Four FDA guidances related to DSCSA awaiting OMB sign-off

The Office of Management and Budget (OMB) on 11 May began reviewing a set of guidances related to the US Food and Drug Administration’s (FDA) implementation of the Drug Supply Chain Security Act (DSCSA). They address suspect products, product identifiers and interoperable electronic tracing of products.

Under the Paperwork Reduction Act of 1995, federal agencies must regularly submit to the OMB guidance document and regulations for review to ensure their cost-effectiveness and compliance with government best practices.

With the enactment of DSCSA in 2013, FDA expects pharmaceutical manufacturers to have interoperable systems in place by 2023 with trading partners to track pharmaceuticals through the supply chain to prevent drug counterfeiting and diversion and increase traceability.

Awaiting OMB clearance are two final guidances and two draft DSCSA guidances. Revised versions of two other DSCSA-related draft guidances are also on FDA’s guidance agenda for this year but have not yet reached the OMB review stage. Those guidances pertain to identifying trading partners and verification systems for certain prescription drugs.

Identification of suspect product

One guidance awaiting OMB clearance, “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification,” was issued in December 2016, and aims to help manufacturers, repackagers, wholesale distributors and dispensers identify suspect products.

The document identifies specific situations that could increase the risk of a suspect product entering the supply chain, recommends how trading partners can identify a suspect product, and outlines a process for trading partners to notify FDA of an illegitimate product.

An attorney asserted at a recent meeting of the Healthcare Distribution Alliance that FDA is overdue in issuing this, as well as other guidance. (RELATED FDA overdue on guidance as DSCSA looms, Regulatory Focus 19 April 2021).

Suspect and illegitimate product

One of the draft guidances pending OMB approval is a revised version of the agency’s 2018 draft guidance, “Definitions of Suspect Product and Illegitimate Product for Verification Obligations under the Drug Supply Chain Security Act.” The guidance provides definitions on what constitutes products that are either suspect, illegitimate, counterfeit or diverted. (RELATED: FDA Unveils Draft Guidance on Track and Trace, Regulatory Focus 1 March 2018).

Product identifiers

The third guidance, “Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers.” issued in September 2018, covers the agency’s expectations for affixing a product identifier, such as a linear barcode, to each product and to homogenous case of products. (RELATED: DSCSA: FDA finalizes 2 guidances and offers new draft Q&A, Regulatory Focus 19 September 2018).

A product identifier is a graphic that includes the product’s standardized numerical identifier, which includes the National Drug Code and a unique serial number, the lot number and expiration dates in both human and machine-readable formats.

The pharmaceutical industry called for changes to the guidance in subsequent comments. (RELATED: Industry calls for changes to FDA’s DSCSA product identifier guidance, Regulatory Focus 20 November 2018).

Enhanced drug distribution security

Also pending at OMB is a draft guidance called “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act.” The guidance would detail FDA’s expectations for enhanced distribution security systems for products at the package level.

OMB notice on FDA guidances awaiting approval

Four FDA guidances related to DSCSA awaiting OMB sign-off

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