Abbreviated New Drug Application (ANDA) - An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
Abbreviated New Drug Application (ANDA) Number - This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.
Acacia – a family of shrubs and trees known for their high concentration of naturally occurring dimethyltryptamine.
Active Ingredient - Any component of a drug product intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans or other animals. Active ingredients include those components of the product that may undergo chemical change during the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.
Active Pharmaceutical Ingredient - Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance.
Addiction - a pattern of consumption marked by compulsive taking of a drug, the need for increased doses over time to maintain the same effect (tolerance), and the appearance of symptons when the drug is stopped that disappear when it is reinstituted (withdrawal).
African Dream Root – aka Silene Capensis, a plant native to South Africa where it is used by the Xhosa people to induce vivid and prophetic dreams.
Agonist - a chemical substance capable of activating a given neuroreceptor to induce a full or partial pharmacological response.
Alkaloid – a substance of plant origin, containing nitrogen, that gives a feeble alkaline reaction in solution. Many alkaloids cause pharmacological effects in animals. Their names end in "-ine" as with caffeine, morphine, quinine, and nicotine.
Amanita - mushrooms of the genus Amanita are gilled mushrooms, distinguised by white gills and spores, a ring around the stipe (called an annulus or partial veil) and a cup at the base of the stipe (the volva).
Amphetamines - stimulants that speed up the body's system. Many are legally prescribed and used to treat attention-deficit hyperactivity disorder (ADHD). Amphetamine was first marketed in the 1930s as Benzedrine in an over-the-counter inhaler to treat nasal congestion. By 1937 amphetamine was available by prescription in tablet form and was used in the treatment of the sleeping disorder narcolepsy and ADHD.
Angel’s Trumpet – aka Brugmansia, a flowering plant, like Datura whose flowers are known to produce strong disturbing hallucinations.
Antagonist - a substance which counteracts the effects of another substance.
API Starting Material - A raw material, intermediate, or an API that is used in the production of an API and that is incorporated as a significant structural fragment into the structure of the API. An API Starting Material can be an article of commerce, a material purchased from one or more suppliers under contract or commercial agreement, or produced in-house. API Starting Materials are normally of defined chemical properties and structure.
Approval History - The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA, BLA, or ANDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.
Approval Letter - An approval letter is an official communication from FDA to a drug application (NDA, BLA, or ANDA) sponsor that allows the commercial marketing of the product.
Atropine - an alkaloid found in many plants of the nightshade family that blocks nerve impulses in the parasypathetic nervous system. It is a potent deliriant hallucinogen whose effects are generally regarded as unpleasant.
Ayahuasca - A psychedelic tea made from a combination of plants native to the Amazon basin. It is typically made with Banisteriopsis caapi (which provides an MAOI to extend the life of ayahuasca’s second active ingredient, DMT) and Psychotria viridis (aka chacruna, which provides DMT), and it used sacramentally by indigenous peoples of South America.
Barbiturates - are depressants that produce a wide spectrum of central nervous system depression from mild sedation to coma. They also have been used as sedatives, hypnotics, anesthetics, and anticonvulsants. Barbiturates are Schedule II, Ill, and IV depressants.
Baseline - the normal phychological and physical state of a person prior to the start of an experiment which, once regained, marks the end of that experiment.
Bath Salts – are synthetic stimulants and are from the synthetic cathinorie class of drugs. Synthetic cathiriories are central nervous stimulants and are designed to mimic effects similar to those produced by cocaine, methamphetamine, and MDMA (ecstasy). These substances are often marketed as "bath salts," "research chemicals," "plant food," "glass cleaner," and labeled "not for human consumption," in order to circumvent application of the Controlled Substance Analogue Enforcement Act.
Belladonna – aka Deadly Nightshade, its red-black berries contain atropine, scopolomine and hyoscyamine. Belladonna has ancient connections to medieval witchcraft and shamanic ceremonies. However, it is extremely toxic and poisonous to humans.
