TrackTrace Rx

Month: January 2015

How to Use the Extension in Deadline for DSCSA Data Exchange Enforcement to Your Advantage

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Consider it a New Year gift, a modern-day miracle, or prayers being answered – the FDA, earlier this month, announced its intent not to take action against manufacturers, wholesale distributors and re-packagers who are still struggling to implement a robust transaction data exchange system within their respective portion of the medical supply chain. The grace period for achieving backward compliance now extends till the 1st of May, 2015 – a good four months beyond the original deadline the 1st of January, 2015.

So why did the FDA announce the postponement in this first place? Grave concerns about the practical consequences of incompliance – drug shortage and medical supply chain disruption – were initially expressed by the Healthcare Management Distribution Management Association. The same was echoed by a number of manufacturers, wholesale distributors and re-packagers highlighting the unforeseen complications associated with the exchange of the three T’s namely Transaction Information, Transaction History and Transaction Statements. To minimize possible disruptions in the dissemination of the prescription drugs as highlighted by the stakeholders, the FDA realized it is only logical to lend the trade partners some extra time.

And what exactly is it that makes the data exchange process so complicated? Well – just about everything. The Transaction Information component of the data, albeit the most straight-forward of the lot, consists of product name, unit numbers, strength, dosage, size, container size, lot number, transaction date, shipment date, business name from and to. The Transaction History includes the Transaction Information for each transaction going all the way back to the manufacturer. Finally, the Transaction Statement ensures that a number of exhaustive ownership transference checks are strictly followed.

It is, however, important to understand that the announcement by FDA is, in essence, an extension in the compliance-check deadline, and not an extension in the actual implementation of the transactional data exchange mechanism. A plethora of companies are unaware that even though the FDA is not enforcing the law until May, the law is in full effect since 1st January, 2015. This means that coming May, the FDA has every right to inspect T3 data all the way from the month of January 2015 to any given point in time. What companies ought to be doing right now is generating, accumulating and storing transactional data right away. This is bound to do away with backlog that might plague the company operations at a later stage.

At the heart of seamless transactional data exchange lies the core transport method used to relay information to corresponding trade partners. The DSCSA law is quite flexible in terms of the recommendations for the transport method and even allows for conventional methods to be used – paper, legacy invoices, pdf receipts, emails are all acceptable means of transport under the act.

There is a catch to these dated methods though – the DSCSA act required transactional data to be kept safe for a span of six years per transaction. And the said condition is set to transition from the per-lot basis of today to a per-packaging basis in the coming decade. Simply printing and storing these documents physically is bound to be a menace, especially for full six years. Let alone the timely retrieval of records if such a print based solution were to be implemented, the storage alone poses stern environmental threats and ridiculously high financial overheads. The most appropriate modern-day solution is to make the most out of secure, cloud-based web portal for transaction data exchange – a server where transaction information is secure, stored in a disaster-proof, eco-friendly manner and available for retrieval within fraction of a second, 24/7 round the year.

The extension in the deadline for DSCSA compliance is a blessing in disguise for manufacturers, wholesale distributors and re-packagers who are yet to implement transaction data exchange mechanism within their operations. Accomplishing compliance is not easy, and this is where we, at TrackTraceRx, come in. Our state-of the-art, cloud-based server meets all the transaction data exchange requirements laid down in the DSCSA act, securing compliance for your organization within merely 3 to 4 working days. TrackTraceRx server allows for advance features including seamless partner integration and transactional, e-commerce portal setup all at an amazingly affordable price plan.

Make sure you make the most out of the awarded grace period. Rather than procrastinating the implementation till the very month of May, the best thing would be to accumulate and store transactional data right away. Feel free to drop us a line and discover how we can help you with accomplishing exactly that all within a matter of 3 to 4 days.

How to Notify the FDA of a Illegitimate Product

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One of the questions we get at TrackTraceRx is, “how do I notify the FDA if i discover a counterfeit product within my supply chain?”

The DSCA section 582(h)(2) requires the FDA to issue guidance to aid trading partners in identifying a suspect product. Let’s first identify what the FDA considers a suspect product.

a – is potentially counterfeit, diverted, or stolen.

b – is potentially intentionally adulterated such that the product would result  in serious adverse health consequences or death to humans.

c – is potentially the subject of a fraudulent transaction.

d – appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.

Pretty clear guidelines for you to classify a product as a suspect product. Once you have determined that the product is a suspect product, here is what you need to do next.

Quarantine

Quarantine the product and conduct an investigation to determine if the product is a illegitimate product.

The DSCSA defines a illegitimate product as:

a – counterfeit, diverted, or stolen.

b – intentionally adulterated such that the product would result in a serious adverse health consequences or death to humans.

c – is the subject of a fraudulent transaction.

d – appears otherwise unfit for distribution such that the product would be reasonable likely to result in a serious adverse health consequences or death to humans.

Identification of a Suspect Product

Trading partners must have systems in place that enables them to start investigating a suspect product either by determining that the product is suspect or by a request from the FDA. The trading partner must then quarantine the product and work with their respective trading partners within the supply chain. Here are some best practices you should follow to identify a suspect product:

1. Exercise vigilance

2. Maintain awareness about suspicious activity

3. Look our for potential threats to your supply chain

4. Devote attention and effort to detect suspect products

Product Sourcing:

Receiving sales offers from a new trading partner or unknown source unwilling to provide a transaction history with the product being purchased.

