NY S00982

Nonresident establishments shipping prescription drugs and devices into New York must register with the department, except for intra-company transfers between commonly owned entities.

Unregistered nonresident establishments may deliver drugs to registered New York establishments during specific patient needs or declared public health emergencies if the establishment is properly licensed in its home state.

Transferred drugs must be FDA-registered (not compounded), delivered in original manufacturer's packaging with lot numbers and expiration dates, and comply with federal Drug Supply Chain Security Act requirements.

Pharmacies receiving recalled, counterfeit, or illegitimate products from unregistered establishments must immediately notify the State Board of Pharmacy and FDA.

Drug transfers cannot exceed 100% of the Wholesale Acquisition Cost, and unregistered establishments remain subject to New York jurisdiction and must cooperate with state audits and investigations.