What is "permanently scheduling" fentanyl-related substances and analogues, and why is it so important?

Last month, the Drug Enforcement Agency (DEA) issued a Federal Register Notice of Proposed Rulemaking to permanently schedule over a dozen specific fentanyl-related substances and analogues as Schedule I controlled substances.

We at the Partnership for Safe Medicines stand with our law enforcement partners and legislators in their efforts. We believe that permanently scheduling fentanyl-related substances and analogues – both specific and broad - on Schedule I of the Controlled Substances Act is a vital policy tool in the fight against counterfeit medicines made with fentanyl. Temporary scheduling allows criminals dealing these drugs a loophole to evade the law.

Why are fake prescription drugs made with fentanyl an issue?

Watch our video to learn why it's critical that the government schedules fentanyl analogues.

Counterfeit pills made with fentanyl analogues are lethal to the public. Counterfeit drugs are a significant issue throughout the United States and a leading contributor to the opioid epidemic plaguing our country. Among the deadliest counterfeit medications are  prescription drugs made with fentanyl, which contribute to numerous poisonings and deaths from fake prescription drugs each year. The DEA has  reported increases in fentanyl pills over the past several years, with its latest 2020 Threat Assessment reporting a 10% increase over 2019. Some fentanyl-analogues also have an increased potency and can therefore be more lethal.

What you can do:

We're collecting letters from all 50 states for the US Senate from families affected by fentanyl. Please contact us to help write a letter to your senators to ask them permanently schedule fentanyl analogs.

We're currently working with families in the following states: CA, CO, GA, LA, NJ, OR, SC, TN, TX, UT. While we're looking for letters from families in all 50 states, if your state is not on the list please reach out to us.

What is a fentanyl-related substance or analogue?

Think of it as Legos or building blocks.

Fentanyl has the chemical building structure C22H28N2O.

A fentanyl analogue moves some of those structures around. Here, for example, is one of the fentanyl analogues the DEA has proposed to permanently schedule: C22H28N2O.

Chemical structure of fentanyl. Source: <a href="https://pubchem.ncbi.nlm.nih.gov#query=C22H28N2O">PubChem</a>
Chemical structure of fentanyl. Source: PubChem
Structure of a fentanyl analogue. Source: PubChem

It’s hard to spot the difference, isn’t it? You might also notice that it contains the exact same building blocks, just arranged differently. But because of scheduling, there is a big difference here for criminals. Fentanyl is a controlled substance. Manufacturing, distributing, or selling it is illegal and punishable by significant jail sentences. But doing the same with an analogue that’s not scheduled is not. Until it is scheduled, criminals can stack these chemical building blocks to create a new fentanyl analogue. Chemically speaking, a new analogue is a new substance that has not yet been scheduled. It isn’t controlled or illegal (yet), but it has the same effects as fentanyl, and it is still highly dangerous.

What is Scheduling?

The United States and the DEA control dangerous substances and illicit drugs using the Controlled Substances Act, which empowers the DEA to put each drug into a classification, known as a schedule, based on its medical value and potential for abuse. Fentanyl is a Schedule II drug: It has a high potential for abuse, but has some medical value. Other fentanyl analogues have high potential for abuse and provide no medical value. Law enforcement can only prosecute illegal behaviors around a substance if it is scheduled.

Once the DEA identifies a substance as an issue, they establish the potential for abuse and seek a waiver from the Department of Health and Human Services (HHS) to verify that there is no medical use for the substance. The substance is then either temporarily or permanently scheduled. It is important to note that the DEA can only schedule exact chemical substances, so they need to schedule each analogue, each variation that criminals create, which creates "whack-a-mole" issue for law enforcement.

So scheduling helps prosecute criminals?

That’s correct. Scheduling allows law enforcement to prosecute the manufacturing, distribution or sale of a controlled substance. It is important for the DEA to permanently schedule substances, because if scheduling lapses criminals can distribute them again without risk of punishment.

This is why it is also important to schedule fentanyl-analogues more broadly. Joe Manchin (D-WV) and Rob Portman (R-OH) have proposed legislation that would outlaw any substance using the same building blocks of illegal fentanyl-related substances and analogues, no matter how those blocks have been rearranged. This offers an elegant solution to law enforcement's "whack-a-mole" problem.

What does that all mean?

Fentanyl-related substances and analogues are built the exact same way. Criminals manufacturing these deadly substances are just moving the chemical pieces of fentanyl around to evade criminal prosecution.  That is why PSM supports – and will continue to support – law enforcement and legislators in their efforts to permanently schedule fentanyl-related substances and analogues as Schedule I controlled substances.

We must not give up the fight against these criminals and work hard to protect our communities against the opioid epidemic by keeping deadly fentanyl and fentanyl-related analogues out of our communities.