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# Naloxone Guidance Attempts to Ease Availability
- URL: https://www.fdaweb.com/naloxone-guidance-attempts-to-ease-availability/
- Published: 2022-09-22T12:00:00.000Z
- Updated: 2026-09-14T18:00:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152791

FDA has made available an “immediately-in-effect guidance” entitled [*Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA5MjIuNjQwNjk5ODEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvZXhlbXB0aW9uLWFuZC1leGNsdXNpb24tY2VydGFpbi1yZXF1aXJlbWVudHMtZHJ1Zy1zdXBwbHktY2hhaW4tc2VjdXJpdHktYWN0LWRpc3RyaWJ1dGlvbi1mZGE%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.4v6soRsWN13lqwDKMfLq7QCeiawQrS1%5FF5xqhlK%5FxAg/s/1255931999/br/144509467572-l?ref=fdaweb.com)*.* The document is intended to increase public availability of, and access to, naloxone, which is the go-to drug for reversing the effects of an opioid overdose. 

“FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs,” the guidance says, adding that it is aware of concerns that these programs are having difficulty acquiring naloxone. One factor hampering acquisition is the Drug Supply Chain Security Act (DSCSA) and its requirement for being an “authorized” trading partner.

To boost the availability of naloxone through harm reduction programs, the guidance clarifies the “exclusion and exemption under the DSCSA as they apply to the distribution of FDA-approved naloxone products indicated for the emergency treatment of opioid overdose to harm reduction programs during the opioid public health emergency.”

Many public health advocates have called on FDA to make naloxone available over the counter. However, FDA’s guidance clarifies that the “prescription status of drug products and prescription requirements under federal and state law are beyond the scope of this guidance. Therefore, this guidance does not address the prescription-only status of FDA-approved naloxone products.”