Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of Food and Drug Administration-Approved Naloxone Products During the Opioid Public Health Emergency; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency." Combating the opioid overdose epidemic is an urgent public health priority for FDA. Naloxone hydrochloride ("naloxone") is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs and is aware of concerns that harm reduction programs are having difficulty acquiring naloxone. FDA is issuing this guidance to clarify the scope of the public health emergency exclusion and exemption under the Drug Supply Chain Security Act 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. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.