TrackTrace Rx

Month: April 2015

HDMA Updates their Q/A for the DSCSA

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The HDMA has updated their Q/A regarding the DSCSA. It is a great read and i recommend everyone to check it out. For the entire document please contact us at info@tracktracerx.com

Here are a few Q/A from the HDMA:

How should wholesale distributors handle shipping a discrepancy? Shortage, Damage, Overage?

FDA has not addressed discrepancies or the need for changes to correct information in TI/TH/TS. Certainly the DSCSA requires that accurate TI/TH/TS be passed, received and stored, so if errors are discovered, they need to be corrected. In the HDMA ASN Exceptions Guidelines for the Drug Supply Chain Security Act (“ASN Exceptions Guidelines”), HDMA describes various scenarios in which there is a discrepancy or error in TI/TH/TS, and proposed responses/corrective actions.

If a wholesale distributor receives more product than it receives data for (e.g., it orders 150 units but only receives TI/TH/TS for 100 units), how does the wholesale distributor handle the 50 units for which it does not have data? How should the manufacturer correct the missing data?

The DSCSA provides that a wholesale distributor may not accept ownership of a product (that is, accept product into inventory) unless, prior to or at the time of product receipt, it has also received sufficient transaction data (TI/TH/TS). So, in the above example, the wholesale distributor could accept ownership of 100 units because it received transaction data for 100 units. Before the wholesale distributor could accept ownership of the final 50 units, the manufacturer would need to send the transaction data for those 50 units to the wholesale distributor. The ASN Exceptions Guidelines addresses this and other discrepancy issues in more detail.

If a wholesale distributor receives less product than it receives data for (e.g., it orders 300 and receives TI/TH/TS for 300 units but only 200 units are shipped), how should the wholesale distributor handle the discrepancy? How should the manufacturer correct the missing units ordered?

As noted in the response to Question 25, the DSCSA prohibits a wholesale distributor from accepting ownership of a product unless it has received sufficient transaction data. In the present example, the wholesale distributor received transaction data for the 200 units shipped, so the wholesale distributor may accept ownership of the 200 units. For the quantity not shipped, the parties would use standard business practices to resolve the shortage. The ASN Exceptions Guidelines addresses this and other discrepancy issues in more detail.

My shipment contains exempted products or other products not covered by the DSCSA, can I use the same ASN?

Yes you can, however, you only need to send TI/TH/TS for products covered by DSCSA.

My shipment contains items that are exempt from DSCSA. Can I use the same ASN?

Yes you can; however, you only need to send TI/TH/TS for products covered by DSCSA. Distributors typically ‘flag’ exempt items in their internal systems based on information from the manufacturer for each product. (For example, manufacturers will be prompted when completing the HDMA Standard Product Information Form for Pharmaceutical Products [the ‘HDMA New Item Form’] to indicate if that particular product is exempt from DSCSA requirements.)

Would an ASN from a manufacturer include more than one product/different lots, etc.? If there are different products/different lots, do they provide the TS at the item/line level?

Yes, an ASN can still accommodate multiple products and different lots. There is line item detail which can provide a TS, including direct purchase statements and other detailed information (name, NDC#, lot #, container size, number of containers, etc.) about the product. The TS at the shipment level directs the receiver to line level for detailed direct purchase statements.

What will the receiving party do if an ASN is not received at the time the shipment arrives at the receiving party’s dock? Hold-off on formal receipt?

The law states that “A wholesale distributor shall not accept ownership of a product unless the previous owner prior to, or at the time of, the transaction provides the transaction history, transaction information, and a transaction statement for the product, as applicable under this subparagraph.” § 582(c)(1)(A)(i). This means that the wholesale distributor must have TI/TH/TS at the time of or before the change of ownership. Trading partners will need to determine how the seller will provide TI/TH/TS to the receiving party (whether by paper, ASN or other form) so that the receiving party may accept ownership of the product.

Because the time at which an ownership change occurs varies based upon commercial agreements between the parties, if product were to arrive at a buyer’s warehouse without TI/TH/TS, holding off on the physical receipt of product would be a business decision of the individual trading partners. Certainly if the buyer physically receives the product prior to receiving TI/TH/TS, the goods would need to remain quarantined until receipt of TI/TH/TS so that ownership could lawfully be accepted. See HDMA’s ASN Exceptions Guidelines for more details.

Are products designated for destruction subject to TI/TH/TS requirements? There is a change of ownership but no exchange of money.

Products designated for destruction are covered by the DSCSA’s “non-saleable returns” provisions. Under DSCSA, the transfer of product by a manufacturer, wholesale distributor, or dispenser (with or without the use of a returns processor) for destruction is exempt from the requirements to pass TI/TH/TS.

