TrackTrace Rx

Month: March 2015

How to Fill out your Wholesale Distributor/3PL Annual Report to the FDA

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From our latest post titled “Wholesale Distributor Annual Reporting Deadline” where we go over the deadline of reporting the necessary information to the FDA on March 31st. We have gotten swamped with request on how to actually fill out the form. We at TrackTraceRx have decided to publish a step-by-step guide.

Step 1.

Visit the login portal: https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:17509663700106:::::

Below you will see the FDA CDER portal. (click to enlarge) Chances are you probably won’t have an account yet. Click on the Create Account link.


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Step 2.

Register for an account. https://direct.fda.gov/apex/f?p=100:5:17509663700106::NO:::

Fill out your company information that is appropriate. You will need a DUNS number to proceed. You can get a free DUNS number at http://dnb.com/. Select the WDD/3PL check box and click submit. Momentarily the FDA will send you your CDER number and credentials on your email.

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Step 3.

Visit again the login portal: https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:17509663700106:::::

Type in your credentials and hit login.

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Step 4.

Once logged in, you will be able to see any previous submittal. Click on the WDD/3PL link.

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Step 5.

Next, you will select “Create a new WDD/3PL using a blank form. Click “continue”.

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Step 6.

You will now be in the SPL submission section. Fill out the appropriate information and click “Save Draft”. Once a draft is saved, you need to add a facility. Click the “Add a Facility” button in the bottom.

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Step 7.

You will now be able to add multiple of your facilities. Fill out the appropriate information. Add any different trade names per facility and select if it is a WDD or 3pl. Click “Save Facility” at the top right.

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Step 8.

Once the facility has been saved, you can add additional ones or click “Submit SPL”.

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Step 9.

Once submitted, you should see your annual report submittal.

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Wholesale Distributor Annual Reporting Deadline

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The Annual Reporting by Prescription Drug Wholesale Distributors and 4 Third-Party Logistics Providers deadline will be on March 31st 2015. This means that if you are pharmaceutical wholesaler you must submit your company information to the FDA. The actual FDA guidance:

This guidance describes FDA’s expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) for the annual reporting to FDA as required under the Drug Supply Chain Security Act of 2013 (DSCSA). Under section 584(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-3(b)), beginning November 27, 2014, 3PLs must report certain information to FDA, including State licensure information for each facility and the name and address for each facility. Under section 503(e)(2)(A) (21 U.S.C. 353(e)(2)(A) (as amended by the DSCSA), beginning January 1, 2015, wholesale distributors also must report certain information to FDA, including State licensure information for each facility, contact information for each facility, and any significant disciplinary actions taken by a State or the Federal Government. This guidance outlines the information that should be submitted to FDA, the timing of the submissions, a preferred format 28 for the submissions, and a preferred method for reporting to FDA.

What needs to be submitted:

The DSCSA requires contact information to be submitted by wholesale distributors. FDA considers contact information to include the email address and telephone number of the person who will interact with the FDA. In addition to the specific information required by DSCSA to be submitted to the Agency, FDA has identified additional information that will enhance efficiencies and improve accuracy in the management of the licensing and facility information submitted to the Agency. Therefore, FDA is requesting that certain additional information be submitted to FDA on a voluntary basis. This additional information will be useful to FDA in its enforcement of the Act and to stakeholders as they make decisions about their drug product distribution. Furthermore, FDA is requesting the same information from wholesale distributors and 3PLs. The ultimate goal is for the public database to serve as a single repository of licensing and facility information for wholesale drug distributors and 3PLs conducting business in the United States.

Where do you need to go to submit this information?

If you are a client of TrackTraceRx, we assist you in this submittal. If not please look at these links:
The actual form:

When should you fill out this information?
Wholesale distributors: January 1, 2015–March 31, 2015
What about for newly registered company?
Wholesale distributor and 3PL facilities that are newly licensed after the dates noted above should initially report within 30 days of obtaining a State or Federal license.
When do I have to re-submit my information on an annual basis?
Wholesale distributors: January 1–March 31 annually
What else?
Reports of significant disciplinary actions should be submitted to FDA when a final action or ruling has been made by a State or Federal licensing authority.

Wholesale distributors: within 30 days of final action

A company should notify FDA if a facility goes out of business or decides to voluntarily withdraw a State or Federal license.

How do i submit this report?

