Introduction to Prescribing Methadone

The requirements in the Controlled Substances Act (CSA) relating to the use of methadone for the treatment for Opioid Use Disorder (OUD) in the United States have remained largely unchanged for many years. The general rule is that dispensing of methadone for OUD must be carried out by a Narcotic Treatment Program (NTP), also known as an Opioid Treatment Program (OTP), by a practitioner registered with the Drug Enforcement Administration (DEA) for that purpose, as noted at 21 U.S.C. 823(h). Exceptions that allow a practitioner who is not registered with DEA as an NTP to dispense methadone for OUD are found in the DEA regulations at 21 CFR 1306.07(b), and (c). These are temporary measures, and a patient must return to the OTP for continued treatment. The first exception, 21 CFR 1306.07(b), states: 

“Nothing in this section shall prohibit a practitioner, who is not specifically registered to conduct a narcotic treatment program, from dispensing (but not prescribing) narcotic drugs, in accordance with applicable Federal, State, and local laws relating to controlled substances, to one person or for one person’s use at one time for the purpose of initiating maintenance treatment or detoxification treatment (or both). Not more than a three-day supply of such medication may be dispensed to the person or for the person’s use at one time while arrangements are being made for referral for treatment. Such emergency treatment may not be renewed or extended.”

In my time in the DEA’s Policy Section, this regulation was known as the “Three-Day Rule.” And we received many questions about this rule. The main questions are related to initiating treatment and not allowing a renewal of the 3-day rule or extending the 3-day rule. This is a regulation that, on its face, is still ambiguous in some respects with regard to administering methadone for OUD treatment.  

Many OUD patients have been to an OTP or sought some sort of treatment and went through an initiation or induction process. If this is true for a patient, does it mean that a practitioner must turn the patient away because a new initiation is not allowed pursuant to the three-day rule?  

Another significant concern involves initiating treatment and the limitations imposed by the three-day rule. When a patient is enrolled in treatment at an OTP but misses an appointment or lacks transportation to the OTP, a critical question arises as to whether that patient can seek treatment in an emergency department. This issue is occurring nationwide.  

As a general matter, emergency departments have a legal and ethical duty to treat patients in distress; however, under current DEA regulations, emergency departments are generally prohibited from providing OUD medication in certain situations because doing so is considered continuation of care rather than initiation of treatment. Even when permitted, the emergency department may only provide such treatment at one time, as stated in 21 CFR 1306.07(b). This regulatory gap presents a serious problem for patients who lack reliable transportation and the ability to travel to OTPs.  

There are approximately 1,700 DEA-registered brick-and-mortar OTPs, some of which have a companion mobile OTP service. PubMed Central.  With relatively few OTPs operating nationwide, many patients are required to travel long distances on a daily basis, a requirement that is often unrealistic and unsustainable. 

Another question often arises due to extending the three-day rule. The practitioner must make arrangements for referral for treatment. What if no treatment options are available within three days or in the local commuting area? Could another practitioner initiate three days of treatment? What if a patient doesn’t make it to an OTP for dosing, or they are dismissed from the OTP? What practical options are available?   

The second exception, 21 CFR 1306.07(c), states: 

“This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.” 

This regulation is used for administration in a hospital setting, and it is helpful for patients who are admitted for something other than OUD. There is no timeframe applied; the OUD treatment should end when the primary condition for which the patient was admitted no longer applies.  

History of Methadone 

• 1930s–1940s: Development and Introduction: Created by German scientists during WWII as a substitute for morphine shortages, it was introduced to the U.S. in 1947. Early on, methadone was used as an analgesic (painkiller) before its efficacy in treating opioid abstinence syndrome was recognized. 

• 1960s: Breakthrough in Addiction Treatment: Researchers Marie Nyswander and Vincent Dole pioneered the use of methadone to manage heroin addiction, shifting the perspective from “addiction as a vice” to “addiction as a treatable disease”. 

• 1970s–1980s: Regulation and Stigma: Due to growing heroin use during the Vietnam War era, the government expanded methadone programs but also instituted strict regulations in 1972 to manage methadone maintenance treatment (MMT) and prevent drug diversion. The Narcotic Addict Treatment Act of 1974 codified strict controls, shaping how programs (OTPs) operate. 

• 2001–Present: Modernization: Recent 2024 regulatory updates have aimed to make access more flexible, expanding the longstanding, yet often stigmatized, use of the medication in authorized clinics. SAMHSA’s oversight changed in various respects, including requiring better accreditation and changes were made to take-home dosing allowances; DEA implemented the allowance of mobile units. On March 6, 2023, Senators Edward J. Markey (D-Mass.) and Rand Paul (R-Ky.) and Representatives Donald Norcross (NJ-01) and Don Bacon (NE-02) introduced the Modernizing Opioid Treatment Access Act (MOTAA) with the aim of enhancing patients’ access to medication for opioid use disorder (MOUD). The bill would permit physicians to prescribing methadone for opioid use disorder (OUD) without many of the safety precautions and supportive services opioid treatment programs (OTPs) provide. It remains pending legislation. S.644 – 118^th Congress.   

