21 CFR 1316.13
§ 1316.13 Frequency of administrative inspections.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1316.13, § 1316.13 Frequency of administrative inspections, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/92240
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Full text
Except where circumstances otherwise dictate, it is the intent of the Administration to inspect all manufacturers of controlled substances listed in Schedules I and II and distributors of controlled substances listed in Schedule I once each year. Distributors of controlled substances listed in Schedules II through V and manufacturers of controlled substances listed in Schedules III through V shall be inspected as circumstances may require, based in part on the registrant's history of compliance with the requirements of this chapter and maintenance of effective controls and procedures to guard against the diversion of controlled substances.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.