TrackTrace Rx

Month: January 2017

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Now, let us briefly see the scope of the planned draft guidance documents related to DSCSA and supply chain security we can expect this year: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 This particular draft guidance is new, published on January 10, 2017.

Note: this draft guidance impacts “authorized party” for DSCSA transactions (not traceability, serialization or verification regulations or implementation), provided the data be in the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

FDA Publishes Guidance On Suspect Product & Notification

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In response to the increasing threat of illegitimate and counterfeit drugs entering the U.S. pharma supply chain, the Food & Drug Administration (FDA) passed the Drug Supply Chain Security Act in 2013, obliging manufacturers to report suspicious drugs to the agency. The FDA was required to publish a guidance no later than 180 days after the enactment of the DSCSA, so the one released on December 8, 2016, is “a little” overdue, but welcome. It is an edit of the draft published back in 2014, with improved readability and a new section on “High Risk of Illegitimacy Notifications” that they seek comments for. You can find the FDA DSCSA Guidance on “Identification of Suspect Product and Notification” here.

Who Should Read It

Everyone in the drug supply chain.  From drug manufacturers, wholesalers, repackagers, & dispensers to online pharmacies, clinics, hospitals and individual practitioners.

The fact that its draft was published two years ago may prompt some companies to take it lightly – bad idea. The guidance is as important as escalating its provisions to every company standard operating procedures. Your employees, too, must be familiar with its provisions. Otherwise, you run the risk of violating the law without realizing it, so make sure you study the new guidance in depth to know your obligations and the procedures for investigating, reporting and terminating the notification of an illegitimate product.

Key Highlights

1. DSCSA requires that the trading partners that identify a suspect product quarantine it during the investigation. If the trading partner determines a product is illegitimate, they must notify their trading partners that might have received the product and the FDA. Illegitimate can be either of the following – stolen, diverted, counterfeit, the subject of a fraudulent transaction, intentionally diverted, or otherwise unfit for distribution.

The new section “for comments purposes” requires manufacturers to notify the FDA and their trading partners within 24 hours after identifying or receiving a notification from the FDA that a product poses a high risk of illegitimacy in the following cases:

a) the trading partner believes there is a high risk a product in an immediate trading partner’s possession is illegitimate;

b) there is a high risk of an illegitimate product entering the U.S. drug distribution & supply chain;

c) “other high risk” (pursuant to subsection 582(h)). A manufacturer is recommended, not required though, to notify FDA only.

The FDA describes specific examples for each of these scenarios and a list of circumstances that may lead to them. The agency points out manufacturers may learn about high-risk products from their employees, trading partners, the FDA itself or other regulatory authorities even “when a product may not be in the manufacturer’s possession or control.”

Therefore, the FDA obliges manufacturers to notify the agency of a high-risk product even if the manufacturer is not in possession or control of the product, and provides examples for such scenarios. This obligation is notable as it is significantly broader than other obligations of the trading partners that typically have to be in possession or control of the suspect product to initiate an investigation and notification process.

Third-party logistics providers are not defined as “a trading partner” by the guidance. Therefore, they are not required (but encouraged) to notify the FDA if a situation arises.

2. In order to help companies identify scenarios that increase the risk of a suspect product entering the U.S. supply chain, the guideline outlines several areas where trading partners must be particularly diligent. These include:

  • buying from new suppliers
  • purchasing from a source that previously engaged in suspicious activity
  • purchasing online from unknown sources
  • when receiving an unsolicited offer from an unknown source
  • when the price is too low for a specific product

and other common sense scenarios. Overall, a transaction that has an increased risk might involve suspiciously low prices, particularly high-in-demand products, drugs subject to a shortage, or those previously counterfeited or diverted, or have a questionable appearance.

3. The FDA recommends for the trading partners to share observations and concerns regarding a suspect product with their partners and seek law enforcement and regulatory authorities help. This is necessary to expedite identification of a suspect product and the following investigation.

Once the suspect product is determined to be illegitimate, a trading partner must notify the FDA and its immediate trading partners of the findings. The FDA will provide an online form on its web page for the companies to fill out.

Note: the guidance goes into detail describing the process of termination of the notification. Companies would have to go back to their submitted notification web form, describe the product & the notification they issued. The companies then need to describe the actions, or the new information, that justify the termination of the notification.

Of special note is that the FDA considers this procedure of termination of notification to be binding, and requires the trading partners to “provide the Agency with an opportunity to provide its expert views and advice.”

Therefore, a trading partner must first receive the response from the FDA to their termination request, and only then notify its trading partners of the termination. The agency sets a 10-business-day period it takes for responding. Only when the company receives a response from the FDA can it notify its trading partners of termination. FDA made minor changes to the Form FDA 3911 and edited the instructions for completing it.

Finally, beginning November 2017, pharmaceutical manufacturers must mark their produce with a National Drug Code (NDC), expiration date, serial number, lot number in the machine- and human-readable formats.

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