Key Aspects of OTP Methadone Dispensing 

• Effectiveness:  Methadone remains one of the most rigorously tested and effective treatments for OUD. The common alternative to methadone is buprenorphine, which is commonly combined with naloxone, and can be prescribed for OUD. There is a difference between these two medications. Methadone is a full agonist that provides increasing effects with higher doses, while buprenorphine is a partial agonist with a “ceiling effect,” making it less potent but safer, with a lower risk of overdose and dependence. 
• Dispensing Window: OTPs are open during certain hours depending on patient population. Patients must arrive during dispensing hours and wait in an area physically separated from narcotic storage and the dispensing area. 21 CFR 1301.74(j). Once they are called to the dispensing area, only one of 4 people are allowed to dispense the methadone to the patient. 21 CFR 1301.74(i). They include a licensed practitioner, or an RN, LPN, or pharmacist under the direction of the licensed practitioner.  
• Take-Home Doses: SAMHSA regulations outline criteria for take-home doses. Practitioners shall consider the following take-home criteria (8 take-home criteria) as defined in 42 CFR 8 in determining whether a patient is responsible in handling any take-home medications for unsupervised use: 
• Exhibit no recent drug use 
• Attend a clinic regularly 
• Exhibit no serious behavioral problems 
• Engage in no criminal activity 
• Demonstrate a stable home environment and good social relationships 
• Meet length of time in treatment requirements (outlined in the Table: Schedule of Maximal Take-Home Medications per 42 CFR 8.12) 
• Provide assurance that take-home medication will be safely stored 
• Show that the rehabilitative benefit outweighs the risk of diversion 

SAMSHA made exceptions for the number of take-home doses a patient was allowed to receive during the COVID-19 public health emergency. With this flexibility, SAMHSA allowed OTPs to dispense up to 28 days of “take-home” methadone doses to “stable” patients for the treatment of OUD, and up to 14 doses of “take-home” methadone for “less stable” patients “who the OTP believes can safely handle this level of take-home medication.” 89 FR 7528. 

• Mobile Units: On June 28, 2021, the DEA introduced allowance for OTPs to add a “mobile component” to their existing registration and waived any obligation for an OTP mobile medication unit complying with these requirements to separately register at the remote locations where it dispenses. 86 FR 33861. 

Barriers to OTP Treatment 

• Limited Access: Over 80% of U.S. counties lack an OTP, forcing some patients to travel long distances, as detailed in this methadone fact sheet. For visual learners, this link shows a map of OTPs in the U.S. Figure 1. You can see that the lack of OTPs for patients in rural areas remains an issue. Additional findings from this article https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2815277, revealed in a cross-sectional analysis of 1018 individuals, 26% of the sample could not access an OTP within 180 minutes. For those who could access these facilities, the average 1-way travel time was 45.6 minutes, with individuals spending approximately 70% of their trip duration on out-of-vehicle travel components (e.g., walking, waiting for public transportation). 

• Treatment Burden: Daily clinic attendance can prevent patients from maintaining employment and managing everyday life, which can act as a barrier to sustained recovery, according to this Johns Hopkins review of barriers to methadone access. 

• Cost Prohibitive: Opening an OTP with a mobile van involves two distinct sets of startup costs: the establishment of a brick-and-mortar hub and the mobile unit itself. While a mobile unit is often listed on an existing NTP’s license, launching both from scratch can require a total investment typically ranging from $450,000 to over $1,500,000.  dhcs.ca.gov .   

What Research Tells Us 

According to HHS, surveys and analyses of data indicate that providing more take-home doses has not resulted in higher rates of overdose, perhaps supporting the case for further loosening of restrictions.  This was noted by HHS in its Rule on Medications for the Treatment of OUD (89 FR 7532): 

• The COVID-19 methadone take-home flexibility was met with widespread support among patients, OTPs, and state authorities.  
• Patients reported that increased take-home doses of methadone left them feeling more respected as responsible individuals.  
• State authorities reported that the flexibilities were appreciated by patients and OTPs alike, with no significant change in rates of diversion seen since the COVID-19 PHE was declared.  
• Analysis of data indicated that the actual level of misuse, diversion or harm from methadone was more likely to occur when it is prescribed for pain as opposed to OUD, and that the rate of diversion is lower than that of oxycodone or hydrocodone. 
• Additionally, a survey found that diversion of methadone is low among patients receiving take-home doses under the COVID-19 PHE flexibility.  
• Analysis of data on fatal overdoses from January 2019 to August 2021 demonstrated that this flexibility did not lead to more deaths involving methadone.  

Countries that Allow Prescribing of Methadone 

• Australia & Canada: Permit methadone to be prescribed by primary care physicians and dispensed at community pharmacies. 
• United Kingdom: Utilizes a system where specialists initiate treatment, but stable patients receive prescriptions from general practitioners. 
• Germany & Switzerland: Use methadone extensively in addiction treatment, including options for pharmacies to dispense medication. 

Final Thoughts 

It seems that after 50 years of strict controls on the dispensing of methadone, perhaps the time has come to loosen these restrictions and give practitioners and their patients more autonomy in treatment of OUD with methadone. Research suggests that some of the initial reasons for restrictions from the Narcotic Addiction Treatment Act of 1974 are not current causes for concern for all OUD patients. It will be interesting to see if the U.S. decides to follow a pathway for prescribing of methadone for OUD.  

How Brinks DEA Consulting Can Help

Navigating the regulatory complexities surrounding MOUD treatment with Methadone requires more than a surface level understanding of DEA rules, it demands practical experience with how those rules are interpreted and enforced. Brinks DEA Consulting brings more than 75 years of combined regulatory, enforcement, and diversion control experience, including more than 75 years of firsthand expertise inside the DEA.