The Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub.L. 91–513, 84 Stat. 1236, enacted October 27, 1970, is a United States federal law that, with subsequent modifications, requires the pharmaceutical industry to maintain physical security and strict record keeping for certain types of drugs. Controlled substances are divided into five schedules (or classes) on the basis of their potential for abuse, accepted medical use, and accepted safety under medical supervision. Substances in Schedule I have a high potential for abuse, no accredited medical use, and a lack of accepted safety. From Schedules II to V, substances decrease in potential for abuse. The schedule a substance is placed in determines how it must be controlled. Prescriptions for drugs in all schedules must bear the physician's federal Drug Enforcement Administration (DEA) license number, but some drugs in Schedule V do not require a prescription. State schedules may vary from federal schedules.
The Controlled Substances Act (CSA), Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970, is the legal foundation of the government's fight against the abuse of drugs and other substances. This law is a consolidation of numerous laws regulating the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and chemicals used in the illicit production of controlled substances. The act also provides a mechanism for substances to be controlled, added to a schedule, decontrolled, removed from control, rescheduled, or transferred from one schedule to another.
Proceedings to add, delete, or change the schedule of a drug or other substance may be initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including the manufacturer of a drug, a medical society or association, a pharmacy association, a public interest group concerned with drug abuse, a state or local government agency, or an individual citizen. When a petition is received by the DEA, the agency begins its own investigation of the drug.
The DEA also may begin an investigation of a drug at any time based upon information received from law enforcement laboratories, state and local law enforcement and regulatory agencies, or other sources of information.
Once the DEA has collected the necessary data, the Administrator of the Drug Enforcement Association, by authority of the Attorney General, requests from the HHS a scientific and medical evaluation and recommendation as to whether the drug or other substance should be controlled or removed from control. This request is sent to the Assistant Secretary of Health of the HHS. Then, the HHS solicits information from the Commissioner of the Food and Drug Administration and evaluations and recommendations from the National Institute on Drug Abuse, and on occasion, from the scientific and medical community. The Assistant Secretary, by authority of the Secretary, compiles the information and transmits back to the DEA a medical and scientific evaluation regarding the drug or other substance, a recommendation as to whether the drug should be controlled, and in what schedule it should be placed.
The medical and scientific evaluations are binding to the DEA with respect to scientific and medical matters. The recommendation on scheduling is binding only to the extent that if HHS recommends that the substance not be controlled, the DEA may not control the substance.
Once the DEA has received the scientific and medical evaluation from HHS, the Administrator will evaluate all available data and make a final decision whether to propose that a drug or other substance be controlled and into which schedule it should be placed.
The CSA also creates a closed system of distribution for those authorized to handle controlled substances. The cornerstone of this system is the registration of all those authorized by the DEA to handle controlled substances. All individuals and firms that are registered are required to maintain complete and accurate inventories and records of all transactions involving controlled substances, as well as security for the storage of controlled substances.
|Comprehensive Drug Abuse Prevention and Control Act of 1970|
|Long title||An Act to amend the Public Health Service Act and other laws to provide increased research, into, and prevention of, drug abuse and drug dependence; to provide for treatment and rehabilitation of drug abusers and drug dependent persons; and to strengthen existing law enforcement authority in the field of drug abuse.|
|Enacted by||the 91st United States Congress|
|Effective||October 27, 1970|
|Statutes at Large||84 Stat. 1236|
|Titles amended||21 U.S.C.: Food and Drugs|
|U.S.C. sections created|
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.
The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submissions of ANDAs have grown by 70% since November 2008. The Section IV challenge has been credited with suppressing new drug innovation.A generic drug product is one that is comparable to a patented drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
Generic drug applications are termed "abbreviated" because (in comparison with a New Drug Application) they are generally not required to include preclinical (animal and in vitro) and clinical (human) trial data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. In cases of topically active drugs, the bioequivalence of a drug can be demonstrated by comparing drugs dissolution or transdermal drug absorption is compared with the innovator drug. In cases of systemically active drugs, active drug blood concentration of that drug is compared with the innovator drug.
Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.Administrative subpoena
An administrative subpoena under U.S. law is a subpoena issued by a federal agency without prior judicial oversight. Critics say that administrative subpoena authority is a violation of the Fourth Amendment to the United States Constitution, while proponents say that it provides a valuable investigative tool.Children in clinical research
In health care, a clinical trial is a comparison test of a medication or other medical treatment (such as a medical device), versus a placebo (inactive look-alike), other medications or devices, or the standard medical treatment for a patient's condition.
