Are all hospital pharmacy cleanrooms a 503A compounding facility?

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Karen Thompson
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Joined: 05/03/2009 - 02:30
Are all hospital pharmacy cleanrooms a 503A compounding facility?

A colleague told me that all hospital pharmacy cleanrooms are 503A compounding facilities, by default. It is my understanding that we are NOT considered a 503A compounding facility if we are only making products for patients that are admitted to our facility. If we were to sell our products to another facility in town (pursuant to a prescriber’s prescription), then we would be considered a 503A. How do others interpret this?

If we are considered a 503A facility, does that mean we are required to purchase all of our IV infusions in a pre-mixed form if they are commerically available** (e.g., Baxter's Myxredlin insulin 100 unit/100mL bags)? That just does not sound right...

**FDA Guidance for Industry: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug under Section 503A of FD&C Act