I have argued here , here, and here that the commissioner of the Food and Drug Administration (FDA) should exercise his authority to make the overdose antidote naloxone available over the counter (OTC). As long ago as 2016, Karen M. Mahoney, MD, then-Deputy Director of the FDA’s Division of Nonprescription Drug Products, stated that the opioid overdose antidote—approved by the FDA in 1971—was safe and ready to be reclassified as OTC, and encouraged the drug’s manufacturers to apply for reclassification. In 2019, then-FDA Commissioner Scott Gottlieb, MD announced the agency took the unprecedented step of preparing and testing the Drug Facts Label that a move from prescription-only to OTC would require—a task that the drug makers usually must perform. In the announcement, the commissioner practically pleaded with naloxone’s makers to officially apply for a change to OTC status.

Until last Friday, if harm reduction organizations operating syringe services programs needed naloxone to hand out to drug users, they needed to obtain a “standing order” prescription from a state-licensed health care practitioner. A standing order usually expires after one year. It instructs pharmacists throughout the state to dispense a drug—in this case naloxone—to any people who request it, under the authority of the prescriber, who assumes responsibility for the action. States have permitted and encouraged standing orders to work around the prescription-only status of naloxone.

Now the FDA has taken another step toward removing the prescription-only obstacle. On September 23, the FDA issued a statement that permits, as an emergency measure, harm reduction organizations to purchase naloxone in bulk without a prescription and to distribute it to their clients.

Writing in the harm reduction publication Filter, Kastalia Medrano states:

Naloxone is still a prescription drug. But this guidance circumvents, in one fell swoop, the entire bureaucratic patchwork of state-level regulations that have long prevented most harm reduction groups from wholesale distribution. The high-threshold requirements included having a unique DEA-licensed prescriber and commercial shipping address, and administrative barriers so cumbersome most groups couldn’t even accept naloxone donated by manufacturers for free.

As I have pointed out before, the FDA commissioner need not wait for a formal request from the naloxone makers to reclassify the drug OTC. The commissioner has the legal authority to order naloxone reclassified over-the-counter.

Naloxone manufacturers lack the incentive to apply for a change in the drug’s status to over-the-counter status. They can charge third party payers a much higher price than they might otherwise get away with if the drug was available without a prescription. In our white paper, “Drug Reformation: End Government’s Power to Require Prescriptions,” Michael Cannon and I point out that prices generally drop when drugs move from prescription-only to over-the-counter.

With the new FDA policy announced September 23, the agency can no longer justify further delaying making naloxone available over the counter not only to harm reduction organizations, but to any individual who wishes to obtain it.