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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