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Six things to keep in mind when contracting with a compounding pharmacy

Pharmacy Regulation Resource, April 13, 2005

Thoroughly check a compounding pharmacy's safety and sterility processes before using its drugs. This will help you comply with the U.S. Pharmacopeia Chapter 797 guidelines on compounding sterile preparations and help you prepare for a JCAHO survey.

"We try to avoid using compounding pharmacies at all costs," says Todd Donnelly, RPh, manager of the department of pharmacy at Health Systems Services in Cleveland, OH. "But when we do use one, we first verify their facility capabilities, qualifications, and quality processes."

Individual states currently regulate compounding pharmacies, but the federal government is receiving more pressure from healthcare trade groups to have the FDA regulate the industry.

Until federal regulation occurs, you can use compounding pharmacies safely by following these measures that Donnelly implemented at Health Systems Services:

1. Try to produce the drug yourself if possible
2. Verify the compounding pharmacy's state licensure
3. Ask for the pharmacy's qualifications, safety processes, and how it tests sterility
4. Ask for copies of quality-monitoring data
5. Make sure it has patient-specific labeling
6. Have a manager in your hospital's pharmacy tour the compounding facility

Trouble spot: Some physicians prescribe non-FDA approved compounded drugs without first getting the patient's consent. If an adverse event related to the medication were to occur, the hospital contracting with the physician could be held accountable.

Solution: Create a policy that requires physicians to check with the hospital's pharmacy and therapeutics committee before they prescribe a compounded drug.

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