Controlled Substance Act (CSA)
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Questions and Answers

What is the primary purpose of the Controlled Substance Act (CSA)?

  • To criminalize the use of all controlled substances
  • To regulate the manufacture, distribution, and dispensing of controlled substances (correct)
  • To establish guidelines for the recreational use of controlled substances
  • To promote the use of controlled substances for medical purposes

    • Which agency is responsible for enforcing the Controlled Substance Act?

  • The Drug Enforcement Administration (DEA) (correct)
  • The Food and Drug Administration (FDA)
  • The Centers for Disease Control and Prevention (CDC)
  • The Federal Bureau of Investigation (FBI)

    • Who is required to register with the DEA under the Controlled Substance Act?

  • Only distributors of controlled substances
  • Only manufacturers of controlled substances
  • Everyone involved in manufacturing, distribution, and prescribing or dispensing controlled substances (correct)
  • Only healthcare professionals who prescribe controlled substances

    • What is the primary reason for requiring registration under the Controlled Substance Act?

    <p>To reduce the diversion of controlled substances into illicit markets</p> Signup and view all the answers

    How do state laws relate to the Controlled Substance Act?

    <p>State laws cannot be less strict than the federal CSA</p> Signup and view all the answers

    Controlled Substances are drugs under the jurisdiction of the ___

    <p>CSA</p> Signup and view all the answers

    Which of the following is NOT true about Schedule 1 substances

    <p>Can be prescribed by practitioners under certain circumstances</p> Signup and view all the answers

    Which of these is a schedule 1 substance

    <p>Heroin</p> Signup and view all the answers

    T/F: Schedule II substances have no medical use do to dependency risk

    <p>False</p> Signup and view all the answers

    Which is FALSE about schedule III substances

    <p>No known risk of dependence</p> Signup and view all the answers

    The Anabolic Steroids Control Act of ___ required anabolic steroids to be placed in Schedule III.

    <p>1990</p> Signup and view all the answers

    Schedule IV substance may lead to ____ physical or psychological dependence

    <p>limited</p> Signup and view all the answers

    Which of these is schedule IV

    <p>All of these are schedule IV</p> Signup and view all the answers

    T/F: SCHEDULE V Mainly consists of limited quantities of certain narcotic drugs in combination with non-narcotic fillers

    <p>False</p> Signup and view all the answers

    The DEA must get permission from the Department of Health and Human Services (DHHS) before a drug can be added, transferred, or removed from schedules

    <p>True</p> Signup and view all the answers

    How should the schedule designation symbol be displayed on commercial containers of controlled substances?

    <p>The symbol should be prominently located, clear, and large enough for easy identification.</p> Signup and view all the answers

    What is the alternative symbol that can be used to designate the schedule of a controlled substance?

    <p>A &quot;C&quot; with the schedule designation inside it.</p> Signup and view all the answers

    A state can move a drug to a less strict class than the DEA's classification.

    <p>False</p> Signup and view all the answers

    Fioricet is federally unscheduled and classified as a Schedule III drug in Mississippi.

    <p>True</p> Signup and view all the answers

    ___ can apply to the DEA for a controlled substance exemption if the product is unlikely to be abused.

    <p>Manufacturers</p> Signup and view all the answers

    T/F: The controlled substance symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper

    <p>True</p> Signup and view all the answers

    Under federal law, which of these would NOT have to register under the CSA as a dispenser of controlled substances?

    <p>Dispensing employee pharmacists</p> Signup and view all the answers

    T/F: In MS pharmacists who dispense controlled substances do have to register with the state board of pharmacy

    <p>True</p> Signup and view all the answers

    A new state pharmacy permit or transfer of ownership should be submitted with the ___ for expedited issuance of a DEA registration number.

    <p>DEA-224</p> Signup and view all the answers

    Who is exempt from registering with the DEA to prescribe, dispense, or administer controlled substances?

    <p>All of the above</p> Signup and view all the answers

    Under what circumstances can the DEA deny or revoke a registration?

    <p>All of the above</p> Signup and view all the answers

    What form should be filled out to register with the DEA as a manufacturer, distributor, researcher, canine handler, analytical lab, reverse distributor, exporter, or importer?

    <p>DEA-225</p> Signup and view all the answers

    What form should narcotic treatment clinics fill out to register with the DEA?

    <p>DEA-363</p> Signup and view all the answers

    What form should chemical manufacturers, distributors, importers, and exporters fill out to register with the DEA?

    <p>DEA-510</p> Signup and view all the answers

    Which DEA form has to be reregsitered after 3 years

    <p>DEA-224</p> Signup and view all the answers

    T/F: The person sending schedule I and schedule II controlled substances fills out the DEA 222

    <p>False</p> Signup and view all the answers

    Which of these does NOT require a DEA 222 form to be filled out?

