Compounding

Question 1

What information is required to be on a label of a compounded parenteral solution made in an institutional pharmacy?

Answer 1

The label must contain:
1) Name, quantity and concentration of the drug added and the primary solution
2) Date and time of addition
3) Expiration date
4) Scheduled time for administration
5) Infusion rate, when applicable
6) Name or initials of the person performing the admixture
7) Identification of the pharmacy where the admixture was performed
8) Name or initials of the verifying pharmacist

Question 2

Does the state have stricter requirements for compounding than federal requirements?

Answer 2

No

Question 3

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)?

Answer 3

A pharmacy compounding patient-specific drugs must register as a pharmacy with Oregon. A pharmacy compounding non-patient specific drugs must register as a 503B outsourcing facility.

Question 4

What are the additional label requirements for compounded products?

Answer 4

The label must include:
1. The generic or official name of each ingredient
2. The strength or concentration of each active ingredient
3. The dosage form and route of administration
4. The rate of infusion for sterile parenteral products
5. The total quantity of the drug product
6. The beyond-use date
7. Handling, storage, drug instructions, cautionary information and warnings