The FDA Considers PI a Closed Issue – So Why the Confusion?

By November 20, 2019 DSCSA, Industry Insight, Serialization

serialized drug product with NDC, GTIN, Serial Number, Expiration Date, and Lot Number

It’s been 14 months since the FDA advised manufacturers, wholesalers, and repackagers on Product Identifier (PI) requirements. You’ll remember that it came as a bit of a shock to most in the industry that what they’d been doing—following the GS1 standard of a GTIN with an embedded 10-digit National Drug Code (NDC) number, plus the serial number, lot number, and expiration date—was insufficient for PI purposes.

The FDA’s draft guidance said that was close to what they wanted, but not close enough. They dismissed the GTIN and confirmed the requirement of using the NDC number as one of the building blocks of a PI. The exact language was found in the answers to questions 4 and 5 of the guidance.

However, the draft guidance document reveals the FDA’s reservation of using GTIN. The FDA confirms the requirement of using the NDC number as one of the building blocks of a PI. Question 4 and its answer state the following:

  1. “…FDA recommends that the human-readable product identifier appears in the following format:
  • NDC: [insert product’s NDC]
  • SERIAL: [insert product’s serial number]
  • LOT: [insert product’s lot number]
  • EXP: [insert product’s expiration date]…”
  1. “The product identifier on the product label must contain the NDC. The NDC is currently a 10 or 11-digit number, in its FDA-assigned 3-segment format, that identifies the labeler, product, and trade package size. While industry’s practice is to use a GTIN that may incorporate the digits of the NDC, the GTIN typically contains additional digits and is not in the 3-segment format by which the NDC is defined in FDA regulations. Moreover, FDA is concerned that use of the GTIN alone in the human-readable portion of the product identifier could lead to improper identification of the NDC and drug product. If the NDC is on the label in its FDA-assigned 3-segment format, a company may also voluntarily affix or imprint the associated GTIN on the label. We note that a manufacturer or repackager may choose to utilize a GTIN to encode the NDC number in the machine-readable portion of the product identifier (2D data matrix barcode).”

So, strict adherence to the structure and layout of NDC seemed to be the core issue: no blending NDC with other data, and no veering from the 3-segment format. Still, the guidance wasn’t as clear as many in the industry had hoped. And, all these months later, and with the industry on verge of an important deadline, the issue still feels unresolved. We wrote about an incident that came up at last month’s HDA Traceability Seminar, in which a supply chain entity tried (and failed, of course) to use a GTIN in place of an NDC for product identification outside of an EPCIS reference.

A well-presented clarification from AmerisourceBergen’s Matt Sample at the event aligned with what we shared in the HDA Seminar Update from LSPediA, and addressed the reality of how industry has progressed with the issue to-date:

  1. The NDC and the associated linear barcode will exist on a saleable package (as it historically has as part of pre-printed package artwork) to identify a product per FDA regulatory requirements.
  2. A GTIN and associated GS1 Application Identifiers for product ID, lot, expiration, and serial number must be printed in human-readable form in the whitespace adjacent to the online printed 2D barcode in case the barcode is not readable via a scanner.

“Move along—nothing to see here” was our position of interpretation at the time, as this is old news for most of us in the DSCSA world. But we thought, given the unresolved air around PI, it was worth revisiting the rationale behind these requirements.

National Drug Code

In the DSCSA statue, the FDA requires manufacturers and repackagers to affix or imprint a PI that contains the Standardized Numerical Identifier (SNI). A product identifier is a standardized graphic that includes the standardized numerical identifier, lot number, and expiration date of the product. This needs to be in human-readable form and readable via a machine data carrier. The FDA further explained in the DSCSA statute that the SNI must contains NDC.

The standardized numerical identifier refers to a set of numbers or characters that uniquely identify each package or homogenous case. It must be composed of the NDC that corresponds to the specific product (including the particular package configuration) and a unique alphanumeric serial number of up to 20 characters.

In 2010, prior to the DSCSA, the FDA published the final guidance to address provisions of the Federal Food, Drug, and Cosmetic Act Section 505 regarding development of standardized numerical identifiers (SNIs) for prescription drug packages. The SNI was clearly defined as “National Drug Code (NDC) … combined with a unique serial number.”

Example of a serialized national drug code (sndc)

Global Trade Identification Number

GTIN is GS1’s Global Trade Item Number, a well-known identification system used in many industries, including healthcare. In DSCSA serialization, the construction of the 14-digit GTIN contains the NDC—but includes additional numbers. Using the above SNI example from the FDA, the GTIN is 0035555566677. Compared to the NDC, it contains an extra “003” at the beginning and an extra “6” at the end. They are marked red in the table below.

Breakdown of GTIN serial number

Despite rejecting GTIN as the human-readable part of the PI, the FDA has allowed GS1’s 2D Data Matrix barcode as the machine-readable part of the PI. The FDA acknowledges that, “a manufacturer or repackager may choose to utilize a GTIN to encode the NDC number in the machine-readable portion of the product identifier (2D data matrix barcode).”

If you avoid discussing a point of conflict, does it go away? Not in my house….

PI may still be open to debate, but this barcode issue definitely is not open to debate

During our involvement in the FDA VRS pilot program, we identified a different and potentially major issue: manufacturers using QR codes, databars, etc. on the outside of saleable packages. We found that these barcodes were being scanned and causing confusion among supply chain personnel, and that they likely would confuse other end users as well. LSPediA urges manufacturers to cease this practice immediately and instead relegate the use of those non-supply chain required barcodes for inner packaging only.

Enable Confidence—Partner with LSPediA for DSCSA Guidance and Supply Chain Efficiency  

LSPediA can help you on your journey, ensuring you meet all compliance requirements and deadlines, and guiding you toward comprehensive business efficiency. Contact us today or request a demo to see how the right partner—and solutions like RXChain and OneScan™ VRS—can make all the difference. Learn to work smarter, reduce waste, and generate profitability.