In short
Act 35-2021 does three concrete things. First, it authorizes the dispensing and sale without a prescription, within the jurisdiction of Puerto Rico, of the drug known as naloxone, in its intranasal and auto-injectable versions or any other form the FDA authorizes for sale and dispensing. Second, it protects whoever seeks help: any person who in good faith is experiencing or believes they are experiencing an opioid overdose and receives medical assistance, or any person who seeks medical assistance for someone believed to be overdosing — including themselves — shall not be arrested, charged, prosecuted or convicted under Articles 401(a), 403(a)(3), 404(a), 411(a) and/or 412(a)(11) and (12) of the Puerto Rico Controlled Substances Act, nor have their parole or probation revoked based exclusively on those offences. Third, it protects whoever administers it: in an emergency, a person who is not a health professional may administer, without compensation, an opioid overdose antidote if they believe in good faith that person is overdosing, and shall not be subject to any civil or criminal liability for their acts or omissions in administering it.
What is it?
The law calls "opioid overdose antidote" naloxone or any other similar drug approved by the FDA for treating opioid overdose. And it defines opioid overdose as a severe condition resulting from excessive consumption of one or more types of controlled substances known as opioids, including physiological symptoms such as breathing difficulty, intoxication and loss of consciousness, among others, that an ordinary person could recognize as requiring medical assistance and that could even cause death. The public policy the law declares recognizes the indispensable role that victims and witnesses of an overdose situation play in saving lives, and affirms that the distribution and use of naloxone is a simple and effective way to help reverse its effects.
Who can do it?
To buy naloxone: anyone, because the law authorizes its dispensing and sale without a prescription. The law also defines "participant" as a person who is not at risk of overdose but who could be in a position to assist another individual suffering one, and who has received orientation on the symptoms and on administering the antidote. For the Article 4 immunity, the law sets conditions: it applies to whoever seeks medical care for another person believed in good faith to be overdosing and in need of medical assistance, and it applies if the evidence for the arrest, charge, prosecution, conviction or revocation was obtained as a direct cause and result of seeking that medical assistance.
Requirements
- To buy naloxone: nothing. The law authorizes its dispensing and sale without a prescription in its intranasal and auto-injectable versions, or any other form the FDA authorizes.Verified against the official source
- For the immunity when seeking help: that medical assistance be sought in good faith, and that the evidence was obtained as a direct cause and result of seeking it.Verified against the official source
- To administer it without being a health professional: that it be in an emergency, without compensation, and believing in good faith the person is overdosing.Verified against the official source
Documents you need
Cost
Step by step
Step 1: Call 9-1-1 first
The law includes it as part of the mandatory content of every naloxone orientation: the importance of calling 9-1-1 emergency services for help in opioid overdose cases. Naloxone reverses, it does not cure, and the medical assistance the law defines expressly includes health services through the 9-1-1 emergency system.
Step 2: Know that seeking help does not expose you to those charges
Article 4 protects two people: whoever in good faith is experiencing or believes they are experiencing an overdose and receives medical assistance, and whoever seeks medical assistance for someone believed to be overdosing, including themselves. Neither will be arrested, charged, prosecuted or convicted under Articles 401(a), 403(a)(3), 404(a), 411(a) and/or 412(a)(11) and (12) of the Controlled Substances Act, nor have their parole or probation revoked based exclusively on committing those offences. The circumstances of the case may be taken into account to set or modify the terms of that supervision.
Step 3: Get naloxone without a prescription
Article 8 authorizes the dispensing and sale without a prescription, within the jurisdiction of Puerto Rico, of the drug known as naloxone, in its intranasal and auto-injectable versions or any other form the FDA authorizes for sale and dispensing. It falls to the Secretary of Health to set the parameters for that dispensing and sale, by circular letter or within the regulation the law requires, including the form for dispensing it as an "Over the Counter" drug through health plans that cover it within their pharmacy coverage.
Step 4: If your plan covers it, it must pay even with no prescription
The law provides it expressly: a health insurance organization, insurer, intermediary, third-party administrator or pharmacy benefit manager, if the drug is within the health coverage, shall bear responsibility for paying the bona fide claims the pharmacy submits for payment or reimbursement of naloxone dispensed without a prescription or through a "Standing Order". And it adds the flip side: the pharmacist or pharmacy may not be penalized, whether within an audit or otherwise, for having dispensed naloxone without a prescription or through a "Standing Order".
Step 5: If you are not a health professional, you may administer it
Article 7(b) allows it: in an emergency, a person who is not a health professional may administer, without compensation, an opioid overdose antidote if they believe in good faith that person is overdosing, and shall not be subject to any civil or criminal liability as a result of their acts or omissions in administering it. The Article 4 immunities also apply to them, provided that article’s requirements are met. The same protection covers members of law enforcement, emergency services and first responders who have received the corresponding information.
Step 6: Ask for the orientation the law owes you
Article 6 requires the organization or health professional who prescribes or dispenses the antidote to ensure the participant, and any family member or member of their support network, receives information about it; and if the participant has not received orientation before, to provide a basic one. That orientation must include identifying and preventing overdose, administering and dosing the antidote, the importance of calling 9-1-1, the proper treatment of a victim after administering it, and information on voluntary electronic home monitoring of certain vital signs of people susceptible to opioid-related repercussions.
