(a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term “for cause” means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances.
(b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant must also file a complete and accurate DEA Form 106 with the Administration through DEA's Diversion Control Division secure network application within 45 days after discovery of the theft or loss. When determining whether a loss is significant, a registrant should consider, among others, the following factors:
(1) The actual quantity of controlled substances lost in relation to the type of business;
(2) The specific controlled substances lost;
(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;
(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,
(5) Whether the specific controlled substances are likely candidates for diversion;
(6) Local trends and other indicators of the diversion potential of the missing controlled substance.
(c) Whenever the registrant distributes a controlled substance (without being registered as a distributor as permitted in §§ 1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), he/she shall comply with the requirements imposed on non-practitioners in § 1301.74(a), (b), and (e).
(d) Central fill pharmacies must comply with § 1301.74(e) when selecting private, common or contract carriers to transport filled prescriptions to a retail pharmacy for delivery to the ultimate user. When central fill pharmacies contract with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106. Retail pharmacies must comply with § 1301.74(e) when selecting private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy. When retail pharmacies contract with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106.
[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997; 68 FR 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005; 79 FR 53562, Sept. 9, 2014; 88 FR 40712, June 22, 2023]
Notes of Decisions
Walters, T. v. UPMC Presbyterian Shadyside, 144 A.3d 104 (Pa. Super. Ct. 2016).
· cites it 10× “As a registrant, Plaintiffs pled that, "UPMC had a legal duty to 'provide effective controls and procedures to guard against theft and diversion of controlled substances' " and notify the DEA " 'in writing, of the theft or significant loss of any controlled substances within one…”
Walters v. UPMC Presbyterian Shadyside, 187 A.3d 214 (Pa. 2018).
· cites it 4× “21 C.F.R. § 1301.76 (b). DEA Form 106, 19 of which we take judicial notice, delineates some of the information *231 that a reporting registrant is expected to provide.”
Bonds v. Tandy, 457 F.3d 409 (5th Cir. 2006).
· cites it 5× “Because Bonds had a prior felony conviction for the illegal distribution of a controlled substance, and because he once owned a pharmacy that had its DEA registration revoked, 21 C.F.R. § 1301.76 prevented MPP from hiring Bonds unless the DEA waives the restriction.”
Visels Drug Store, Inc. v. Drug Enf't Admin., 593 F. App'x 12 (2d Cir. 2014).
· cites it 4× “” 21 C.F.R. § 1301.76 (a). We assume the parties’ familiarity with the facts and the record of prior proceedings, which we reference only as necessary to explain our decision.”
Rankin v. Longs Drug Stores California, Inc., 28 I.E.R. Cas. (BNA) 1330 (Cal. Ct. App. 2009).
“§§ 801-904 ; CSA) and an implementing DEA regulation *1251 ( 21 C.F.R. § 1301.76 (a) (2005)) barred the application of section 432.”
In Re Establishment Inspection Of: Wedgewood Vill. Pharmacy, Inc., 270 F. Supp. 2d 525 (D.N.J. 2003).
“This inter-agency effort related to “matters currently under investigation,” most notably Wedgewood’s failure to report the theft of controlled drug substances to the DEA, required under 21 C.F.R. 1301.76(b). The theft of the drug substances may have resulted in overdoses by…”
Woods v. U.S. Drug Enf't Admin., 895 F.3d 891 (6th Cir. 2018).
· cites it 2× “21 C.F.R. § 1301.76 (a). In 2016, the DEA enforced this regulation against McDonald and Woods, who had voluntarily surrendered their registrations while in addiction treatment, but who have regained full registrations with the DEA since.”
Woods v. U.S. Drug Enf't Admin., 283 F. Supp. 3d 649 (W.D. Tenn. 2017).
· cites it 19× “, seek to prevent Respondents from enforcing 21 C.F.R. § 1301.76 (a) against them with respect to their current or future employment as physicians with access to controlled substances.”
Walters v. UPMC Presbyterian Shadyside, 31 Pa. D. & C.5th 281 (2013).
· cites it 4× “A registrant must comply with 21 C.F.R. §1301.76 (b) which reads in part as follows: *285 (b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business…”
Walters, T. v. UPMC Presbyterian Shadyside (Pa. Super. Ct. 2016).
“21 C.F.R. § 1301.76 . - 12 - J-A07013-16 I agree with the majority’s determination that Appellants’ complaint sufficiently pled that, as a registrant under the act, UPMC was required to report to the DEA Kwiatkowski’s known diversion and substitution of controlled substances,…”
— 21 C.F.R. § 1301.76(b) — 2 cases
Walters, T. v. UPMC Presbyterian Shadyside, 144 A.3d 104 (Pa. Super. Ct. 2016).
“As a registrant, Plaintiffs pled that, "UPMC had a legal duty to 'provide effective controls and procedures to guard against theft and diversion of controlled substances' " and notify the DEA " 'in writing, of the theft or significant loss of any controlled substances within one…”
In Re Establishment Inspection Of: Wedgewood Vill. Pharmacy, Inc., 270 F. Supp. 2d 525 (D.N.J. 2003).
“This inter-agency effort related to “matters currently under investigation,” most notably Wedgewood’s failure to report the theft of controlled drug substances to the DEA, required under 21 C.F.R. 1301.76(b). The theft of the drug substances may have resulted in overdoses by…”
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