DEA Exceptions and Quota Increase During the COVID-19 Pandemic

To facilitate patient care during the public health emergency, the Drug Enforcement Administration (DEA) has issued four exceptions to regulations for DEA-registered pharmacies, hospitals and clinics. The first exception pertains to satellite hospital/clinics.[1] DEA is permitting registrants to utilize alternate satellite hospital/clinic locations and to accept controlled substances (CS) from distributors at these non-registered locations.[2]

The second exception allows narcotic treatment programs to accept CS deliveries and waives the delivery signature requirement.[3] The invoice may be signed and returned within 7 day of delivery.[4]

The third exception pertains to the commonly-called “5 Percent Rule” which previously did not allow dispensers such as pharmacies and physicians to distribute more than 5% of the total number of dosage units of CS based on prescription volume to other dispensers.[5] To meet the increasing demand for CS, such entities will no longer have to register as distributors.[6]  All other security, recordkeeping and applicably requirements remain in effect. However, DEA has also issued a temporary exception regarding the mailing of DEA Form 222 (order forms).[7]

The fourth exception pertains to the requirement for a face-to-face encounter between the prescriber and patient. DEA is permitting prescribers to issue prescriptions for CS based on a telemedicine encounter in the absence of an in-person medical evaluation. DEA has provided a FAQ and a decision-tree flow chart to assist with the prescribing and dispensing of CS during the COVID-19 pandemic.[8]

Finally, DEA, which has authority to establish quotas for CS under the SUPPORT Act[9] to avoid overproduction, shortages or diversion, has increased the 2020 quotas for certain Schedule I and II CS, particularly those used for patient on ventilators, by up to 15%, subject to further adjustment. Specifically increased are the quotas for methadone, fentanyl, morphine, hydromorphone, codeine, and certain intermediates for their production. In addition, DEA is increasing the amounts of Schedule III and IV controlled substances used for ventilator dependent patients (e.g. ketamine, midazolam, lorazepam)  that may be imported into the U.S.[10]

These exceptions remain in effect until the public health emergency ends, unless DEA specifies an earlier date.

If you have any questions or need guidance on remaining compliant with Federal and State regulations you can contact Frier Levitt and speak with one of our Pharmacist-Attorneys.

[1] https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-28)(DEA084)_Hospital_Clinic_Registration_Exception_(final).pdf

[2] https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-028)(DEA084)_Hospital_Clinic_Registration_Exception_(final).pdf

[3] 21 CFR 1301.74(h).

[4] https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-027)(DEA083)_DEA_Dist_MNF_narcotics_shipments_to_OTP_signed_delivery_exception_(final).pdf

[5] 21 CFR 1307.11.

[6] 21 CFR 1307.03

[7] See www.deadiversion.usdoj.gov/coronavirus.html.

[8] https://www.deadiversion.usdoj.gov/coronavirus.html

[9] Substance Use Disorder Prevention the Promotes Opioid Recovery Treatment for Patients and Communities Act of 2018, P.L. 115-271.

[10] DEA Takes Additional Steps to Allow Increased Production of Controlled Substances. https://www.dea.gov/press-releases/2020/04/07/dea-takes-additional-steps-allow-increased-production-controlled