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. Continue Reading DEA Submits Proposed Quotas for 2021
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. 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
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.” Continue Reading OMB Has a Backlog of DEA Regulatory Actions
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. Continue Reading DEA Re-Opens Comments for EPCS
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. Continue Reading DEA: COVID-19 Does Not Relieve Distributors of Certain Compliance Obligations
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.” Continue Reading DEA Announces Exception to 5% Rule
UPDATE: The Healthcare Distribution Alliance has retooled its annual conference and expo and is now offering the programs via webinar at no cost.
If you are involved in pharmaceutical distribution, I highly recommend you check out this year’s lineup. Whether virtual or in person, this annual event remains on my list of “must-attend” conferences on healthcare supply chain management.
HDA Distribution Management Webinar Series
April 14-16, 2020
On Thursday, April 16, 2020, I will again be serving on a virtual panel at a session on controlled substances where my colleagues and I will share our perspective on suspicious order monitoring and reporting along with other legal and regulatory issues affecting the pharmaceutical supply chain.
Regardless of your company’s role in the supply chain, this webinar series will provide you with a range of sessions geared toward improving the efficiency, effectiveness and safety of the healthcare supply chain.
I hope you can join us!
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:
On March 13, 2020, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) seeking to raise registration fees on all DEA registrants. The proposed fees represent a 21% increase over current fees for all registrant categories. DEA indicates that the increase will provide an additional $318 million for the Diversion Fee Account over the next three fiscal years.
As discussed here, the Controlled Substances Act requires that registration fees “shall be set at a level that ensures the recovery of the full costs of operating the various aspects of [the diversion control program].” 21 USC 886a(1)(C). DEA alleges in the NPRM that “[w]ithout an increase in registration fees, DEA will be unable to continue current operations” and will be unable to comply with the statutory mandate to recover all costs associated with managing the Diversion Control Program (DCP).
To support this doom and gloom prediction, DEA points to several reasons to justify the fee increase. They include, but are not limited to, the ongoing opioid crisis, the growing number of DEA registrants, a need for additional personnel at Headquarters and in Field Division Offices throughout the country, and additional requirements imposed by Congress in recent legislation. Continue Reading DEA Proposes 21% Increase in Registration Fees