Are items distributed for emergency medical reasons subject to TI/TH/TS requirements?

The distribution of product for emergency medical reasons (which does not include a drug shortage) is exempt from the definition of “transaction” (§ 581(24)(B)(iii)), and thus exempt from the requirements to pass TI/TH/TS.

What transaction data (TI/TH/TS) needs to be passed in the following scenario: Affiliate Manufacturer to Affiliate Repackager to Wholesale Distributor?

In this scenario, one affiliate manufactures the finished product and sells to the other affiliate, who is the repackager. The repackager packs into NEW finished product packaging and sells to wholesale distributors.

First, because the manufacturer and repackager are affiliates, the manufacturer’s transfer of product to the repackager qualifies for an exemption from the definition of “transaction.” Thus, the manufacturer would not have to pass TI/TH/TS to the repackager. Second, the repackager would have to pass TI/TH/TS to the wholesale distributor, with TH starting with the repackager. Finally, DSCSA § 582(c)(1)(A)(ii) [21 U.S.C. 360eee-1(c)(1)(A)(ii)] creates the “direct purchase option” under which purchases made directly from (i) the manufacturer, (ii) the exclusive distributor, or (iii) a repackager that purchased direct from the manufacturer, qualify for abbreviated TI and TH. Under this transaction scenario, because the wholesale distributor is purchasing from a direct-purchase repackager, the wholesale distributor would not have to include the lot number in TI or TH, and would not have to include the transaction date or shipment date (associated with its acquisition of product from the repackager) in TH.

How should wholesale distributors address the gap between the requirement for wholesale distributors to provide TI/TH/TS on January 1, 2015*, and the requirement for dispensers to receive it on July 1, 2015?

Trading partners will need to decide how they wish to address this gap as a business matter.

For a given transaction, when does ownership transfer take place?

Supply agreements may specify different points for actual transfer of title of goods, e.g., title may pass when goods leave the shipper’s dock, when the goods are delivered to the buyer’s dock, or when the buyer opens the truck, inspects the delivery and accepts it. “Transaction” is defined in DSCSA as “the transfer of product between persons in which a change of ownership occurs.” § 581(24)(A); 21 U.S.C. § 360eee(24)(A). HDMA has recommended that FDA permit trading partners to use any commercially reasonable and supportable transaction date.

Can you provide clarification on transaction date and shipment date as it relates to the ASN and packing list?

For the purposes of the DSCSA, transaction date is the date of ownership transfer as recognized by the trading partners. The DSCSA does not define specifically how a company is to determine transaction date. HDMA has recommended that FDA permit trading partners to use any commercially reasonable and supportable transaction date in whatever document is sent, whether the ASN or a packing slip. In the ASN, the segment containing the transaction date is the Beginning Segment Date or “BSN”.

When a seller prepares a packing list, the shipment date is unknown. It might ship the same day or within the next couple of days. Which date should be printed on the packing list? After the ASN is sent, the seller has an actual ship date. Does the ship date in the ASN need to match the date on the packing list? If so, how can this be achieved?

The transaction date must be included on whichever document/documents that the seller designates to satisfy the DSCSA requirement to pass TI/TH/TS (whether packing slip, ASN or other). DSCSA does not require that the dates used on the packing slips and ASNs match, nor does HDMA offer any guidance on this.

FDA recognizes 10-digit NDC numbers, yet certain customers require 11 digit or 12 digit NDC numbers for a variety of business reasons. What NDC number should be included in the TI/TH in order to comply with the DSCSA requirements?

Trading partners should use the same NDC number (whether 10 or 11 digits) when placing orders and sending ASN’s.

What is a “return” under the Drug Supply Chain Security Act (DSCSA)?

“Return” as used under the DSCSA means providing product to the authorized immediate trading partner from whom such product was purchased or received, or to a returns processor or reverse logistics provider for handling of such product. §581(17). Sending product to a trading partner from whom the product was not purchased is a new transaction and not a return. As discussed in Question 13 below, the DSCSA provides streamlined procedures for certain product movements that meet the definition of a “return.”

What requirements apply to nonsaleable returns to or from a wholesale distributor?

Under the DSCSA, a wholesale distributor may return a nonsaleable product to the manufacturer or repackager, to the wholesale distributor from whom such product was purchased, or to a person acting on behalf of such a person, such as a returns processor, without providing TI/TH/TS.

Further, the DSCSA does not require a dispenser to provide TI/TH/TS when it returns nonsaleable product to the wholesale distributor from whom it acquired the product. Implicitly, this means that the wholesale distributor is relieved of any requirement to receive TI/TH/TS when accepting the nonsaleable returned goods from the dispenser. Further, we believe this transfer may be outside the scope of the DSCSA because when a drug is nonsaleable, it is not for “administration to a patient.” If a drug is not for administration to a patient, it does not meet the definition of “product” under the DSCSA in §581(13).

