New FDA Draft Guidance Throws A Wrench into Manufacturer and Repackager Serialization

Last week, many manufacturers and repackagers learned that their serialized labels are incorrect or perceived as unsatisfactory by the FDA.  With only 2 months left before the serialization deadline, the FDA threw a wrench in serialization implementation with the publication of a Product Identifier Draft Guidance, titled “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers”.

Breaking News – No GTIN

Manufacturers and repackagers who implemented serialization for the US market have done so by aligning to the GS1 standard. GS1 US structures a GTIN with the embedded NDC number. The GTIN, along with the serial number, lot number, and expiration date, became the GS1’s answer to the DSCSA Product Identifier (PI) construction.

However, the draft guidance document reveals the FDA’s reservation of using GTIN.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:

“4. How should the human-readable portion of the product identifier required by the DSCSA be formatted to appear on the drug package label?

To aid healthcare practitioners that may use product information, such as checking the expiration date or recording the NDC and lot number into a patient record, in the human-readable portion of the product identifier, 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]…”

The answer to Question 5 tells the manufacturers and repackagers that they cannot print a GTIN in place of the NDC as part of the human-readable PI on serialized labels.

“5. Can the GS1 Global Trade Identification Number (GTIN) be used in place of the NDC to comply with the requirements for a human-readable NDC as part of the product identifier?

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).”

National Drug Code (NDC)  

In the DSCSA statue, the FDA requires manufacturers and repackagers to affix or imprint a PI that contains the Standardized Numerical Identifier (SNI).

“The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”

The FDA further explains in the DSCSA statute that the SNI contains the National Drug Code (NDC).

“The term ‘standardized numerical identifier’ means a set of numbers or characters used to uniquely identify each package or homogenous case that is composed of the National Drug Code that corresponds to the specific product (including the particular package configuration) combined with a unique alphanumeric serial number of up to 20 characters.”

Back in March 2010, prior to the DSCSA, the FDA published the final guidance titled “Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages” 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”.

Global Trade Identification Number (GTIN)

GTIN is GS1’s Global Trade Item Number, a well-known identification system used in many industries, including healthcare. The construction of the 14-digit GTIN contains the NDC but includes more than the NDC. Using the above SNI example from the FDA, the GTIN of the above NDC is 0035555566677. Compared to the NDC, it contains an extra “003” in the front and an extra “6” in the back. They are marked red in the table below.

Despite rejecting GTIN as the human-readable part of the Product Identifier, the FDA is ok with GS1’s 2D Data Matrix barcode as the machine-readable part of the Product Identifier. 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).”

New Concerns

“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.”

Interestingly enough, “The National Drug Code (NDC) number is requested but not required to appear on all drug labels and in all drug labeling, including the label of any prescription drug container furnished to a consumer,” stated CFR 21 Part 201 (Labeling). A drug package without an NDC number clearly printed on the label is problematic.

While the FDA is concerned the GTIN alone is not enough, the industry is concerned that the NDC alone is not enough. For each NDC number, there are multiple GTINs. Using NDC alone in the human-readable portion of the PI will definitely lead to the improper identification of the drug package.

Here is an example of a product packaged into 3 levels – bottle, inner-pack, and case. This product has one NDC but three GTINs. NDC alone in the human-readable does not tell the single truth of the drug package.

Solutions

Guidance documents in “Questions and Answers” format are normally the best communications from the FDA. They are clear, specific, and relevant to the concerns and questions from the industry. Out of 19 Q&As, I agree that the 17 others in this guidance document are exactly that. Q&A four and five, however, left more questions and created new ones.

To make pharmaceutical serialization work, the government and the industry need to come together with practical agreements and standards. The FDA did not close the door on GTIN. With this guidance document, the FDA opens the door for the NDC.

The solution can be as simple as adding an NDC to the readable portion of the PI while keeping the GTIN. Or for products that already have NDC printed in big bold letters, the FDA would accept it as part of the PI.

A Trusted Partner

The DSCSA is a brand-new regulation with progressive requirements over a ten-year period. Since 2013, the FDA has published 19 guidance and policies documents, and more will come. In this ever-changing regulatory environment, aligning with a trusted advisor and a trusted partner like LSPediA is paramount. Our core business is taking on the heavy lifting of compliance through a turnkey solution and best industry practice, so our customers can focus and be successful in their core business.

An example of heavy lifting is unpacking regulations like this one and providing sound solutions. Timely regulatory briefings, helpful advisories, and software updates supporting regulatory changes are part of the services we provide for free. To experience the difference of unparalleled legislative acumen and the best DSCSA solution RxChain®, call us for a demo today.

 

 


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