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Marijuana Science Medical Marijuana Policy

DEA Eases Requirements For FDA-Approved Clinical Trials On Cannabidiol

cannabidiol cbd cannabis marijuanaThe United States Drug Enforcement Administration (DEA) recently eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting FDA-approved clinical trials on cannabidiol (CBD), an extract of the marijuana plant.  These modifications will streamline the research process regarding CBD’s possible medicinal value and help foster ongoing scientific studies.  The DEA notified affected researchers by letter of the changes, which take effect immediately.

Federal Regulation (21 CFR 1301.18) requires researchers conducting CBD-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration.  This registration permits the possession of an approved amount of CBD for a specific research protocol.  Prior to now, researchers who expanded the scope of their studies and needed more CBD than initially approved for had to request, in writing, a modification to their DEA research registrations – potentially delaying that research while the modification underwent an approval process that includes both the DEA and the Food and Drug Administration (FDA).  Under these changes, a previously registered CBD clinical researcher who is granted a waiver can readily modify their protocol and continue their research seamlessly.  This waiver effectively removes a step from the approval process.

Marijuana is a Schedule I controlled substance because of the presence of tetrahydrocannabinol (THC), marijuana’s psychoactive ingredient.  Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications.  Currently, CBD is a Schedule I controlled substance as defined under the CSA.  Though the FDA approves drugs for medical use in the United States, the DEA regulates the handling of all controlled substances, including those being used by researchers to conduct studies.

Source: DEA press release

  • Valient

    So…they’re specifically only giving waivers to research they feel like giving it to, which at this point is only going to be GW Pharma.

    This whole farce needs to end. The war on drugs is a clear human rights violation. It’s supposed to be on the UN agenda next year, but at least the US and UK are still putting out reefer madness propaganda.

    • Little steps like this are how you get progress. Just imagine what President Willard “What’s Hemp?” Romney would have his DEA doing…

      • Denny

        Probably the same thing “O” is doing now.

        • Probably not. This administration has made lots of positive steps you refuse to see because you hate Democrats so much. And Willard was/is a hard ass on weed.

          http://2012.republican-candidates.org/Romney/Marijuana.php

          > Romney opposes the legalization of marijuana, including medical marijuana.

          > “People talk about medicinal marijuana. And you know, you hear that story that people who are sick need medicinal marijuana. But marijuana is the entry drug for people trying to get kids hooked on drugs. I don’t want medicinal marijuana; there are synthetic forms of marijuana that are available for people who need it for prescription. Don’t open the doorway to medicinal marijuana.”
          July 25, 2007, Romney speaking at a town hall meeting in Bedford, New Hampshire

          • Denny

            Why do you keep digging up things that are no longer relevant, and no, I don’t hate democrats, but I don’t have any use for close minded people and those who habitually jump to false assumptions.

          • False assumption? You mean false conclusion?

            What false conclusion? The math is simple. You have a much better chance of getting reform on marijuana with Democrats. It’s a fact.

            Now, let’s look at what you ignored: You said Willard would “probably” be doing the same thing “O” is now. This is demonstrably wrong. You should admit you were wrong. Instead, you attack me for bringing up something you thought was relevant just one comment before.

            Now, if you don’t hate Democrats, why do you lie about them?

          • Him

            “Happy Festivus”

          • moses

            Jackass, corporate, mouth

  • Rob Shaffer

    Make sure to sign. Ask Senator Grassley to schedule a hearing for the Carers Act which gives each state the freedom of choice on medical marijuana. Sign the petition.

    https://www.change.org/p/senator-chuck-grassley-tell-senator-grassley-to-give-the-carers-act-a-hearing?recruiter=67109396&utm_source=share_petition&utm_medium=facebook&utm_campaign=autopublish&utm_term=mob-xs-action_alert-reason_msg

  • Rob Shaffer
  • rsteeb

    “Schedule I Cannabis” is a Damned lie.

    Cannabis SHALL be removed from CSA “Schedule I”, and instead be placed in “CSA Subchapter I, Part A, §802. Definitions, paragraph (6)”, appended to the list “distilled spirits, wine, malt beverages, or tobacco”, where it will STILL be the least-toxic in the category [by orders of magnitude].

    In other words, it shall be made completely EXEMPT from CSA scheduling, just like whiskey, wine, beer and tobacco…

    Anything short of that is *ABSOLUTELY* unacceptable.

    • Falcon89

      I couldn’t agree more

  • ” CBD contains less than 1 percent THC”

    This sentence makes no sense.

    • The Huel Perkins cut of Cannatonic or ‘charlot’s web’ has around 15% CBD and less than 1 % THC

      This is the standard strain for CBD research

  • Closet Warrior

    To pro legal trees guy, I don’t whine about anything, that’s your department. I worship no man as you claim and do not care for your bullyish belittling of everyone who doesn’t have your exact sentiments. So to sum it up I don’t attack, malign or self-depricate. Again, your department and just because I don’t personally care for your slash and bash rhetoric- it’s the very reasons I give you no time to explain, defend or personally care about your weak ass you tube bit you have by exploiting this site for personal agenda: SELF SERVING!!! BTW, I love Ohio, I just don’t like you. Quit stalking me pervert!!!

  • Sinclair

    It’s amazing that what a little bitch session (reference dea. head petition )but this still is not enough.