Maintaining Marijuana in Schedule I of the Controlled Substances 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. -
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............................................................................................................ -
Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health
MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 4200.3 Rev. 1 POLICY AND PROCEDURES OFFICE OF THE CENTER DIRECTOR Consulting the Controlled Substance Staff on Drug Abuse Potential and Labeling, Drug Scheduling, Dependence Liability and Drug Abuse Risks to the Public Health Table of Contents PURPOSE ..............................................................................1 BACKGROUND ...................................................................1 POLICY .................................................................................2 PROCEDURES .....................................................................4 REFERENCES ......................................................................6 DEFINITIONS ......................................................................6 CHANGE CONTROL TABLE ............................................8 PURPOSE This MAPP establishes responsibilities and procedures in the Center for Drug Evaluation and Research (CDER) for consulting the Controlled Substance Staff (CSS) regarding the evaluation of drug abuse potential and labeling, drug scheduling, dependence liability, and drug abuse risks to the public health. This MAPP also provides a description of the role of CSS in the drug abuse assessment and the drug scheduling process within CDER. BACKGROUND CSS provides expertise to the Food and Drug Administration (FDA) Centers and CDER Offices and Divisions as part of the review process in assessing drugs for abuse potential and dependence liability. CSS fulfills -
A Guide to State Controlled Substances Acts
FROM THE NATIONAL CRIMINAL O JUSTICE ASSOCIATION oo.~v ~ ~ A GUIDE TO STATE CONTROLLED SUBSTANCES ACTS I~WSED Jx~J~' ~999 in cooperation with the pa~'~e~ of J~stfice~ B~re~ e~" g~s¢fice Ass[s¢~r~ce THE NATIONAL CRIMINAL JUSTICE ASSOCIATION Serving Criminal Justice Professionals Since 1971 Based in Washington, D.C., the National Criminal Justice Association (NCJA) represents state and local governments on crime control and public safety issues. Its 1,500 members represent all facets of the criminal justice community, from law enforcement, corrections, prosecution, defense, victim-witness services, and educational institutions, to federal, state, and local elected officials. Guided by a 17-member Board of Directors, the NCJA serves as the states' formal mechanism for informing the Congress of state and local criminal justice needs and accomplishments. Through collaboration with practitioners and policymakers, the NCJA also communicates state and local views on crime control to federal executive and other public and private agencies at all levels. The NCJA's staff support to the National Governors' Association on justice and public safety issues is one example of these collaborative efforts. As the representative of state and local criminal justice practitioners, the NCJA works to promote a balanced approach to communities' complex public safety and criminal justice system problems. The NCJA recognizes the importance of interrelationships among system components and the strong, steady advocacy necessary to achieve comprehensive planning and policy coordination goals. The mission of the NCJA is to foster development of state and local criminal justice systems that: Enhance public safety. Prevent or reduce the harmful effects of criminal behavior on individuals and communities. -
Prandin (Repaglinide) Tablets
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 020741/S-044 SUPPLEMENT APPROVAL Clinipace, Inc. Agent for Gemini Laboratories, LLC Attention: Catherine Kessler Vice President 4840 Pearl E Cir, Ste 201E Boulder, CO 80301 Dear Ms. Kessler: Please refer to your Supplemental New Drug Application (sNDA) dated and received June 29, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Prandin (repaglinide) tablets. This Prior Approval supplemental new drug application provides for revisions to the prescribing information (PI) to conform to the Pregnancy and Lactation Labeling Rule (PLLR). APPROVAL & LABELING We have completed our review of this supplemental application, as amended. It is approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling text with the minor editorial revisions, listed below, and reflected in the enclosed labeling. • In the HIGHLIGHTS OF PRESCRIBING INFORMATION, the date has been revised to 1/2019. • The footer on all pages has been deleted. WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of Prescribing Information. This waiver applies to all future supplements containing revised labeling unless we notify you otherwise. Reference ID: 4378916 NDA 020741/S-044 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA automated drug registration and listing system (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. -
(Ezogabine): a REMS Assessment Survey
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Drugs - Real World Outcomes (2015) 2:335–344 DOI 10.1007/s40801-015-0042-5 SHORT COMMUNICATION Physician and Pharmacist Understanding of the Risk of Urinary Retention with Retigabine (Ezogabine): A REMS Assessment Survey 1,2 3 4 5,6 Lianna Ishihara • Melissa Beck • Sara Travis • Olusegun Akintayo • Neil Brickel5 Published online: 7 October 2015 Ó The Author(s) 2015. This article is published with open access at Springerlink.com Abstract RTG/EZG and to evaluate the effectiveness of the com- Background The Risk Evaluation and Mitigation Strategy munication plan. (REMS) for retigabine/ezogabine (RTG/EZG) required an Methods This was a US-based, cross-sectional, non-in- evaluation of the effectiveness of the communication plan terventional, observational survey, conducted from Febru- to communicate about the risks with use of RTG/EZG. ary to April 2013, of physicians who had prescribed RTG/ Objective GlaxoSmithKline conducted a survey to assess EZG in the past year, and pharmacists who had dispensed understanding of the risk of urinary retention (UR) with an antiepileptic drug within the past 3 months. Thirteen primary objective questions (five specific to UR risk) were included in the survey, which assessed healthcare profes- sionals’ (HCPs’) understanding of UR risk and symptoms of acute UR associated with RTG/EZG. The primary out- Electronic supplementary material The online version of this article (doi:10.1007/s40801-015-0042-5) contains supplementary come was the proportion of HCPs correctly answering each material, which is available to authorized users. -
Download FDA's Expedited Drug Approval Programs
Expedited Drug Approval Programs The process for collecting evidence in support of a new drug approval involves multiple steps. Drug developers (sponsors) collect evidence during pre-clinical and clinical phases of the process and submit it to the U.S. Food and Drug Administration (FDA) for evaluation of the drug’s safety and efficacy. The next step is a final review for marketing authorization which occurs when a drug sponsor submits a New Drug Application (NDA) to FDA for small molecule drugs or a Biologics Licensing Application (BLA) for biologics. FDA follows a standard review process – which typically takes up to 10 months – to determine whether to approve the drug. Throughout this process, from drug development to post- market monitoring, there are various points in which drug sponsors and FDA interact and exchange information. The time it takes for drug development and approval varies by drug and therapeutic area and FDA review is only part of this process. In most cases, most of this time is spent by drug sponsors in the data collection phases, e.g. clinical trials. But not all approvals follow the standard review process. Drug therapies that address unmet medical needs, treat serious or life-threatening conditions, or show a significant advantage over current therapies may be eligible for one or more of FDA’s four Expedited Review Programs. These programs are designed to accelerate the approval process and make the therapies available to patients quicker if it is determined the therapies’ benefits justify their risks.1 The four Expedited Review Programs are Priority Review, Accelerated Approval, Fast Track, and Breakthrough Therapy.