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The Drug Enforcement Agency classifies marijuana as a Schedule I drug — but does that extend to all cannabinoids? Learn all about if the DEA controlled substances list. For something to be a controlled substance under the federal Controlled Substances Act (CSA), it must be specifically scheduled and assigned one of five scheduling criteria. Questions and answers about FDA regulation of cannabis and cannabis-derived products

Drug Scheduling & Controlled Substances in the US: Regulations For Cannabinoids

The Drug Enforcement Agency classifies marijuana as a Schedule I drug — but does that extend to all cannabinoids?

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The DEA classifies marijuana as a Schedule I drug, but does that mean all cannabinoids are a Schedule I drug, too?

There isn’t one simple answer, unfortunately.

The DEA classification of non-psychoactive cannabinoids like CBD depends on what type of plant they’re derived from and what type of product it is.

This doesn’t mean cannabinoids are completely illegal — most states have completely legalized hemp-derived products, including THC isomers like delta 8 and delta 10 THC.

Table of Contents

How Does Drug Scheduling in the United States Work?

The drug scheduling system in the United States is a classification system used by the Drug Enforcement Agency, or DEA. The DEA uses drug scheduling to classify drugs, substances, and chemicals based on their medical uses and potential for abuse or addiction.

Each schedule correlates with what the DEA determines as accepted medical use and abuse potential. For example, Schedule I drugs have no accepted medical use and a high potential for abuse, according to the DEA. Schedule V, the lowest in the DEA’s scheduling system, refers to drugs with low potential for abuse or that contain small amounts of narcotics.

While the DEA does hold power to enforce drug laws throughout the country, it’s important to remember that the scheduling system doesn’t necessarily mean that a drug is safe or not. For instance, THC (tetrahydrocannabinol) is on the Schedule I list despite having known, accepted, and frequently prescribed medical use cases and low potential for abuse.

Drug scheduling also doesn’t correlate with whether a drug is legal or not. For instance, cocaine is considered Schedule II, which includes drugs with high potential for abuse as well as accepted medical use. It’s no secret that cocaine hasn’t been widely used for medical purposes in several decades — but it remains on the list.

Why Does Drug Scheduling Exist?

So if DEA drug scheduling doesn’t always correlate with safety or illegality, why does it exist at all?

When the Controlled Substances Act was enacted in 1971, it established the drug scheduling system and the DEA’s enforcement of those drugs. This law was intended to give the federal government a way to limit access to (and, inadvertently, research on) drugs that are either controlled substances or dangerous to the public.

The drug scheduling system exists so that the public and the government, namely law enforcement agencies like the DEA and police, can enforce rules and regulations around drugs in the US. As drugs climb higher on the scheduling list, they’re easier for the federal government to control and easier for lawmakers to create policies around.

As you can imagine, this system is ripe for political bias and racial inequality. The reasons that certain drugs remain in certain schedules, like marijuana, have to do with the way police view the people that have used those drugs historically.

Schedule I

Schedule I drugs have no accepted medical use, lack of safety for use under medical supervision, and a high potential for abuse.

Examples of Schedule I substances are heroin, marijuana, LSD, peyote, ecstasy, and magic mushrooms.

Schedule II

Schedule II drugs have a high potential for abuse and addiction. This includes some narcotics and some non-narcotics.

Examples of Schedule II substances are oxycodone, morphine, opium, cocaine, amphetamine, methamphetamine, fentanyl, methadone, and more.

You might recognize Adderall and Ritalin from the Schedule II list.

Schedule III

Schedule III drugs have a lower potential for abuse than Schedule I and II drugs and potential for addiction.

Examples of Schedule III substances are products containing less than 90 mg of codeine per dose, ketamine, and anabolic steroids.

Schedule IV

Schedule IV drugs have a lower potential for abuse than Schedule I, II, and III drugs.

Examples of Schedule IV substances include diazepam (Valium), lorazepam (Ativan), clonazepam (Klonopin), and alprazolam (Xanax).

Schedule V

Schedule V drugs have a lower potential for abuse than Schedule I-IV drugs. Most Schedule V drugs contain small amounts of narcotics or other high-schedule substances.

One example of a Schedule V substance is Robitussin with codeine.

What Are the Penalties For Possessing Schedule I Restricted Substances?

As discussed, the drug scheduling system doesn’t necessarily correlate with illegality. However, some Schedule I drugs are also illegal at the federal level, including marijuana, which has only been legalized at the state level.

The penalties for possessing Schedule I substances that are restricted depending on your record, how much of the drug you have, whether you have evidence of intent to distribute, and the state you’re in.

If you hold a medical marijuana card or live in a state that has legalized weed, you don’t have to worry about the federal government cracking down on you. You are legally entitled to have that Schedule I substance within state lines — make sure not to cross over to another state with your stash in tow.