To be ethical, researchers must obtain the full and voluntary informed consent of participating human subjects. If the subject is unable to consent for him/herself, researchers can seek consent from the subject's legally authorized representative. For a minor child this is typically a parent or guardian since as under the age of 18 cannot legally give consent to participate in a clinical trial.Continuing Criminal Enterprise
The Continuing Criminal Enterprise Statute (commonly referred to as CCE Statute or The Kingpin Statute) is a United States federal law that targets large-scale drug traffickers who are responsible for long-term and elaborate drug conspiracies. Unlike the RICO Act, which covers a wide range of organized crime enterprises, the CCE statute covers only major narcotics organizations. CCE is codified as Chapter 13 of Title 21 of the United States Code, 21 U.S.C. § 848. The statute makes it a federal crime to commit or conspire to commit a continuing series of felony violations of the Comprehensive Drug Abuse Prevention and Control Act of 1970 when such acts are taken in concert with five or more other persons. For conviction under this statute, the offender must have been an organizer, manager, or supervisor of the continuing operation and have obtained substantial income or resources from the drug violations.The sentence for a first CCE conviction is a mandatory minimum twenty years' imprisonment (with a maximum of life imprisonment), a fine of not more than $2 million, and forfeiture of profits and any interest in the enterprise. Under the so-called "super kingpin" provision added as subsection (b) to the CCE statute in 1984, a person convicted of being a "principal" administrator, organizer, or leader of a criminal enterprise that either involves a large amount of narcotics (at least 300 times the quantity that would trigger a five-year mandatory-minimum sentence for possession), or generates a large amount of money (at least $10 million in gross receipts during a single year), must serve a mandatory life sentence without possibility of parole (sometimes referred to as a "living death" or "pine box" sentence, since the offender is strictly ineligible for release while alive). Anyone engaging in a continuing criminal enterprise who intentionally kills a person or causes an intentional killing may be sentenced to death. Probation, parole, and suspension of the sentence are prohibited.Controlled Substances Act
The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated. It was passed by the 91st United States Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970 and signed into law by President Richard Nixon. The Act also served as the national implementing legislation for the Single Convention on Narcotic Drugs.
The legislation created five schedules (classifications), with varying qualifications for a substance to be included in each. Two federal agencies, the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA), determine which substances are added to or removed from the various schedules, although the statute passed by Congress created the initial listing. Congress has sometimes scheduled other substances through legislation such as the Hillory J. Farias and Samantha Reid Date-Rape Prevention Act of 2000, which placed gamma hydroxybutyrate (GHB) in Schedule I and sodium oxybate (the isolated sodium salt in GHB) in Schedule III. Classification decisions are required to be made on criteria including potential for abuse (an undefined term), currently accepted medical use in treatment in the United States, and international treaties.Controlled Substances Penalties Amendments Act of 1984
The Controlled Substances Penalties Amendments Act of 1984, 98 Stat. 2068 (21 U.S.C. § 841(b)), generally enhanced the penalties for violations of the Comprehensive Drug Abuse Prevention and Control Act of 1970. The 1984 legislation removed an ambiguity in the then-existing law by providing that a State drug felony conviction would trigger the provisions enhancing penalties for recidivists; it went further by providing that a Foreign drug felony conviction would have the same effect. Finally, the 1984 legislation doubled the penalties for distribution of controlled substances where the offense is committed on or within 1,000 feet of school property.Drug-related crime
A drug-related crime is a crime to possess, manufacture, or distribute drugs classified as having a potential for abuse (such as cocaine, heroin, morphine and amphetamines). Drugs are also related to crime as drug trafficking and drug production are often controlled by drug cartels, organised crime and gangs.
