FDA exempts naloxone distribution from DSCSA tracking requirements

Regulatory NewsRegulatory News
| 23 September 2022 | By Joanne S. Eglovitch 

The US Food and Drug Administration (FDA) announced on Thursday that it will not take enforcement action against distributors of approved naloxone products for treating opioid overdoes under the prescription drug tracking requirements under the Drug Supply Chain Security Act (DSCSA).
The exemption would “help facilitate and expedite the distribution of naloxone to harm reduction programs on the front lines of the opioid overdose crisis, and thus directly aid in addressing this public health emergency,” FDA announced in an immediately effective final guidance.
“Combating the opioid overdose epidemic is an urgent public health priority for FDA. The Agency is committed to advancing solutions to reduce opioid overdose deaths in the United States, including by supporting efforts to increase public availability of and access to naloxone,” said FDA. “FDA is aware that harm reduction programs are having difficulty acquiring naloxone and cited this is a contributing factor in the shortage of these products. There are currently three FDA-approved forms of naloxone: injectable, auto-injectors and nasal sprays, which all require a prescription. Access to these medicines “continues to be limited in some communities.”
Under DSCSA, specific activities are automatically excluded from the law, including distributing a product for emergency medical reasons in a public health emergency.
FDA announced that during the opioid public health emergency, it will not take enforcement action related to the distribution of FDA-approved naloxone products to harm reduction suppliers, as well as the distribution of FDA-approved naloxone products to harm reduction programs that are not authorized trading partners (ATPs). Under DSCSA, ATPs such as distributors, wholesalers and dispense, must be able to track and trace their products through the supply chain.
“This exemption and exclusion provided under the DSCSA during the opioid public health emergency strike a balance between the need to facilitate the effective distribution of lifesaving FDA-approved naloxone products to harm reduction programs and harm reduction suppliers under emergency conditions while helping to protect consumers from exposure to products that may be counterfeit, stolen, or otherwise harmful,” the agency said.
FDA said this policy builds on its overdose prevention framework released in August that aims to support primary prevention, encourage harm reduction and advance evidence-based treatments for opioid addiction. (RELATED: FDA targets online opioid retailers in new overdose prevention framework, Regulatory Focus 30 August 2022)


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Tags: DSCSA, naloxone

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