FDA prefers the use of extensible markup language (XML) files in a standard Structured Product 268 Labeling (SPL)4 format.

or

Register and fill out the form here:

https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP:2674113566440:::::

Follow our Step-by-Step guide here:

http://blog.tracktracerx.com/wholesale-distributor3pl-annual-reporting-instructions/

Are Web Portals The Solution For DSCSA Transaction Data Exchange

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The deadline of 1st May 2015 for securing compliance with the data exchange requirements laid down in the Drug Supply Chain Security Act is approaching fast. Pharmaceutical manufacturers, whose sale distributors and re-packagers are in a rush to get their operations and business processes straightened up and in line with the guidelines chalked down by the FDA in the DSCSA documentation.

The FDA has suggested that companies make use of secure web portals for achieving data exchange compliance. A number of companies are now considering web portals as a viable option for implementing data exchange requirements. It is worth digging deep into what web portals are and how they function.

So, what exactly is a secure web portal? By definition, it is a website provided by the seller of drugs to the trading partners within the medical supply chain that conduct mutual business. The website facilitates the buyers with access to the required Transaction Information, Transaction History and Transaction Statement documents. These documents are provided by the seller to the buyer. The same web portal then function to fulfill the data exchange requirements that are obligatory on the seller’s part.

While choosing on a DSCSA compliance web portal, the most important thing to ensure is the existence of an underlying core data-exchange mechanism. It is this very data-exchange mechanism that enables the seller to provide the buyer with the required TI, TH, and TS documentation whenever needed. At times, the same may also be offered by the supplier to fulfill the buyer’s DSCSA requirement, mostly in the event of an investigation, but this is NOT the main purpose the web portal is built to serve.

In addition to meeting the data exchange requirements, the DSCSA requires the web portal to be secure. By being secure, it is implied that the portal offered by the seller must be fortified with standard internet security features, and must allow the buyer to log on to, and access relevant transaction documents describing the procurements from that specific seller. There exists no standard requirement for a user interface though, and web portals for different sellers are bound to be different from one another. The common core characteristic that prevails in all the portals, however, is the capability to manually login and access transaction documents.

It is also imperative that the seller keeps your DSCSA transaction documents safe for a good six years, so that they are retrievable over the said time span effortlessly. It would be foolish to assume that the seller will be doing this by default – it is not at all mandatory upon the seller to provide such a level of service. Instead, the storage and retrieval for full six years is the responsibility of the buyer. As a seller, it is of utmost importance the web portal you select has this capability of extended document storage and retrieval. Similarly, as a buyer, it is only logical to engage in business with a buyer that offers not merely a web based data exchange platform, but a thorough document storage and retrieval system. After all, manually downloading each and every transaction document, printing it and then storing it physically for six years is the last thing you would want.

Dispensers will opt to and rely on their suppliers to store their T3s for them. There are few things to make sure your organization is ok with.

  1. Is the supplier providing the portal access reliable? What happens when you are audited and the supplier portal is not responding to your request? Is this risk worth it?
  2. Is your supplier going to be ready for serialization? Wouldn’t it be better to start building your serialization strategy now?
  3. How well are you having visibility to your incoming T3s with your inventory?
  4. When there are issues with your shipment, does their portal allow you to log this issue? How is the audit trail created?
  5. What about the other requirements of the DSCSA? How are you managing doing business with suppliers that are DSCSA “authorized”.
  6. Is your supplier going to be on top of the many changes in the law?

To wrap it up, a secure web portal with data exchange capabilities is not enough – document storage and retrieval features need to be added to the feature mix for real value addition. At TrackTraceRx, we’ve painstakingly incorporated data storage and retrieval capabilities right in our state-of the-art, cloud-based server. With TrackTraceRx, securing compliance with transaction data exchange requirements is as easy as it gets.

TrackTrace ERP – The First ERP Fully Integrated with DSCSA Traceability

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Press Release – ORLANDO, Fla. March 9 2015.

TrackTraceRx, a market leader on the development of traceability solutions for the Life Science industry, has launched a new software that encompasses DSCSA Traceability with a full fledge ERP system called the TrackTraceERP.

On November 27, 2013, President Obama signed into law The Drug Quality and Security Act (DQSA). Specifically in that bill, Title II of the DQSA, is the Drug Supply Chain Security Act (DSCSA). The DSCSA, outlines the steps necessary to build an electronic interoperable system that can track and trace types of prescription drugs as they are sold and distributed in the United States.

The biggest challenge in selecting a software that handles the new DQSA law is the fact that other solutions in the market only focuses on providing DSCSA traceability. The problem with this is, once you choose a DSCSA software solution, you must spend weeks, even months, getting your DSCSA solution provider integrated with your ERP, according to TrackTraceRx Operations Manager Christian Souza.