Benzodiazepines - Benzodiazepines are depressants that produce sedation and hypnosis, relieve anxiety and muscle spasms, and reduce seizures. Benzodiazepines are controlled in Schedule IV.
Biologic License Application (BLA) - Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
Biological Product - Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. In general, the term "drugs" includes therapeutic biological products.
Blue Lilly – aka the Sacred Lily of The Nile. It is most commonly brewed as a tea or added to wine. It’s affects are compared to MDMA, with a markedly less intense calming trip. It is used by some to alleviate depression.
Bolvian Torch – a specie of cactus known to contain mescaline.
Brand Name Drug - A brand name drug is a drug marketed under a proprietary, trademark-protected name.
Brunfelsia – A plant with purple and white flowers often used in Ayahuasca and reputed to have aphrodisiac qualities.
Bulk Drug Substance - According to 21CFR207.3(a)(4) means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.
Bupropion - an atypical antidepressant which blocks the reuptake of dopamine.
Caapi - a tropical vine which contains harmala alkaloids in its stems. It is classed as a monoamine oxidase inhibitor, allowing other substances to have more potent effect, such as in its inclusion in ayahuasca brews.
Calea Zacatechichi – a flowering plant reputed to induce lucid dreaming.
Cannabis – aka the Devil’s Salad, aka marijuana, is a plant at contains over 480 constituents. THC (delta-9-tetrahydrocannabinol) is believed to be the main ingredient that produces the psychoactive effect. Marijuana is a Schedule I substance.
Central Nervous System - the brain and spinal cord.
Cerebral Cortex - The region of the brain responsible for cognitive functions including reasoning, mood, and perception of stimuli.
Chacruna – aka psychotria viridis, is an essential ingredient plant to ayahuaca brew. It contains high levels of naturally occurring dimethyltryptamine.
Chaliponga – a vine that, like acacia, contains high levels of naturally occurring dimethyltryptamine.
Christmas Vine – aka Turbina Flower, is a plant with bell-shaped flowers and heart-shaped leaves, whose seeds contain natural concentration of LSA.
Cocaine – an intense, euphoria-producing stimulant drug with strong addictive potential. Cocaine is derived from coca leaves. Cocaine is a Schedule II drug.
Colorado River Reed – a grass that contains naturally high levels of dimethyltryptamine.
Datura – aka Jimson weed, a plant whose large trumpet-like white flowers produce large spiked seed pods whose seeds contain naturally high levels of atropine, a potent deliriant hallucinogen.
Demethylation - removal of a methyl group.
Depressants – induce sleep, relieve anxiety and muscle spasms, and prevent seizures.
A form of depressant, Barbiturates, are older drugs and include butalbital (Fiorina), phenobarbital, Pentothal, Seconal, and Nembutal. A person can rapidly develop dependence on and tolerance to barbiturates, meaning a person needs more and more of them to feel and function normally. This makes them unsafe, increasing the likelihood of coma or death.
Another form of depressant, Benzodiazepines, were developed to replace barbiturates, though they still share many of the undesirable side effects including tolerance and dependence. Some examples are Valium, Xanax, Halcion, Ativan, Klonopin, and Restoril. Rohypnol is a benzodiazepine that is not manufactured or legally marketed in the United States, but it is used illegally. Lunesta, Ambien, and Sonata are sedative-hypnotic medications approved for the short-term treatment of insomnia that share many of the properties of benzodiazepines. Other CNS depressants include meprobamate, methaqualone (Quaalude), and the illicit drug GHB.
Dietary Supplement - The Food, Drug & Cosmetics Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), defines a “dietary supplement” as a product intended to supplement the diet that contains one or more of the following: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a) through (e). 21 U.S.C. § 321(ff).
Dissociative - a type of compound, such as phencyclidine or ketamine, that produces an anesthetic effect characterized by a feeling of being detached from the physical self.
