21 CFR § 1316.13 - Frequency of administrative inspections.

---
identifier: "/us/cfr/t21/s1316.13"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1316.13 - Frequency of administrative inspections."
title_number: 21
title_name: "Food and Drugs"
section_number: "1316.13"
section_name: "Frequency of administrative inspections."
chapter_name: "DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE"
part_number: "1316"
part_name: "ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
regulatory_source: "36 FR 7820, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973."
cfr_part: "1316"
---


# 1316.13 Frequency of administrative inspections.

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.

[62 FR 13969, Mar. 24, 1997]