“Imagine getting a one stop solution,” says Souza. “The TrackTraceERP is an entire ERP solution that manages your business, manages your inventory, sales, CRM, and passes traceability data required by the DSCSA. ”

The TrackTraceERP is the world’s first and only solution that fully automates traceability with an ERP system, starting with manufacturing all the way to passing serialized traceability data to your trading partners. No integration needed, the solution is fully automated and works right off the bat.

The TrackTraceERP is currently accepting a limited number of users to beta test this newly launched solution. Please contact us at sales@tracktracerx.com or visit http://tracktracerx.com.

 

There’s No Escaping the Serialization of the Pharmaceutical Industry

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Constituent entities making up the United States drug supply chain – pharmaceutical manufacturers, whole sale distributors, dispensers and re-packagers – are extremely busy nowadays securing compliance with guidelines for transaction data exchange laid down in the recently passed Drug Supply Chain Security Act.

Things have not always been this way though. Before the DSCSA was proposed, the focus of the pharmaceutical industry was around getting the California-mandated serial numbers done on 50% of their packages, and that as well, latest by 1st January, 2015. The mandate, however, quickly evaporated by dint of federal preemption the very moment the Federal bill was signed into law. The result – a shift in focus from serialization to establishing mechanisms that track and trace on a lot-level Transaction Information (TI), Transaction History (TH) and Transactions Statements (TS).

While the May 01, 2015 deadline for enforcement of DSCSA by the FDA should be the prime concern for supply chain constituents, drug manufacturers and re-packagers need to pay special attention to serializing their drug packages and homogeneous cases. And that too, real soon. Why is that? Because the process is too intricate and the deadline (November 27, 2017 for manufacturers and 2018 for re-packagers) is not that far away either.

Regarding serialization, there exist a number of questions that need to be answered directly by the FDA. The first question is around the continuation of the usage of existing linear barcodes for serialization. To be more specific, the FDA needs to educate manufacturers and repackages on whether printing human readable lot number and expiration date as part of the new 2D barcode adequate as the sole information printed on the package or not? Deliberation is due by the FDA on what does and does not need to be printed on packages for streamlining the flow of the said thorough the drug supply chain resulted in improved operations, worker efficiency and stakeholder experience.

There is a spectrum of technical challenges that manufacturers and re-packagers are facing as they shortlist the optimal candidate serialization solution for themselves. Conventionally, while selecting a serialization solution, manufacturers and re-packagers get to choose only two from the set of three desirable features inherent to the solution – speed, reliability and requisite print quality.

Manufacturers and re-repackagers also need to choose how to handle serialization data management and any use of randomization. The DSCSA does not require serial randomization, however there are regulations elsewhere, like in Europe that require randomizatione. In this case, randomization is something to consider.

There are two types of ways for approaching randomization. The first is “randomness”, which is a way to choose the serial number where it is unpredictable. The second way is “sparseness”, which is a way where you have a long list of serial numbers and you are only allocating only using a fraction of the list. You can also use both, which make it more difficult for counterfeiters. Another property of randomization is “monotonically” or “non-monotonically”, monotonically is where an ascending successive serial number is always greater than the one that preceded it. In the end, which ever approach and property you choose will help towards the goal of securing your supply chain.

If companies chooses not to randomize, they run the risk of having someone in the supply chain to guess or estimate your manufacturing volume. This is done by looking at your serial numbers and sequentially seeing a pattern. If a pattern shows numbers 1,2,3, its obvious what comes next. Discovering a pattern, can allow a counterfeiter to put something in your supply chain by following your serial number sequence. By exploiting this, counterfeirs avoid discovery from being detected. One of the purposes of randomizing is to protect against anyone from detecting a pattern.

Some of the other challenges with serialization is considering the unique combinations of numbers and characters and length size. Imagine a serial number twenty characters in length. It is a pretty enormous number to manage for data entry and also consuming a lot of space on a bar code.

Consider also that serial numbers are treated just as a string of characters. The number “5” is not defined as an integer but a character. There is no difference between “5” or “05” these are two different serial numbers. What about uppercase vs lowercase letters? The same applies.

The biggest challenge moving forward for distributors and dispensers is having a system in place that can be open enough to interchange and manage this new data coming into your supply chain. Manual T3s will be gone, as lot level traceability will be “upgraded” to package level serialized data flowing into your supply chain.

Delivering all the three features together within a unified serialization solution might sure be difficult, but it is by no means impossible. At TrackTraceRx, we’ve painstakingly incorporating support for serialization in our state-of the-art, cloud-based server delivering on a serialization solution.

Feel free to drop us a line and discover how we can help you with serialization in particular, and DSCSA compliance in general. Again, no more than 3 to 4 working days and you’re up and running – the TrackTraceRx advantage on your side.