Emergency Dispensing for Harm Reduction

Emergency Dispensing for Harm Reduction

Recently, Gov. Hochul signed legislation[1] amending the New York State Controlled Substances Act which, when read in conjunction with federal regulations, would expand the authority of institutional practitioners to dispense up to a three-day supply of controlled substances “as emergency treatment” of opioid use disorder (OUD) with “narcotic drugs” for detoxification or maintenance (“harm reduction”) of this disease.[2] The legislation aligns with boundary-setting DEA regulation and overcomes the baseline prohibition of providing controlled substance medication for maintenance and/or detoxification treatment of opioid use disorder.

History of Regulation

For well over a century, the federal government has exercised control over the care of patients dependent on opioids. With the passage of the Harrison Narcotic Tax Act in 1914,[3] the federal government began to control treatment of OUD, prosecuting harm reduction by licensed physicians and pharmacists under this law. Defendants argued that such application of this tax law conflicted with 10^th Amendment to the Constitution that would leave health care and other public safety matters to the states. At first the United States Supreme Court agreed with this position but then reversed course[4] permitting federal control and chilling care of OUD with medication. The philosophy of federal regulation involved a flat prohibition of prescribing and dispensing for harm reduction.[5] After decades of this policy, state and federal governments have begun to permit treatment with methadone and more recently buprenorphine.

The Law

In 1972, the federal government acted on research demonstrating the value of harm reduction therapy with methadone as codified in the Narcotic Addict Treatment Act of 1974. For this purpose, methadone was only available to patients through licensed opioid treatment programs (OTP). Though pharmacies may dispense methadone for chronic pain, dispensing is prohibited for OUD. Difficulty in finding and connecting to an OTP proved a significant barrier to care in most of the United States. Acknowledging this concern, in 2023 DEA amended its regulations to permit “dispensing (but not prescribing)” up to a three-day supply of “narcotic drugs” “while arrangements are being made for referral to treatment”. DEA characterized this “emergency treatment”.[6]

Unfortunately, New York and many other states had laws and regulations that prohibited practitioners from easily aligning  practice to take advantage of this flexibility. Specifically, New York law provides controlled substances “may not be prescribed, administered, or dispensed to persons with substance use disorder…”[7]. In addition, institutional practitioners in the emergency department are prohibited from dispensing controlled substances for off-premises use unless the hospital has no full-time pharmacy and then limited dispensing to a 24-hour maximum supply.[8] The new emergency dispensing legislation overcomes these difficulties by amending section 3342 of Public Health Law “Dispensing and administering by institutional dispensers”.[9]  

The new law overcomes barriers to alignment with DEA flexibility by adding a new sub-section 2-a to PHL 3342 specifically providing:

“…any institutional dispenser may dispense controlled substances as emergency treatment for use off the premises … for the purpose of initiating maintenance treatment, detoxification, or both.”

Notice that while DEA regulation identifies “narcotic drugs”, New York’s new law provides for “controlled substances”. Taken together, the laws seem to limit emergency dispensing to treatment of OUD, but not the medications that may be dispensed.

It is obvious that the medication contemplated by both state and federal law is methadone. This is the reason that the phrase “dispensing (but not prescribing)” is explicitly included in the federal law. Buprenorphine would also be fair game for dispensing, but its pharmacology as a partial agonist has the potential to precipitate withdrawal—an outcome that would make this undesirable as a single emergency encounter. However, withdrawal is mitigated by concurrently dispensing a pure agonist (e.g., morphine) with the low dose buprenorphine. Termed “microdosing” by experts, this temporary combination is commonly used to bridge patients to exclusive harm reduction with buprenorphine by slowly tapering the pure agonist, while increasing the buprenorphine to a daily maintenance dose.

Conclusions

The Emergency Dispensing law is the latest step in mitigating the current opioid crisis in New York State. New York has made numerous changes in public policy to address concerns. This has included permitting pharmacists to dispense naloxone without a prescription, limiting new opioid prescriptions to an initial 7-day supply, giving professionals legal immunity for intervening in good faith in a presumed overdose, enabling access to the prescription monitoring program registry, and requiring risk information with every controlled substance dispensed. Still, after over a century of opioid crises, our society still struggles with morbidity and mortality caused by opioids.

The new law became effective on Feb. 19, 2026. Pharmacists practicing in institutions will find hospitalists and emergency department practitioners eager to implement this new law, representing a momentous change from established practice standing for over 50 years. This may be viewed as a step in the right direction for patients who may otherwise get into treatment but for the prospect of short-term OUD withdrawal. New workflows will be required in hospital emergency departments for controlled substance management processes. Pharmacy leadership will no doubt be called on to support this new opportunity for bridging patients with OUD into harm reduction care.

[1] Laws of NY, Ch. 546 (2025).
[2] 21 Code of Federal Regulations (“CFR”) §1306.07, Article 33 of Public Health Law (“PHL”) §§3342(2-a) and 3351(3)-(6).
[3] 38 Stat. 785, Public Law 63-223 (1914).
[4] US v. Jin Fuey Moy, 241 US 394 (1915), followed by US v. Doremus, 249 US 86 (1919), implicitly overruling Jin Fuey Moy.
[5] NY PHL §3350, 10 NYCRR.
[6] 21 CFR §1306.07(b).
[7] PHL §3350.
[8] PHL §3342 and in regulation 10 NYCRR §80.75.
[9] Chapter 45, Article 33, Title IV, Public Health Law.

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