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Law: The Closed Distribution System
Terms in this set (121)
The Controlled Substances Act regulates the ________, ______, and ______ of controlled substances as well as the management of __________ by means of a "closed system."
manufacturing, distributing, dispensing, opioid treatment programs (OTP)
In a closed system, any person or entity involved in the regulated activities must register with the _______.
Drug Enforcement Administration
What does DEA stand for?
Drug Enforcement Administration
The Controlled Substances Act is administered by the _____.
The DEA is a part of the _______ and a part of the ____ branch.
US Department of Justice, executive
The schedule in which a drug appears depends on what?
Accepted medical use
Potential for abuse
Potential for physical or mental dependence
With ______ dependence, a person experiences physical symptoms of withdrawal that can be as mild as a headache or as severe as a seizure.
With _____ dependence, a person experiences a mental desire for the substances that negatively affects their daily life.
C-I drugs have ____ potential for abuse and _____ potential for physical/mental dependence.
T/F: There are no legitimate uses for heroin or LSD.
T/F: C-I drugs have no accepted medical use.
C-II drugs have ______ potential for abuse and _____ potential for physical/mental dependence.
What are the C-II drugs?
Duragesic (fentanyl transdermal)
OxyContin (oxycodone, extended release)
Adderall (amphetamine salts)
C-III drugs have _____ potential for physical/mental dependence.
moderate to low
What are the C-III drugs?
Butrans (buprenorphine transdermal)
Suboxone (buprenorphine/naloxone sublingual)
Tylenol No. 3 (codeine/APAP)
Androgel (testosterone transdermal)
Estratest (esterified estrogens/methyltestosterone)
C-IV drugs have a _____ potential for abuse and ____ potential for physical or mental dependence.
What are the C-IV drugs?
What are the C-V drugs?
Robitussin A-C (codeine/guafenesin)
The manufacture, distribution, or dispensing of marijuana is a violation of _____ law.
The CSA grants that authority to schedule, reschedule, or unschedule a drug to _________.
Attorney General of the US (AG)
The AG must consult _____ before making a change to a drug schedule.
Secretary of the Department of Health and Human Services
The AG may temporarily for up to _____ place a drug in C-I to avoid an "imminent hazard to the public safety" without consulting the secretary.
The Secretary of HHS must notify the AG if a manufacturer submits a NDA for any drug that has a _____, _____, or _____ effect.
stimulant, depressant, hallucinogenic
All commercial packages of controlled substances must be labeled with what?
A symbol that identifies the schedule of the drug (must be clear and large enough to see without removing it from the shelf)
The CSA requires anyone who manufactures, distributes, or dispenses controlled substances to register with the _____.
A ______ is a person who is registered with the DEA to receive expired controlled substances and dispose of them.
A practitioner registered to dispense may distribute controlled substances to other practitioners without registering as a distributor if what?
Recipient is registered to dispense
Distribution is recorded by the distributing practitioner and the receiving practitioner
DEA Form 222 is used for C-I and C-II drugs
The number of dosage units is no more than 5% of the total controlled substance dosage units distributed or dispensed in one year
____ means to deliver a controlled substance to an ultimate use or research subject by pursuant to the lawful order of a practitioner, including prescribing, administering, packaging, labeling or compounding to prepare for such delivery.
Who are considered dispensers?
Who is exempt from registering with the DEA when working with controlled substances?
Common carriers (FedEx, UPS, etc.)
Agents/employees of registered manufacturers, distributors, or dispensers
Ultimate users (patients with prescriptions)
Officials of the Armed Forces, the Public Health Service, and Bureau of Prisions who are authorized
T/F: Medical residents are not required to register with the DEA and may prescribe, dispense, and administer controlled substances under the registration of the hospital or other institution.
Manufacturers, distributors, and opioid treatment programs (OTP) must register using _____ and must renew _____.
DEA Form 225, annually
If a DEA registrant changes name or address, the DEA must be notified ____ or _____.
online, in writing
T/F: When a new certificate of registration with the DEA is issued, the old one can be thrown away.
