Recent FDA Guidance Sparks Concerns from Industry Leaders

Several key industry players have issued responses to the FDA in regard to the recent draft guidance on the use of Product Identifiers, and the policy on grandfathered product, in compliance with the Drug Supply Chain Security Act (DSCSA).

The most requested change was for the FDA to allow the use of the Global Trade Item Number (GTIN) in place of the National Drug Code (NDC) in order to fulfill the human-readable requirement of product identification. The FDA believes that GTIN is not clear enough, due to the formatting of the NDC within, and could lead to misidentification of product. The GTIN can be used for the machine-readable portion, according to the FDA.

Bausch + Lomb, a prominent Canadian healthcare supplier, believes that, “given that use of the GTIN, which incorporates the NDC, has been standard pharmaceutical industry practice for many years,” the risk for confusion is minimal. Adding that, “the location of the NDC number on the [Healthcare Distribution Alliance] -proposed label has not changed from this historical location and would likely not cause confusion to those familiar with its current location.”

Many suppliers and manufacturers use the GTIN, which adheres to global standards.

Bausch added, “that many manufacturers have already implemented human readable portions of product identifiers that include all of the required information, but that may not exactly follow FDA's recommended format.”

Rather than request United States specific formatting, The Association for Accessible Medicines (AAM), the leading provider of generic pharmaceuticals worldwide, “urged [the] FDA to allow flexibility of human readable formats to allow current industry practices to follow globally recognized standards for data elements.”

AAM further voiced their concerns saying, “the format recommended in the draft guidance would require significant changes to be made to product packaging and labels.”

Additionally, manufacturers are asking for flexibility on the formatting of the expiration date.

Biotechnology Innovation Organization (BIO), the worlds largest trade association representing biotechnology companies and related organizations, “wants the FDA to consider using the widely accepted standards outlined by the HDA on the use of dates,” adding that, “the expiration date format outlined is counter to current industry practice, global GS1 standards, and USP compendial requirements.”

Another primary concern of the industry is the timeliness of the guidance’s supplied by the FDA in relation to the deadlines they are expected to meet. Many industry partners do not believe they are given enough time to make necessary changes to adhere to the requirements.

Bausch said, “requiring manufacturers to change the format of their already implemented human-readable portion this close to the compliance date to match FDA's recommended format would require manufacturers to expend significant time, effort, and resources.”

Resources and time that many do not have.

AAM echoed Bausch’s concerns saying, “this is a serious concern for industry in this late stage of implementation.”

We will provide further updates as they become available.


Draft Guidance: Grandfathered Product, Product Identifiers, Public Docket 


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