us-doj-guidance-DEA-DC-034•Civil Unrest Q&A Pharmacy move CS without Address Change
Civil Unrest Q&A Pharmacy move CS without Address Change
us-doj-guidance-DEA-DC-034Civil Unrest Q&A Pharmacy move CS without Address ChangeGuidance
Drug Enforcement Administration Diversion Control Division Civil Unrest Emergency Guidance Document Title: Civil Unrest Q&A Pharmacy Movement of Controlled Substances without Address Change. Question: My pharmacy has been looted or may be looted in the near future as a result of the ongoing civil unrest and rioting. I don’t want to change my registered pharmacy address, but I want to move my controlled substances stock to a secure warehouse until possible rioting or looting ends. Is it permissible for me to do this? Answer: You may choose to move your controlled substance and inventory to a warehouse for storage and safekeeping under certain circumstances. First, you should ensure that this movement of controlled substances stock is allowed by applicable state and local law. Second, the move must be consistent with DEA physical security regulations, including your obligation to ensure that your controlled substances are stored securely and otherwise protected against theft and loss. See, e.g., 21 CFR 1301.71(a), 1301.75(b). Third, the warehouse to which you plan to move your controlled substances inventory must either be registered with DEA or a registration exemption must apply. In particular, you may move your controlled substance inventory from your registered location to an unregistered warehouse for storage or safekeeping if that inventory will thereafter be returned to you at your original location, i.e., the same registered location from which it was moved. If that inventory will instead be moved to another location after being stored at the warehouse, the warehouse itself must be registered with DEA. See 21 CFR 1301.12(b)(1). Fourth, you must transfer any schedule II controlled substances to the warehouse using a DEA Form 222 or the equivalent electronic order form, unless the warehouse is exempt from the requirement of DEA registration because, as just explained, your controlled substances will be returned to you at your original registered location after temporary storage at the warehouse. See 21 CFR 1305.03(a). Regardless of whether you are required to use DEA Form 222, however, your records must reflect the movement of the controlled substances to and (if they are returned to you) from the warehouse. If the option of temporary warehouse storage is allowed by state and local law, DEA recommends you contact your local field office regarding further logistics of utilizing a warehouse to store controlled substances on a temporary basis. Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or
cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department’s guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws. EO-DEA161, June 7, 2020
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