us-doj-guidance-DEA-DC-031•Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy)
Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy)
us-doj-guidance-DEA-DC-031Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy)Guidance
Drug Enforcement Administration Diversion Control Division Civil Unrest Emergency Guidance Document Title: Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy) Question: My pharmacy was destroyed or heavily damaged during the civil unrest. I would like to open a temporary pharmacy at the same physical address as my current pharmacy. Am I required to obtain a new DEA registration while my pharmacy is being repaired or rebuilt? Answer: If a pharmacy’s temporary structure would be located at the same registered address (e.g., a temporary structure located at the address’s parking lot), it is permissible to operate a temporary pharmacy at the same registered address under certain conditions. If a temporary pharmacy is deployed, it is recommended that you notify your local field office of the new security established at your temporary location. The temporary pharmacy is authorized to operate under the same DEA number that was issued to the destroyed or heavily damaged pharmacy. The temporary structure must comply with all regulatory requirements applicable to registered pharmacies. In particular, please note that security controls for controlled substances stored or dispensed in the temporary structure must be adequate to comply with 21 CFR 1301.71, including the requirements specifically listed at 21 CFR 1301.75(b). If the destroyed or heavily damaged pharmacy is temporarily moved to a different physical address, the address on the DEA registration for the pharmacy must be modified to reflect the new physical address. 21 CFR 1301.51. The DEA registration may be modified to the new physical address by using the online modification form. Also, registrants should ensure that applicable state and local law allows for this type of transfer. Again, it is recommended that the pharmacy personnel contact the local field office for assistance in DEA record-keeping and security requirements. As with temporary structures at the same address, the temporary location at the new address must also comply with all regulatory requirements applicable to registered pharmacies, including security control requirements. 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-DEA156, June 4, 2020
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