    <p>Dispensing to a patient</p> Signup and view all the answers

    Which of these are NOT a way to order more forms for purchasing controlled subtances?

    <p>All of these are ways to order more forms</p> Signup and view all the answers

    T/F: You can change pre-printed information on DEA 222 forms as long as you let the DEA know

    <p>False</p> Signup and view all the answers

    Partial filling of the controlled substance order is permitted, provided the supplier sends the balance within __ days. The order form is invalid after __ days from the date of execution by the purchaser.

    <p>60 ; 60</p> Signup and view all the answers

    How many lines are available on each controlled substance order form to correspond with the different items ordered?

    <p>20 lines</p> Signup and view all the answers

    T/F: Physicians are prohibited from issuing a prescription as a means of obtaining any controlled substance for use in an office practice

    <p>True</p> Signup and view all the answers

    If a pharmacist supplies (to another pharmacy or physician) more than __ of the total number of dosage units of all controlled substances dispensed by the pharmacy in a 12- month period, the pharmacy dispenser must register with the DEA as a distributor.

    <p>5%</p> Signup and view all the answers

    T/F: CSOS regulations require registrants to order schedule I and II controlled substances electronically if they have the equipment to do so

    <p>False</p> Signup and view all the answers

    Which is true about the Controlled Substance Ordering System (CSOS)

    <p>You can order CIII-CV and noncontrolled substances along with the CIs and CIIs</p> Signup and view all the answers

    For distributing III-V back to the supplier, to a physician, or another pharmacy, a commercial ____ is appropriate as long as one copy is held by the pharmacy and another copy held by whoever the drug is given to

    <p>invoice</p> Signup and view all the answers

    Controlled substance ordering forms are ___ numbered

    <p>serially</p> Signup and view all the answers

    Which is NOT true about executing a controlled substance orderign form?

    <p>The pharmacy receiving the drugs will fill in its own DEA number</p> Signup and view all the answers

    A ____ can supply CIs or CIIs to a physician for his or her office practice, provided the physician fills out A DEA Form 222 and furnishes it to the pharmacy

    <p>pharmacist</p> Signup and view all the answers

    CIII and CIVs can be refilled __ times in __ months

    <p>5 ; 6</p> Signup and view all the answers

    T/F: Prescriptions for schedule II drugs can only be refilled once in 6 months

    <p>False</p> Signup and view all the answers

    ___ prescriptions may be refilled in accordance with the prescriber’s instructions

    <p>CV</p> Signup and view all the answers

    A pharmacist must notify the Board in writing by mail or fax of change of address within ___ of the change

    <p>10 days</p> Signup and view all the answers

    How much is the fine if a pharmacist fails to tell the state board they moved?

    <p>$500</p> Signup and view all the answers

    T/F: Techs must notify the board of pharmacy of a change in employment within 30 days

    <p>False</p> Signup and view all the answers

    What is the primary purpose of NABP's PMP InterConnect?

    <p>To facilitate data sharing between state PMPs</p> Signup and view all the answers

    What was the purpose behind the Anabolic Steroids Control Act of 1990?

    <p>To stem abuse of anabolic steroids</p> Signup and view all the answers

    What significant change did the Anabolic Steroids Act of 2004 introduce regarding anabolic steroid regulation?

    <p>It redefined anabolic steroids to include precursors and salts</p> Signup and view all the answers

    How does the federal government support states in enhancing their Prescription Monitoring Programs (PMPs) according to the text?

    <p>By providing grant funding</p> Signup and view all the answers

    What is the main purpose of the Rohrabacher-Farr Amendment?

    <p>To protect the implementation of state medical cannabis laws from interference by the Justice Department</p> Signup and view all the answers

    How did the passage of the Rohrabacher-Farr Amendment in 2014 impact cannabis reform at the federal level?

    <p>It was the 1st time the first time either chamber of Congress had voted to protect medical cannabis patients</p> Signup and view all the answers

    Which of the following is NOT one of the eight prioritization areas described in the text?

    <p>Improper prescribing</p> Signup and view all the answers

    The Rohrabacher-Farr Amendment must be renewed how often to stay in effect?

    <p>Each Fiscal Year</p> Signup and view all the answers

    Who has the authority to enforce federal laws related to marijuana possession and use, despite state laws?

    <p>The U.S. Department of Justice</p> Signup and view all the answers

    What did the $1.3 trillion omnibus spending bill signed by President Trump include in 2018?

    <p>An updated version of the Rohrabacher-Farr Amendment</p> Signup and view all the answers

    What does the U.S. Department of Justice have the authority to enforce according to federal laws?

    <p>'Civil and criminal federal laws' relating to marijuana possession and use</p> Signup and view all the answers

    What is the federal law stance on growing, distributing, and possessing marijuana?

