ClearGate helps pharmaceutical sponsors connect program design, access decisions, and pharmacy verification. Gatehouse manages the program. Passage verifies authorization at checkout.
Program ControlCandidate manifest · CR-VRX-0007 · generated 25 Aug 2026, 09:42 ET
Requirement-to-test lineage for this release candidate
ACNU means Additional Condition for Nonprescription Use. Under the FDA framework, a consumer must complete an additional condition to obtain and appropriately use a specific nonprescription drug.
ClearGate is designed to support technology-based ACNU programs: turn sponsor-defined criteria into versioned questions and rules, validate changes, verify authorization, and retain the records needed to review what happened.
Designed for sponsor-specific implementation. The demonstration is not a commercially qualified deployment. Each implementation requires validation, security qualification, operating procedures, partner certification, and service agreements.
Gatehouse controls how the program is defined and run. Passage connects its approved outcomes to pharmacy and ecommerce verification. A signed handoff links the two.
Configure questionnaires and rules, prepare studies, validate releases, and review access decisions. Gatehouse records the program version behind each decision and signs the handoff to Passage.
Passage checks an approved upstream result, issues or verifies an authorization, and applies transaction policies. Pharmacy and ecommerce partners receive the information needed to verify access without receiving questionnaire answers.
Built to work with other systems. Passage can accept an approved result from Gatehouse or another approved upstream system. An authorization is not a prescription; clinical and prescribing responsibilities remain with the appropriate parties.
The Passage demonstration shows authorization checks, single-use redemption, safe retries, reversals, and a record of each transaction. The pharmacy and product below are fictional.
Product detected at checkout · Location AVL-014
Reference pharmacy adapter
cgp1.eyJraWQiOiJwYXNzYWdlLWtleS0wMSI…Review which rules were used, which release was approved, and how an authorization reached the retailer. The example below shows how assessment and transaction records stay connected.
ASM-9B82F4C1DEC-382910AUTH-VRX-829401TXN-70F18ASynthetic demonstration data. No real drug, consumer, clinical criteria, identity, or transaction is represented.
Explore the workflows demonstrated across Gatehouse and Passage.
Define candidate products, sponsor objectives, program owners, system boundaries, and release versions.
Approved questions, criteria, reason codes, outcome messages, rule tests, and change history stay versioned and traceable.
Study-specific configuration supports sponsor and research workflows while preserving the relationship to the future operating model.
Consumers receive only the approved experience while decisions remain deterministic, version-bound, and ready for minimal signed handoff.
Verification and transaction enforcement stay separate from clinical logic through scoped, versioned partner contracts.
Signals become investigations, affected records can be identified, corrective action stays linked, and released history cannot be silently rewritten.
Demonstration scope: the screens use fictional data. Commercial use requires sponsor-specific validation, security qualification, partner certification, operating procedures, and service agreements.
Trace an issue to affected decisions and transactions, investigate its cause, and link corrective action to a controlled release. The example below illustrates that workflow.
If a reliable decision or valid authorization is unavailable, access is not permitted.
Released configuration and ledger events cannot be silently rewritten.
Authors, approvers, operators, source systems, and retailers remain distinct.
Each downstream actor receives only what its approved transaction requires.
We are seeking pharmaceutical sponsors, research organizations, pharmacy technology teams, and advisors to help shape program requirements and plan pilot implementations.
Discuss a candidate product, an active or planned Rx-to-nonprescription program, or a medication-access workflow that needs supporting infrastructure.
Partners equipped to design or operate label comprehension, self-selection, actual-use, human-factors, or adjacent research against a controlled program configuration.
Partners willing to shape how product detection, verification, redemption, reversal, exception handling, and channel accountability should work in practice.
Experienced operators who can pressure-test responsibility boundaries, validation strategy, failure procedures, quality systems, and sponsor buying requirements.
We can begin before every downstream vendor or implementation detail is selected.
Sponsors retain clinical criteria, regulatory strategy, and product obligations. ClearGate provides the software that implements program rules and records its operation.
Understand the framework, the products, and what comes next.
An Additional Condition for Nonprescription Use is an extra step a consumer must complete to obtain and appropriately use a particular nonprescription drug when labeling alone is insufficient. A technology-based assessment may support that condition. Requirements and FDA approval are specific to the drug product.
Gatehouse manages program configuration, validation, releases, and access decisions. Passage verifies the signed upstream result and manages authorization checks and transaction records for pharmacy and ecommerce partners.
ClearGate is currently a working enterprise demonstration using fictional data. A commercial implementation requires sponsor-specific validation, security qualification, operating procedures, partner certification, and service agreements. We are seeking design and pilot partners.
Gatehouse applies sponsor-defined rules consistently; generative AI does not decide qualification. Sponsors retain responsibility for clinical criteria and regulatory strategy. Clinician-mediated prescription workflows are a potential future extension, in which licensed clinicians would retain medical judgment and prescribing authority.
Tell us about your product, program stage, or integration needs. We can walk through Gatehouse and Passage and discuss the requirements for a design engagement or pilot.
Email the team: contact@cleargateaccess.com
Email the ClearGate team with a short introduction to your organization and the program or workflow you have in mind.
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For business inquiries only. Do not include patient information, adverse-event reports, or confidential clinical data.