Compounding Flashcards
Does the state have stricter requirements for compounding than federal requirements?
No
What requirements must be met before an out-of-state pharmacy can compound drugs for dispensing to patients in this state (e.g., inspections, permits, fees)?
Registration as an outsourcing facility is required along with a copy of a current inspection report. If no FDA inspection has been conducted within the prior two-year period, the outsourcing facility must undergo an inspection.
What are the additional label requirements for compounded sterile products?
In addition to meeting state and federal law requirements, the label of each sterile preparation shall contain the following:
1) The name and quantity of each component
2) The beyond-use-date
3) The prescribed flow rate
4) The name or initials of each person who compounded the sterile preparation;
5) Any special storage instructions
