Podcast
Questions and Answers
What is the primary purpose of the Controlled Substance Act (CSA)?
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?
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?
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?
What is the primary reason for requiring registration under the Controlled Substance Act?
How do state laws relate to the Controlled Substance Act?
How do state laws relate to the Controlled Substance Act?
Controlled Substances are drugs under the jurisdiction of the ___
Controlled Substances are drugs under the jurisdiction of the ___
Which of the following is NOT true about Schedule 1 substances
Which of the following is NOT true about Schedule 1 substances
Which of these is a schedule 1 substance
Which of these is a schedule 1 substance
T/F: Schedule II substances have no medical use do to dependency risk
T/F: Schedule II substances have no medical use do to dependency risk
Which is FALSE about schedule III substances
Which is FALSE about schedule III substances
The Anabolic Steroids Control Act of ___ required anabolic steroids to be placed in
Schedule III.
The Anabolic Steroids Control Act of ___ required anabolic steroids to be placed in Schedule III.
Schedule IV substance may lead to ____ physical or psychological dependence
Schedule IV substance may lead to ____ physical or psychological dependence
Which of these is schedule IV
Which of these is schedule IV
T/F: SCHEDULE V Mainly consists of limited quantities of certain narcotic drugs in combination with non-narcotic fillers
T/F: SCHEDULE V Mainly consists of limited quantities of certain narcotic drugs in combination with non-narcotic fillers
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
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
How should the schedule designation symbol be displayed on commercial containers of controlled substances?
How should the schedule designation symbol be displayed on commercial containers of controlled substances?
What is the alternative symbol that can be used to designate the schedule of a controlled substance?
What is the alternative symbol that can be used to designate the schedule of a controlled substance?
A state can move a drug to a less strict class than the DEA's classification.
A state can move a drug to a less strict class than the DEA's classification.
Fioricet is federally unscheduled and classified as a Schedule III drug in Mississippi.
Fioricet is federally unscheduled and classified as a Schedule III drug in Mississippi.
___ can apply to the DEA for a controlled substance exemption if the product is unlikely to be abused.
___ can apply to the DEA for a controlled substance exemption if the product is unlikely to be abused.
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
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
Under federal law, which of these would NOT have to register under the CSA as a dispenser of controlled substances?
Under federal law, which of these would NOT have to register under the CSA as a dispenser of controlled substances?
T/F: In MS pharmacists who dispense controlled substances do have to register with the state board of pharmacy
T/F: In MS pharmacists who dispense controlled substances do have to register with the state board of pharmacy
A new state pharmacy permit or transfer of ownership should be submitted with the ___ for expedited issuance of a DEA registration number.
A new state pharmacy permit or transfer of ownership should be submitted with the ___ for expedited issuance of a DEA registration number.
Who is exempt from registering with the DEA to prescribe, dispense, or administer controlled substances?
Who is exempt from registering with the DEA to prescribe, dispense, or administer controlled substances?
Under what circumstances can the DEA deny or revoke a registration?
Under what circumstances can the DEA deny or revoke a registration?
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?
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?
What form should narcotic treatment clinics fill out to register with the DEA?
What form should narcotic treatment clinics fill out to register with the DEA?
What form should chemical manufacturers, distributors, importers, and exporters fill out to register with the DEA?
What form should chemical manufacturers, distributors, importers, and exporters fill out to register with the DEA?
Which DEA form has to be reregsitered after 3 years
Which DEA form has to be reregsitered after 3 years
T/F: The person sending schedule I and schedule II
controlled substances fills out the DEA 222
T/F: The person sending schedule I and schedule II controlled substances fills out the DEA 222
Which of these does NOT require a DEA 222 form to be filled out?
Which of these does NOT require a DEA 222 form to be filled out?
Which of these are NOT a way to order more forms for purchasing controlled subtances?
Which of these are NOT a way to order more forms for purchasing controlled subtances?
T/F: You can change pre-printed information on DEA 222 forms as long as you let the DEA know
T/F: You can change pre-printed information on DEA 222 forms as long as you let the DEA know
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.
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.
How many lines are available on each controlled substance order form to correspond with the different items ordered?
How many lines are available on each controlled substance order form to correspond with the different items ordered?
