Section 3100.310  Security Requirements Generally

a)         All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a person has provided effective controls against diversion, the Department shall use the security requirements set forth herein as standards for the physical security controls and operating procedures necessary to prevent diversion.  Substantial compliance with these standards may be deemed sufficient by the Department after evaluation of the overall security system and needs of the applicant or registrant.

b)         Physical security controls shall be commensurate with the Schedules, and quantity, type and form of controlled substances (e.g., bulk liquids or dosage units, usable powders or non-usable powders) in the possession of the registrant in normal business operations.  When physical controls become inadequate as a result of a controlled substance being transferred to a different Schedule, or as a result of a non-controlled substance being listed on any Schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth herein when the need for such controls decreases as a result of a controlled substance being transferred to a different Schedule, or as a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of a controlled substance in the possession or the registrant during normal business operations.

c)         Physical security controls of locations registered under the federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (Public Law 90-513, 84 Stat. 1236), shall be deemed to comply substantially with the standards set forth herein.  Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved, shall not necessarily be deemed to comply substantially with the standards set forth herein, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved.