The Case for Office Use of Compounded Medications

The prohibition of dispensing medication for office use, or the requirement that any pharmacy doing so must be regulated by the FDA against manufacturer-like standards, is most likely the result of misunderstanding this much needed—and in many states explicitly permitted—healthcare practice.

Dispensing for office use is a pharmacy practice, regulated by state boards of pharmacy, in which a pharmacist receives an order from a licensed prescriber for a specified medication, and then dispenses that medication to that prescriber for use in treating their patients. The key component of this practice is the prescriber-pharmacist relationship that exists at the time the order is being placed. Under no circumstances is the pharmacist dispensing medication without that relationship with the prescriber who is directly involved in treating patients.

Without the pharmacist-prescriber relationship, it is manufacturing and/or wholesale distribution. As such, it should be regulated by the FDA.

The New England Compounding Center (NECC), while it called itself a pharmacy and may have tried to explain its activities as “dispensing for office use,” was in reality distributing many of its medications without the pharmacist-prescriber relationship, and therefore was acting as a manufacturer/wholesaler.

Dispensing for office use is critical to effective patient care in many settings. While emergency-use preparations are most widely recognized, prescribers in many specialties rely on office use to effectively treat their patients. 

 

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