    <p>It is only allowed through federally-approved research programs.</p> Signup and view all the answers

    Which state recently signed into law a Medical Cannabis Program?

    <p>Mississippi</p> Signup and view all the answers

    T/F: The Obama Administration sent a memo to federal prosecutors encouraging them not to prosecute people who distribute marijuana for medical purposes in accordance with state law

    <p>True</p> Signup and view all the answers

    What must the pharmacy maintain a record of when transferring controlled substances III-V to a reverse distributor for destruction?

    <p>The drug name, dosage form, strength, quantity, and date transferred</p> Signup and view all the answers

    Who is responsible for submitting the DEA Form 41 to the DEA when the controlled substances have been destroyed?

    <p>The DEA registered reverse distributor</p> Signup and view all the answers

    When did the drug take back program started by the DEA begin, and when was it meant to end?

    <p>September 2010 and meant to end in September 2014</p> Signup and view all the answers

    Which of the following conditions does NOT provide for the federal investigation of pharmaceutical theft?

    <p>The stolen product was an investigational drug authorized for emergency use</p> Signup and view all the answers

    Which DEA form is used to report the inventory of drugs surrendered for disposal?

    <p>DEA Form 41</p> Signup and view all the answers

    For controlled substances kept for compounding, what do the the records NOT have to contain?

    <p>The list of conditions the compound is intended to treat</p> Signup and view all the answers

    Which of the following is NOT a requirement for when a pharmacist does a controlled inventory count?

    <p>Sending the inventory to the DEA</p> Signup and view all the answers

    What is the primary purpose of the Controlled Substances Act (CSA) according to the information provided?

    <p>To establish the scheduling of controlled substances based on their potential for abuse and medical use</p> Signup and view all the answers

    T/F: The Original drug take back program was meant to be replaced by the Secure and Responsible Drug Disposal Act of 2010

    <p>True</p> Signup and view all the answers

    T/F: Controlled substances can ONLY be stored in a securely locked, substantially constructed cabine

    <p>False</p> Signup and view all the answers

    According to the CSA, if you notice a theft of significant loss of any controlled substances, you MUST do all of these except which?

    <p>Complete DEA Form 199 and submit it to the DEA</p> Signup and view all the answers

    T/F: A complete and accurate inventory of stocks of controlled substances must be taken annually

    <p>False</p> Signup and view all the answers

    How long should all controlled substance records be maintained for?

    <p>2 years</p> Signup and view all the answers

    Which is true about THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005?

    <p>Logbook entry not required if customer purchases a single sales package that contains 100 mg or less of pseudoephedrine</p> Signup and view all the answers

    The Combat Meth Act is enforced by the ___

    <p>DEA</p> Signup and view all the answers

    T/F: A significant loss of controlled substances means more than 10% of the facilities total controlled substances were stolen or lost

    <p>False</p> Signup and view all the answers

    T/F: DEA Form 106 is what you should fill out if a controlled substance is stolen or lsot

    <p>True</p> Signup and view all the answers

    When all or part of a shipment disappears, or never reaches its intended destination, the ____ is responsible for reporting the in-transit loss of controlled substances to the DEA.

    <p>Supplier</p> Signup and view all the answers

    T/F: Breakage, damage or spillage does not constitute a loss of controlled substances

    <p>True</p> Signup and view all the answers

    If controlled substance records are kept in 3 files, which IS not one of the three files

    <p>One file for OTC medications</p> Signup and view all the answers

    If Controlled substance records are kept in two files, one file must contain CII and the other file must contain what?

    <p>All other controlleds and and non-controlled</p> Signup and view all the answers

    What is the maximum quantity of a Schedule V controlled substance containing opium that can be sold or dispensed to the same buyer in any 48-hour period?

    <p>240 mL or 48 dosage units</p> Signup and view all the answers

    Where can records of controlled substance refills be kept?

    <p>All of the above</p> Signup and view all the answers

    What is required for a paper patient medication record used to record controlled substance refills?

    <p>The record should be readily retrievable.</p> Signup and view all the answers

    If a new and separate prescription is required for additional quantities beyond the 5 refill, 6-month limitation, what must the prescriber do?

    <p>Issue a new prescription for the additional quantities.</p> Signup and view all the answers

    What is the purpose of recording controlled substance refills?

    <p>All of the above.</p> Signup and view all the answers

    What is the requirement for transferring controlled substance prescription information for refills (III-V)?

    <p>The transfer must be communicated directly between two licensed pharmacists.</p> Signup and view all the answers

    How long must the original and transferred controlled substance prescriptions be maintained?

    <p>2 years from the date of last refill</p> Signup and view all the answers

    If a controlled substance prescription initially authorized for less than 5 refills exceeds the total allowable refills within 6 months, what should happen?

