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.
Based on information posted on its website, the National Technical Information Service (NTIS) will end its Controlled Substances Act (CSA) subscription service, effective November 17, 2020. As you may recall, the NTIS CSA subscription service provides near-real time information on all active and retired DEA registrations. This is/was a useful tool, particularly for distributors and pharmacies, to check the status of a DEA registration before controlled substances are distributed or dispensed. Many entities have embedded and automated this data into their order management and/or dispensing software. So, this is potentially a big deal.
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:
DEA rolled out its proposed aggregate production quotas for 2021 earlier this week, the same day, in fact, that it proposed adjustments to its 2020 quotas. Let’s start off by looking at the Big Five, at least as far as the SUPPORT Act is concerned: fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone.
With 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.
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:
On June 5, 2020, the Office of Management and Budget (OMB) received an Interim Final Rule from the Drug Enforcement Administration titled, Implementation of the SUPPORT Act: Dispensing and Administering Controlled Substances for Medicated-Assisted Treatment. This rule implements certain provisions of the SUPPORT Act “relating to the expansion of medication-assisted treatment providers and to the delivery of a controlled substance by a pharmacy to a practitioner.”
A little more than 10 years ago the Drug Enforcement Administration (DEA) issued an Interim Final Rule with Request for Comment regarding Electronic Prescriptions for Controlled Substances (EPCS). The Interim Final Rule became effective on June 1, 2010. DEA received over 200 comments but never issued a Final Rule.
On April 21, 2020, DEA issued a second Interim Final Rule regarding EPCS, this time re-opening the comment period to obtain additional feedback from industry. While this is a somewhat unorthodox approach, it is a prudent step toward finalizing the EPCS rule.
In response to issues raised by the Healthcare Distribution Alliance (“HDA”), earlier this week the Drug Enforcement Administration (“DEA”) published additional guidance for DEA-registered distributors on the agency’s COVID-19 Information Page. Among other issues previously addressed by DEA, the recent guidance addresses suspicious order monitoring and conducting due diligence on customers.
In its ongoing efforts to ensure an adequate supply of controlled substances for the legitimate medical needs of the United States, DEA is granting a temporary exception to 21 C.F.R. 1307.11 – what industry commonly refers to as the 5% Rule.
The 5% Rule allows practitioners to distribute controlled substances without being registered as a distributor, if they fulfill certain requirements. In addition to the security and recordkeeping obligations, practitioners wishing to use the authority granted by the 5% Rule must ensure that the “total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section … during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.”