“The Controlled Substances, Drugs, Device, and Cosmetic Act”
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A Bill to Repeal Criminal Drug Laws: Replacing Prohibition with Regulation Joseph L
Hofstra Law Review Volume 18 | Issue 3 Article 10 1990 A Bill to Repeal Criminal Drug Laws: Replacing Prohibition with Regulation Joseph L. Galiber Follow this and additional works at: http://scholarlycommons.law.hofstra.edu/hlr Part of the Law Commons Recommended Citation Galiber, Joseph L. (1990) "A Bill to Repeal Criminal Drug Laws: Replacing Prohibition with Regulation," Hofstra Law Review: Vol. 18: Iss. 3, Article 10. Available at: http://scholarlycommons.law.hofstra.edu/hlr/vol18/iss3/10 This document is brought to you for free and open access by Scholarly Commons at Hofstra Law. It has been accepted for inclusion in Hofstra Law Review by an authorized administrator of Scholarly Commons at Hofstra Law. For more information, please contact [email protected]. Galiber: A Bill to Repeal Criminal Drug Laws: Replacing Prohibition with R A BILL TO REPEAL CRIMINAL DRUG LAWS: REPLACING PROHIBITION WITH REGULATION Joseph L. Galiber* Conventional wisdom obliges elected officials to beat the narcodrums loudly and incessantly, and to demand increasingly harsh criminal penalties for the sale and use of illegal drugs.' It is reasonable to wonder why I, a senator, would dare submit a bill2 to the New York State Legislature which would regulate all drugs cur- rently proscribed as illegal in precisely the same manner as alcohol.3 The short answer is that the use of the criminal law to control drug use has not, and never will, have anything more than a costly and marginal impact on drug consumption.4 Despite all the public hyperventilation, drug consumption remains a private, consensual * New York State Senator; B.A. -
Definition of Controlled Substance Schedules
UPDATED MARCH 2018 DEFINITION OF CONTROLLED SUBSTANCE SCHEDULES Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules. An updated and complete list of the schedules is published annually in Title 21 Code of Federal Regulations (C.F.R.) §§ 1308.11 through 1308.15. Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the U.S., their relative abuse potential, and likelihood of causing dependence when abused. Examples of the drugs in each schedule are listed below. Schedule I Controlled Substances Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse. Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4- methylenedioxymethamphetamine ("Ecstasy"). Schedule II/IIN Controlled Substances (2/2N) Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence. Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone. Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital. 1 Schedule III/IIIN Controlled Substances (3/3N) Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. -
Synthetic Drugs: Overview and Issues for Congress
Synthetic Drugs: Overview and Issues for Congress Lisa N. Sacco Analyst in Illicit Drugs and Crime Policy Kristin Finklea Specialist in Domestic Security May 3, 2016 Congressional Research Service 7-5700 www.crs.gov R42066 Synthetic Drugs: Overview and Issues for Congress Summary Synthetic drugs, as opposed to natural drugs, are chemically produced in a laboratory. Their chemical structure can be either identical to or different from naturally occurring drugs, and their effects are designed to mimic or even enhance those of natural drugs. When produced clandestinely, they are not typically controlled pharmaceutical substances intended for legitimate medical use. Designer drugs are a form of synthetic drugs. They contain slightly modified molecular structures of illegal or controlled substances, and they are modified in order to circumvent existing drug laws. While the issue of synthetic drugs and their abuse is not new, Congress has demonstrated a renewed concern with the issue. From 2009 to 2011, synthetic drug abuse was reported to have dramatically increased. During this time period, calls to poison control centers for incidents relating to harmful effects of synthetic cannabinoids (such as “K2” and “Spice”) and stimulants (such as “bath salts”) increased at what some considered to be an alarming rate. The number of hospital emergency department visits involving synthetic cannabinoids more than doubled from 2010 to 2011. In 2012 and 2013, however, the number of calls to poison control centers for incidents relating to harmful effects of synthetic cannabinoids and synthetic stimulants decreased. Calls regarding bath salts have declined each year since 2011, while calls regarding synthetic cannabinoids have increased since the drops in 2012 and 2013. -
CRPT-113Hrpt565-Pt2.Pdf
113TH CONGRESS REPT. 113–565 " ! 2d Session HOUSE OF REPRESENTATIVES Part 2 IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT SEPTEMBER 19, 2014.—Committed to the Committee of the Whole House on the State of the Union and ordered to be printed Mr. GOODLATTE, from the Committee on the Judiciary, submitted the following R E P O R T [To accompany H.R. 4299] [Including cost estimate of the Congressional Budget Office] The Committee on the Judiciary, to whom was referred the bill (H.R. 4299) to amend the Controlled Substances Act with respect to drug scheduling recommendations by the Secretary of Health and Human Services, and with respect to registration of manufac- turers and distributors seeking to conduct clinical testing, having considered the same, report favorably thereon with an amendment and recommend that the bill as amended do pass. CONTENTS Page The Amendment ...................................................................................................... 1 Purpose and Summary ............................................................................................ 2 Background and Need for the Legislation ............................................................. 2 Hearings ................................................................................................................... 3 Committee Consideration ........................................................................................ 3 Committee Votes ..................................................................................................... -
