Guidance Documents
Guidance on the Scope of Agency under the Foreign Agents Registration Act (FARA)
The guidance discusses the meaning of the term “agent of a foreign principal” as used in FARA.
COVID-19 Office Site Delivery Buprenorphine
During the COVID-19 health emergency, DEA will permit OTPs to regularly use off-site locations located in the same state in which they are registered with DEA to deliver take-home doses of buprenorphine to patients authorized to receive them, without separately registering those locations. OTPs must obtain approval for unregistered delivery locations from local DEA offices and SOTA.
COVID-19 Exception (5% Rule)
During the Covid19 Public Health Emergency, DEA will temporarily permit registered practitioners such as hospitals, pharmacies, and physicians to distribute controlled substances (CS) in excess of five percent of their total number of dosage units of CS distributed to other registered dispensers during this calendar year, without registering as a distributor. All DEA security, recordkeeping and other applicable regulations, including state requirements, remain in effect.
COVID-19 OTP Signed Delivery Exception to Regs
During the Covid-19 Public Health Emergency, DEA will permit distributors to deliver narcotic substances to Narcotic Treatment Programs without requiring immediate signature by the NTP’s authorized individual accepting delivery. Distributors must confirm physical possession by the NTP and complete additional recordkeeping requirements in a timely manner.
Industry Letter: Business Premises Guidance for FFLs
Letter to all federal firearms licensees (FFLs) in response to questions from industry members regarding the legality of firearm sales and deliveries exterior to the brick-and-mortar structure at which the firearms business is licensed, in light of the March 13, 2020, declaration of a national emergency concerning the outbreak of the novel coronavirus disease (COVID-19), and the Department of Homeland Security’s subsequent classification of firearms businesses as essential.
COVID-19 H.D.A. Question and Responses
Due to the Covid-19 Public Health Emergency, DEA has issued guidance to Distributors to ensure regulatory compliance regarding secure delivery of controlled substance shipments to hospitals, pharmacies and NTPs, documentation and recordkeeping, due diligence requirements, and authorization for emergency alternate distribution sites.
COVID-19 Off-Site OTP Delivery Method
During the COVID-19 health emergency, DEA will permit OTPs to regularly use off-site locations located in the same state in which they are registered with DEA to deliver take-home doses of methadone to patients authorized to receive them, without separately registering those locations. OTPs must obtain approval for unregistered delivery locations from local DEA offices and SOTA
COVID-19 QA EPCS Hospitals & Remote ID Proofing
During the COVID-19 public health emergency, DEA-registered hospitals/clinics may conduct remote identity proofing of individual practitioners to issue authentication credentials to eligible practitioners engaged in electronic prescribing of controlled substances, in conformance with existing regulations. DEA suggests using a device that allows for real-time, two-way, audio-visual interactive communication to do so.
COVID-19 SAMHSA Telemedicine (Phone)
In light of the nationwide public health emergency declared by the HHS on 1-31-20, for the duration of this public health emergency, unless DEA specifies earlier, DEA has establish guidance concerning the use of a telephone call to conduct a telemedicine visit using controlled substances.
COVID-19 Prescription Chart
In response to the COVID19 public health emergency(PHE) declared by HHS, the DEA has adopted policies to allow DEA reg. practitioners to prescribe controlled substances(CS) without having to interact in-person with their patients. This chart only addresses prescribing CS and doesn’t address administering or direct dispensing of CS, including by OTPs or hospitals. These go into effect 3-31-20, and will remain in effect for the duration of the PHE, unless DEA specifies an earlier date.