The Drug Enforcement Administration (DEA) recently issued guidance regarding the emergency dispensing of Schedule II controlled substances.
First, as per its newly released guidance document, the DEA recognizes that it may not be feasible for a practitioner to deliver, in response to an emergency oral prescription, the follow-up paper prescription to the pharmacy within 7 days as required by 21 CFR 1306.11(d)(4). Therefore, exercising its authority under 21 CFR 1307.03 to grant an exception to the application of any provision in its regulations, the DEA hereby grants practitioners 15 days within which to provide that prescription to the pharmacy.
Next, as per the guidance document, for the duration of the COVID-19 Public Health Emergency, the DEA allows the practitioner to send the follow-up prescription to the pharmacy via facsimile, or to take a photograph or scan of this follow-up prescription and send the photograph or scan to the pharmacy in place of the paper prescription. It is the responsibility of the practitioner and the pharmacy to ensure that, whichever method the practitioner uses, the prescription contains all of the required information outlined in 21 CFR 1306.05 and 1306.11(d), including the statement that the prescription is “Authorization for Emergency Dispensing.”
Regardless of any exceptions that the DEA has made in response to COVID-19, pharmacists continue to have a corresponding responsibility to ensure that any controlled substance prescription that they fill was issued for a legitimate medical purpose by a practitioner acting in the usual course of his/her professional practice.
A copy of the guidance document is attached here.
If you are a physician or pharmacist with questions regarding the emergency dispensing of Schedule II controlled substances during COVID-19, contact Angelo Cifaldi.
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