New York Assembly Bill A01412

New York 2025-2026 Regular Session

• Introduced: 1/9/25
• Refer: 1/9/25
• Refer: 1/7/26

Caption

Permits an exception from registration for nonresident pharmacies in cases of a specific patient need or a declared public health emergency under certain conditions.

Summary

This bill amends the Education Law provisions governing registration of nonresident pharmacies, manufacturers, wholesalers, and outsourcing facilities that ship prescription drugs or devices into New York. It creates a limited exception allowing an unregistered nonresident establishment to ship, mail, or deliver prescription drugs or devices to a registered New York establishment in two situations: when there is a specific patient need, or during a declared public health emergency. The exception is conditioned on a series of safeguards, including proof of licensure in the home state, documentation and recordkeeping requirements, retention of records for six years, use of FDA-registered manufactured products, and compliance with federal Drug Supply Chain Security Act requirements. The bill also limits the exception to non-controlled substances, requires the product to be in original manufacturer packaging with identifying information such as lot number and expiration date, and restricts partial or unsealed quantities to no more than one such transfer in any consecutive 90-day period. It further caps the transfer price at no more than 100 percent of wholesale acquisition cost and requires pharmacies to notify the state Board of Pharmacy and the FDA if they learn a product was illegitimate, recalled, or counterfeit. Unregistered nonresident establishments participating in these transactions would be subject to New York jurisdiction and must cooperate with audits or investigations.

Impact

The bill would narrow and clarify New York’s registration rules for out-of-state drug suppliers by expressly authorizing limited, documented transactions without full registration when needed to fill an identified patient prescription or respond to a public health emergency. It would amend Education Law section 6808-b to add detailed conditions for these exceptions, while preserving the general registration requirement for nonresident establishments that ship prescription drugs or devices into the state. The bill would also reinforce state oversight, recordkeeping, and enforcement authority over these transactions and align the state framework with federal DSCSA supply-chain rules.

Sentiment

Based on the bill text and available context, the measure appears generally practical and regulatory in tone, with an emphasis on patient access and emergency flexibility rather than deregulation. The absence of recorded committee debate or votes suggests there is no documented public controversy in the provided materials. The bill’s structure indicates support for allowing narrowly tailored exceptions while maintaining strong safeguards against diversion, counterfeit products, and uncontrolled distribution.

Contention

The main points of potential contention are the balance between access and oversight, and whether allowing unregistered nonresident establishments to participate could weaken New York’s pharmacy registration regime. Opponents might focus on the risk of counterfeit, recalled, or improperly tracked drugs entering the state, while supporters would likely emphasize the need to avoid treatment delays for specific patients and to ensure supply continuity during public health emergencies. The bill addresses these concerns by excluding controlled substances, limiting the exception to specific patient need or emergencies, and imposing extensive documentation, packaging, and pricing restrictions.