Item 2140 – Compounding Issues
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.
quoted from here Thank you to Dr. Woliner for brining this to my attention
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