When a sponsor conducting a nonclinical laboratory study intended to be submitted to or reviewed by the Food and Drug Administration utilizes the services of a consulting laboratory, contractor, or grantee to perform an analysis or other service, it shall notify the consulting laboratory, contractor, or grantee that the service is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part.
21 CFR Part 58 · Good Laboratory Practice for Nonclinical Laboratory Studies
§ 58.10 Applicability to studies performed under grants and contracts
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 58.10
Form FDA 483 observations citing this section, fiscal years 2010–2014 (Bioresearch Monitoring).
- Notifying contractor of GLP status 2
FDA guidance that cites § 58.10
- Assessment of Abuse Potential of Drugs 18 Jan 2017
Amendment history
Federal Register documents that created or amended this section.
- 43 FR 60013 22 Dec 1978