The DEA has made several important changes to the rules that govern prescription of controlled substances, in response to the public health emergency posed by the COVID-19 pandemic.
The initial evaluation of the patient may now occur by telemedicine “using a real-time, two-way, audio-visual communications device,” rather than in person. Previously, telemedicine visits were only allowed for maintenance appointments.
Under certain circumstances, the prescriber may call in the prescription to the pharmacy, rather than providing a written prescription. For Schedule II drugs, the phone-in prescription is allowed if the proper treatment requires immediate administration, if there is no alternative treatment available, and it is not “reasonably possible for the prescribing practitioner to provide a written Rx to the pharmacy prior to dispensing.” A written prescription, electronic prescription, or photograph of the written prescription should be delivered to the pharmacy within 15 days of the phone-in prescription, rather than the 7 days specified in the regulations that authorize emergency oral prescribing.
“Whether an emergency situation exists is a determination made by a practitioner based on the individual facts of a particular medical situation,” according to guidance issued by the DEA. “Thus, an emergency situation does not necessarily exist with regard to every prescription of a Schedule II controlled substance issued during the Public Health Emergency: this determination must still be made by practitioners on a case-by-case basis.”
The full guidance is here: Dear Practitioner Registrants and Pharmacists
A useful flow chart summarizing the current regulations is here: How to Prescribe Controlled Substances to Patients During the COVID-19 Public Health Emergency
In a separate Guidance Letter, the DEA reiterated its policy regarding early refills of Schedule II substances considering the pandemic. The Controlled Substances Act prohibits refilling a prescription, but does allow issuing multiple prescriptions “authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance,” provided the prescriptions are signed and dated, and indicate the earliest date for which each successive prescription can be filled.
That letter can be found here: Dear Registrant Community
In a third Guidance Letter, the DEA waived a portion of its regulations requiring state-by-state registrations for physicians who prescribe across state lines. DEA notes that many states have granted medical licensing reciprocity to practitioners in neighboring states, but DEA regulations would normally require a physician to register with the DEA in both the state in which the physician practices and the state in which the prescription is filled. In light of the pandemic, DEA has changed this regulation as follows: “DEA-registered practitioners are not required to obtain additional registration(s) with DEA in the additional state(s) where the dispensing (including prescribing and administering) occurs, for the duration of the public health emergency declared on January 31, 2020, if authorized to dispense controlled substances by both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs.”
That letter can be found here: Dear Registrant
Further policy and guidance documents pertinent to COVID-19 are available from DEA here: https://www.deadiversion.usdoj.gov/coronavirus.html
Published date: Jan. 7, 2021
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