DMT (or N,N-Dimethyltryptamine) - A intense, and short-acting psychedelic compound (unless paired with an MAOI). This tryptamine molecule is found in many plants and animals. Dimethyltryptamine are naturally occurring psychedelics found in a variety of plants around the world, several of which are native to the Amazon region. These alkaloids, which are usually found together in the plants, are also found in the human brain as neurotransmitters, as well as m our blood, urine, and spinal fluid. 1 DMT is produced in the human pineal gland which is correlated to the "3rd eye" or Ajna Chakra in the Indian spiritual system. Meditative states attained by yogis who concentrate on the 3rd eye may be the result of increased DMT levels. DMT is produced in heavy concentration in the glands of some tropical toads, such as Bufo Alvarius. Some people actually make a practice of squeezing out this venom, then drying and smoking it to get high.
Dopamine - a chemical believed to act as a neurotransmitter in parts of the brain by serving as a messenger between one nerve and another.
Dosage Form - A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.
Drug – as defined at Section 201 of the FDCA, a "drug" is any article (item) "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man." 21 U.S.C. § 321(g)(1)(B) Other definitions include, "anything that enters into the body and affects its functioning or some part of it in some way". "A drug, affects the body, mind or perceptions and changes the way a body works". Contrast this with food. For example, although a banana or a sandwich changes the body by providing nutrients, these nutrients are required to function correctly, and do not alter the body's metabolism. A drug changes some function of the body, provide a perception shift etc. Some foods contain drugs, or are also drugs. For example, chocolate and psilocybin mushrooms.
Drug Product - A finished dosage form, for example, a tablet, capsule or solution that contains an active pharmaceutical ingredient, generally, but not necessarily, in association with inactive ingredients. Reference: Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients FDA Guidance
Dysphoria - a state of dissatisfaction, anxiety, restlessness, or fidgeting.
Ecstasy – See MDMA.
Empathogen - A psychoactive drug that produces a heightened sense of connectedness, emotional openness, and compassion. MDMA, or Ecstasy, is such a drug. Also sometimes called an entactogen.
Entactogen - substances which generate a sense of "the touch within". Entactogen is used interchangeably with empathogen.
Entheogen - from the Greek, “generating the divine within.” A psychoactive substance that produces or facilitates a spiritual experience. The word is intended to help rehabilitate psychedelics by reference to their ancient spiritual role.
Ephedra – a shrub containing ephedrine alkaloids, which have a psychoactive effect.
Ergot – a fungus that grows in rye grain and which produces active levels of ergotamine, the source of LSD. The effects of ergot are historically associated with witchcraft.
Ethnobotany - plant lore and agricultural customs of a people.
Excipients - Examples of excipients include fillers, extenders, diluents, wetting agents, solvents, emulsifiers, preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring agents.
FDA Action Date - The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place.
FDA Application Number - FDA assigns a unique number to each application for approval to market a drug in the United States. The types of application numbers are: NDA (New Drug Application), ANDA (Abbreviated New Drug Application) and Biologic License Application (BLA). One drug can have more than one application number if it has different dosage forms or routes of administration
Fentanyl - a potent synthetic opioid drug approved by the Food and Drug Administration for use as an analgesic (pain relief) and anesthetic. It is approximately 100 times more potent than morphine and 50 times more potent than heroin as an analgesic. Fentanyl is a Schedule II narcotic.
Formulations - Pharmaceutical formulation, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product.
Free Base - the "free" base form of an alkaloid, i.e., not paired with an acid molecule.
Fungus - any of numerous organisms that lack chlorophyll and reproduce by spores, ranging in form from a single cell to a mass of branched filaments that may produce specialized fruiting bodies. Yeasts, molds, rusts, smuts, and mushrooms are all examples of fungi.
GABA - a neuroreceptor type and neurotransmitter.
Generic Drug - A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product.
