Mail Order Pharmacies & Nonresident Establishments Flashcards
A registered nonresident manufacturer or wholesaler shall notify the department on forms prescribed by the department of a change of address of the establishment or the discontinuance of the establishment within…
within 10 days after such change of address or discontinuance
A registered nonresident outsourcing facility shall notify the department on forms prescribed by the department not less than…
30 days prior to the expected date of relocation or discontinuance.
In order to be registered nonresident establishments shall:
i. be licensed and/or registered in good standing with the state of residence;
ii. maintain, in readily retrievable form, records of drugs and/or devices shipped into NY;
iii. supply, upon request, all information needed by the department to carry out the department’s responsibilities under law;
iv. comply with all statutory and regulatory requirements of the state where the nonresident establishment is located,
For Rx drugs or devices shipped, mailed, or delivered into NY, except for controlled substances shipped, mailed, or delivered into NY, the nonresident pharmacy shall follow…
Federal and NY State law
Nonresident establishments that are pharmacies shall provide a toll-free telephone number that is on a label affixed to each drug/device AND is…
available during normal business hours at least 40 hours per week, to enable communication with a pharmacist
A mail order pharmacy shall make the offer to counsel either by…
telephone or by sending a written offer together with the filled prescription. The written offer shall include a toll-free telephone # of the pharmacy which a patient or caregiver may use to obtain counseling.
Pharmacies delivering prescriptions by mail or licensed express delivery services must submit schedules II-V controlled substance dispensed prescription data to the Bureau of Narcotic Enforcement (BNE) no later than…
72 hours after the substance was shipped from the pharmacy
When mail-order pharmacies send a prescription where an alternative drug was dispensed after consultation with the prescriber, the pharmacy must:
Make 2 documented call attempts to the patient within 48 hours of mailing/delivery
