Proposed regulations intended to improve the safety of compounded medications often use quantity measurements as a “marker” for safety.
The more compounds prepared, these laws reason, the less safe the compounds. So, by this rationale, the quantity of compounds made by a compounder ought to be part of a formula that distinguishes between a “traditional compounder” and a “compounding manufacturer.”
But in truth, safety in healthcare more often than not improves with volume. For example, it is common wisdom that when contemplating any medical procedure, the patient ought to choose the practitioner with the most experience with that specific procedure.
Similarly, in compounding pharmacy, the volume of medications made, the scale of an operation, the percentage of total sales or the use of automated equipment should in no way be associated with defining a business as a manufacturer instead of a compounding pharmacy.
The distinction between a pharmacy and a manufacturer should be made based on how and to whom the medications are sold:
- A manufacturer sells medication to someone other than a patient or prescriber, based on an order by someone who is not a prescriber, without any interaction with any patient or prescriber, for the purposes of that medication being subsequently resold numerous times before it actually reaches a patient.
- A pharmacy only sells medication either to a patient or to a prescriber, based on a prescription or medication order from a prescriber, after direct communication with the prescriber, for the purposes of that medication being administered to the patient by the person who receives the medication directly from the pharmacy.
Based on this perspective, it becomes much clearer as to where to draw the line between a compounding pharmacy and a manufacturer. This also eliminates the challenges of trying to determine numeric values numbers (overall compounded volume, percentage sold to practitioners, percentage sold out of state, etc.) at which a pharmacy crosses over into being a manufacturer.