On November 19, 2021, the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) “to allow the transfer of electronic prescriptions for schedule II-V controlled substances between registered retail pharmacies for initial filling on a one-time basis.”

This proposed rule aligns with the regulatory guidance provided by DEA in October 2017, that specifically restricted the transfer of unfilled prescriptions for controlled substances to electronic prescriptions.


Continue Reading New DEA Regulation Addresses Transfers of Prescriptions

On November 17, 2021, the Drug Enforcement Administration (DEA) issued an Advanced Notice of Proposed Rulemaking (the “Notice”) seeking the public’s help with understanding the “practice, industry, and state regulations of telepharmacy.”

As DEA acknowledges in the Notice, telepharmacy is not a term defined by the Controlled Substances Act or DEA’s regulations. The agency’s current understanding of telepharmacy is that it involves “the provision of pharmacist care by a remote pharmacist, through the use of telecommunications and other technologies, to a patient located at a dispensing site.” DEA further states that the dispensing site is usually a “brick and mortar remote site” or “self-service, automated machines.”


Continue Reading DEA Seeks Your Help with the Practice of Telepharmacy

The Washington Post reports that the Biden Administration is preparing to pull back recent Health and Human Services (HHS) guidance designed to expand access to prescribing buprenorphine for opioid use disorders (OUD).

On January 14, 2021, HHS published Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder.  In a nutshell the guidelines eliminated certain X-waiver certification requirements, allowing any DEA-registered prescriber to issue buprenorphine prescriptions for medication-assisted treatment of OUDs.  The HHS notice does not reference any coordination with the Drug Enforcement Administration (DEA) and DEA has yet to publicly comment on this change.
Continue Reading Not So Fast: Biden Expected to Halt Expansion of Buprenorphine Prescribing

As I was reviewing the public comments regarding the Drug Enforcement Administration’s (DEA’s) Notice of Proposed Rulemaking (NPRM) providing a much-needed update to the agency’s suspicious order regulations, I noticed a similar issue raised by multiple commenters.  Apart from the myriad of comments and requests seeking greater clarity from DEA on several definitions and provisions, there appears to remain a misunderstanding of using the 5% rule for distributions amongst practitioners.

Continue Reading Confusion Persists with the 5% Rule

Update: DEA has reopened the comment period for the proposed rulemaking from February 25, 2021, until March 29, 2021.

The Drug Enforcement Administration (DEA) published its long-awaited Notice of Proposed Rulemaking  (NPRM)  regarding suspicious orders of controlled substances. This will likely be the most heavily scrutinized rule issued by DEA this year. Registrants impacted by this rule should submit comments by March 29, 2021.
Continue Reading DEA Creates Two-Option Framework for Reporting Suspicious Orders

On October 5, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) establishing a registration category for emergency medical services (EMS) agencies and the corresponding regulatory requirements for the new category of registrants.  This regulatory action implements the ‘‘Protecting Patient Access to Emergency Medications Act of 2017 (the Act). The NPRM includes the following provisions mandated by the Act:
Continue Reading DEA Establishes Registration Category for EMS Agencies

Prescription and magnifying glassWith the filing of two class action lawsuits, one against Walgreens and Costco, and one against CVS, in two federal district courts on August 6, pharmacies find themselves in a perplexing situation (yet again). For these suits were filed not by those who suffered from the over-dispensing of opioids, but by chronic pain patients who were denied opioid medication by pharmacies.
Continue Reading Lawsuits Filed Against Retail Chain Pharmacies: The Corresponding Responsibility Catch-22

Theft and Loss Reporting

On July 29, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) related to the reporting of thefts or significant losses of controlled substances.  Specifically, DEA proposes two changes to the reporting process:
Continue Reading DEA Proposes Changes to Theft/Loss Reporting and Finalizes New Registration Fees