Glutamate - an excitatory neurotransmitter found throughout the brain that influences the reward system and is involved in learning and memory, among other functions.
Hallucinogens – A drug that produces hallucinations, distortions in perception of sights and sounds, and disturbances in emotion, judgment, and memory. Hallucinogens are found in plants and fungi or are synthetically produced and are among the oldest known group of drugs used for their ability to alter human perception and mood. Many hallucinogens are Schedule I.
Harmaline - a plant-derived MAOI found in Syrian Rue & Banisteriopsis Caapi.
Hawaiian Baby Woodrose – a plant whose seeds contain high levels of LSA, a natural analogue of LSD.
Henbane - a psychoactive and toxic plant of the nightshade family, containing the tropane alkaloids used in European witchcraft of the Middle Ages.
Heroin – is a highly addictive drug and it is a rapidly acting opioid. Heroin is processed from morphine, a naturally occurring substance extracted from the seed pod of certain varieties of poppy plants. Heroin is a Schedule I narcotic.
Homeopathy - The practice of treating the syndromes and conditions which constitute disease with remedies that have produced similar syndromes and conditions in healthy subjects.
Homeopathic Drug - Any drug labeled as being homeopathic which is listed in the Homeopathic Pharmacopeia of the United States (HPUS), an addendum to it, or its supplements.
Homeotherapeutics - Involves therapy which utilizes drugs that are selected and administered in accordance with the tenets of homeopathy.
Homeopathic Pharmacopeia of the United States (HPUS) - A compilation of standards for source, composition, and preparation of homeopathic drugs. HPUS contains monographs of drug ingredients used in homeopathic treatment. It is recognized as an official compendium under Section 201(j) of the FDCA.
Iboga – the roots of the African Iboga plant produce ibogaine, a strong and long-lasting hallucinogen that is sometimes used to treat opioid addiction.
Inactive Ingredient - According to 21 CFR 210.3(b)(8), an inactive ingredient is any component of a drug product other than the active ingredient.
Indole – An indole is an aromatic heterocyclic organic compound with formula C₈H₇N. It has a bicyclic structure, consisting of a six-membered benzene ring fused to a five-membered pyrrole ring. Indole is widely distributed in the natural environment and can be produced by a variety of bacteria. As an intercellular signal molecule, indole regulates various aspects of bacterial physiology, including spore formation, plasmid stability, resistance to drugs, biofilm formation, and virulence. The amino acid tryptophan is an indole derivative and the precursor of the neurotransmitter serotonin.
Intermediate - A material produced during steps in the synthesis of an API that must undergo further molecular change or processing before it becomes an API.
Insufflate - to snort or to have blown up one’s nose.
Kappa Opioid Receptor - a receptor on nerve cells that is activated by certain opioid-like compounds produced in the body. These receptors differ from those activated by the more commonly known opioids, such as heroin and morphine.
Ketamine – is a dissociative anesthetic that has some hallucinogenic effects. It distorts perceptions of sight and sound and makes the user feel disconnected and not in control. It is an injectable, short-acting anesthetic for use in humans and animals. It is referred to as a "dissociative anesthetic" because it makes patients feel detached from their pain and environment. Ketamine can induce a state of sedation (feeling calm and relaxed), immobility, relief from pain, and amnesia (no memory of events while under the influence of the drug). Ketamine is a Schedule Ill non-narcotic substance.
Kratom - is a tropical tree native to Southeast Asia. Consumption of its leaves produces both stimulant effects (in low doses) and sedative effects (in high doses), and can lead to psychotic symptoms, and psychological and physiological dependence. The psychoactive ingredient is found in the leaves from the kratom tree. These leaves are subsequently crushed and then smoked, brewed with tea, or placed into gel capsules. Kratom has a long history of use in Southeast Asia, where it is commonly known as thang, kakuam, thom, ketum, and biak. Kratom is not controlled under the Federal Controlled Substances Act.
Label - The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.
