NY A01067

Nonresident pharmacies, manufacturers, wholesalers, and outsourcing facilities must register with the Department of Education to deliver prescription drugs to New York establishments, prescribers, and patients, with exemptions for intra-company transfers between affiliated entities.

Unregistered nonresident establishments may deliver prescription drugs to registered New York pharmacies during a specific patient need or public health emergency if the establishment is properly licensed in its home state and documentation is maintained.

Drugs delivered under the emergency exception must be FDA-registered (non-compounded), come from authorized manufacturers or distributors, be delivered in original manufacturer's packaging with lot numbers and expiration dates, and cost no more than 100 percent of Wholesale Acquisition Cost.

Registered pharmacies receiving recalled, counterfeit, or illegitimate drugs from unregistered establishments must immediately notify the State Board of Pharmacy and the FDA, and must maintain all records for six years.

Unregistered nonresident establishments engaged in emergency transfers are subject to New York State jurisdiction and must cooperate with state audits and investigations, with violations punishable under state law.