Generally, possession of a Schedule I substance other than marijuana in a legal state will land you around one year in jail and a multi-thousand-dollar fine. You will also lose your driver’s license for six months.

If you are caught with intent to distribute or while manufacturing a Schedule I substance, you may be looking at a fine of multiple tens of thousands of dollars, as well as a decade or two of prison time.

Equivalents of Schedule I In Other Countries

The drug scheduling system in the US is somewhat unique. Most other countries have some form of prescription drug regulation, but the classifications used by the US are dissimilar from other places. Here’s the breakdown.

A) Canada

In Canada, the National Drug Schedules were established by the Controlled Drugs and Substances Act of 1996. Drugs may appear on schedules I, II, or III and are otherwise listed as uncontrolled substances in schedules IV or V.

Schedule I drugs are those that require a prescription, require a diagnosis before prescription, and are controlled by provincial pharmacy regulations. This includes the derivatives and preparations of certain substances like opium poppy, coca, fentanyl, and amphetamines. That means cocaine, opium, morphine, hydrocodone, and more are all Schedule I drugs in Canada.

THC and CBD are not listed on Canada’s scheduling system, but synthetic cannabinoids are. That includes some common THC:CBD ratio drugs like Nabilone.

B) The United Kingdom

In the United Kingdom, the Misuse of Drugs Act of 1971 established a list of controlled substances at the same time as the US. Like Canada, the UK’s drug scheduling system is mainly used to help pharmacists and doctors better understand the prescriptions they’re doling out while also giving the government a way to control those drugs.

The UK’s Schedule 1 includes drugs that are not used medically, such as DMT and LSD. However, Schedule 2 is more similar to the US’s Schedule I, containing drugs like cannabis, heroin, cocaine, methadone, and fentanyl.

Schedule 2 means that when doctors prescribe the drugs listed, there must be a complete description of the drug’s strength, amount, form, and use. While cannabis is present on the Schedule 2 list, CBD is not a controlled substance. However, CBD in the UK contains less than 0.2% of THC — lower than the threshold for CBD in the US.

C) Germany

The drug scheduling system in Germany includes Anlage I and II — drugs that are illegal to prescribe — and Anlage III — drugs that require controlled substances prescriptions.

Similar to the UK and Canada, German scientists may study the drugs on Anlage I and II with special permission from the government. In the US, Schedule I drugs are wholly impossible for scientists to study, which is part of what makes it so hard to move marijuana off the Schedule I list.

Anlage I and II include drugs like cannabis, codeine, morphine, psilocybin (magic mushrooms), and more. Anlage III includes substances such as amphetamine, medical cannabis produced in state-regulated labs, diazepam, fentanyl, lorazepam, methadone, Nabilone, and more.

Germany’s authorities can only prosecute you for holding controlled substances without a prescription or those on the Anlage I and II lists. Regulated medical marijuana and CBD products are controlled, but you can easily get them with a prescription.

D) Spain

Unlike the other countries on this list, Spain does not have a drug scheduling system. The Spanish government refers to their 1961 Single Convention on Narcotics Drugs and 1971 Convention on Psychotropic Substances to define narcotics and psychotropic drugs, but a scheduling system isn’t in place for the government’s use.

However, penalties for drug possession do differ depending on the hazards of the drug at hand, with more dangerous drugs resulting in longer jail time and more expensive fines. Additionally, it isn’t illegal to possess a drug for personal use — just trafficking and consuming it in public will cause you problems with the police.

Weed is decriminalized in Spain, but you won’t find dispensaries there. CBD is entirely legal at concentrations below 0.2% THC.

E) France

In France, the drug scheduling system is used to classify illicit substances. Each list, ranging from I to IV, includes a category of controlled and illegal substances.

List I is most similar to the US’s Schedule I, with heroin, cocaine, cannabis, methadone, and opium listed because they’re considered narcotics by the French government. It’s illegal to possess or use any of these List I-IV drugs, which include other substances like codeine, amphetamines, LSD, ketamine, and Nabilone, without a prescription.

Despite efforts by the French government, CBD has been ruled legal in France by the European Union. The French government still prohibits the smoking of CBD flower, but all other CBD products with 0.2% or less THC are legal.

F) Australia & New Zealand

In Australia, the drug scheduling system consists of several lists that denote how the public can access those substances. For example, Schedule 7 includes dangerous poisons that may have special rules around sale and storage.

The most similar to the US’s Schedule I is Schedule 8, which is titled Controlled Drugs and includes cannabis, fentanyl, morphine, oxycodone, methadone, and more. This means the government can regulate the prescription and sale of these drugs.

In Australia, medical marijuana is legal, as is CBD. CBD is listed on the Schedule 3 list for Pharmacist Only Medicine, which means the drug requires a doctor’s prescription for sale.

The drug scheduling system in New Zealand uses classes, but the system isn’t used to prosecute people who hold or use those drugs. In fact, nearly all drug possession has been effectively decriminalized in New Zealand in 2019’s Misuse of Drugs Amendment Bill, though intent to distribute and use of drugs can still garner legal action.

New Zealand’s Class B includes substances with a very high risk of harm, which are only available with prescriptions. Class B contains amphetamine, cannabis oil, MDMA, opium, oxycodone, and more. Class C contains drugs with a moderate risk of harm, including cannabis plants, leaves, and seeds.

Cannabis is not legal in New Zealand, but CBD is legal with a prescription. CBD falls into Class B since it is cannabis oil and so must be prescribed by a doctor or pharmacist.

Current Legal Status of Cannabinoids

None of the non-psychoactive cannabinoids derived from hemp are considered Schedule I. This includes cannabidiol (CBD), cannabigerol (CBG), cannabinol (CBN), cannabichromene (CBC), and others.

There are more than 100 cannabinoids and 400 terpenes in cannabis plants. The only one listed on the DEA list of restricted substances is delta 9 THC.

Legal Differences Between Hemp & Marijuana

Hemp is a type of cannabis plant with less than 0.3% THC, whereas marijuana plants contain more than 0.3% THC.

All CBD products derived from hemp plants contain less than 0.3% THC and, in the eyes of both federal and state governments, are not considered marijuana products. However, any product derived from a marijuana plant is considered a marijuana product according to the DEA — even if there’s less than 0.3% THC in the product.

The 2018 Farm Bill

The change in CBD’s legal status is largely due to the 2018 Farm Bill, which legalized cannabis plants with less than 0.3% THC content. This was the first time the US government recognized the difference between a cannabis plant with high THC content and a hemp plant with low THC content.

The result was that hemp plants were suddenly totally legal in the US, which created a huge boom in the CBD industry. Previously, CBD companies were dealing with outsourced hemp farms and under-the-table labs, and now they could grow their own plants, in the US, totally on the books.

This also meant that banks were more willing to give loans to CBD businesses since they knew the federal government wasn’t going to crack down on the industry. CBD companies could suddenly ship products and plants across state lines without worrying about breaking federal law.

Why Is Marijuana (Delta 9 THC) A Schedule I Drug?

What is a Schedule I drug anyway? The DEA defines Schedule I as a drug, substance, or chemical with “no currently accepted medical use and high potential for abuse.” The main difference between Schedule I drugs and Schedule I-V drugs is an accepted medical use.

Although other drugs in the Schedule I class are highly dangerous and addictive, like heroin, marijuana has been scientifically proven to be safe for recreational use time and time again.

The reason marijuana remains a Schedule I drug is largely politicized and bureaucratic. While the passage of the 2018 Farm Bill de-scheduled hemp, legalizing CBD products derived from hemp, it’s still challenging for new studies on marijuana specifically to get underway. Without further studies, dispelling the Schedule I requirement of “no accepted medical use” is even more challenging.

With more and more states legalizing marijuana in the last five years, labs have been able to conduct more studies than ever on the medical benefits and safety of marijuana. There are renewed calls for the rescheduling of marijuana in Congress, but there’s no clear timeline of when marijuana may be rescheduled.

Is Delta 8 THC A Schedule I Drug?

Delta 8 THC is not considered a Schedule I drug as long as it’s made from hemp.

Despite being a form of THC, delta 8 is not listed on the DEA list of Schedule I substances. The same rules apply for delta 10 THC and delta 7 THC.

Final Thoughts: Are Cannabinoids Schedule I Drugs?

The only cannabinoid listed as a Schedule I drug in the US is delta 9 THC. Other forms of THC are considered a legal grey area if they’re made from hemp and illegal if they’re made from marijuana.

The only exception here is individual US states with recreational marijuana laws or licensed medical programs.

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CBD and other non-psychoactive cannabinoids are not listed as Schedule I drugs.

Always ensure that you buy cannabinoid products from a reputable manufacturer with third-party testing, U.S.-grown hemp, and less than 0.3% THC to ensure you’re ordering federally and state-compliant products.

CBD Has Never Been A Controlled Substance

My job is to shed light. Most specifically on the great intricacies of cannabis law, policy, and regulation. The past several years have seen extensive debate about the legal status of cannabidiol (CBD). Is it legal? Was it ever a controlled substance? How is it regulated? Lawyers, industry professionals, and learned scholars debate this with so much vigor that it creates confusion, if not a misstatement of the facts. It hurts my ears and burns my eyes to hear or see an argument that identifies CBD as a controlled substance, because the law is quite clear in this regard.

For something to be a controlled substance under the Federal Controlled Substances Act (CSA), it must be specifically scheduled and assigned one of five scheduling criteria. Schedule I is the most restrictive, which indicates that this controlled substance has no medicinal value and a high potential for abuse. Schedule V, the least restrictive, indicates a drug with currently accepted medical uses and treatments in the United States and a low potential for abuse. Schedule V drugs typically consist of preparations containing limited quantities of certain narcotics, but not always. When one combs through the CSA, the word “cannabidiol” or “CBD” is nowhere to be found — not in the code of federal regulations or in the enacting legislation. One must look deeper to find out what is scheduled and what is not.

Hemp-derived CBD oil

First, let’s look at the definition of marijuana with an “H” (marihuana), which is indeed scheduled. This comprises all parts of the Cannabis Sativa L. plant, excluding non-viable seeds stock and fiber, but including the resins and the remainder of the plant. CBD, of course, is present within the marijuana plant. If you derive CBD from the marijuana plant, it would in fact be controlled, because it came from a controlled substance. This is known as the “source rule” — the source of the material dictates its legality. But what if CBD and other non-psychoactive cannabinoids are derived from a legal source, such as the 25 other plant species that contain levels of cannabinoids or industrial hemp?

The only cannabinoid mentioned in the CSA is tetrahydrocannabinol, THC, the psychoactive compound in cannabis. While it is specifically scheduled, courts have disagreed on whether THC needs to be synthetically or naturally derived to fall within the definition of tetrahydrocannabinol under the CSA. Six years ago, industrial hemp was for the first time ever defined separately from marijuana as holding less than 0.3 Δ9-THC percent by dry weight. The 2014 Farm Bill specifically authorized the use of industrial hemp as a legal substance for purposes of market, scientific, and agricultural-based research. The CBD industry exploded because of the “market-based research exception” — one could only study the plant with a viable market in place for its products. This position was litigated in 2018 in HIA v. DEA III and the restrictions were removed by the 2018 Farm Bill.

The industrial hemp plant is no longer a controlled substance, including all of its derivatives, not the least of which is THC. Even THC from industrial hemp is no longer defined as a controlled substance (we’ll dive into this in more detail at a later time). The 2018 Farm Bill didn’t remove CBD from the Controlled Substances Act, but clarified that it was never on it. To be perfectly clear, if CBD is derived from a lawful substance, it is not and never has been a controlled substance. That’s a fact and the law.

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Yet complexities and legal challenges remain. Greenwich Biosciences (the North American subsidiary of GW Pharmaceutical) had received approval for the new drug, Epidiolex, which was identified and placed on schedule V. While CBD was not defined as schedule V, Epidiolex was because the CBD present in it is derived from marijuana. But as with every other aspect of the growth of the cannabis industry, the law rules. The makers of Epidiolex recently requested that it be removed entirely from the schedule of substances and the DEA agreed with this request.

When derived from lawful materials such as hemp, CBD and other non-psychoactive cannabinoids are not controlled substances because they’re not specifically scheduled. Still, there is pushback. Some folks refer to the Analogue Act, a section of the CSA passed in 1986 allowing any chemical similar to a schedule I or II substance to be listed as schedule I if it’s intended for human consumption. However, CBD is not identified as a chemical in schedule I or schedule II and is one of more than 100 identified cannabinoids contained within the cannabis plant.

The nexus of cannabis law, policy, and regulations has evolved a great deal in the past decade. Prior to the 2014 and the 2018 Farm Bill there was no legal distinction – it was all marijuana. Now, our definitions of cannabis are rooted in science and a plant’s legality is judged based on its chemical makeup.

Despite the perceived uncertainty regarding the legality of the compound CBD, we can officially put it to rest. Unless derived specifically and strictly from a marijuana plant, CBD is not now, and has never been, a controlled substance.

FDA Regulation of Cannabis and Cannabis-Derived Products, Including Cannabidiol (CBD)

There is a significant interest in the development of therapies and other consumer products derived from cannabis and its components, including cannabidiol (CBD). FDA recognizes the potential opportunities that cannabis or cannabis-derived compounds may offer and acknowledges the significant interest in these possibilities. However, FDA is aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk. The agency is committed to protecting the public health while also taking steps to improve the efficiency of regulatory pathways for the lawful marketing of appropriate cannabis and cannabis-derived products. FDA has a number of resources available that address cannabis and cannabis-derived products, such as CBD, and the agency wants to ensure that consumers and other stakeholders have access to these resources in a centralized location.

Consumer Information

FDA Communications

Regulatory Resources

Questions and Answers

Below are a number of frequently asked questions and answers on this topic.

1. What are cannabis and marijuana?

A. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Parts of the Cannabis sativa plant have been controlled under the Controlled Substances Act (CSA) since 1970 under the drug class “Marihuana” (commonly referred to as “marijuana”) [21 U.S.C. 802(16)]. “Marihuana” is listed in Schedule I of the CSA due to its high potential for abuse, which is attributable in large part to the psychoactive effects of THC, and the absence of a currently accepted medical use of the plant in the United States.

