Operationalizing an ACNU, part of the information the FDA requires from a sponsor, comprises the system and technology used not only to guide a consumer through an extended self-selection step, but also to provide approval the consumer needs to buy a product from retailers.

The CDER grants ACNU switch sponsors room for designing and implementing those operations.

“While it is important for FDA to understand how the ACNU is operationalized because this is part of achieving appropriate self-selection or use, the specific way an ACNU is operationalized is not a key element of the ACNU,” the center states.

In addition to administering questionnaire using a website, systems could offer questionnaires pharmacy kiosk on display screens and make it available through mobile applications or through automated telephone response technology.

A consumer’s pass to present at the point of sale would be a barcoded voucher printed or downloaded onto a mobile device from the ANCU drug marketer’s secure website.

“These examples differ in the way the ACNU is operationalized … but the key elements (including the questions in the questionnaire and responses that ensure appropriate self-selection) remain the same,” the center states.

However, it also indicates it anticipates questions on ACNU components moving consumers from selection to purchase. “FDA seeks comment on any unique issues that might arise for retailers or consumers based on the way the applicant operationalizes the ACNU … e.g., in a store kiosk, online, or otherwise,” the proposal states.

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