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.

As a reminder, DEA’s regulations allow practitioners to distribute, without being registered with DEA as a distributor, up to 5% of the total controlled substances dispensed in a calendar year.  While a useful tool, especially for intra-company transfers of controlled substances, I was never a big fan of how the rule was drafted.  The 5% calculation is based on a calendar year which means that a practitioner may not know if they violated the rule (and need to register as a distributor) until at or after the end of the calendar year.  While many of the registrants who use this rule to transfer controlled substances use it very sparingly, a few use it right up to the limit, which can be problematic.

Another beef I have with the rule (Is it possible to have a beef with a regulation? Maybe a topic for a future blog.), is the lack of a complete list of requirements in the 5% Rule provisions or, at a minimum, a citation or reference to additional regulatory requirements. Hence the confusion.

In the NPRM DEA states:

“…DEA believes all practitioners who distribute pursuant to the provisions of the five percent rule already understand the requirement to ‘‘design and operate a system’’ also applies to them as well.”

They do not, however, provide a citation.  This statement came as a surprise to some who rightly focused on the 5% Rule provisions at 21 CFR 1307.11(a) but did not scrub the regulations for requirements “hidden” elsewhere.  Specifically, 21 CFR 1301.76(c).

This is the legal basis for DEA’s statement in the NPRM and reads:

“Whenever the registrant distributes a controlled substance (without being registered as a distributor as permitted in §§1301.13(e)(1), 1307.111317.05, and/or 1317.10 of this chapter), he/she shall comply with the requirements imposed on non-practitioners in §1301.74(a), (b), and (e).”

As a reminder, the suspicious order regulations are found at 21 CFR 1301.74(b).

As DEA works on updating its regulations, it would be great for them to at least reference all regulatory requirement in the provisions for the 5% Rule.  Perhaps this can be a technical change made to the regulations as the Final Rule is rolled out?

Regardless, registrants should tread carefully with taking advantage of this rule.  In addition to the 5% calculation and suspicious order requirement, complete and accurate distribution records must be maintained to account for the transfer.  This is an area often overlooked by registrants and where civil monetary penalties may easily be obtained by the government.

Give me a call or send me an email if you want to chat more about this or any other DEA compliance matter.

More than four years ago, the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) was signed into law. CARA, among other things, includes provisions allowing for the partial filling of prescriptions for Schedule II controlled substances. On December 4, 2020, the Drug Enforcement Administration (“DEA”) published a Notice of Proposed Rulemaking (“NPRM”) implementing the partial fill provisions of CARA. While DEA does include additional provisions in the NPRM “to address certain regulatory requirements not addressed by the CARA[,]” the agency appears to have neglected to fully address circumstances when a prescription for a Schedule II is partially filled. Continue Reading DEA Proposes Regulations for Partial Fills of C-IIs

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 within sixty (60) days of publication in the Federal Register. Continue Reading DEA Creates Two-Option Framework for Reporting Suspicious Orders

Pharmacies and pharmacists have always been on the front lines in terms of medication safety and the pandemic has produced a new layer of challenges for the industry. I know we are all tired of Zoom meetings (and cheesy headlines), but this year’s American Society for Pharmacy Law Fall Meeting is the one conference you should attend if you want to stay on top of evolving pharmacy law regulations and industry trends.

Continue Reading ASPL Virtual Conference: Your Rx for Developments in Pharmacy Law

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. Continue Reading NTIS Ending Its DEA Registration Subscription Service

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

On September 30, 2020, DEA published a Final Rule (FR) adopting the Interim Final Rule (IFR) implementing the Ryan Haight Act. The FR made a few technical changes to the regulations and did not substantively change the IFR. What garnered my attention was DEA’s response to comments submitted after publication of the IFR.

Continue Reading DEA’s New/Old View on Due Diligence Requirements

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

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