FDA Details DSCSA Implementation Plans in Four Guidelines
Posted on June 04, 2021 | Through
The United States Food and Drug Administration (FDA) on June 3 released four guidance on its plans to implement the Drug Supply Chain Security Act (DSCSA), setting out the agency’s expectations on how pharmaceutical manufacturers should comply with new product tracing requirements.
They discuss situations that may increase the risk of entry of suspect products into the supply chain, expectations regarding product identifiers, interoperable electronic product tracing, and definitions of suspect and counterfeit products.
“Ensuring the quality of prescription drugs and preserving the integrity of pharmaceutical distribution are critical roles the FDA plays in protecting the health of the American public. Illegitimate and dangerous products must be kept out of the drug supply chain in the United States, ”said Donald Ashley, director of the Office of Compliance at the Center for Drug Evaluation and Research at the FDA.
These orientations were soon awaited; last month they were awaiting authorization from the Bureau of Management and Budget (OMB). (RELATED: Four DSCSA-Related FDA Guidelines Pending OMB Approval, Regulatory guidance May 12, 2021). Under the PAPER REDUCTION Act From 1995, federal agencies are required to regularly submit guidance documents and regulations to the OMB for review to ensure their cost effectiveness and compliance with government best practices.
Increased security of drug distribution
The Guidance Project on Improving the Safety of Drug Distribution at the Package Level outlines the expectations for the system attributes needed for secure product tracing and lays the foundation for the data architecture systems needed to create interoperable electronic systems by the November 27, 2023 deadline set out in DSCSA.
The agency said there are several data architecture models governing how data can be stored, managed and integrated. These include the centralized model, the distributed model, or a mixture of the centralized and distributed models.
The FDA supports a distributed or semi-distributed data architecture model, as either one can allow trading partners to “maintain control” over their data.
The deadline for public comments is August 3.
Identification of the suspect product
This final guide on identifying suspicious products covers specific situations that could increase the risk of a suspicious product entering the pharmaceutical supply chain and recommends how trading partners can identify these products. It also describes a process for notifying the FDA of an illegitimate product.
According to an FDA announcement, changes from a previous version include clarifying what is meant by “immediate business partner” and replacing the term “suspect” with “questionable” throughout the document.
The final guide on product identifiers meets the agency’s expectations on the format of product identifiers, such as linear barcodes, which must be affixed to each product and to homogeneous cases of products. The draft guidance, which takes the form of a question-and-answer document, was released on September 30, 2018. (RELATED: DSCSA: the FDA finalizes 2 directives and proposes a new draft of questions and answers, Regulatory guidance September 19, 2018).
A Product Identifier is a graphic that includes standardized numeric product identifiers, which include the National Drug Code and a unique serial number, lot number, and expiration dates in human and machine readable formats. .
Some of the major changes from the draft include the expiration date format: the FDA no longer recommends using a space between day, month, and year; it now recommends using a hyphen or slash between expiration date elements. It also amends the statements regarding the use of the human-readable GS1 global trade identification number to explain the relevance of the national three-segment drug code format to patient safety, and clarifies how to affix or print multiple bar codes on the label with enough space to avoid confusion in reading and scanning.
Some of these changes were requested by industry in comments on previous guidelines. (RELATED:Industry calls for changes to FDA DSCSA product identification guidelines, Regulatory guidance, November 20, 2018)
Comments are accepted at any time.
Suspicious and illegitimate product
The revised draft guidelines on suspicious and illegitimate products define these terms as well as what constitutes counterfeit, misappropriated, stolen, fraudulent and unfit for distribution products. (RELATED: FDA unveils draft tracking and traceability guidelines, Regulatory guidance March 1, 2018).
The revision adds the FDA definition of a stolen product, which is “any product in its entirety (that is, the prescription drug and its packaging) that has been taken or removed without the authorization of the product owner (for example, a bottle and all of its contents of the drug are taken or removed from business partners, or the product taken as a result of cargo theft, warehouse theft or theft of messaging). It is also revising the definition of “not suitable for distribution” by tying it more closely to the language of the DSCSA, according to an agency announcement.
The deadline for public comments is August 3.
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