LSD (d-lysergic acid diethylamide) - is a potent hallucinogen that has a high potential for abuse and currently has no accepted medical use in treatment in the United States. LSD is a Schedule I substance. LSD is a synthetic compound. It is derived from Iysergic acid which is found in Hawaiian Woodrose and Morning Glory seeds, or Ergot fungus, which can grow on rye, wheat, and other grams. Lysergic acid is also psychoactive, although not nearly as potent as LSD.
MAOI (Monoamine Oxidase Inhibitor)-a substance which inhibits the enzyme MAO.
MDMA – aka Ecstasy, acts as both a stimulant and psychedelic, producing an energizing effect, distortions in time and perception, and enhanced enjoyment of tactile experiences. MDMA is a Schedule I drug. Ecstasy is a synthetic compound developed in 1914 as a potential dietary aid. However, its psychoactive effects were not discovered until the mid-Seventies. It was used widely in therapy from this time until 1985 when it was made illegal.
Mescaline - Mescaline is a naturally occurring psychedelic found in several cactus species, most notably, Peyote (Lophophora williamsii) and San Pedro (Trichocereus pachanoi). Several other members of the trichocereus family also contain mescaline. Mescaline belongs to a family of compounds known as phenethylamines, making it distinct from the other psychedelics which belong to the indole family. For example, LSD, psilocybin, harmaline, and DMT are indoles. Many synthetic "designer" psychedelics, such as ecstasy (MDMA) and 2C-B, are phenethylamines, and are related to the chemistry of mescaline. In addition to containing mescaline, the cacti mentioned above contain a large variety of related psychoactive compounds and will produce experiences that are qualitatively different than pure mescaline. The experience produced by Peyote is also quite distinct from that produced by cacti from the trichocereus family.
Methamphetamine - Methamphetamine is a stimulant. The FDA approved brand-name medication is Desoxyn. Methamphetamine is a Schedule II stimulant. Hitler’s Wehrmacht relied upon heavy doses of methamphetamine marketed under the brand Pervitin.
Morphine - is a non-synthetic narcotic with a high potential for abuse and is derived from opium. It is used for the treatment of pain. Morphine is a Schedule II narcotic.
Mucuna Pruriens – aka Velvet Bean, contains L-dopa and hallucinogenic tryptamines. It is also widely used to treat erectile dysfunction.
Muscimol - the psychoactive compound found in Amanita muscaria.
Narcotics – aka "opioids," the term "narcotic" comes from the Greek word for "stupor" and originally referred to a variety of substances that dulled the senses and relieved pain. Though some people still refer to all drugs as "narcotics," today "narcotic" refers to opium, opium derivatives, and their semi-synthetic substitutes. A more current term for these drugs, with less uncertainty regarding its meaning, is "opioid." Examples include the illicit drug heroin and pharmaceutical drugs like OxyContin, Vicodin, codeine, morphine, methadone, and fentanyl.
The poppy Papaver somniferum is the source for natural opioids, whereas synthetic opioids are made entirely in a lab and include meperidine, fentanyl, and methadone. Semi-synthetic opioids are synthesized from naturally occurring opium products, such as morphine and codeine, and include heroin, oxycodone, hydrocodone, and hydromorphone.
Besides their medical use, narcotics/opioids produce general sense of well-being by reducing tension, anxiety, and aggression. These effects are helpful in a therapeutic setting but contribute to the drugs' abuse. Narcotic/use comes with a variety of unwanted effects, including drowsiness, inability to concentrate, and apathy.
Neurotransmitter - a chemical compound that acts as a messenger to carry signals from one nerve cell to another.
New Drug Application (NDA) - When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDAs are assigned an NDA number.
New Drug Application (NDA) Number - The FDA assigns a six-digit number to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration.
New Molecular Entity (NME) - A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form. An NME is an active ingredient that contains no active moiety that has been previously approved by the Agency in an application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act or has been previously marketed as a drug in the United States.
