FDA updates guidance on DSCSA verification systems

The FDA has updated its guidance on the verification procedures for suspect or illegitimate products in the pharma supply chain, after receiving comments from stakeholders.

The new document - Verification systems under the Drug Supply Chain Security Act for certain prescription drugs – lays out how the FDA expects manufacturers, wholesale distributors, dispensers, and repackagers to respond to verification requests from trading partners.

That includes clarification of what information should be communicated among trading partners when determining whether a suspect product is illegitimate.

It covers quarantine and investigation of suspect medicinal products, as well as quarantine and disposal of illegitimate products, and notification of the FDA and trading partners of the outcome of verification and in particular product "cleared" as being okay to remain in the supply chain.

It also lays out the statutory requirements for verification, including verification of saleable returned products, as interpreted by the FDA.

It's an update to 2018's Verification systems: FDA drafts guidance on what to include, and among other changes explains FDA's interpretation of what 'possession or control' means in the context of the DSCSA, the nature of 'electronic quarantine' and when it is appropriate, and when samples of illegitimate product should be retained.

Possession or control is defined as physical custody of the product, or ownership of the product, while electronic quarantine is defined as "an electronic system or process that designates specific products as being quarantined to prevent the sale and further distribution of the product."

One of the main sticking points for stakeholders which commented on the earlier draft was a short 24-hour time window to respond to verification requests from trading partners, with industry groups pointing out that could be tricky, for example if the request is received on a holiday weekend.

That's still the target, but the FDA has introduced some leeway on the time allowed, saying it can be "in 'other such reasonable time' as determined by FDA, based on the circumstances of the request."

If a verification request doesn’t get a response within 24 hours, the product should automatically be considered suspect, says the guidance.

Retention of illegitimate samples was another bone of contention, with concerns that some supply chain partners may not have suitable storage facilities, and that keeping them for an extended period could be a resource burden.

The guidance notes this should occur "if asked to do so by the manufacturer, FDA, or other federal or state official…in an amount sufficient for further physical examination and laboratory analysis," with samples appropriately stored until they can be collected.

The regulator says it will inform trading partners "in a timely manner" if collection of samples is necessary to complete an investigation, and will expect manufacturers to inform trading partners to follow suit.