Pharmacy Practice FAQs
WHOLESALING/PRESCRITPION DRUG WHOLESALERS Q: May a pharmacy transfer prescription drugs to another pharmacy? Prescription drug transfers between or among pharmacies that fall outside this limited, emergency exception are wholesale transactions would require a North Carolina wholesaler license. Note that the sale of excess stock to another pharmacy would be a wholesale activity. Pharmacists should also be aware that transfers of prescription drugs between or among pharmacies must comply with the requirements of Title II of the federal Drug Quality and Security Act, also known as the Drug Supply Chain Security Act. More information is found here: FDA Guidance on Drug Supply Chain Security Act
Q: What federal law product tracing requirements apply to pharmacies? A: Pharmacists with questions about Drug Supply Chain Security Act’s application to pharmacy operations should contact the North Carolina Department of Agriculture’s Food and Drug Protection Division and consult the FDA Guidance on Drug Supply Chain Security Act.
Q: How can I find out whether a company is properly registered in North Carolina as a prescription drug wholesaler?
Q: I have been approached by a business that says it can broker sales of prescription drugs among pharmacies. Is this business model allowed under North Carolina law? A: No. Board staff and North Carolina Department Agriculture and Consumer Services, Food & Drug Protection staff (the latter are responsible for wholesale prescription drug regulation in North Carolina) have received multiple inquiries regarding contacts from businesses that represent themselves as Internet-based marketplaces for independent pharmacies. The business model described is an on-line point of product exchange, allowing independent pharmacies to buy and sell t over-stocked prescription drug inventory and prescription drugs in short supply among themselves. Typically, such businesses suggest that, under FDA guidelines, a pharmacy may transfer up to 5% of its annual sales to another pharmacy without a wholesale license. Board staff and Food & Drug Protection staff view these models as inconsistent with both federal and state law governing wholesale prescription drug transactions. North Carolina General Statutes are consistent with applicable portions of the federal Food, Drug & Cosmetic Act with respect to limited transfers of prescription drugs between pharmacies for legitimate emergency medical reasons; transfers between retail pharmacies without a wholesale license simply for inventory management reasons are not allowed in North Carolina. Board and Food & Drug Protection staff also are concerned that such business models are but another version of the “secondary” and “gray market” wholesaling. Staff has cautioned about this practice for years. See Item 2240 in the April 2012 Newsletter.
Q: How do I apply for a drug wholesaler's license in North Carolina?
|