The statistics on this page summarise various ways that drugs and crime are related in the United States. Links for other countries are provided below. Some drug-related crime involves crime against the person such as robbery or sexual assaults.Drug nomenclature
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs. In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are the International Nonproprietary Names (INNs); and trade names, which are brand names. Generic names for drugs are nowadays constructed out of affixes and stems that classify the drugs into different categories and also separate drugs within categories. A marketed drug might also have a company code or compound code.Fast track (FDA)
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.Investigational New Drug
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at 21 C.F.R. 312. Similar procedures are followed in the European Union, Japan, and Canada.Leary v. United States
Leary v. United States, 395 U.S. 6 (1969), is a U.S. Supreme Court case dealing with the constitutionality of the Marihuana Tax Act of 1937. Timothy Leary, a professor and activist, was arrested for the possession of marijuana in violation of the Marihuana Tax Act. Leary challenged the act on the ground that the act required self-incrimination, which violated the Fifth Amendment. The unanimous opinion of the court was penned by Justice John Marshall Harlan II and declared the Marihuana Tax Act unconstitutional. Thus, Leary's conviction was overturned. Congress responded shortly thereafter by replacing the Marihuana Tax Act with the newly written Controlled Substances Act while continuing the prohibition of certain drugs in the United States.Marihuana Tax Act of 1937
The Marihuana Tax Act of 1937, Pub.L. 75–238, 50 Stat. 551, enacted August 2, 1937, was a United States Act that placed a tax on the sale of cannabis. The H.R. 6385 act was drafted by Harry Anslinger and introduced by Rep. Robert L. Doughton of North Carolina, on April 14, 1937. The seventy-fifth Congress held hearings on April 27, 28, 29th, 30th, and May 4, 1937. Upon the congressional hearings confirmation, the H.R. 6385 act was redrafted as H.R. 6906 and introduced with House Report 792. The Act is now commonly referred to, using the modern spelling, as the 1937 Marijuana Tax Act. This act was overturned in 1969 in Leary v. United States, and was repealed by Congress the next year.Outline of clinical research
The following outline is provided as an overview of and topical guide to clinical research:
Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans.Prescription Drug Marketing Act
The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government. It establishes legal safeguards for prescription drug distribution to ensure safe and effective pharmaceuticals and is designed to discourage the sale of counterfeit, adulterated, misbranded, subpotent, and expired prescription drugs. It was passed in response to the development of a wholesale sub-market (known as the "diversion market") for prescription drugs.
The PDMA was modified by the Prescription Drug Amendments of 1992 (P.L. 102-353, 106 Stat. 941) on August 26, 1992.
The U.S. Food and Drug Administration (FDA) issued regulations implementing the PDMA in 1990 (21 C.F.R. Part 205) and 1999 (21 C.F.R. Part 203).Psychotropic Substances Act (United States)
The Psychotropic Substances Act of 1978 amended the Comprehensive Drug Abuse Prevention and Control Act of 1970 and Controlled Substances Act to ensure compliance with the Convention on Psychotropic Substances. 21 U.S.C. § 801a notes, "It is the intent of the Congress that the amendments made by this Act, together with existing law, will enable the United States to meet all of its obligations under the Convention and that no further legislation will be necessary for that purpose." The Psychotropic Substances Act created mechanisms by which the U.S. Government would add substances to the Schedules of controlled substances as required by the Convention. It also established a framework for exercising the U.S.'s rights to influence drug scheduling at the international level. The Secretary of Health and Human Services was given the power to make scheduling recommendations that would be binding on the U.S. representative in discussions and negotiations related to drug scheduling proposals before the Commission on Narcotic Drugs.
The Act viewed the regulations of Schedules IV and V of the Controlled Substances Act as being adequate to fulfill the minimum treaty obligations in the event of a disagreement between the U.S. and the U.N. on drug scheduling.
The S. 2399 legislation was passed by the 95th U.S. Congressional session and enacted into law by the 39th President of the United States Jimmy Carter on November 10, 1978.Regulation of therapeutic goods in the United States
Regulation of therapeutic goods in the United States is carried out by the U.S. Food and Drug Administration (FDA), which makes some drugs available over the counter at retail outlets and others by prescription only.
The possession of some substances is prohibited by scheduling under the Controlled Substances Act, under the joint jurisdiction of the FDA and the Drug Enforcement Administration (DEA)Research on Adverse Drug Events and Reports
Research on Adverse Drug Events and Reports (RADAR) is a pharmacovigilance team of 25 doctors who receive calls about possible adverse drug reactions (ADR) and investigate. RADAR is based at Northwestern's Feinberg School of Medicine. RADAR is led by Dennis West. Though it was without funding for its first four years, RADAR has raised about $12 million through grants from the National Institutes of Health, the American Cancer Society and other such institutions. Its work has identified safety problems with 33 drugs. Adverse drug events are a serious health problem.Timeline of the Black Power movement
This is a timeline of the Black Power movement.Title 21 of the United States Code
Title 21 of the United States Code governs Food and Drugs in the United States Code (U.S.C.).