House of Representatives Staff Analysis Bill #: Hb 6095
HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: HB 6095 Scheduling of Drug Products Containing Cannabidiol SPONSOR(S): Fischer TIED BILLS: IDEN./SIM. BILLS: SB 1476 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Professions & Public Health Subcommittee 17 Y, 0 N Morris McElroy 2) Criminal Justice & Public Safety Subcommittee 18 Y, 0 N Padgett Hall 3) Health & Human Services Committee 20 Y, 0 N Morris Calamas SUMMARY ANALYSIS Federal and state law both classify controlled substances into five schedules. The scheduling determination for a controlled substance is based on a substance’s potential for abuse, accepted medical use, and potential for addiction. The classifications range from a Schedule I substance, which has a high potential for abuse, with no accepted medical use, and high potential for addiction; to a Schedule V substance, which has a low potential for abuse, an accepted medical use, and a mild potential for addiction. Generally, cannabis and compounds derived from cannabis are listed in Schedule I of both federal and Florida law. Cannabis contains delta-9-tetrahydrocannabinol (THC), which is the psychoactive chemical in marijuana which produces the “high” commonly associated with marijuana use. Epidiolex is a prescription cannabidiol, a non-psychoactive compound derived from the cannabis plant which is used to treat seizures. Epidiolex does not contain THC. On June 25, 2018, the U.S. Food and Drug Administration approved Epidiolex for use by patients two years of age or older and the federal Drug Enforcement Administration (DEA) rescheduled Epidiolex in Schedule V of the federal Controlled Substances Act (CSA). In 2019, the Legislature, mirroring federal law, formally rescheduled Epidiolex as a Schedule V controlled substance. -
Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions on the content of the draft document contact (CDER) Min Chen, 301-827- 3169 (phone); 301-827-5190 (fax), or (CBER) Miles Braun, 301-827-3974 (phone); 301- 827-3529 (fax). U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) March 2001 G:\4177dft.doc Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines Additional copies are available from: Drug Information Branch (HFD-210) Center for Drug Evaluation and Research (CDER) 5600 Fishers Lane, Rockville, MD 20857 (Tel) 301-827-4570 Internet at http://www.fda.gov/cder/guidance/index.htm or Office of Communication, Training and Manufacturers Assistance (HFM-40) Center for Biologics Evaluation and Research (CBER) 1401 Rockville Pike, Rockville, MD 20852-1448 (Fax) 1-888-CBERFAX or 301-827-3844 (Voice Information) 1-800-835-4709 or 301-827-1800 Internet at http://www.fda.gov/cber/guidelines.htm U.S. -
Trends in Stimulant Dispensing by Age, Sex, State of Residence, and Prescriber Specialty — United States, 2014–2019☆
HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Drug Alcohol Manuscript Author Depend. Author Manuscript Author manuscript; available in PMC 2021 December 01. Published in final edited form as: Drug Alcohol Depend. 2020 December 01; 217: 108297. doi:10.1016/j.drugalcdep.2020.108297. Trends in stimulant dispensing by age, sex, state of residence, and prescriber specialty — United States, 2014–2019☆ Amy R. Boarda,b,*, Gery Guyb, Christopher M. Jonesc, Brooke Hootsb aEpidemic Intelligence Service, Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop S106-8, Atlanta, GA, 30341-3717, United States bDivision of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop S106-8, Atlanta, GA, 30341-3717, United States cOffice of the Director, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway, Mailstop S106-8, Atlanta, GA, 30341-3717, United States Abstract Background: Stimulant medications are commonly prescribed for the treatment of attention- deficit/hyperactivity disorder; however, they also have high potential for diversion and misuse. We estimated national stimulant dispensing trends from 2014 to 2019 and differences in dispensing by age, sex, state, prescriber specialty, payor type, patient copay, and stimulant type. Methods: We calculated rates of stimulant dispensing using IQVIA National Prescription Audit (NPA) New to Brand, NPA Regional, and NPA Extended Insights data, which provide dispensing estimates from approximately 49,900 pharmacies representing 92 % of prescriptions dispensed in the United States. Average annual percent change (AAPC) from 2014 to 2019 was analyzed using Joinpoint regression. Results: From 2014 to 2019, the national annual rate of stimulant dispensing increased significantly from 5.6 to 6.1 prescriptions per 100 persons. -
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency
Contains Nonbinding Recommendations Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency Guidance for Industry April 2020 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This guidance is being implemented without prior public comment because the Food and Drug Administration (FDA or the Agency) has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. Comments may be submitted at any time for Agency consideration. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to https://www.regulations.gov. All comments should be identified with the docket number FDA- 2020-D-1136 and complete title of the guidance in the request. Additional Copies Additional copies are available from the FDA webpage titled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,” available at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related- guidance-documents-industry-fda-staff-and-other-stakeholders and from the FDA webpage titled “Search for FDA Guidance Documents” available at https://www.fda.gov/regulatory- information/search-fda-guidance-documents. -
FDA Regulation of Cannabidiol (CBD) Products
