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North Carolina News: Item 2140 - Compounding Issues
Reprinted from the July 2007 North Carolina Board of Pharmacy Newsletter.
North Carolina Board of Pharmacy staff members are aware that several pharmacies, both in-state and out-of-state, regularly engage in the compounding of prescription veterinary drug products for resale. This practice plainly violates North Carolina law, which states that “[c]ompounded drug products shall not be offered to other entities for resale.” 21 NCAC 46.1810(1). The Board is investigating this behavior and, where appropriate, taking disciplinary action.
Compounders are also reminded that, in a recent disciplinary action concerning the resale of compounded prescription drugs, the Board has ruled that negligence in the practice of pharmacy can result from a pharmacist’s failure to take affirmative steps to determine whether compounded products are being resold. The Board further stated that it “recognized that compounding pharmacists can, and do, provide valuable services to patients. But with the ability to compound medications for patients comes a tremendous responsibility to ensure that these products are safe and used appropriately. Where . . . facts and circumstances should have alerted a pharmacist that compounded products [a]re not being used appropriately, that responsibility extends beyond the pharmacy counter.”
Board staff is also aware that a handful of out-of-state pharmacies lacking North Carolina permits have regularly shipped compounded products (human and veterinary) into the state. A recent investigation of one such pharmacy has resulted in its discontinuing business in North Carolina. North Carolina law is clear that “out-of-state pharmacies that ship, mail, or deliver in any manner a dispensed legend drug into this State” must have an out-of-state pharmacy permit. 21 NCAC 46.1607(a). The shipping of compounded products into the state may also run afoul of wholesaler statutes and regulations. There is no “exception” to the permit requirement for compounded products, nor has there ever been any such exception.
