Release Inspections

Non-Sterile Compounding <795>

Purpose/ Applicability:  To outline the proper procedure for the release inspections associated with non-sterile compounded products.

Scope: This applies to all non-sterile compounded preparations

Definition(s):

USP: United States Pharmacopeia

Equipment:

• N/A

Procedure:

1. At the completion of compounding and before release and dispensing, the non-sterile compounded preparation must be visually inspected to determine whether the physical appearance and characteristics are as expected. Inspections must also confirm that the compounded product and its labeling match the Compounding Record and the prescription or medication order. Final checks and inspections must be documented by the Pharmacist or Certified Technician for verification.
   1. Refer to each MFR to find expectations
      
      
2. Products should be stored in accordance with specific storage requirements identified for that preparation
   1. Master formulation / Compounding record
   2. Note: If product should be protected from light, must be stored in light protect bag
   3. If stock bottle is made, it must have all appropriate stickers per the compounding record on it.
      
      
      

Report any adverse event or product defect using Form FDA 1932a within 15 business days