Commissioner's Ruling - Exempt Distribution
Whereas, the Department is aware of instances in which patients are not able to obtain controlled substances for their immediate, legitimate medical needs. Such instances typically occur in health care facilities which have onsite pharmacies, but these difficulties also arise in the retail pharmacy setting; and
Whereas, there are occasions when a Class 3 institutional pharmacy (hospital or nursing home) cannot fill a practitioner's order for a controlled substance because the facility's in-house pharmacy lacks the specialized equipment necessary to prepare the drug (e.g. laminar flow hoods.) In the retail pharmacy setting, there are occasions when a pharmacist is presented with a prescription and is unable to fill it because the pharmacy has either exhausted its stock of the controlled substance or does not ordinarily stock the medication. Such instances result in patients either having to wait for the appropriate medication, travel to another pharmacy to fill their prescription, or obtain a new prescription for a different medication.
Now therefore, pursuant to the authority contained in Public Health Law Section 3321(1)(b), I hereby make the following ruling:
- Any health care facility which is licensed by the Department as a class 3 institutional dispenser or any retail pharmacy which is licensed by the State, and which health care facility or retail pharmacy is also duly registered with the United States Drug Enforcement Administration (DEA), is exempt from the licensing requirements for the sale of a controlled substance stock by a pharmacy to a pharmacy provided such sale is solely to meet the immediate needs of the pharmacy receiving the controlled substance. An immediate need exists when the facility or retail pharmacy is not capable of preparing a controlled substance medication or does not have a controlled substance in stock and immediate administration or dispensing of the drug is necessary for proper treatment.
- This ruling shall only apply to transfers or sales of stocks of controlled substances. Transfers or sales of other prescription medications are governed by the State Education Law.
- A pharmacy, under the direct supervision of the pharmacist, may sell or transfer schedule III, IV or V controlled substances to another authorized pharmacy pursuant to a written request submitted by the purchasing pharmacy or facility on business stationery. All such requests shall indicate the name and address of the requesting pharmacy, the name and address of the pharmacy furnishing the controlled substance, the DEA registration number of both pharmacies, date of the request, and the name, strength, dosage form and quantity of the controlled substance being requested. Schedule II controlled substances shall be ordered only on an official DEA 222 order form or any successor form and/or methodology authorized by the U.S. DEA. All controlled substance requests must be signed and dated by both the furnishing and the requesting pharmacist.
- The pharmacy (vendor) furnishing the requesting pharmacy (vendee) shall provide the vendee pharmacy with an itemized list of the drugs sold or transferred and shall include the name and address of the vendor pharmacy, the name and address of the vendee pharmacy, DEA numbers of both pharmacies, date of the sale or transfer and name, strength, dosage form and quantity of controlled substances being sold or transferred. Upon receipt of the controlled substance, the vendee pharmacist shall sign and date the itemized list of drugs sold or transferred.
- The vendor pharmacy and the vendee pharmacy shall maintain all required records of such transfers and request in a separate file or in such a manner as will make them readily available for inspection by authorized representatives of the Bureau of Narcotic Enforcement, New York State Health Department and/or the United States Drug Enforcement Administration or other law enforcement officials authorized by law to inspect such records