Does a sponsor need FDA authorization to charge for the costs of drug delivery, formulation, packaging, instrumentation, monitoring, disposables, setup, and nursing care?


No. The provision in 21 CFR 312.8(d)(1) is intended to permit a sponsor to recover the direct costs incurred in making a drug available from the onset of manufacturing to the point it arrives at the destination to which it was shipped or, for a drug acquired from another source as a finished product (e.g. when manufacturing is outsourced), acquisition, shipping, and handling costs for the drug.

Recovery of subsequent costs incurred at a clinical trial site (e.g., a hospital or clinic), including pharmacy costs (e.g., the cost to reconstitute a drug for infusion), nursing costs (e.g. costs associated with administering a drug and monitoring study subjects), equipment costs (e.g. intravenous administration sets, infusion pumps), and costs for study-related procedures (e.g. chemistry labs, radiographic procedures), do not fall within the scope of § 312.8. In other words, FDA authorization is not needed for a sponsor to recover those costs.

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About the Author
Proxima CRO Team
Ellie Reynolds
Quality Assurance

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

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