Category Archives: Deadlines

Countdown to May 27th: Manufacturers & Repackagers Prepare for DSCSA

The clock is ticking for pharmaceutical manufacturers and repackagers. By May 27, 2025, they must comply with the Drug Supply Chain Security Act (DSCSA) requirements, a crucial step toward achieving transparency, safety, and accountability within the U.S. drug supply chain. This deadline marks a critical step in creating an interoperable electronic system to track and trace prescription drugs throughout their lifecycle. For those in the pharmaceutical supply chain, the time to act is now.

Why May 27, 2025, Matters

This DSCSA deadline specifically targets manufacturers and repackagers, mandating compliance with enhanced product tracing and verification systems. By this date, every prescription drug must have a standardized serialized identifier encoded in a 2D Data Matrix barcode. Additionally, manufacturers and repackagers must ensure that their systems can provide transaction information (TI), transaction history (TH), and transaction statements (TS) in electronic formats.

Failure to comply could result in regulatory penalties, loss of market access, and reputational damage. Beyond legal ramifications, non-compliance undermines the collective industry goal of ensuring a safer supply chain for patients and consumers.

Countdown to May 27th: Manufacturers & Repackagers Prepare for DSCSA
RX Manufacturers: Be ready for the DSCSA May 27, 2025 deadline

Key Requirements to Meet Before the Deadline

  1. Serialization Compliance Manufacturers and repackagers must ensure that every unit-level package of prescription drugs includes a unique product identifier, expiration date, lot number, and serial number. These identifiers play a critical role in preventing counterfeit drugs from entering the supply chain.
  2. Data Interoperability The DSCSA requires interoperable systems for sharing transaction information. Manufacturers and repackagers must adopt solutions that integrate seamlessly with partners across the supply chain to enable efficient and secure data exchange.
  3. Verification Systems Companies must have systems in place to verify the authenticity of serialized identifiers. This includes the ability to respond promptly to verification requests and investigate any suspect products.
  4. Record Retention Retaining accurate transaction records for a minimum of six years is mandatory. These records must be readily accessible to support investigations and audits.
Countdown to May 27th: Manufacturers & Repackagers Prepare for DSCSA
Repackagers: Ensure compliance by the DSCSA

Challenges on the Road to Compliance

While the DSCSA represents a significant step forward for the pharmaceutical industry, achieving compliance is not without its hurdles:

Technological Integration: Many companies face challenges in integrating serialization and traceability systems with their existing ERP or supply chain platforms.

Data Accuracy: Ensuring the accuracy and integrity of shared data requires rigorous testing and quality assurance.

Collaboration: Manufacturers and repackagers must work closely with trading partners to align their systems and processes for seamless compliance.

Time Constraints: With the deadline fast approaching, companies must act swiftly to address gaps in their compliance strategies.

Steps to Accelerate Compliance

  1. Audit Current Systems Conduct a thorough review of your existing systems to identify gaps in serialization, data exchange, and verification capabilities.
  2. Invest in Scalable Solutions Choose DSCSA-compliant solutions that integrate easily with your supply chain operations. Scalable platforms ensure long-term adaptability as requirements evolve.
  3. Collaborate with Trading Partners Open communication with wholesalers, distributors, and dispensers is critical. Ensure alignment on data formats, protocols, and system interoperability.
  4. Train Your Teams Equip your staff with the knowledge and skills to operate and troubleshoot new systems effectively. Training programs should cover serialization processes, regulatory updates, and verification procedures.
  5. Engage DSCSA Experts Partnering with industry specialists can provide invaluable guidance. Experts can help streamline your compliance efforts, reduce risks, and ensure readiness ahead of the deadline.

The Benefits of Proactive Compliance

Meeting the DSCSA requirements is not merely about avoiding penalties. Compliance enhances operational efficiency, bolsters supply chain security, and fosters trust among trading partners and consumers. By investing in compliance today, manufacturers and repackagers position themselves as leaders in delivering safe and reliable medications.

Don’t Wait – Start Now

The May 27, 2025, DSCSA deadline is non-negotiable, and the window for preparation is closing. Manufacturers and repackagers must take decisive action to meet the stringent requirements. By prioritizing serialization, interoperability, and collaboration, the pharmaceutical industry can achieve a safer and more transparent supply chain—one that protects patients and upholds public trust.

If your organization is still navigating the path to compliance, it’s time to act. Solutions tailored for the pharmaceutical industry can help you achieve your goals swiftly and effectively. Prepare now to ensure a seamless transition and secure your place in a compliant, forward-looking supply chain.