2. How does the 2018 Farm Bill define hemp? What does it mean for FDA-regulated products?

A. At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on Dec. 20, 2018. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” These changes include removing hemp from the CSA, which means that cannabis plants and derivatives that contain no more than 0.3 percent THC on a dry weight basis are no longer controlled substances under federal law.

The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing cannabis or cannabis-derived compounds as it does any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of whether the cannabis or cannabis-derived compounds are classified as hemp under the 2018 Farm Bill.

3. Has FDA approved any medical products containing cannabis or cannabis-derived compounds such as CBD?

A. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.

The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.

4. Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?

A. No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a “monograph” for a particular drug category, as established by FDA’s Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.

FDA continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA. Often such products are sold online and are therefore available throughout the country. Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective. This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.

Unlike drugs approved by FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.

The agency has and will continue to monitor the marketplace and take action as needed to protect the public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and that are being marketed for therapeutic uses for which they are not approved. At the same time, FDA recognizes the potential therapeutic opportunities that cannabis or cannabis-derived compounds could offer and acknowledges the significant interest in these possibilities. FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The Center for Drug Evaluation and Research (CDER) is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug (IND) and drug approval process (see Question #16).

5. Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

A. FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products (see Question #2).

FDA relies on applicants and scientific investigators to conduct research. The agency’s role, as laid out in the FD&C Act, is to review data submitted to the FDA in an application for approval to ensure that the drug product meets the statutory standards for approval.

The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products. The agency’s July 2020 draft guidance, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, highlights quality considerations for anyone wishing to conduct clinical research in this area, particularly those who are less familiar with the FDA.

The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of cannabis. Additional information concerning research on the medical use of cannabis is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and National Institute on Drug Abuse (NIDA).

6. What is FDA’s reaction to states that are allowing cannabis to be sold for medical uses without the FDA’s approval?

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A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of cannabis and its derivatives or are considering doing so. It is important to conduct medical research into the safety and effectiveness of cannabis products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of cannabis and its derivatives, so that we can provide information on Federal and scientific standards.

7. Has the agency received any adverse event reports associated with cannabis use for medical conditions?

A. The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects. Consumers and healthcare providers can report adverse events associated with cannabis or cannabis-derived products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088. For more information, please see the FDA’s webpage on MedWatch.

Information from adverse event reports regarding cannabis use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

8. Is it legal for me to sell CBD products?

A. It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of “hemp” under the 2018 Farm Bill (see Question #2), it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.

We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

9. Can THC or CBD products be sold as dietary supplements?

A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

There is an exception to section 201(ff)(3)(B) if the substance was “marketed as” a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

FDA is not aware of any evidence that would call into question its current conclusions that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When a substance is excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act, the exclusion applies unless FDA, in the agency’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under the FD&C Act. To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements. However, all products marketed as dietary supplements must comply with all applicable laws and regulations governing dietary supplement products. For example, manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (i.e., dietary ingredients that were not marketed in the United States in a dietary supplement before October 15, 1994) generally must notify FDA about these ingredients (see section 413(d) of the FD&C Act [21 U.S.C. § 350b(d)]). Generally, the notification must include information demonstrating that a dietary supplement containing the new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. A dietary supplement is adulterated if it contains a new dietary ingredient for which there is inadequate information to provide reasonable assurance that the ingredient does not present a significant or unreasonable risk of illness or injury (see section 402(f)(1)(B) of the FD&C Act [21 U.S.C. 342(f)(1)(B)]).

Numerous other legal requirements apply to dietary supplement products, including requirements relating to Current Good Manufacturing Practices (CGMPs) and labeling. Information about these requirements, and about FDA requirements across all product areas, can be found on FDA’s website.

10. Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?

A. No. Under section 301(ll) of the FD&C Act [21 U.S.C. § 331(ll)], it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or a drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. There are exceptions, including when the drug was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted or, in the case of animal feed, that the drug is a new animal drug approved for use in feed and used according to the approved labeling. However, based on available evidence, FDA has concluded that none of these is the case for THC or CBD. FDA has therefore concluded that it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. FDA is not aware of any evidence that would call into question these conclusions. Interested parties may present the agency with any evidence that they think has bearing on this issue. Our continuing review of information that has been submitted thus far has not caused us to change our conclusions.

When this statutory prohibition applies to a substance, it prohibits the introduction into interstate commerce of any food to which the substance has been added unless FDA, in the agency’s discretion, has issued a regulation approving the use of the substance in the food (section 301(ll)(2) of the FD&C Act [21 U.S.C. § 331(ll)(2)]). To date, no such regulation has been issued for any substance.

Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of 301(ll), and therefore might be able to be added to food. For example, as discussed in Question #12, certain hemp seed ingredients can be legally marketed in human food. However, all food ingredients must comply with all applicable laws and regulations. For example, by statute, any substance intentionally added to food is a food additive, and therefore subject to premarket review and approval by FDA, unless the substance is generally recognized as safe (GRAS) by qualified experts under the conditions of its intended use, or the use of the substance is otherwise excepted from the definition of a food additive (sections 201(s) and 409 of the FD&C Act [21 U.S.C. §§ 321(s) and 348]). Aside from the three hemp seed ingredients mentioned in Question #12, no other cannabis or cannabis-derived ingredients have been the subject of a food additive petition, an evaluated GRAS notification, or have otherwise been approved for use in food by FDA. Food companies that wish to use cannabis or cannabis-derived ingredients in their foods are subject to the relevant laws and regulations that govern all food products, including those that relate to the food additive and GRAS processes.

11. In making the two previous determinations about THC, why did FDA conclude that THC is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act? In making the two previous determinations about CBD, why did FDA determine that substantial clinical investigations have been authorized for and/or instituted, and that the existence of such investigations has been made public?

A. THC (dronabinol) is the active ingredient in the approved drug products, Marinol capsules (and generics) and Syndros oral solution. CBD is the active ingredient in the approved drug product, Epidiolex.

The existence of substantial clinical investigations regarding THC and CBD have been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain )

12. Can hulled hemp seed, hemp seed protein powder, and hemp seed oil be used in human food?

A. In December 2018, FDA completed its evaluation of three generally recognized as safe (GRAS) notices for the following hemp seed-derived food ingredients: hulled hemp seed, hemp seed protein powder, and hemp seed oil. FDA had no questions regarding the company’s conclusion that the use of such products as described in the notices is safe. Therefore, these products can be legally marketed in human foods for the uses described in the notices, provided they comply with all other requirements. These GRAS notices related only to the use of these ingredients in human food. To date, FDA has not received any GRAS notices for the use of hemp-derived ingredients in animal food (see Question #25).

Hemp seeds are the seeds of the Cannabis sativa plant. The seeds of the plant do not naturally contain THC or CBD. The hemp seed-derived ingredients that are the subject of these GRAS notices contain only trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant. Consumption of these hemp seed-derived ingredients is not capable of making consumers “high.”

The GRAS conclusions can apply to ingredients for human food marketed by other companies, if they are manufactured in a way that is consistent with the notices and they meet the listed specifications. Some of the intended uses for these ingredients include adding them as source of protein, carbohydrates, oil, and other nutrients to beverages (juices, smoothies, protein drinks, plant-based alternatives to dairy products), soups, dips, spreads, sauces, dressings, plant-based alternatives to meat products, desserts, baked goods, cereals, snacks and nutrition bars. Products that contain any of these hemp seed-derived ingredients must declare them by name on the ingredient list.

These GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food.

13. What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?

A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”

Under the FD&C Act, cosmetic products and ingredients are not subject to premarket approval by FDA, except for most color additives. Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients. Ingredients not specifically addressed by regulation must nonetheless comply with all applicable requirements, and no ingredient – including a cannabis or cannabis-derived ingredient – can be used in a cosmetic if it causes the product to be adulterated or misbranded in any way. A cosmetic generally is adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual (section 601(a) of the FD&C Act [21 U.S.C. § 361(a)]).

If a product is intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug, even if it affects the appearance. (See Question #3 for more information about drugs.)

FDA can take action if it has information that an ingredient or cosmetic product is unsafe to consumers. Consumers can report adverse events associated with cosmetic products via the FDA’s MedWatch reporting system, either online or by phone at 1-800-FDA-1088, or by contacting your nearest FDA district office consumer complaint coordinator. For more information, please see the FDA’s webpage on how to report a cosmetic-related complaint.

14. Will FDA take action against cannabis or cannabis-related products that are in violation of the FD&C Act?

A. The FDA has sent warning letters in the past to companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.

See also  Whole Foods CBD Oil

15. Can I import or export cannabis-containing or cannabis-derived products?

A. General information about the import/export of drug products regulated by FDA can be found online here. The Drug Enforcement Administration (DEA) is the federal agency responsible for enforcing the controlled substance laws and regulations in the U.S. and, as such, should be consulted with respect to any regulations/requirements they may have regarding the import or export of products containing cannabis. Please see here for information about importing or exporting food ingredients.

Regarding imports, if it appears that an article is adulterated, misbranded, in violation of section 505 of the FD&C Act, or prohibited from introduction or delivery for introduction into interstate commerce under section 301(ll) of the FD&C Act, such article will be refused admission (see section 801(a)(3) of the FD&C Act [21 U.S.C. § 381(a)(3)]).

