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: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Government Regulation Legislation, Drug Naloxone -- supply & distribution Opioid Epidemic -- prevention & control United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- 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. The opioid crisis was initially declared a public health emergency under section 319 of the Public Health Service Act on October 26, 2017, and the determination that a public health emergency exists has been subsequently renewed at 90-day intervals. Naloxone hydrochloride (“naloxone”) is medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose. FDA believes that this lifesaving drug can help address the devastating consequences of the opioid overdose epidemic and supports efforts to make this emergency treatment more readily available and more accessible. FDA understands that naloxone is being made available to underserved communities through entities such as harm reduction programs. FDA is issuing this guidance to support efforts by these entities to facilitate public availability of and access to FDA-approved naloxone products for emergency treatment of opioid overdoses, particularly in underserved communities. FDA is aware of concerns that harm reduction programs are having difficulty acquiring naloxone. The Agency is also aware that some stakeholders consider contributing factors to be the current availability of approved naloxone products only as prescription drugs and certain requirements under the Drug Supply Chain Security Act (DSCSA)5 for distribution of FDA-approved prescription drug products, e.g., being an “authorized” trading partner. 6 To help facilitate the availability of naloxone to harm reduction programs, FDA is issuing this guidance to clarify the scope of the public health emergency 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. This guidance is limited to clarifying the applicability of this public health emergency exclusion and exemption only with respect to the distribution of such naloxone products to: (1) Organizations, referred to in this guidance as “harm reduction programs,” that provide harm reduction services to individuals at risk of experiencing an opioid overdose or those who might respond to an overdose, including providing FDA-approved naloxone products to such individuals (2) Entities/organizations, referred to in this guidance as “harm reduction suppliers,” that distribute FDA-approved naloxone products to harm reduction programs The guidance does not address the applicability or FDA’s interpretation of the public health emergency exclusion or exemption under the DSCSA as they relate to the distribution of other products during the opioid public health emergency or the distribution of FDA-approved naloxone products among entities other than harm reduction programs or harm reduction suppliers during the opioid public health emergency. Further, 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (7 pages))
- NLM Unique ID:
- 9918504189006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918504189006676