Drug Services may compound preparations not currently listed within our formulation database. However, we must first make the following assessments, per regulatory and institutional standards. Any information the requestor can provide would be appreciated.
- Assurance that a comparable commercial product is not available
- Whether the preparation is to be of limited use (e.g., one patient for short-term therapy versus routine use spread over a number of patients)
- Whether the preparation is currently available from other sources (e.g. another pharmacy in the region)
- Evidence in the form of credible professional literature that supports the use of the preparation
- Evidence or assurance that the compounded preparation would represent an acceptable benefit-risk ratio, and whether any known or suspected patient safety issues are associated with the use of the preparation
- Copies of comparable existing formulations
- Assurance of competency of the end-user(s)
- If used in human-use research, an accredited IRB approval for the preparation’s use
- Assurance that patients, using High Risk (sterile injectable) compounded preparations, are to be given appropriate informed consent
- Estimate of how often and how much the new preparation might be used
The requestor should also take into consideration whether compounding costs may be prohibitive. Current compounding labor costs for non-sterile preps are at the rate of $1.50 per minute plus ingredient and component costs. The compounding labor rate for sterile and chemo preps is $2.50 per minute plus the ingredient, component, and appropriate lab test costs. Certain labor-intensive activities (e.g., hand-filling capsules) may be charged at higher labor rates. Ambulatory Clinics seeking to add a new compounded item to their stock list, must first obtain approval from the pharmacy department’s Clinic Stock List committee, clinicmed@uw.edu. Also, be advised that many healthcare insurance programs may not adequately reimburse pharmacies for compounded medications.
Upon approval of a new compounded preparation, it may take 4-8 weeks to conduct formulation research, development, and testing prior to the first dispense. This timeline may be much longer if compounding the new preparation requires the purchase or installation of new equipment.