Guidance Information for Studies Seeking Drug Services Services
We encourage researchers to use our Investigational Drug Services (IDS) for human studies, and Drug Services (without IDS participation) for other studies.
Drug Services can do encapsulations and certain other preparations. The customer must provide formulation information (recipe) for any High Risk (Sterile Injectable) product. It is also strongly recommended that formulation information be provided for any preparations that need more than simple over-encapsulation. If Drug Services must research and develop a formulation (non-High Risk), the customer will be charged the cost of development. Compounding rates are explained later in this document. Human studies must first be reviewed by the UW IRB Process, or UW Researchers must have their protocol reviewed by an accredited IRB, with a copy of the IRB application and approval given to Drug Services.
In order to determine if we can provide services for a study, we will need the following. This information may be provided via email:
- The name of the Principle Investigator.
- The billing contact person, mailing address and phone number (who the bill must be sent to for payment), and the UW budget number, if applicable.
- The number of subjects.
- The total number, or quantity, of each product needed.
- The desired amount, concentration, or size of the product.
- If applicable, the total number of placebos needed.
- The number of dosage units for actives and placebos needed for the first phase of the study, and the estimated total of each needed to complete the study.
- When any portion of the product would first be needed.
- How long the study is expected to run.
- How the medication is to be dispensed to patients (through IDS?).
- Whether randomization services are expected. If yes, then our Investigation Drug Services staff may be involved.
- Evidence of an application to the UW IRB for human studies.
It is best not to request all the preparation at once. Needs tend to vary over time and the preparation can expire, plus we have limited ability to produce large batches at once. The beyond-use dating for compounded preparations or repackaged preps is six months from the date of compounding/repackaging.
For controlled substance drugs, if the customer does not choose to pick up the drug from Drug Services, we can have it delivered, but only to the address listed on your DEA registration. We cannot use prescriptions for these preparations. We will fill the order for the actives based upon receipt of an email request and a completed Drug Services Controlled Substance Order form, and if applicable, a completed Schedule II Order blank (Form 222) made out to Drug Services for the exact amount of drug involved.
Billing and cost information for:
Studies involving capsules: (100 capsule minimum order)
Over-encapsulations are 75 cents per capsule plus active ingredient cost, for those preparations that simply involve placing a dosage unit within a capsule using lactose as the filler. If the preparation involves the use of tablet-splitting, serial dilutions (mixing powdered drug with an inert ingredient), using other than a lactose filler, and the capsules can be made with our filler device, the cost is $3.00 per capsule plus ingredient cost. If the capsules must be individually hand-filled and weighed (to within plus or minus 5% of target weight), the cost is $5 per capsule plus ingredient cost. All lactose placebo capsules are 50 cents each. Placebos with fillers other than lactose (e.g., corn starch) are $1 each. There is an additional $15 fee for controlled substance orders. If we must ship the capsules to a location, there is presently a $20 shipping charge. The drug wholesaler’s cost for full packages will be used in computing the cost for active ingredients. In other words, if 350 capsules of actives are requested and we must order four bottles of 100 dosage units to fill the order, the customer would have to pay for the four bottles.
Studies involving other compounded products:
Compounded preparations, such as topicals, rectals, and non-sterile otics will be billed to the customer at the rate of $1.50 per minute compounding time, plus ingredient, component, and development costs if applicable.
High Risk injectables, chemos, sterile otics and ophthalmics, will be billed at the rate of $2.50 per minute, plus ingredient, component costs, and if applicable, microbiological, endotoxin, and potency testing lab fees, and formulation development cost.
If the investigator has a UW budget number, Drug Services will bill for the product via this budget number. If the investigator does not have a UW budget number Drug Services will invoice the appropriate parties for billing.
Cost estimates for more complex studies can usually be provided within 5-7 business days. Compounded product availability will not occur until formulation research, development, and testing is performed. Product availability is variable, but should take approximately 4-6 weeks, once the terms of the study have been mutually agreed upon.
Please be advised, there may be occasions when Drug Services is unable to work on a study request. In determining whether we can assist with a drug study, Drug Services must consider current resources and workload. At present, our activities are limited to smaller pilot-type studies.