June 12, 2019 FDA Regulation of Cannabidiol (CBD) Products Cannabidiol (CBD) is promoted as treatment for a range of and hemp-derived compounds, including CBD. However, conditions, including epileptic seizures, post-traumatic the farm bill explicitly preserved FDA’s authority under the stress disorder, anxiety, and inflammation—despite limited Federal Food, Drug and Cosmetic Act (FFDCA, 21 U.S.C. scientific evidence to substantiate many of these claims. In §§301 et seq.) and Section 351 of the Public Health Service the United States, CBD is marketed in food and beverages, Act (PHSA, 42 U.S.C. §262), including for hemp-derived dietary supplements, and cosmetics—products that are products. According to FDA, “because the 2018 Farm Bill regulated by the Food and Drug Administration (FDA). did not change FDA’s authorities, cannabis and cannabis- CBD is also the active ingredient in an FDA-approved pharmaceutical drug, Epidiolex®. CBD is a plant-derived derived products are subject to the same authorities and substance from Cannabis sativa, the species of plant that requirements as FDA-regulated products containing any includes both hemp and marijuana, but from different plant other substance, regardless of whether the products fall varieties or cultivars. CBD is the primary nonpsychoactive within the definition of ‘hemp’ under the 2018 Farm Bill.” compound in cannabis, whereas tetrahydrocannabinol (THC) is cannabis’s primary psychoactive compound. FDA Regulation of CBD Products FDA, under the FFDCA, regulates many of the products Regulation of CBD Products marketed as containing cannabis and cannabis-derived Hemp and marijuana have separate definitions in U.S. law compounds, including CBD. -
Guidance for Industry
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) November 2020 User Fees Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email: [email protected] https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and/or Office of Communication, Outreach and Development Center for Biologics Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 71, Room 3128 Silver Spring, MD 20993-0002 Phone: 800-835-4709 or 240-402-8010 Email: [email protected] https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics- guidances U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) November 2020 User Fees Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION............................................................................................................ -
Prescription Drug Abuse See Page 10
Preventing and recognizing prescription drug abuse See page 10. from the director: The nonmedical use and abuse of prescription drugs is a serious public health problem in this country. Although most people take prescription medications responsibly, an estimated 52 million people (20 percent of those aged 12 and Prescription older) have used prescription drugs for nonmedical reasons at least once in their lifetimes. Young people are strongly represented in this group. In fact, the National Institute on Drug Abuse’s (NIDA) Drug Abuse Monitoring the Future (MTF) survey found that about 1 in 12 high school seniors reported past-year nonmedical use of the prescription pain reliever Vicodin in 2010, and 1 in 20 reported abusing OxyContin—making these medications among the most commonly abused drugs by adolescents. The abuse of certain prescription drugs— opioids, central nervous system (CNS) depressants, and stimulants—can lead to a variety of adverse health effects, including addiction. Among those who reported past-year nonmedical use of a prescription drug, nearly 14 percent met criteria for abuse of or dependence on it. The reasons for the high prevalence of prescription drug abuse vary by age, gender, and other factors, but likely include greater availability. What is The number of prescriptions for some of these medications has increased prescription dramatically since the early 1990s (see figures, page 2). Moreover, a consumer culture amenable to “taking a pill for drug abuse? what ails you” and the perception of 1 prescription drugs as less harmful than rescription drug abuse is the use of a medication without illicit drugs are other likely contributors a prescription, in a way other than as prescribed, or for to the problem. -
The Controlled Substances Act: Regulatory Requirements
The Controlled Substances Act: Regulatory Requirements Brian T. Yeh Legislative Attorney December 13, 2012 Congressional Research Service 7-5700 www.crs.gov RL34635 CRS Report for Congress Prepared for Members and Committees of Congress The Controlled Substances Act: Regulatory Requirements Summary This report highlights certain non-criminal regulatory requirements of the Controlled Substances Act (CSA). The CSA and its implementing regulations establish a framework through which the federal government regulates the use of controlled substances for legitimate medical, scientific, research, and industrial purposes, and prevents these substances from being diverted for illegal purposes. The CSA assigns various plants, drugs, and chemicals (such as narcotics, stimulants, depressants, hallucinogens, and anabolic steroids) to one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability. Schedule I contains substances that have no currently accepted medical use and cannot safely be made available to the public under a prescription, while Schedules II, III, IV, and V include substances that have recognized medical uses and may be manufactured, distributed, and used in accordance with the CSA. The order of the schedules reflects substances that are progressively less dangerous and addictive. To restrict access to chemicals used in the illicit manufacture of certain controlled substances, the CSA also regulates 40 “listed chemicals.” Furthermore, the CSA regulates controlled substance “analogues,” which are substances that are not controlled but are structurally or pharmacologically similar to substances found in Schedule I or II and have no accepted medical use. Unless specifically exempted by the CSA, any person who handles controlled substances or listed chemicals (such as drug manufacturers, wholesale distributors, doctors, hospitals, pharmacies, and scientific researchers) must register with the Drug Enforcement Administration (DEA) in the U.S.