T/F: Physicians are prohibited from issuing a prescription as a means of obtaining any controlled
substance for use in an office practice
T/F: Physicians are prohibited from issuing a prescription as a means of obtaining any controlled substance for use in an office practice
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.
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.
T/F: CSOS regulations require registrants to order schedule I and II controlled substances electronically if they have the equipment to do so
T/F: CSOS regulations require registrants to order schedule I and II controlled substances electronically if they have the equipment to do so
Which is true about the Controlled Substance Ordering System (CSOS)
Which is true about the Controlled Substance Ordering System (CSOS)
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
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
Controlled substance ordering forms are ___ numbered
Controlled substance ordering forms are ___ numbered
Which is NOT true about executing a controlled substance orderign form?
Which is NOT true about executing a controlled substance orderign form?
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
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
CIII and CIVs can be refilled __ times in __ months
CIII and CIVs can be refilled __ times in __ months
T/F: Prescriptions for schedule II drugs can only be refilled once in 6 months
T/F: Prescriptions for schedule II drugs can only be refilled once in 6 months
___ prescriptions may be refilled in accordance with the prescriber’s instructions
___ prescriptions may be refilled in accordance with the prescriber’s instructions
A pharmacist must notify the Board in writing by mail or fax of change of address within ___ of the change
A pharmacist must notify the Board in writing by mail or fax of change of address within ___ of the change
How much is the fine if a pharmacist fails to tell the state board they moved?
How much is the fine if a pharmacist fails to tell the state board they moved?
T/F: Techs must notify the board of pharmacy of a change in employment within 30 days
T/F: Techs must notify the board of pharmacy of a change in employment within 30 days
What is the primary purpose of NABP's PMP InterConnect?
What is the primary purpose of NABP's PMP InterConnect?
What was the purpose behind the Anabolic Steroids Control Act of 1990?
What was the purpose behind the Anabolic Steroids Control Act of 1990?
What significant change did the Anabolic Steroids Act of 2004 introduce regarding anabolic steroid regulation?
What significant change did the Anabolic Steroids Act of 2004 introduce regarding anabolic steroid regulation?
How does the federal government support states in enhancing their Prescription Monitoring Programs (PMPs) according to the text?
How does the federal government support states in enhancing their Prescription Monitoring Programs (PMPs) according to the text?
What is the main purpose of the Rohrabacher-Farr Amendment?
What is the main purpose of the Rohrabacher-Farr Amendment?
How did the passage of the Rohrabacher-Farr Amendment in 2014 impact cannabis reform at the federal level?
How did the passage of the Rohrabacher-Farr Amendment in 2014 impact cannabis reform at the federal level?
Which of the following is NOT one of the eight prioritization areas described in the text?
Which of the following is NOT one of the eight prioritization areas described in the text?
The Rohrabacher-Farr Amendment must be renewed how often to stay in effect?
The Rohrabacher-Farr Amendment must be renewed how often to stay in effect?
Who has the authority to enforce federal laws related to marijuana possession and use, despite state laws?
Who has the authority to enforce federal laws related to marijuana possession and use, despite state laws?
What did the $1.3 trillion omnibus spending bill signed by President Trump include in 2018?
What did the $1.3 trillion omnibus spending bill signed by President Trump include in 2018?
What does the U.S. Department of Justice have the authority to enforce according to federal laws?
What does the U.S. Department of Justice have the authority to enforce according to federal laws?
What is the federal law stance on growing, distributing, and possessing marijuana?
What is the federal law stance on growing, distributing, and possessing marijuana?
Which state recently signed into law a Medical Cannabis Program?
Which state recently signed into law a Medical Cannabis Program?
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
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
What must the pharmacy maintain a record of when transferring controlled substances III-V to a reverse distributor for destruction?
What must the pharmacy maintain a record of when transferring controlled substances III-V to a reverse distributor for destruction?
Who is responsible for submitting the DEA Form 41 to the DEA when the controlled substances have been destroyed?
Who is responsible for submitting the DEA Form 41 to the DEA when the controlled substances have been destroyed?
When did the drug take back program started by the DEA begin, and when was it meant to end?
