Guidance Documents

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.

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

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.

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.

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.

This is a guidance letter clarifying the circumstances under which oral schedule II prescriptions are permitted and provides temporary exceptions due to the COVID-19 Public Health Emergency declared by the Secretary of Health and Human Services. 

On March 26, 2020, due to the HHS declared health crises, DEA has granted an exception to 21 CFR 1305.13 regarding the requirement that a purchaser mail a hard copy version of DEA Form 222 to the original supplier in order to ensure an adequate supply of controlled substances for the duration of this public health emergency.

Due to the current public health crisis declared by HHS on 1-31-20, DEA grants an exception of 21 CFR 1303.24(b) that normally require the inventory for individual manufacturers to remain at 65% or less.  All DEA reg. bulk manufacturers are allowed to exceed the 65% ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredient(s). This exception does not authorize any manufacturer to exceed his previously established annual manufacturing quota.

Due to the COVID-19 public health emergency declared by HHS on 1-31-20, the DEA is granting an exception to the requirement that a practitioner be registered in each state where they dispense controlled substances. However, under this temporary exception, practitioners may dispense controlled in states where they do not hold a registration, provided that they still hold at least one registration, and comply with all applicable state laws.

DEA’s regulations prohibiting mail delivery of methadone to NTP patients remain in effect. DEA believes that the potential for diversion and abuse of methadone for MAT treatment of narcotic dependent persons is too high to permit NTPs to dispense via the USPS. To ensure continued access during the COVID-19 health emergency, DEA has authorized NTP employees, law enforcement and National Guard personnel to deliver methadone to patients who cannot travel to the NTP.