NMDA Receptors - N-methyl-D-aspartate receptors, a type of glutamate receptor that is important for learning and memory; it is the target of drugs such as PCP and ketamine.
Nootropic - capable of enhancing mental function.
Opium – Opium is a highly addictive non-synthetic narcotic that is extracted from the poppy plant, Papaver somniferum. The opium poppy is the key source for many narcotics, including morphine, codeine, and heroin. Opium is a Schedule II drug.
Over-the-Counter Drugs (OTC) - FDA defines over-the-counter (OTC) drugs as safe and effective for use by the general public without a doctor's prescription.
Patient Package Insert (PPI) - A patient package insert contains information for patients' understanding of how to safely use a drug product.
PCP (Phencyclidine) - was originally developed in the 1950s as a general anesthetic for surgery. While it can be found in a variety of forms, including tablets or capsules, it is usually sold as a liquid or powder. PCP can be snorted, smoked, injected, or swallowed.
Peyote (Lophophora williamsii) – is a small, spineless cactus. The active ingredient in peyote is the hallucinogen mescaline. Peyote and mescaline are Schedule I substances.
Phalaris Grass – a grass with naturally high levels of dimethyltryptamine.
Pharmaceutical Equivalents - FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria: they contain the same active ingredient(s); they are of the same dosage form and route of administration; and they are identical in strength or concentration. Pharmaceutically equivalent drug products may differ in characteristics such as shape, release mechanism, labeling (to some extent), scoring, and excipients (including colors, flavors, preservatives).
Phenethylamines - A class of organic molecule, and the name for one of the two principal types of psychedelic compounds; the other is the tryptamines. Mescaline and MDMA are examples of phenethylamines.
Pituri Bush – a shrub containing natural levels of nicotine and scopolamine.
Prescription Drug - A human drug that is not safe for use except under the supervision of licensed medical practitioner.
Product Number - A product number is assigned to each drug product associated with an NDA (New Drug Application), ANDA (Abbreviated New Drug Application) and Biologic License Application (BLA). If a drug product is available in multiple strengths, there are multiple product numbers.
Psilocybin (4-phosphoryloxy-N,N-dimethyltryptamine) – is a chemical obtained from certain types of fresh or dried mushrooms. Psilocybin is a Schedule I substance. There are dozens of species of mushrooms which contain the psychoactive alkaloids psilocybin/psilocin in active amounts.
Psychedelic - Mind manifesting. From the Greek: psyche=mind delos=manifesting. Coined by Humphry Osmond in his 1957 article "A Review of the Clinical Effects of Psychotomimetic Agents". A psychedelic drug is one which, without causing physical addiction, craving, major physiological disturbances, delirium, disorientation, or amnesia, more or less reliably produces thought, mood, and perceptual changes otherwise rarely experienced except in dreams, contemplative and religious exaltation, flashes of vivid involuntary memory and acute psychoses”.
Psychoactive - having effects on the mood or mind.
Psychosis - loss of ability to distinguish reality, as perceived by others, from one's own private mental productions. It is a serious category of mental illness, often marked by hallucinations, delusions, and disturbances of thought and mood.
Psychotomimetic - The name for a drug that produces effects resembling psychosis.
Psychotropic - mind-turning.
Review - A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.
Review Priority - The NDA classification system provides a way to describe New Drug Applications (NDAs) upon initial receipt and throughout the review process and to prioritize their review. For details, see FDA/CDER MAPP 6020.3 Rev. 2
Risk Evaluation and Mitigation Strategy (REMS) - A Risk Evaluation and Mitigation Strategy, or REMS, is a safety plan to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.
RLD (Reference Listed Drug) - A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
Route - A route of administration is a way of administering a drug to a site in a patient.
Salvia Divinorum – Salvia divinorum is a perennial herb in the mint family that is abused for its hallucinogenic effects. Salvia is not controlled under the Controlled Substances Act.