Suspicious Appearance, label misspellings or not following usual color, font and images. Also packages that are missing key information such as a lot number and a different identification number rather than the National Drug Code (NDC)

Trading partners should closely examine the package and look for signs that is has been opened, broken seal, damaged, repaired and altered. Trading partners should also look for missing information such as a lot number, lot identification, NDC or strength of drug.

Notifying the FDA

Once you have identified that a product is “illegitimate”, the trading partner has 24 hours to notify the FDA and their respective trading partners.

Trading partners should have a system in place that can automatically send out a notification to the FDA (like the TrackTraceRx Portal). If not, the trading partner will have to perform this manually by accessing the FDA’s web site: http://www.accessdata.fda.gov/scripts/cder/email/drugnotification.cfm and follow the instructions to construct their own form. (The form on the FDA web site is only a draft.)

Trading partners will then have to create and manually fill out a form (roughly four pages long). This form will include:

Type of Notification:

This form will require initially that you identify what type of report this is:

a – Initial notification – first notification to the FDA of an illegitimate product or product with a high risk of illegitimacy.

b – Follow-up Notification – subsequent notification to FDA, related to an initial notification already submitted to the FDA.

c – Request for Termination – request for consultation with the FDA to terminate a notification of an illegitimate product or production with a high risk illegitimacy.

Classification of Notification:

Counterfeit – A product in your possession or control is determined to be counterfeit.

Diverted – A product in your possession or control is determined to be counterfeit.

Stolen – A product in your possession or control is determined to be a stolen product.

Intentional adulteration – A product in your possession or control is intentionally adulterated such that use of the product would result in serious adverse health consequences or deaths to humans.

Unfit for distribution – A product in your possession or control appears otherwise unfit for distribution such that use of the product would be reasonably likely to result in serious adverse health consequences or death to humans.

Fraudulent transactions – A product in your possession or control is the subject of a fraudulent transaction.

Description of Product:

A description of the illegitimate product will need to be added. The following description will need to be added such as, Generic name, Trade name, Drug use, Drug description, Strength, Dosage form, Quantity, NDC, Serial, Lot, and Expiration.

Company and Facility Information

The Company name of the Trading partner and address will need to be provided that is responsible for the product or for the notification. A unique identifier for the facility should be provided. For now, the only identifier that the FDA accepts is A D-U-N-S number. If the facility does not have a D-U-N-S number then this field should be left blank. A D-U-N-S number can be obtained for no cost from Dun & Bradstreet for free.

The name of the person needs to also be reported that submitted the notification. This person will also need to provide their email and telephone information.  Finally, a category for the company needs to be submitted. This category will need to be one of the following:

Manufacturer, Wholesale distributor, Dispenser, Repackager.

Emailing the FDA

Once the form is complete, the Trading partner will have to email the form to  DrugNotifications@fda.hhs.gov

Free DSCSA Evaluation

With the deadline fast approaching, contact TrackTraceRx today to receive a free evaluation of your DSCSA current policy and procedures. This free consultation will allow you to have a piece of mind that you are following the correct procedures in order to meet ALL DSCSA requirements. TrackTraceRx will also provide you with a FREE Standard Operating Procedure (SOP) template which is required by the DSCSA during a FDA inspection.

DSCSA Q/A With Dirk Rodgers from RxTrace

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Recently I contacted Dirk Rodgers from RxTrace  (rxtrace.com) and asked him a few questions. He was kind enough to get back to me.

Chris –  If a wholesaler purchases directly from the manufacturer do they need to pass down the 3Ts even if they are an exclusive distributor?

Dirk –  In my opinion, exclusive distributors must receive the 3Ts from the manufacturer.  The HDMA appears to disagree with my opinion.  You will need to figure out who you agree with.

Chris – To be an exclusive distributor does it mean that  you just purchase directly from the manufacturer? or do you need an agreement signed between both parties?

Dirk – If you are acting as a manufacturer’s exclusive distributor, you would have a contract with that manufacturer stating that fact.

Chris – So in this case you would need to let your downstream trading partners know the reason why some TI/TH are not being passed?

Dirk – Yes, you will need to inform your customers that you are the exclusive distributor for a given product so they know what to expect from you and how they must construct their 3Ts.

Chris – When a wholesale distributor is simply exporting internationally? Do they need to pass any 3Ts?

Dirk – The FDA needs to provide guidance on this question.  The DSCSA does not have an explicit exemption for this type of transaction so you should assume you need to document those sales and keep a copy of the 3Ts just like any other sale.

Chris – A lot of companies are complaining that they are showing their customers who their supplier sources are when passing the 3Ts. They fear their customers will stop buying from them and start sourcing from their suppliers. Is this just a reality of the industry or is there anything they can do to protect this information?

Dirk – It may be a valid complaint, but there is nothing you can do about it.  The law requires everyone to receive the full supply chain transaction history going back to the manufacturer, repackager, or exclusive distributor of the manufacturer.

Chris – If a trading partner finds a product illegitimate, based on the law they need to report to the FDA. How is this process done?

Dirk –  See the FDA guidance document about suspect products here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400470.pdf