Research and Expanded Access

16. What is FDA’s role when it comes to the investigation of cannabis and cannabis-derived products for medical use?

A. To conduct clinical research that can lead to an approved new drug, including research using materials from plants such as cannabis, researchers need to work with the FDA and submit an IND application to the Center for Drug Evaluation and Research (CDER). The IND application process gives researchers a path to follow that includes regular interactions with the FDA to support efficient drug development while protecting the patients who are enrolled in the trials. For research for use as an animal drug product, researchers would establish an investigational new animal drug (INAD) file with the Center for Veterinary Medicine to conduct their research, rather than an IND with CDER.

As discussed above (see Question #2), the 2018 Farm Bill removed hemp from the CSA. This change may streamline the process for researchers to study cannabis and its derivatives, including CBD, that fall under the definition of hemp, which could speed the development of new drugs.

As also discussed above (see Question #5) the agency also issued a draft guidance in July 2020, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry, for individuals considering clinical research in this area.

Conducting clinical research using cannabis-related substances that are scheduled by the DEA often involves interactions with several federal agencies. This includes: a registration administered by the DEA; obtaining the cannabis for research from NIDA, within the National Institutes of Health, or another DEA-registered source; and review by the FDA of the IND or INAD application and research protocol. Additionally:

  • For a Schedule I controlled substance under the CSA, DEA provides researchers with investigator and protocol registrations and has Schedule I-level security requirements at the site cannabis will be studied.
  • NIDA provides research-grade cannabis for scientific study. The agency is responsible for overseeing the cultivation of cannabis for medical research and has contracted with the University of Mississippi to grow cannabis for research at a secure facility. Cannabis of varying potencies and compositions is available. DEA also may allow additional growers to register with the DEA to produce and distribute cannabis for research purposes.
  • Researchers work with the FDA and submit an IND application to the appropriate division in the Office of New Drugs in CDER depending on the therapeutic indication. Based on the results obtained in studies conducted at the IND stage, sponsors may submit a marketing application for formal approval of the drug.

17. Does the FDA object to the clinical investigation of cannabis for medical use?

A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from cannabis. The FDA supports the conduct of that research by:

  1. Providing information on the process needed to conduct clinical research using cannabis.
  2. Providing information on the specific requirements needed to develop a drug that is derived from a plant such as cannabis. In December 2016, the FDA updated its Guidance for Industry: Botanical Drug Development, which provides sponsors with guidance on submitting IND applications for botanical drug products.
  3. Providing specific support for investigators interested in conducting clinical research using cannabis and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
  4. Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Research’s Small Business and Industry Assistance group.

18. How can patients gain access to cannabis or cannabis-derived products for medical use through expanded access?

A. Expanded access is a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there are no comparable or satisfactory therapies available. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations.

19. Can patients gain access to cannabis or cannabis-derived products for medical use through Right to Try?

A. Information for patients on Right to Try (RTT) is available on our website. RTT is designed to facilitate access to certain investigational drugs through direct interactions between patients, their physicians and drug sponsors – FDA is not involved in these decisions. Sponsors developing drugs for life-threatening conditions are responsible for determining whether to make their products available to patients who qualify for access under RTT. If you are interested in RTT, you should discuss this pathway with your licensed physician. Companies who develop drugs and biologics, also known as sponsors, can provide information about whether their drug/biologic is considered an eligible investigational drug under RTT and if they are able to provide the drug/biologic under the RTT Act.

Children and Pregnant/Lactating Women

20. Does the FDA have concerns about administering a cannabis product to children?

A. We understand that parents are trying to find treatments for their children’s medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing cannabis or cannabis-derived compounds, and will continue to work with companies interested in bringing safe, effective, and quality products to market. With the exception of Epidiolex, Marinol, and Syndros, no product containing cannabis or cannabis-derived compounds (either plant-based or synthetic) has been approved as safe and effective for use in any patient population, whether pediatric or adult.

21. Does the FDA have concerns about administering a cannabis product to pregnant and lactating women?

A. The FDA is aware that there are potential adverse health effects with use of cannabis products containing THC in pregnant or lactating women. Published scientific literature reports potential adverse effects of cannabis use in pregnant women, including fetal growth restriction, low birth weight, preterm birth, small-for-gestational age, neonatal intensive care unit (NICU) admission, and stillbirth. [1, 2, 3] Based on published animal research, there are also concerns that use of cannabis during pregnancy may negatively impact fetal brain development. [4, 5, 6 ] The American College of Obstetricians and Gynecologists (ACOG) recommends that women who are pregnant or contemplating pregnancy should be encouraged to discontinue cannabis use. In addition, ACOG notes that there are insufficient data to evaluate the effects of cannabis use on breastfed infants; therefore, cannabis use is discouraged when breastfeeding. [7] Pregnant and lactating women should talk with a health care provider about the potential adverse health effects of cannabis use.