    <p>The prescribing practitioner needs to issue a new prescription for any further refills</p> Signup and view all the answers

    Which controlled substance labels would NOT have to say “Caution; Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”

    <p>CV</p> Signup and view all the answers

    T/F: A person purchasing a controlled substance without a prescription must be at least 21 years of age

    <p>False</p> Signup and view all the answers

    Study Notes

    Prescription Monitoring Programs (PMPs)

    • States review data generated through PMPs to determine if diversion or abuse exists
    • PMPs track patients, physicians, and pharmacies
    • Can identify situations such as patients shopping multiple prescribers or pharmacies
    • The federal government provides grant funding to states to develop or enhance their PMPs
    • NABP’s PMP InterConnect facilitates the sharing of data between state PMPs

    History of Anabolic Steroid Regulation

    • Anabolic Steroids Control Act of 1990: made anabolic steroids for human use schedule III substances under the CSA
    • Purpose was to stem abuse of anabolic steroids
    • Anabolic Steroids Act of 2004: re-defined anabolic steroid definition to include precursors and salts

    History of Federal Cannabis Regulation

    • Eight Prioritization Areas:
      1. Distribution to minors
      2. Revenue to criminal enterprise
      3. Sale over state lines
      4. Drug trafficking
      5. Violence, firearms related to cultivation and sale of marijuana
      6. Drugged driving or other actions with public health consequences
      7. Growing of marijuana on public lands
      8. Possession or use on federal property
    • Rohrabacher-Farr Amendment (2001): prohibited the Justice Department from spending funds to interfere with the implementation of state medical cannabis laws
    • Reauthorized in 2014 and 2018

    Regulatory Elements of State Medical Cannabis Laws

    • Patient Requirements:
      • Qualifying conditions
      • Dosage forms
      • Possession limit
    • Practitioner Requirements:
      • Registration
      • Continuing education
      • Dose determination
    • Dispenser Requirements:
      • Pharmacist staffing
      • Storefronts
      • Registration
      • Permits
      • Proof of capital
    • Producer Requirements:
      • Registration
      • Training course
      • Permits
      • Proof of capital

    State Medical Marijuana Programs

    • Managed by State Departments of Public Health
    • Qualifying conditions vary by state
    • Some states leave it to the physician to determine qualifying conditions

    Status of Medical Marijuana in Mississippi

    • Medical Cannabis Program signed into law on February 2, 2022

    Disposal of Controlled Substances

    • DEA registered reverse distributor responsible for submitting DEA Form 41 when controlled substances are destroyed
    • Pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred

    Inventory Requirements

    • Initial and biennial inventory of controlled substances
    • Inventory must include all controlled substances “on hand”
    • Exact count of schedule II substances and estimated count of schedule III-V substances
    • Records of controlled substances distributed, dispensed, and transferred
    • Reports of theft or significant loss of controlled substances### Transferring Controlled Substance Prescription Information
    • Original prescription information for a controlled substance (III-V) can be transferred on a ONE-TIME BASIS only for the purpose of refill dispensing.
    • Pharmacies electronically sharing a real-time online database can transfer up to the maximum refills permitted by law and the prescriber’s authorization.
    • The transfer must be communicated directly between two licensed pharmacists.
    • The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.

    Recording Refills for Controlled Substance Prescriptions

    • Records of controlled substance refills may be kept in one of three ways:
      • On the back of a paper prescription
      • On a paper patient medication record
      • On the computer
    • When recording refills on the back of a paper prescription:
      • The refill should be noted
      • The note should be initialed and dated by the pharmacist
      • Indicate the quantity dispensed (if not indicated, it is assumed that the full amount of the refill was dispensed)
    • The transferring pharmacist completes the following:
      • Writes the word “VOID” on the face of the invalidated prescription
      • Writes on the reverse side of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information
    • The pharmacist receiving the transferred prescription information completes the following:
      • Writes the word “TRANSFER” on the face of the transferred prescription
      • Enters all information required on the prescription by the CSA

    Regulations for the Sale of Controlled Substances without a Prescription

    • A controlled drug in Schedule V that is not a prescription drug under federal or state law may be sold over the counter provided that certain conditions are met:
      • The sale is made only by a pharmacist
      • No more than 240 mL or 48 dosage units of an opium-containing controlled substance or 120 mL or 24 dosage units of any other controlled substance may be sold or dispensed to the same buyer in any 48-hour period
      • The purchaser must be at least 18 years of age and provide ID and proof of age (when appropriate)

    Regulations for Refilling Controlled Substances

    • CV prescriptions may be refilled in accordance with the prescriber’s instructions
    • Many states limit refills of CV prescriptions to the same maximum of 5 refills within a 6-month period
    • The prescriber must issue a new and separate prescription for any additional quantities beyond the 5 refill, 6-month limitation

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    Description

    Test your knowledge on the Controlled Substance Act (CSA), the federal law that regulates drugs with abuse potential. Learn about narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and more.

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