21 C.F.R. § 1301.75

Physical security controls for practitioners

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(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.

(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

(c) Sealed mail-back packages and inner liners collected in accordance with part 1317 of this chapter shall only be stored at the registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access, except as authorized by § 1317.80(d).

(d) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.

(e) Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.

[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997; 79 FR 53562, Sept. 9, 2014; 81 FR 58839, Aug. 26, 2016]

Notes of Decisions

Cited in 6 cases (2 in the last 5 years), 1996–2023 · leading case: DE VILLERS v. Cnty. of San Diego, 67 Cal. Rptr. 3d 253 (Cal. Ct. App. 2007).

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DE VILLERS v. Cnty. of San Diego, 67 Cal. Rptr. 3d 253 (Cal. Ct. App. 2007). “” ( 21 C.F.R. § 1301.75 (c) (2007).) Finally, part 1301.”

United States v. Poulin, 926 F. Supp. 246 (D. Mass. 1996). · cites it 3× “” 21 C.F.R. § 1301.75 (b). Neither the regulations nor precedents specify a penalty for violation of these security provisions.”

Wedgewood Vill. Pharmacy v. Drug Enf't Admin., 509 F.3d 541 (D.C. Cir. 2007). “72 (storage and security requirements for "non-practitioner”) with 21 C.F.R. § 1301.75 (security requirements for practitioner).”

Ontario Provincial Council of Carpenters' Pension Trust Fund v. Walton (Del. Ch. 2023). “A pharmacy must implement security measures to maintain control over its inventory of controlled substances, 21 C.F.R. § 1301.75 , and the security measures must enable the pharmacy to identify instances of loss or theft and notify the DEA, id.”

Ontario Provincial Council of Carpenters' Pension Trust Fund v. Walton (Del. Ch. 2023). “23 18 21 C.F.R. § 1301.75 . 19 Id. § 1301.76. 20 Id.”

Becker v. Drug Enf't Admin., 541 F. App'x 587 (6th Cir. 2013). “12 ; (2) Becker’s continued administering of controlled substances at the Avon location after having received notice this was in violation of the registration requirement justified finding the violation “flagrant;” (3) Becker maintained controlled substances at the Avon location…”

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