DEA Provides Additional Guidance Regarding Prescription and Other Policies During the COVID-19 Public Health Emergency

The Drug Enforcement Administration (DEA) recently updated its COVID-19 Information Page to address areas of concern brought to its attention by a variety of sources.

Practicing Across State Lines

Citing the fact that many states have declared public emergencies and have granted reciprocity to neighboring states and their practitioners to allow for practice across state lines, the DEA granted an exception to its requirement that that practitioners are required to register in each state in which they dispense controlled substances. Specifically, the DEA stated that “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 the practitioner is registered with DEA and the state in which the dispensing occurs.” The DEA noted that this exception will also apply to prescribing controlled substances via telemedicine to patients in states in which the practitioner is not DEA-registered. (See our previous On the Subject regarding the DEA’s position on the issuance of prescriptions based on telemedicine encounters.) The exception is granted from March 23, 2020, through the duration of the public health emergency as declared by the Secretary of Health and Human Services (HHS).

Early Refills

The DEA has noted that some states have issued orders allowing pharmacies to dispense early refills of controlled substances due to the COVID-19 emergency. The DEA has agreed that this practice may be permitted if the early dispensing is allowed by state law and regulation. The DEA also noted, however, that the prohibitions against refills of Schedule II controlled substances continue to apply.

Oral Schedule II Prescriptions

The DEA provided guidance and two “temporary exceptions” regarding the use of oral prescriptions for Schedule II controlled substances. The exceptions are:

• The DEA will allow practitioners “15 days within which to provide [a follow-up paper copy of an emergency oral prescription] to the pharmacy.” This represents an extension of the standard seven-day requirement.
• Recognizing that providing the pharmacy with a paper prescription may be “very challenging or impossible,” the DEA will allow practitioners to send the follow-up prescription via facsimile or to take a photograph or scan of such follow-up prescription and send the photograph or scan to the pharmacy in place of the paper prescription. The prescription must include the standard required information as well as a statement that the prescription is “Authorization for Emergency Dispensing.” The original paper prescription must be maintained in the patient file. The DEA also noted that emergency oral prescriptions for Schedule II drugs should be limited to the amount adequate to treat the patient during the emergency period.

Both exceptions are effective on March 16, 2020, and will last through the duration of the public health emergency.

Narcotic Treatment Programs/Medication-Assisted Treatment

At the request of the Substance Abuse and Mental Health Services Administration (SAMHSA), the DEA granted exceptions to the requirement that narcotics dispensed or administered at narcotic treatment programs (NTPs) be dispensed or administered by certain licensed personnel (21 C.F.R. 1301.74). The DEA noted that the exception was granted in order to allow for consistent dosing of patients enrolled in NTPs during the public health emergency. The DEA will allow, in the event that a patient is quarantined due to coronavirus, for alternative delivery methods using the NTP’s established chain of custody protocols for take-home medications. NTPs may make “doorstep” deliveries of take-home medications where diversion controls, such as a lockbox, are implemented. The DEA also expanded the category of person who can deliver the medications to include authorized NTP staff members, law enforcement officers and National Guard personnel. This exception is effective on March 16, 2020, through the duration of the public health emergency.

DEA Form 222

In response to concerns raised on behalf of its members by the Healthcare Distribution Alliance regarding purchasers’ “inability to mail a hard copy version of a DEA Form 222 to the supplier for fulfillment” considering the public health emergency, the DEA granted an exception to the 21 C.F.R. 1305.13 requirement that purchasers submit a hardcopy 222 to the supplier (where paper copies are used).

The DEA has allowed that “all DEA registrants who order controlled substances are permitted to fax or scan/email a DEA Form 222 to their respective suppliers.” The fax/scan/email may be treated as the original order form for purposes of the regulation. The exception is effective as of March 20, 2020, and will remain in place through the duration of the public health emergency. At the conclusion of the public health emergency, purchasers must send the original 222s to their suppliers.

Manufacturing/Quota

Noting the need to ensure that there is an adequate and uninterrupted supply of controlled substances during the public health emergency, the DEA issued an exception to the requirement that the inventory of an individual manufacturer remain at or below 65% of its estimated net disposal as determined at the time its quota was issued. The DEA will allow all DEA-registered bulk manufacturers “to exceed the 65% ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredients” with the goal of avoiding potential drug shortages. The DEA noted, however, that the exception does not authorize any manufacturer to exceed its previously established annual quota. The exception is effective as of March 23, 2020, and will last for the duration of the public health emergency.