Coronavirus Regulatory and Legal-DEA

Coronavirus Regulatory and Legal-DEA

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LEGAL/REGULATORY—DEA 
July 2, 2020


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DEA Exception on In-person Examination Under Ryan Haight to Combat Coronavirus
The DEA has invoked an exception to the in-person examination requirement under the Ryan Haight Online Pharmacy Consumer Protection Act (21 U.S.C. 829). While the COVID-19 public health emergency remains in effect, practitioners may issue prescriptions for controlled substances (schedules II-IV) to patients for whom they have not conducted an in-person medical evaluation, provided all the following conditions are met:

  • The prescription is issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.
  • The telemedicine communication is conducted using an audio-visual, real-time, two-way interactive communication system.
  • The practitioner is acting in accordance with applicable federal and state law.

In addition, for the prescription to be valid, the practitioner must comply with any applicable state laws. 

Distributing Controlled Substance at Satellites
As of April 10th, the DEA will temporarily allow DEA-registered hospitals/clinics the flexibility to handle and deliver controlled substances at or to a satellite hospital/clinic (one or more locations under their existing registrations). To be “eligible” for such flexibility, the following general conditions must be met:

  • The satellite hospital/clinic was set up to provide temporary services connected to the COVID-19 public health emergency.
  • The satellite hospital/clinic is authorized by the state in which it operates to handle controlled substances and operate in a manner permitted by the state.
  • The DEA-registered hospital/clinic maintains all records required by DEA regulations at the registered location, including a current list of all satellite hospitals/clinics that it utilizes which handle controlled substances.
  • The DEA-registered hospital/clinic ensures the satellite hospital/clinic maintains physical security of the controlled substances and maintains effective controls against diversion.
  • The DEA-registered hospital/clinic notifies the DEA field office in writing before utilizing a satellite hospital/clinic that will handle controlled substances.
  • Except as provided in the next bullet point, the satellite hospital/clinic is affiliated with or owned by the DEA-registered hospital/clinic.
  • Satellite hospitals/clinics not affiliated with or owned by the DEA-registered hospital/clinic must enter into a written agreement that creates an agency relationship with the satellite hospital/clinic.

With respect to deliveries of controlled substances, the following additional requirements apply:

  • The delivery must be received by an employee or agent of the satellite hospital/clinic.
  • If, due to social distancing considerations, the delivery is not made inside the premises, the receiving employee or agent must identify himself/herself to pick up the shipment.
  • The delivery driver must record the delivery in his/her log and observe that the receiving individual takes the shipment inside the satellite hospital/clinic (if the delivery is not made inside the premises).
  • Deliveries must be person-to-person. The controlled substances may not be left at a location for pickup.

Exception to the 5% Rule
The DEA issued a temporary exception to the 5% Rule (21 CFR 1307.11). A DEA-registered practitioner may now distribute controlled substances to another practitioner (including physicians, hospitals, and pharmacies) for use by patients in excess of the existing 5% limit.  Before the exception went into effect, a DEA-registered practitioner could only distribute 5% of the total number of dosage units of all controlled substances to another registered practitioner during any calendar year. A DEA-registered practitioner must still comply fully with all other requirements of 21 CFR 1307.11. This exemption remains in effect until the public health emergency declared by the Secretary of HHS ends, unless terminated sooner by the DEA, and is retroactive to January 1, 2020.

For additional guidance and details, please go to https://www.deadiversion.usdoj.gov/coronavirus.html