Sponsored: How Long Until You Are Fully Serialized?

This week, IQPC released the final report of a very interesting survey they conducted in April through June this year.  The results are fresh and they paint a picture with good news, and not so good news about the readiness of pharmaceutical manufacturers facing serialization deadlines in the United States, the European Union and elsewhere.  The survey focused on serialization planning, implementation progress, traceability in operation and benefits beyond compliance.  You can download the full report here, but let’s take a look at the responses to just one of the questions they asked. Continue reading Sponsored: How Long Until You Are Fully Serialized?

FDA Delays Enforcement of DSCSA November Deadline: What It Means

Business man trying to stop the clockAs you have read, the FDA has let it slip, with a draft guidance document, that they have decided not to enforce the DSCSA’s November 27, 2017 deadline for manufacturers to apply the new serialized product identifier on drug packages and verification requirements for one year, but it also contains cascading enforcement delays (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”).  This is a major move by the FDA and it will have important consequences for the industry.  Let’s break it down. Continue reading FDA Delays Enforcement of DSCSA November Deadline: What It Means

FDA Delays UDI and FSMA: What About DSCSA?

Image of November 27, 2017 calendarA few weeks ago I predicted that the FDA would soon announce a delay in enforcement of the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for serialization of drug packages (see “FDA Tea Leaves: Are They About To Delay The November Deadline?”, see also “Breaking: FDA Official Offers Advice In Absence Of DSCSA Waiver Guidance”).  As I said, I don’t have any “inside information”, I’m just looking at the evidence that we can all see.  I provided links to the public information I used for evidence so you can decide for yourself.  Don’t just take my word for it.  It is entirely speculation.

Now there is new evidence that the FDA is in a “delay” mood these days.  In the last 4 business days the FDA has Continue reading FDA Delays UDI and FSMA: What About DSCSA?

FDA Tea Leaves: Are They About To Delay The November Deadline?

Drawing of tea leaves to be read
Can you read these?

I don’t have any hard evidence, but there are some interesting things out there that just might point to a coming delay in the Drug Supply Chain Security Act (DSCSA) November 27, 2017 deadline for drug manufacturer serialization and electronic transaction data exchange.  Let’s call them “tea leaves”, and let me attempt to “read” them.  They might turn out to be meaningless, so don’t take any action based on such speculation.  And if you know something more, or interpret something differently, leave a message.

During the Cold War the U.S. government and the press attempted to figure out what was going on in the Soviet Union by paying attention to who was standing next to whom during military parades.  Our exercise might seem a little like that. Continue reading FDA Tea Leaves: Are They About To Delay The November Deadline?

‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again

Dear FriendI hope your holidays were filled with love and cheer.  Mine were.  It was great.  So great, in fact, that I did not have time to write a brand new essay for today.  Not much has happened lately since we are still awaiting publications from the FDA, the EC and ANVISA (and others),  Instead, here is one of my best essays from 2015, reposted as it appeared on August 31, 2015 without modification (see “An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?“).  I’m even leaving in the off-season references.  If you read this essay back then, you might enjoy it again.  If you did not read it back then, I recommend that you read it now.  Let me know what you think.

Before we begin, if you have not yet responded to the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz, please to so now.  It is open to everyone and the survey will be closed soon.

And now Continue reading ‘An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?’, Again

Sponsored: Pharma Serialization Deadlines In Flux

iqpc.zoomThe industry is rife with rumors that Brazil’s ANVISA has made the decision to push out their serialization deadline for multiple years—and perhaps redefine the requirements.  I cannot confirm any of these rumors at this point and I do not recommend acting on rumors.  I suggest you continue down the path of meeting the existing, known regulation until—if ever—you get the official word from an official publication of ANVISA.  Who knows when that might occur.  If/when you see something official, let me know. Continue reading Sponsored: Pharma Serialization Deadlines In Flux

An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?

Dear FriendDear FDA, EMA and ANVISA,

How are you?  I’m sure your summer has been busy, just like mine.  Hope you were able to get at least some time away.  I’ve taken most Saturdays off, but the other days of the week have been very full with consulting, and then writing RxTrace essays every Sunday.  You know, the wife is not very happy about that!

The reason I am writing directly to you at this time is to ask a question that I hope you are asking yourselves and planning ahead for. Continue reading An Open Letter To The FDA, EMA and ANVISA, RE: Who Are You Going To Punish?