Opioid Crisis 101: DEA's “Closed System” Requirements
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An undisputed fact in opiate litigation is that defendants were allowed to legally operate in a "closed system" of distribution designed to prevent the diversion of dangerous narcotics. The Controlled Substances Act ("CSA"), 21 U.S.C. § 801 et seq., established the framework of a “Closed System” for everyone involved in the distribution chain of prescription opioids. The administration of closed systems can grant, deny, or revoke a registration under the CSA.?
In a closed system, record-keeping is required for controlled substances from the creation to disposal, thus keeping controlled substances within the system. Pharmaceutical controlled substances outside this closed system are said to have been diverted. The United States Drug Enforcement Administration ("DEA”) provides registration to all legitimate handlers of controlled substances. To maintain such registration, one must take reasonable steps to ensure that it is not for recreational use.??
?The DEA is determined to watch over the distributor-customer relationship. This legislation will deliver a trusted exchange between both parties lawfully. Congress has expressed its concern about the illegal distribution of controlled substances. It is general knowledge that the distribution of illicit substances has a significant and harmful result on our society's health and well-being. The CSA stated: "[a]ll applicants and registrants shall provide adequate controls and procedures to guard against theft and diversion of controlled substances.”) The registrants who fail to follow this authority may revoke their registration; see Masters Pharmaceuticals, Inc.; Revocation of Registration, 72 FR 36487-01, 36500, 2007 WL 1886484 (DEA July 3, 2007).?
With our society in crisis with the illicit use of harmful substances, the DEA must implement a way for registrants to avoid diverted drug use. The DEA clearly stated that "they cannot protect the American people from the extraordinary threat to public health and safety." Instead, they give the responsibility to registrants imposing the obligation on how they design and operate the system.?
Source: https://preventionsolutions.edc.org/services/resources/dea-closed-system-requirements
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