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Distinguish medication administration from pharmacy compounding. Adding a medication to an IV for immediate administration to an identified patient under a lawful order is not automatically the same regulatory activity as preparing sterile products in advance for stock, batches, resale, or future dispensing. The exact workflow determines the analysis.
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Which questions change whether preparing an IV bag is compounding?
Is the bag prepared for one identified patient? Immediately before administration? Who ordered it and who prepares it? Is it stored for later use, prepared in batches, transferred to another location, or dispensed to the patient? Is a commercially manufactured product being altered? Is the clinic operating in a way that resembles a pharmacy compounding operation? These facts can move you from “administration” toward regulated sterile compounding/dispensing.
What is the safer operational model for preparing IV bags?
Prefer clearly identified patient-specific orders, pharmacy-dispensed sterile products where appropriate, exact labeling, manufacturer/pharmacy storage instructions, concentration verification, lot/expiration documentation, and no speculative batch preparation unless clearly lawful under the applicable framework.
Owner takeaway
Don’t say “we compound our own IVs” casually. Determine whether you are administering an ordered medication or engaging in activity regulated as sterile compounding or dispensing — and confirm with the Board of Pharmacy and counsel.