For the entire HDMA Q/A please contact us at info@tracktracerx.com

Understanding Interoperability in the Context of the DSCSA

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Organizations that make up the US drug supply chain are left with just two more weeks to meet the FDA’s extended deadline of 1st May, 2015 for securing compliance with the transaction data exchange guidelines mentioned in the DSCSA. As part of the said act, pharmaceutical manufacturers, wholesale distributors, dispensers and re-packagers are required to generate, track and store Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) for each and every shipment – over the period of a good six years.

While expounding on the details of the transaction data exchange set to take place between various trading partners, the text of the DSCSA law refers to the term ‘interoperability’ a number of times, without explicitly defining it. This pretty much leaves the core definition of the term up to the FDA.

Before trying to making sense of the FDA’s definition of the ‘interoperability’, it’s worth revisiting the timeline of the events chalked out in the DSCSA for establishing standards around interoperable transaction data exchange – including TI, TH and TS. Back in November 2013, President Obama signed the DSCSA into law. One year down the road, the FDA published a draft that provided guidance on the initial standards proposed for the interoperable exchange of transaction data. It is this very draft that needs to be conformed to for meeting the May 2015 data exchange requirements. Moving forward, the FDA is now required to hold a public meeting to collect input on the core system that will support secure, interoperable data exchange among trading partners anytime between 2014 and 2021. To seal the deal, the FDA is obligated to publish final guidance on the standards for industry-wide exchange of interoperable electronic data, no later than November, 2022. For streamlining the standardization process, the FDA would obviously want to collect information from as many sources as possible pushing the finalization of the definition to early 2021 – around six years from today.

Let’s have a closer look at interim definition that is currently in place. As per the initial standard draft, interoperability is all about the ability to exchange product tracing information among trading partners, making sure that the said is done accurately, efficiently and consistently. For a compliance system to be interoperable, the trading partners should be empowered to successfully capture and maintain the product tracing information.

While the existing definition might be suitable for the current phase of implementation, it still does not specify the architecture of a single, standardized underlying electronic format based upon which the transaction exchange data is to be engineered. Till that is done, there are going to be inefficiencies plaguing the compliance mechanism in one form or the other, resulting in lost time and increased incurred costs. A finer definition of operability is what the FDA needs to work towards – that’s something the FDA totally understands and is already planning to do in the final guide for transaction data exchange.

For now, your goals should be to choose a DSCSA provider that can start laying down the framework of what is required to exchange data at a batch lot level and have a foundation ready for serialization. This DSCSA provider should be able to:

1. Accept T3s,

2. Provide portals for your upstream and downstream trading partners

3. Store data for up to 6 years

4. Provide an audit system to handle T3 data

5. Manage electronic communication such as EDI and handle low end T3s such as paper format

6. Integrate with your ERP/WMS

7. Provide visibility for your supply chain

Data Exchange

The United States is one of the twenty pharmaceutical markets in the world that require constituent organizations making up the respective drug supply chain to conform to serialization and data exchange requirements.

In regards to electronic product tracing, the US drug supply chain is governed by laws laid down by the Food and Drug Administration over the entire implementation period. The Drug Supply Chain Security Act, signed into law back in November 2013, is the core governing document set up by the FDA to regulate generation, serialization, tracking, exchange and storage of supply chain data at the shipment level. The FDA also enjoys full legal authority to delineate other methods of compliance with the said law.

Here’s a quick breakdown of the most important aspects of the traceability data exchange architecture and the DSCSA you need to consider while securing compliance for your organization.

Serialization: 

The DSCSA puts forward stern requirements for serialization of prescription drugs that are related directly to human health. With the serial numbers assigned by the manufacturer of the drug itself, the core serialization process is to be carried out at both the item and the case level. The data bearing mechanisms for serialization, recommended by the FDA, comprise of: a two-dimensional data barcode at the item level, a one-dimensional barcode at the case level.

Furthermore, a standard numerical identifier as per law is also required to be included along with each package – comprising of a National Drug Code and the 20 digit alphanumeric serial number. The long-term objective here is to make the National Drug Code a part of the Global Grade Identification Number coupled with a 12-digit numeric serial number.

Supply Chain Data:

Documenting the 3Ts, namely the Transaction Information (TI), the Transaction History (TH) and Transaction Statements (TS), is an important requirement laid down by the FDA in the DSCSA. Beginning 1st January 2015, not only should the TI, TH and TS be generated, provided and captured with each instance of ownership change, but the documentary evidence at each step should also be retained for a six years as well.

