DEA Actions: Marijuana Rescheduling, Industrial Production for R&D
FDA BRIEF: Week of August 8, 2016
DENIAL : Petitions to Reschedule Marijuana
- 2 petitions to reschedcule marijuana from Schedule I (high abuse risk, no therapeutic value) to Schedule II (high abuse risk, with therapeutic value) based on:
- Accepted medical use in US
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Safe for use under medical supervision
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Low abuse potential for medical use
- DEA consulted with FDA and NIDA on scientific evaluation of efficacy/safety and scheduling recommendation
- DENIED rescheduling requests:
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Marijuana has a high potential for abuse. Based on additional data gathered by DEA
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Marijuana has no currently accepted medical use in treatment in US. Chemistry is not known and reproducible; no adequate studies on safety and efficacy; not accepted by qualified experts, scientific evidence is not widely available
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Marijuana lacks accepted safety for use under medical supervision. No FDA-approved marijuana product, no NDA under FDA review. Known risks outweighed by specific benefits in well-controlled clinical trials that scientifically evaluate safety and efficacy
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- Product needs to be approved by FDA prior to rescheduling
Federal Register responses READ AND READ
INCREASE: Number of Authorized Marijuana Manufacturers Supplying Researchers
- Policy change to expand DEA- registered marijuana manufacturers
- Consistent with the CSA and U.S. treaty obligations
- Allow additional entities for DEA registration to grow and distribute marijuana
- Facilitate research and development of products