and 60% of respondents believe they have just enough time for proper testing of serialization. 12% said the time until 2019 is insufficient.

Implementation Status

33.3% of respondents don’t know how many packaging lines they will need to upgrade in response to serialization. 35.9% will need to upgrade less than 10 packaging lines, 28% – 10-99 lines.

Early adopters add serialization capabilities to most of their lines, sometimes consolidating lines with similar requirements to save on the upgrades in the future as new location-specific regulations emerge over time. Early adopters see significant benefits of serialization beyond compliance. However, the SMEs trail behind in upgrading their packaging lines, and the key reasons are:

  • changing regulations in some countries
  • no clear guidance on aggregation & grandfathering
  • industry standards set by industry leaders, and not the governments
  • hopes the deadlines will be delayed
  • the deficit of resources

The report concludes most global health agencies responsible for enforcement of serialization regulations might have to delay deadlines eventually, as the industry is far from being ready.

Major Roadblocks to Serialization

Compliance is a top concern with regards to the implementation of serialization efforts, as regulations keep changing continuously in various countries. Compliance and integration with third parties such as CMOs, 3PLs and CFAs is another resource-hungry roadblock alongside the cost increase stemming from multi-region compliance efforts.

Optimal use of existing equipment and technologies (41.7%) and integration with legacy systems (35.4%) are among top challenges companies see in their serialization efforts. 10.4% report having issues with cross-site coordination for the serial generation for similar product lines; 6.3% with the creation of unique serialization codes for individual products during production, and 6.3% listed high-speed printing and verification of codes.

Cost concerns revolve around training and associated downtime, and the challenge of fully understanding the serialization costs and potential ROI beyond compliance.

Planning and deadlines are among the main challenges, with some respondents noting the difficulty of implementing track and trace and serialization simultaneously, choosing reliable partners, and adhering to requirements in time. Many SMEs fear that CMOs will not reach serialization compliance in time, which may have serious consequences.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza

FDA Releases DSCSA Guidance Agenda for 2017

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The FDA recently released the agenda for the Drug Supply Chain Security Act (DSCSA) guidance documents it plans to release in 2017. The document outlines revised drafts, and new guidances CDER will be releasing, with some of the documents already issued.

The FDA is good at keeping the suspense, as the agency took its time publishing some of the last year’s guidance documents until December 2016, when it went on a publishing blitz. The agency issued four new draft and final guidance documents for drug compounders and two track-and-trace implementation programs under the DSCSA – Identification of Suspect Product and Notification Guidance for Industry [PDF]. Read our coverage and insights here.

Now, let us briefly see the scope of the planned draft guidance documents related to DSCSA and supply chain security we can expect this year:

Annual Reporting by Prescription Drug Wholesalers and Third-Party Logistics Providers: Questions and Answers. This particular draft guidance is new, published on January 10, 2017.

Note: this draft guidance impacts “authorized party” for DSCSA transactions (not traceability, serialization or verification regulations or implementation), provided the data be in the FDA licensure database.

It addresses the reporting procedures, related questions and details on the FDA’s expectations as to what information the agency wants to see in the annual reporting for licensure wholesalers and third-party logistics providers have under DSCSA. The convenient Q/A format helps you navigate the information with ease, and describes:

  1. what entities must report and under what circumstances (manufacturers distributing their produce, third-party logistics providers).
  2. means of reporting (XML file via FDA ESG, or CDER website).
  3. what information must be provided in the reports, such as licenses.
  4. when the agency expects the reports (annually is obligatory while there may be incremental updates).

Category – Procedural

  • Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (for pharmaceuticals without product identifiers that are in the supply chain after the serialization deadline is due).
  • Identifying Trading Partners under DSCSA.
  • Product Identifier Requirements under DSCSA – Compliance Policy.
  • The Product Identifier for Human, Finished, Prescription Drugs (questions and answers regarding SNI and other serialization data, as well as barcode carriers).
  • Standardization of Data and Documentation Practices for Product Tracing.
  • Verification Systems under DSCSA for Certain Prescription Drugs.
  • Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate.
  • Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act.

Category – User Fees

  • Fees Incurred Under the DSCSA.

Category – Pharmaceutical Quality/Manufacturing Standards (CGMP)

  • Repackaging of certain drug products by pharmacies and outsourcing facilities.

As you can see, the FDA plans to issue quite a handful of DSCSA-related guidances this year. It is worth noting the majority of these documents are relics from the past year’s agenda except for a few new ones. The new additions are The Product Identifier for Human, Finished, Prescription Drugs Q/A, Identifying Trading Partners Under the DSCSA and the Fees Incurred Under the DSCSA. The rest were initially scheduled for release in 2016; see our brief roundup of the last year’s list here.

Considering the FDA is “a little” overdue with many of the items on its 2016 agenda, there does not seem to be any unexpected items on this year’s list. There are many questions pending that the agency needs to clarify. For example, the industry is expecting for the guidance on verification systems to detail on the definitions of a diverted product and a fraudulent transaction under the DSCSA definition of the suspect and illegitimate products. This topic is important, and the agency needs to address the proliferation of shortage drug diversion and price diversion schemes. The industry is hopeful the new guidance can change that situation.

Typically, the wholesale distribution of prescription and shortage drugs by pharmacies (including those licensed for wholesale distribution) is prohibited according to provisions of contracts with primary wholesale distributor suppliers. Hence, the FDA should define such activity as a diversion. Another event that is supposed to be designated as a diversion is the wholesale distribution of discounted produce by pharmacies that violate their own-use and/or closed-door pricing arrangements with primary wholesalers. More so, the drugs diverted by pharmacies engaging in such schemes are very likely to be the subject of fraudulent transactions. Therefore, the FDA should define them as suspect products under DSCSA. Or, so we expect.

If the agency gives more attention to the general diversion schemes in its future verification systems guidance, it will motivate the trading partners to find working solutions to this problem on their end. For example, restricting the shipment of products to pharmacies known to engage in such diversion schemes would be a strong message.

We will keep you updated as the agency releases new guidance documents from the list, providing the digestible overview of their impact on the drug supply chain.

Find the full FDA Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2017 text here.

About TrackTraceRx Suite

Other solutions on the market today are totally fragmented by only providing one piece of the puzzle. Pharmaceutical companies today are stuck subscribing to multiple services, accessing different companies for support and paying thousands of dollars to integrate different systems. The TrackTraceRx Suite is a game changer by combining the TrackTraceRx Traceability Solution, a ERP, and a Commerce Platform completely integrated out of the box. This eliminates having to deal with multiple support, feature services and integration costs.

Please watch our video at http://www.tracktracesuite.com

About the Author

Chris Souza is the Co-Founder of TrackTraceRx. He loves all things traceability in order to keep products safe! Follow him on Twitter

Chris Souza