21 C.F.R. § 1316.13 Frequency of administrative inspections.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 1316—ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
Subpart A—Administrative Inspections
§ 1316.13 Frequency of administrative inspections.