22. What does the FDA think about making CBD available to children with epilepsy?

A. The FDA has approved Epidiolex, which contains a purified form of the drug substance CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 1 years of age and older. It has also approved Epidiolex for the treatment of seizures associated with tuberous sclerosis complex in patients 1 year of age or older. That means the FDA has concluded that this particular drug product is safe and effective for its intended use. Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring cannabis-derived treatments to patients. Because of the adequate and well-controlled clinical studies that supported this approval, and the assurance of manufacturing quality standards, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.

23. What should I do if my child eats something containing cannabis?

A. With the exception of products such as the hemp seed ingredients discussed in Question #12, which have been evaluated for safety, it is important to protect children from accidental ingestion of cannabis and cannabis-containing products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion. If the parent or caregiver has a reasonable suspicion that the child accidentally ingested products containing cannabis, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.

Pets and other Animals

24. I’ve seen cannabis products being marketed for pets. Are they safe?

A. FDA is aware of some cannabis products being marketed as animal health products. We want to stress that FDA has not approved cannabis for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products and recommends that you talk with your veterinarian about appropriate treatment options for your pet.

Signs that your pet may be suffering adverse effects from ingesting cannabis may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions.

If you have concerns that your pet is suffering adverse effects from ingesting cannabis or any substance containing cannabis, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.

While the agency is aware of reports of pets consuming various forms of cannabis, to date, FDA has not directly received any reports of adverse events associated with animals given cannabis products. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting cannabis, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal drug or for how to report an adverse event or problem with a pet food.

25. Can hemp be added to animal food?

A. All ingredients in animal food must be the subject of an approved food additive petition or generally recognized as safe (GRAS) for their intended use in the intended species. If an animal food contains an ingredient that is not the subject of an approved food additive petition or GRAS for its intended use in the intended species, that animal food would be adulterated under section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]. In coordination with state feed control officials, CVM also recognizes ingredients listed in the Official Publication (OP) of the Association of American Feed Control Officials (AAFCO) as being acceptable for use in animal food. At this time, there are no approved food additive petitions or ingredient definitions listed in the AAFCO OP for any substances derived from hemp, and we are unaware of any GRAS conclusions regarding the use of any substances derived from hemp in animal food. Learn more about animal food ingredient submissions here.

With respect to products labeled to contain “hemp” that may also contain THC or CBD, as mentioned above it is a prohibited act under section 301(ll) of the FD&C Act to introduce or deliver for introduction into interstate commerce any animal food to which THC or CBD has been added.

26. Can approved human drugs containing CBD or synthetic THC be used extralabel in animals?

A. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA), permits veterinarians to prescribe extralabel uses of approved human and animal drugs for animals under certain conditions. Extralabel use must comply with all the provisions of AMDUCA and its implementing regulation at 21 CFR § 530. Among other limitations, these provisions allow extralabel use of a drug only on the lawful order of a licensed veterinarian in the context of a valid veterinarian-client-patient relationship and only in circumstances when the health of an animal is threatened or suffering, or death may result from failure to treat.

In addition, under 21 CFR 530.20, extralabel use of an approved human drug in a food-producing animal is not permitted if an animal drug approved for use in food-producing animals can be used in an extralabel manner for the use. In addition, under 21 CFR 530.20(b)(2), if scientific information on the human food safety aspect of the use of the approved human drug in food-producing animals is not available, the veterinarian must take appropriate measures to ensure that the animal and its food products will not enter the human food supply.
For more information on extralabel use of FDA approved drugs in animals, see Extralabel Use of FDA Approved Drugs In Animals.

[1] Gray, et al. Identifying Prenatal Cannabis Exposure and Effects of Concurrent Tobacco Exposure on Neonatal Growth. Clinical Chemistry. 2010; 56(9): 1442-1450.

[2] Gunn, et al. Prenatal Exposure to cannabis and maternal and child health outcomes: a systematic review and meta-analysis. BMJ Open. 2016; 6:e009986.

[3] Hayatbakhsh, et al. Birth Outcomes associated with cannabis use before and during pregnancy. Pediatric Research. 2012; 71 (2): 215-219.

[4] Silva, et al. Prenatal tetrahydrocannabinol (THC) alters cognitive function and amphetamine response from weaning to adulthood in the rat. Neurotoxicol and Teratol 2012; 34(1): 63-71.

[5] Trezza, et al. Effects of perinatal exposure to delta-9-tetrahydrocannabinol on the emotional reactivity of the offspring: a longitudinal behavioral study in Wistar rats. Psychopharmacology (Berl) 2008; 198(4): 529-537.

[6] Campolongo, et al. Perinatal exposure to delta-9-tetrahydrocannabinol causes enduring cognitive deficits associated with alteration of cortical gene expression and neurotransmission in rats. Addict Biol 2007; 12(3-4): 485–495.

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