When did the drug take back program started by the DEA begin, and when was it meant to end?
Which of the following conditions does NOT provide for the federal investigation of pharmaceutical theft?
Which of the following conditions does NOT provide for the federal investigation of pharmaceutical theft?
Which DEA form is used to report the inventory of drugs surrendered for disposal?
Which DEA form is used to report the inventory of drugs surrendered for disposal?
For controlled substances kept for compounding, what do the the records NOT have to contain?
For controlled substances kept for compounding, what do the the records NOT have to contain?
Which of the following is NOT a requirement for when a pharmacist does a controlled inventory count?
Which of the following is NOT a requirement for when a pharmacist does a controlled inventory count?
What is the primary purpose of the Controlled Substances Act (CSA) according to the information provided?
What is the primary purpose of the Controlled Substances Act (CSA) according to the information provided?
T/F: The Original drug take back program was meant to be replaced by the Secure and Responsible Drug Disposal Act of 2010
T/F: The Original drug take back program was meant to be replaced by the Secure and Responsible Drug Disposal Act of 2010
T/F: Controlled substances can ONLY be stored in a securely locked, substantially constructed cabine
T/F: Controlled substances can ONLY be stored in a securely locked, substantially constructed cabine
According to the CSA, if you notice a theft of significant loss of any controlled substances, you MUST do all of these except which?
According to the CSA, if you notice a theft of significant loss of any controlled substances, you MUST do all of these except which?
T/F: A complete and accurate inventory of stocks of controlled substances must be taken annually
T/F: A complete and accurate inventory of stocks of controlled substances must be taken annually
How long should all controlled substance records be maintained for?
How long should all controlled substance records be maintained for?
Which is true about THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005?
Which is true about THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005?
The Combat Meth Act is enforced by the ___
The Combat Meth Act is enforced by the ___
T/F: A significant loss of controlled substances means more than 10% of the facilities total controlled substances were stolen or lost
T/F: A significant loss of controlled substances means more than 10% of the facilities total controlled substances were stolen or lost
T/F: DEA Form 106 is what you should fill out if a controlled substance is stolen or lsot
T/F: DEA Form 106 is what you should fill out if a controlled substance is stolen or lsot
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.
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.
T/F: Breakage, damage or spillage does not constitute a loss of controlled substances
T/F: Breakage, damage or spillage does not constitute a loss of controlled substances
If controlled substance records are kept in 3 files, which IS not one of the three files
If controlled substance records are kept in 3 files, which IS not one of the three files
If Controlled substance records are kept in two files, one file must contain CII and the other file must contain what?
If Controlled substance records are kept in two files, one file must contain CII and the other file must contain what?
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?
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?
Where can records of controlled substance refills be kept?
Where can records of controlled substance refills be kept?
What is required for a paper patient medication record used to record controlled substance refills?
What is required for a paper patient medication record used to record controlled substance refills?
If a new and separate prescription is required for additional quantities beyond the 5 refill, 6-month limitation, what must the prescriber do?
If a new and separate prescription is required for additional quantities beyond the 5 refill, 6-month limitation, what must the prescriber do?
What is the purpose of recording controlled substance refills?
What is the purpose of recording controlled substance refills?
What is the requirement for transferring controlled substance prescription information for refills (III-V)?
What is the requirement for transferring controlled substance prescription information for refills (III-V)?
How long must the original and transferred controlled substance prescriptions be maintained?
How long must the original and transferred controlled substance prescriptions be maintained?
If a controlled substance prescription initially authorized for less than 5 refills exceeds the total allowable refills within 6 months, what should happen?
If a controlled substance prescription initially authorized for less than 5 refills exceeds the total allowable refills within 6 months, what should happen?
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”
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”
T/F: A person purchasing a controlled substance
without a prescription must be at least 21 years of age
T/F: A person purchasing a controlled substance without a prescription must be at least 21 years of age
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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:
- Distribution to minors
- Revenue to criminal enterprise
- Sale over state lines
- Drug trafficking
- Violence, firearms related to cultivation and sale of marijuana
- Drugged driving or other actions with public health consequences
- Growing of marijuana on public lands
- 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)
Legal Transfer of Controlled Substance Prescription Information
- 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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