San Pedro – a specie of cactus containing mescaline.
Serotonin - a neurotransmitter involved in a broad range of effects on perception, movement, and emotions. Serotonin and its receptors are the targets of most hallucinogens.
Set – as in ‘mind set’, an expectation as a variable that determines people's reactions to drugs and other stimuli
Setting – the environment in which one takes a psychoactive substance that like set is a variable that determines people's reactions to drugs and other stimuli.
Shaman - a priest or medicine man who mediates personally between the human world and spirit world and often attempts to control the forces of good and evil within a tribal community. Shamanism frequently involves the use of psychoactive plants to induce altered states of consciousness conducive to magical operations.
Soma - a psychoactive drink used ritually and religiously by the Aryan peoples of the Indian subcontinent in ancient times.
Spore - an asexual, reproductive cell of lower plants and fungi.
St. Anthony's Fire - a reference form Medieval chronicles in which villages and towns where nearly everyone went mad for a few days after ergot-diseased rye was unknowingly milled into flour and baked as bread.
Stimulants – Stimulants speed up the body's systems. This class of drugs includes: prescription drugs such as amphetamines [Adderall and dexedrine], methylphenidate [Concerta and Ritalin], diet aids [such as didrex, Bontril, Preludin, Fastin, Adipex P, ionomin, and Meridia] and illicitly produced drugs such as methamphetamine, cocaine, and methcathinone.
Strength - The strength of a drug product tells how much of the active ingredient is present in each dosage.
Supplement - A supplement is an application to allow a company to make changes in a product that already has an approved drug application. CDER must approve all important drug application changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.
Submission - Submissions are used to group supporting documents relative to an application. A submission belongs to only one specific application. There must be at least one submission for each application.
Submission Classification - For original (ORIG) NDA submissions, classification provides a way of categorizing new drug applications. The Submission Classification Code, previously known as the Chemistry Classification Code, is assigned as a “Type” code, for example, “Type 1,” New molecular entity (NME). Details about NDA Classification Codes are available in MAPP 5018.2 NDA Classification Codes, including a list of all the codes and their meanings. For Supplements (SUPPL), the Submission Classification describes the kind of change to an FDA approved application. For example, a change may be labeling related, efficacy related (i.e., a new dosage form or a new indication) or manufacturing related.
Summary Review - A summary review is a review conducted by the FDA signatory authority of an application that includes a final decision whether to approve an application.
Syrian Rue – a plant whose seeds contain harmine and other harmala alkaloids and is both a mild psychoactive and an MAOI.
Tabernaemontana – is a shrub that produces indole alkaloids including ibogaine and voacangine.
Tentative Approval - If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product.
THC (Tetrahydrocannabinol) - the psychoactive ingredient in marijuana.
Therapeutic Biological Product - A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.
Therapeutic Equivalence (TE) - Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria: they are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.); they are assigned by FDA the same therapeutic equivalence codes starting with the letter "A ." To receive a letter "A", FDA; designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD) and assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).
Therapeutic Equivalence (TE) Codes - The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). Sample TE codes: AA, AB, BC (More on TE Codes). Over-the-counter drugs are not assigned TE codes. FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products. A drug product is deemed to be therapeutically equivalent ("A" rated) only if: a drug company's approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug; and those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected. Some drug products have more than one TE Code. Those products which the FDA does not deem to be therapeutically equivalent are "B" rated.
Tryptamine - A class of organic molecule common in nature, and the name for one of the two principal types of psychedelic compounds; the other is the phenethylamines. Serotonin is a tryptamine.
Wormwood - a psychoactive plant that produced the toxic substance thujone, which was used to produce the famed ‘green fairy’ alcoholic beverage, Absinthe.
Yopo – the seedpods of this tree produce natural high levels of dimethyltryptamine.
Zacatechichi – the leaves of this shrub are used to induce lucid dreaming.