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for a compounder that's registered as a 503(b) facility, a classifi-
cation that ensures the pharmacy is held to the same standard
operating procedures as large pharmaceutical manufacturers.
This means the facility is required to comply with current good
manufacturing requirements, report adverse events to the FDA
and perform proper labeling practices in accordance with the
Drug Quality and Security Act (DQSA).
3. How do guarantee the sterility? Confirm the pharmacy adds
preservatives to compounded medications to ensure sterility.
For example, compounders that make wound creams typically
include methylparaben or propylparaben preservatives.
4. Do you perform appropriate checks? After a staff member
draws up the medication, does a second person perform a dou-
ble-check? Then, does a third person come back and check the
label of the compounded medication? The importance of this
three-level oversight can't be overstated, and there are facilities
that will skip the critical steps because of issues like staffing
availability. However, all levels are needed to ensure the right
dose of the right drug are prepared for the right patient.
5. Do you have the right culture? You can phrase this question in
any way that helps you get at whether the facility takes ownership
for a compounding issue. You're looking for any type of response
from a compounder that showcases accountability, not plausible
deniability.
— Jared Bilski
