21 C.F.R. § 1301.74 - Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs
| Cite as | 21 C.F.R. § 1301.74 |
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84 practice notes
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Perry County Food & Drug Decision and Order
...and phenergan with codeine to the Arkansas Board of Pharmacy on a DEA Form 106, the report was never filed with DEA as required by 21 CFR 1301.74(c). Tr. While Respondent stipulated to most of these acts, this is not the only evidence of misconduct on the part of Respondent's principals. Mo......
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Masters Pharmaceuticals, Inc.; Decision and Order
...alleged that Respondent ``failed to detect and report suspicious orders of oxycodone products by its pharmacy customers, as required by 21 CFR 1301.74(b).'' Following service of the Show Cause Order, Respondent requested a hearing on the allegations. ALJ Ex. 3. The matter was placed on the ......
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Disposal of Controlled Substances
...of the regulation because such losses would be attributable to the unique activities involving the disposal of controlled substances. 21 CFR 1301.74(c)(3). Also, because the controlled substances collected cannot be individually handled or sorted, it must be assumed that the loss includes S......
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Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
...from 21 CFR 1310.05(b)(1). The commenter also suggested that the inclusion of these factors, while being similar to those factors in 21 CFR 1301.74(c), might cause DEA field staff to consider these factors In the alternative to removing the factors from the regulatory text, this same commen......
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43 cases
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City of S.F. v. Purdue Pharma L.P., Case No. 3:18-cv-07591-CRB
...and distributors—to "design and operate a system to disclose to the registrant suspicious orders of controlled substances." 21 C.F.R. 1301.74(b). The MDL court concluded that these regulations impose duties on manufacturers and distributors to identify, report, and refrain from shipping sus......
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Walmart Inc. v. U.S. Dep't of Justice, CIVIL NO. 4:20-CV-817-SDJ
...suspicious orders of controlled substances" and to notify DEA of such "suspicious orders" when discovered by the registrant. 21 C.F.R. § 1301.74(b). The regulation defines "suspicious orders" to include "orders of unusual size, orders deviating substantially from a normal pattern, and order......
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Virtus Pharm. v. Garland, Civil Action 21-2308 (CKK)
...For example, registrants must “design and operate a system to disclose . . . suspicious orders of controlled substances, ” 21 C.F.R. § 1301.74(b), report instances of theft to the DEA, id. at § 1301.74(c), and maintain certain physical security conditions at their facilities, see id. at §§ ......
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W. Boca Med. Ctr., Inc. v. Amerisourcebergen Drug Corp. (In re Nat'l Prescription Opiate Litig.), MDL 2804
...("SOMS"), as well as by failing to actually disclose such suspicious orders, as required of ‘registrants’ by the federal CSA, 21 C.F.R. § 1301.74(b), which is incorporated into Florida law by the FLDCA [Drug and Cosmetic Act], including Fla. Stat. § 499.0121.Doc. #: 385 at ¶902. West Boca f......
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9 firm's commentaries
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Coronavirus: Relief for Behavioral Health Providers in Agency Waivers, Guidance
...to Patients On March 16, 2020, the Drug Enforcement Administration (DEA) granted a waiver request by SAMHSA from the requirements in 21 C.F.R. § 1301.74(i) during the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020 to allow DEA-regist......
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First of Its Kind: Drug Wholesaler Accepts DPA and Two Executives Face Criminal Charges in SDNY For Illegal Distribution of Opioids
...other than legitimate medical, scientific, and industrial channels” under 21 USC § 823(b)(1) and reporting suspicious orders under 21 CFR § 1301.74(b). The criminal pleadings include allegations For five years (2012-2017), RDC allegedly “took steps to conceal its illicit distribution of con......
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First of Its Kind: Drug Wholesaler Accepts DPA and Two Executives Face Criminal Charges in SDNY For Illegal Distribution of Opioids
...other than legitimate medical, scientific, and industrial channels” under 21 USC § 823(b)(1) and reporting suspicious orders under 21 CFR § 1301.74(b). The criminal pleadings include allegations that: For five years (2012-2017), RDC allegedly “took steps to conceal its illicit distribution ......
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First Of Its Kind: Drug Wholesaler Accepts DPA And Two Executives Face Criminal Charges In SDNY For Illegal Distribution Of Opioids
...other than legitimate medical, scientific, and industrial channels" under 21 USC § 823(b)(1) and reporting suspicious orders under 21 CFR § 1301.74(b). The criminal pleadings include allegations For five years (2012-2017), RDC allegedly "took steps to conceal its illicit distribution of con......
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1 provisions
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P.A. 19-0191, HB 7159 – AN ACT ADDRESSING OPIOID USE
...Division a copy of any suspicious [activity reporting] orders submitted to the federal Drug Enforcement Administration pursuant to 21 CFR 1301.74. (2) Each registered manufacturer or wholesaler of drugs that, based on concerns of potential diversion, ceases or declines distribution of any s......