Product owners and trading partners must also verify the 3Ts and provide the same to the FDA or other relevant authorities in event of an investigation. Guidelines expounding the nitty-gritties related to unit-level tracing interoperability are in the pipeline and are expected to be out around the year 2022.

Funding: 

Supply chain organizations are expected to fund compliance systems by themselves – the government is not liable for providing funds of any sort for setting up compliance systems.

Governance: 

The existing implementation of any compliance system is based solely upon the understanding of the DSCSA statute by the organizations making up the drug supply chain. A specific data architecture or governance model has not been specified by the FDA just yet – the setting up the said is still in the works.

The FDA is actively seeking input from the pharmaceutical industry via workshops and respond to comments, and encourages participation of the supply chain constituent companies in pilot studies and trainings to speed up the finalization of the governance documents. The extended deadline for the enforcement of the DSCSA, 1st May 2015, is just two weeks away. It is important that your organization start now before being put in risk of sanctions or fines.

Challenges with Using ASN/EDI for Passing Lot-Based DSCSA Transaction Data

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The night before last Christmas, the FDA did what it could to reduce the unrest in the drug industry by extending the enforcement of the DSCSA to 1st May, 2015. Well, time flies … the revised due date is just four weeks away.

In an attempt to put out the fire, some companies that constitute the medical supply chain are passing the required transaction exchange data to their respective trading partners using Advanced Shipment Notices.

An ASN lies in the broad category of electronic data interchange documents, and is a notification of deliveries that are pending. In essence, an ASN is similar to packing list and is typically sent out in an electronic format. An ASN can be used for a variety of purposes from listing the goods in a shipment to additional information including order details, product description, packaging type, physical depiction, carrier particulars, and arrangement of goods within the transportation used.

A number of companies are thinking of opting in for ASNs to carry the core transaction exchange data mandated by the Drug Supply Chain Security Act – the Transaction Information (TI), the Transaction History (TH) and the Transaction Statements (TS) are to be sent out to trading partners as instances of Advanced Shipment Notices.

While ASNs might be good enough to temporarily serve the purpose of choreographing transaction data exchange, the question is that are ASNs an actual long-term solution to the fundamental problem of information exchange?

The initial guess was that once companies begin using ASNs to exchange lot-based transaction data, they will most likely continue with the same for at least five years down the road. But surprisingly, that has not been the case. Companies that initially chose ASNs are finding it extremely difficult to continue with the same for carrying compliance data without hiccups. That’s because the DSCSA-specific solutions deployed by the companies to generate ASNs have been built with poor understanding of the underlying EDI standards. EDI itself is not the right way to pass information mandated by the DSCSA.

I will give you an example. At TrackTraceRx we deal with our clients EDI/ASN integration on a daily basis. One of our clients upstream trading partner who happens to be a big deal in the industry was not passing lot numbers in their ASN. They were compliant, as they purchased directly from the manufacturer and was passing a direct purchase statement. However, this definitely posed a challenge as without the lot number, we were not accurately able to map the shipment order quantity with their appropriate lot number. With the DSCSA not requiring to pass the lot number electronically adds a manual process within the supply chain. Our client needed to receive the shipment and manually add a lot number. We reached out to their upstream trading partner and asked if they could add the lot number within the ASN. Their response:

“A note regarding lot number: As per the DQSA, title II DSCSA, wholesalers are not required to pass lot or original transaction date if the wholesaler purchases direct from the manufacturer, or a repackager that purchases direct from the manufacture, or an exclusive distributor.  Upstream Trading Partner only purchases from these entities and is not required to pass the lot number or original transaction date.

And …

You are correct about the exclusion of the Lot and Expiration on the ASNs by us. We do have plans to include these pieces of data into the ASNs in a future phase. Our DQSA project team is currently working through the inclusion of Lot and Expiration so that it complies with the FDA deadline and requirements. Any information regarding this will be passed onto business partners once said information is available for distribution.”

Interestingly enough, we received two answers. One that corresponds to the law, and the second is acknowledging that this could cause a problem and that they are working on adding this information to help their client and probably their other clients who have complained about the same issue.

At TrackTraceRx we were able to create a solution within our portal to handle  missing lot numbers in EDI/ASNs. This is just one example of the challenges facing our supply chain by not having a standard defined.

Turbulent experience with ASNs should serve as an eye-opener for others. Whole sale distributors and pharmaceutical manufacturers who previously relied on ASN for conventional financial purposes cannot simply extend the same for transaction data exchange. With additional requirements such as saving pertinent data for six years, securing the relevant information, printing the documentation, and integration with ERP software, ASN clearly doesn’t cut it anymore.