Yesterday (22 September 2022) USFDA issued “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.” guidance that is immediately in effect.
Naloxone is a critical drug to help reduce opioid overdose deaths and three FDA-approved forms of naloxone (injectable, auto-injector, and nasal spray) currently require a prescription.
Medications such as Naloxone hydrochloride reverse the effects of opioid overdoses rapidly and are used as emergency treatments under the heading of opioid overdose.
The FDA is issuing this guidance to support improving the availability and access to FDA-approved naloxone products, especially in underserved areas.
In response to community engagements, the FDA is providing this guidance to help address some of the obstacles to naloxone access and to promote harm reduction by expanding the availability of naloxone and its accessibility.
Click this LINK to know more about DSCSA Statutory Exemption and Exclusion for Public Health Emergency and Authorized Trading Partner Requirements etc from this guidance.
How To Obtain a Covered Product Authorization
Also, there was another draft guidance released "How To Obtain a Covered Product Authorization" in which CREATES Act details the process by which eligible product developers can obtain a Covered Product Authorization (CPA) from FDA.
As a result of the CREATES Act, eligible product developers are able to receive samples of the product they need to comply with testing and other regulatory requirements to support their applications.
Click this LINK to know more about How To Obtain a Covered Product Authorization