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.

Quota

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….

 

 

Image by Visuals3D from Pixabay

The Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) revising the registration requirements for mobile narcotic treatment programs (NTP).  DEA’s justification for the rule is to “make maintenance or detoxification treatments more widely available,” especially in rural and underserved communities. Continue Reading DEA Publishes New Rule Expanding Access to Maintenance and Detoxification Treatment

If you are involved in pharmaceutical distribution, I highly recommend you check out this year’s Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo, an annual event on my list of “must-attend” conferences on healthcare supply chain management.

On Tuesday, March 10, 2020, I will again be serving on a panel at a session on controlled substances where my colleagues and I will share our perspective on suspicious orders monitoring and reporting along with other legal and regulatory issues affecting the pharmaceutical supply chain.

HDA Distribution Management Conference and Expo
March 8 – 11, 2020
San Diego, California

Regardless of your company’s role in the supply chain, this conference will provide you with a range of sessions geared toward improving the efficiency, effectiveness and safety of the healthcare supply chain. Read more at hda.org.

I hope to see you there!

It appears that the Drug Enforcement Administration (DEA) is on the cusp of publishing a new regulation in the next few weeks, with two more to follow in the coming months.  This is based on notifications received by the Office of Management and Budget (OMB), the government’s final review authority for Executive Branch regulations.

Continue Reading DEA Poised to Roll Out Three Regulations in the Coming Months

On January 30, 2020, the Drug Enforcement Administration (DEA) released the 2019 National Drug Threat Assessment (NDTA).  The 152-page publication “outlines the threats posed to the United States by domestic and international drug trafficking and the abuse of illicit drugs.”  Of specific relevance to readers of DEA Chronicles, the report also discusses the abuse and misuse of controlled prescription drugs (CPDs).  While I encourage you to read the entire report, here are a few key takeaways regarding CPDs: Continue Reading 2019 National Drug Threat Assessment: Key Takeaways

On January 20, 2020, the Government Accountability Office (GAO) released its report Drug Control: Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders.  The report, mandated by Congress in the SUPPORT Act, focuses almost exclusively on the need for the Drug Enforcement Administration (DEA) to beef up its capabilities for analyzing the vast amount of data provided to DEA by registrants. GAO’s investigation revealed, among other things, that DEA conducted “limited proactive and robust analysis of industry reported data” and that DEA did not have the appropriate data governance structure in place to manage drug transaction data. Continue Reading DEA Signals that Substantive SOM Guidance is Not Likely Forthcoming

Note: The following is my best guess for what to expect in the coming year regarding controlled substance compliance obligations.  I have relied on publicly available information, my experience and expertise with all things involving pharmaceutical controlled substance, and a Magic 8 Ball in creating the list below.

Suspicious Orders

This is the year (I think) that DEA will publish a Notice of Proposed Rule Making (NPRM) updating 1301.74(b).  While industry is anxiously awaiting the new regulations, I fear that many will be disappointed.  My best guess is that the new regulations will be more about changing the process for reporting suspicious orders and less about guidance for industry on the metrics to use for detecting suspicious orders.  This is in part because Congress recently codified the existing definition of suspicious orders that has been in DEA’s regulations for decades, which takes away a great deal of DEA’s interpretative authority and discretion.  There is also an argument to be made that DEA would prefer suspicious order guidance and definitions to be vague, providing the agency significant enforcement discretion. Continue Reading What to Expect from DEA in 2020 – One Guy’s Opinion

DEA is investigating two pharmacies in Colorado. It doesn’t want those pharmacies to know it is investigating them. But it needs information relating to these pharmacies and the prescriptions they are dispensing to assist with its investigation. So DEA is doing what it does on a regular basis in many states. It is issuing subpoenas for the Colorado Prescription Drug Monitoring Program (“PDMP”) data relevant to these registrants. And Colorado is objecting.

Continue Reading The Curious Case of Colorado: DEA Sues the BOP

In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone. Continue Reading Judge Dissolves ISO Against West Virginia Pharmacy: Suspicion Of Diversion Not Enough to Support Suspension