The US Food and Drug Administration (FDA) on 3 June released four guidances on its plans for implementing the Drug Supply Chain Security Act (DSCSA), setting the agency’s expectations for how pharmaceutical manufacturers should comply with new product tracing requirements.
They address situations that can increase the risk of suspect products entering the supply chain, expectations for product identifiers, interoperable electronic tracing of products and definitions of suspect and counterfeit products.
“Ensuring the quality of prescription drugs and safeguarding the integrity of pharmaceutical distribution are crucial roles the FDA plays in protecting the health of the American public. Illegitimate and unsafe products must be kept out of the US drug supply chain,” announced Donald Ashley, director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research.
These guidances were soon expected; last month they were awaiting clearance from the Office of Management and Budget (OMB). Under the Paperwork Reduction Act of 1995, federal agencies must regularly submit guidance documents and regulations to OMB for review to ensure their cost-effectiveness and compliance with government best practices.
Enhanced drug distribution security
The draft guidance on enhanced drug distribution security at the package level outlines expectations for the system attributes necessary for secure tracing of products, and lays the groundwork for the data architecture systems needed to build electronic, interoperable systems by the 27 November 2023 deadline called for in DSCSA.
The agency said that 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 the distributed models.
FDA supports a distributed or semi-distributed data architecture model, because either can allow trading partners to “maintain control” over their data.
The deadline for public comment is 3 August.
Identification of suspect product
This final guidance on identification of suspect products covers specific situations that could increase the risk of a suspect product entering the pharmaceutical supply chain and recommends how trading partners can identify these products. It also outlines a process for notifying FDA of an illegitimate product.
According to an FDA announcement, the changes from a previous version include clarifying what is meant by an “immediate trading partner” and replaces the term “suspicious” with “questionable” throughout the document.
The final guidance on product identifiers addresses the agency’s expectations on the format of product identifiers, such as linear barcodes, that must be affixed to each product and to homogeneous case of products. The draft guidance, which takes the form of a question-and-answer document, was issued on 30 September 2018.
A product identifier is a graphic that includes the product’s standardized numerical identifiers, which includes the National Drug Code and a unique serial number, the lot number and expiration dates in both human- and machine-readable formats.
Among the key changes from the draft are the expiration date format: FDA no longer recommends using a space between the day, month and year; it now recommends using a hyphen or forward slash between the expiration date elements. It also modifies statements regarding the use of the human-readable GS1 Global Trade Identification Number to explain the relevance of the three segment National Drug Code format for patient safety, and clarifies how to affix or imprint multiple barcodes on the label with sufficient space to avoid confusion in reading and scanning.
Some of these changes were called for by industry in comments on the earlier guidance. Comments are being accepted anytime.
Suspect and illegitimate product
The revised draft guidance on suspect and illegitimate products define these terms as well as what constitutes products that are counterfeit, diverted, stolen, fraudulent and unfit for distribution.
The revision adds FDA’s definition of a stolen product, which is “any product in its entirety (i.e. the prescription drug and its packaging) that has been taken or removed without permission of the owner of the product (e.g., a bottle and all of its content of drug are taken or removed from the trading partners, or product taken as the results of cargo theft, warehouse theft, or courier theft).” It also revises the definition of “unfit for distribution” by tying it more closely to the language in the DSCSA, according to an agency announcement.
The deadline for public comment is 3 August.
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