Step 7: Look for an ASSMCA-authorized organization
The law created the Opioid Overdose Prevention Program, which authorizes certain non-profit organizations of a health or community nature to act on ASSMCA’s behalf. Eligible are ASSMCA’s regional offices; correctional and police institutions, hospitals and universities; methadone and buprenorphine programs; and organizations running certain programs the law lists. ASSMCA organizes an orientation workshop of no more than one day that simultaneously authorizes the organization, is responsible for facilitating and expediting authorized organizations’ access to the antidotes — free of charge or through a collaborative agreement — and must maintain a publicly open registry of every authorized organization. In addition, community-based non-governmental organizations will not need to apply for a medicine-cabinet license to possess, store, transport and provide naloxone in all its forms.
Where to do it
Naloxone is obtained at a pharmacy, without a prescription, or through an ASSMCA-authorized organization under the Opioid Overdose Prevention Program. ASSMCA runs that program and must keep a publicly open registry of authorized organizations. The Secretary of Health sets the parameters for prescription-free dispensing and sale. If you need to talk to someone now, ASSMCA’s PAS Line is its help service. And if the problem is an insurer or pharmacy benefit manager refusing to pay for naloxone dispensed without a prescription, the law sets an administrative fine for that non-compliance.
How long it takes
What to do if something goes wrong
The immunity’s edges, stated precisely, because overpromising here would be dangerous. Article 4 protects against the offences it names — Articles 401(a), 403(a)(3), 404(a), 411(a) and/or 412(a)(11) and (12) of the Controlled Substances Act — and not others. It applies when the evidence to arrest, charge, prosecute, convict or revoke was obtained as a direct cause and result of seeking medical assistance. The law further clarifies that nothing in that article shall be interpreted to limit: the admission of evidence tied to the investigation or prosecution of a crime relating to a defendant who does not qualify for these protections, or tied to other crimes committed by a person who does qualify; the lawful seizure of evidence or contraband; a law officer’s authority to detain or take a person into custody during an investigation or to arrest them for any offence other than the protected ones; nor the liability immunity that already covers public entities or public employees. And a separate protection for whoever dispenses: a health professional or pharmacist who, acting in good faith, directly or by prescription, dispenses the antidote to a participant who in their judgment is capable of administering it in an emergency, shall not be subject to civil or criminal liability nor to professional disciplinary action by the Medical Licensing and Discipline Board or the Nurses Examining Board. On the "Standing Order": the law defines it as a standing, standardized medical order authorizing administration of the antidote conditioned on an overdose occurring, and clarifies its use is limited to naloxone. The fine: every health insurance organization, insurer, intermediary, third-party administrator or pharmacy benefit manager that fails to comply with Article 8 incurs an administrative violation punishable by a fine of up to a maximum of twenty thousand ($20,000) dollars per incident or violation. What we do not publish: naloxone’s price, which the law does not set; the registry of authorized organizations, which ASSMCA maintains and we do not reproduce; nor the Department of Health circular letter or regulation with the dispensing parameters, which we did not read. ASSMCA also publishes on its site a PDMP page, a Fentanyl page and an Overdose Event Monitoring System; we verified they exist and that it links them itself, but their content is generated with JavaScript and we could not read it, so we do not describe what they contain.
Common mistakes
- Not calling 9-1-1 for fear of arrest: the law expressly protects whoever seeks medical assistance in good faith.
- Believing a prescription is needed to buy naloxone: the law authorizes its dispensing and sale without one.
- Administering the antidote and not calling: naloxone reverses, it does not replace medical assistance.
- Thinking the immunity covers any offence: it covers the Controlled Substances Act articles the law names.
- Accepting that the health plan will not pay for naloxone dispensed without a prescription when it is within coverage.
- Believing the pharmacy can be penalized in an audit for dispensing it without a prescription: the law prohibits that.
- Leaving the pharmacy without the basic orientation the law requires be given to anyone who has not had it before.
Frequently asked questions
Do I need a prescription to buy naloxone?
No. The law authorizes the dispensing and sale without a prescription, within the jurisdiction of Puerto Rico, of naloxone in its intranasal and auto-injectable versions, or any other form the FDA authorizes for sale and dispensing.
Can I be arrested if I call 9-1-1 about an overdose?
The law protects both the person overdosing and whoever seeks help, including themselves: they shall not be arrested, charged, prosecuted or convicted under Articles 401(a), 403(a)(3), 404(a), 411(a) and/or 412(a)(11) and (12) of the Controlled Substances Act, when the evidence was obtained as a direct cause and result of seeking medical assistance. The protection does not reach other offences and does not prevent lawful seizure of evidence or contraband.
May I administer it if I am not a health professional?
Yes, in an emergency and without compensation, if you believe in good faith the person is experiencing an opioid overdose. You will not be subject to any civil or criminal liability as a result of your acts or omissions in administering it.
Does my health plan have to pay for it?
If the drug is within your coverage, the health insurance organization, insurer, intermediary, third-party administrator or pharmacy benefit manager bears responsibility for paying the bona fide claims the pharmacy submits for naloxone dispensed without a prescription or through a "Standing Order". Non-compliance carries an administrative fine of up to twenty thousand ($20,000) dollars per incident.
Where do I get naloxone besides a pharmacy?
Through an organization authorized under ASSMCA’s Opioid Overdose Prevention Program. ASSMCA is responsible for facilitating and expediting those organizations’ access to the antidotes, free of charge or through a collaborative agreement, and for keeping a publicly open registry of every authorized organization.
Official sources
These are the government pages this guide is based on.
- Administración de Servicios de Salud Mental y Contra la Adicción (ASSMCA)
ASSMCA
bvirtualogp.pr.gov
- ASSMCA
ASSMCA
www.assmca.pr.gov
- ASSMCA PAS Line
ASSMCA
lineapas.assmca.pr.gov
Last verified
August 23, 2026
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