About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Senior Quality Assurance & Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

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.

Related Terms:
No items found.
Related FAQs:
More Questions? We're here to help!