As you are likely aware, the Drug Enforcement Administration (DEA) has created a COVID-19 Information Page to “assure that there is an adequate supply of controlled substances” during the current public health emergency associated with the coronavirus. DEA previously published guidance regarding telemedicine and Medication Assisted Treatment, where the agency granted certain exceptions to regulatory requirements.
In the past few days, DEA issued additional guidance regarding other areas of concern brought to the agency’s attention by the regulated industry. Below is a quick summary of that guidance:
Practicing Across State Lines
Following the immediate steps taken by many states to grant reciprocity for doctors to practice across state lines, DEA granted an exception to its regulations and for the duration of the public health emergency DEA will not require practitioners to obtain a separate DEA registration for “out-of-state” prescribing if the prescribing is authorized “in both the state in which a practitioner is registered with DEA and the state in which the dispensing occurs.” This exception will also apply to prescribing controlled substances via telemedicine and is effective as of March 23, 2020.
DEA Form 222
The Healthcare Distribution Alliance sought guidance from DEA regarding “a purchaser’s inability to mail a hard copy version of a DEA Form 222 to the supplier for fulfillment” considering the public health emergency. In response, DEA granted an exception to 21 C.F.R. 1305.13.
Specifically, DEA declared 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 can 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 during the entirety of the public health emergency. At the conclusion of the public health emergency, purchasers must send the original 222s to their suppliers who should maintained the forms with the fax/scan/email copy.
Oral Schedule II Prescriptions
In response to requests from practitioners and pharmacies, DEA provided clarification and two “temporary exceptions” regarding the use of oral prescriptions for schedule II controlled substances. The exceptions are:
- DEA is allowing practitioners “15 days within which to provide [a hard copy of an emergency oral prescription] to the pharmacy.” Recall that the regulations require the follow-up paper prescription to be sent to the pharmacy within 7 days.
- Acknowledging the challenges that practitioners may face with sending a hard copy of an emergency oral prescription to the dispensing pharmacy, DEA will allow “the practitioner to send the follow-up prescription via facsimile or to take a photograph or scan of this follow-up prescription and send the photograph or scan to the pharmacy ion place of the paper prescription.”
Both exceptions are effective on March 16, 2020 and will last through the duration of the public health emergency.
To ensure that there is an adequate and uninterrupted supply of controlled substances during the public health emergency, DEA is making an exception to the requirement that the inventory of an individual manufacturer remain at or below 65 percent of its estimated net disposal as determined at the time its quota was issued. DEA will allow all DEA registered bulk manufacturers “to exceed the 65 percent ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredients” with the goal of avoiding potential drug shortages. This exception is effective as of March 23, 2020 and will last for the duration of the public health emergency.
I encourage you to bookmark DEA’s COVID-19 Information Page to stay abreast of the evolving regulatory landscape during this public health crisis. If you have any questions about the issues above or any other DEA-related litigation and compliance matters, please do not hesitate to contact me as I could use a break from my kids. Seriously. Even if you want to chat about non-DEA matters, I could really use a break from my kids…call me….please….