False (must be kept with the new one)
If a pharmacy is sold and is being transferred, the current resident must submit the proposal for transfer either _______ or by ________.
in person, certified mail with return receipt requested
The transfer proposal must be submitted to who and when?
Special agent in charge of the DEA field office in the registrant's area
14 days in advance of the transfer
The transfer proposal must include what?
Name, address, DEA registration and business activity of the current registrant
Name and address of the transferee
Whether the business will remain at current location
Whether the transferee will manufacture schedule C-I or C-II drugs
Date of proposed transfer of controlled substances
The closest DEA field office to us is where?
New Orleans, LA
T/F: The transfer of the pharmacy may proceed unless the administrator of the DEA notifies the registrant otherwise.
What needs to happen if a DEA registrant dies, ceases legal existence, or discontinues the business?
DEA must be notified and the registration must be returned to DEA
After termination of the registration, controlled substances in the possession of the registrant must be ____ in accordance to _______.
disposed of, DEA requirements
The AG may ____, _____, or ______ a registration if registration would not be in the public interest.
deny, revoke, suspend
The AG must consider what when denying, revoking, or suspending a registration?
Recommendation of the state licensing authority
Conviction record of the registrant
History of compliance with federal, state, and local laws
Exclusion from Medicare/Medicaid
Status of state licensure
Any other conduct that may threaten public heath or safety
In determining whether security measures are adequate for the controlled substances, the DEA considers what?
Business activity conducted by the registrant
Type/form/quantity of controlled substances presence
Location of premises
Type of building
Vaults, safes, security enclosures
Adequacy of keyed locks, combination locks, and alarms
Extent of unsupervised public access to the premises
In addition to the general security requirements, the are more specific requirements that apply based on whether the registrant is a ______ or a ______.
practitioner (prescriber, hospital, OTP, or pharmacy)
non-practitioner (manufacturer, distributor)
All practitioners must store schedule C-I drugs where?
securely locked, substantially constructed cabinet
Prescribing practitioners must store C-II drugs where?
securely locked, substantially constructed cabinet
Pharmacies must store schedule C-II drugs where?
Locked cabinet or dispersed throughout the stock of non-controlled drugs
Non-practitioners must store schedule C-I and C-II drugs where?
safe weighing more than 750 lbs and bolted or cemented to the floor
Non-practitioners must store C-III through C-V where?
Secure area that is subject to stringent security regulations
Penalties for violations of the CSA depend on what?
Nature of the activity
Drugs involved and the amount of drugs involved
Defendant's prior record of controlled substances convictions
It is illegal under the CSA to manufacture, distribute or dispense; or possess with intent to manufacture, distribute, or dispense a controlled substance except as authorized by the CSA and by violating this you could have a ______ offense.
Penalties for Drug trafficking range from _______, _______, or both.
imprisonment for 10 years to life, fines up to $4 million
Penalties for drug trafficking are less severe for what?
C-III through C-V drugs
_______ or _______ outside the usual course of professional practice may qualify as trafficking under the CSA.
Failure to make and keep records of controlled substances is a violation of the _____.
A record keeping violation made with knowledge or intent is a ____ offense and penalties may include _____, _____, or _____.
imprisonment up to 1 year, a fine of $25,000, both
A record keeping violation made negligently is eligible for ______ penalties of _____ per violation.
_____ is required to transfer C-I and C-II drugs from one registrant to another.
DEA Form 222
Failure to use the DEA Form 222 is a ______ offense and may include penalties of _____, ______, or _____.
imprisonment of up to 4 years, fines up to $30,000, both
Knowingly or intentionally possessing a controlled substance except pursuant to a valid prescription issued by a prescriber in the usual course of professional practice is a violation of ______.
The penalty for the first offense of illegal possession is what?
imprisonment for up to 1 year
minimum $1,000 fine
The penalty for the second offense of illegal possession is what?
Imprisonment for at least 15 days up to 2 years
Minimum $2,500 fine
The penalty for the third and subsequent offenses of illegal possession is what?
Imprisonment for at least 90 days up to 3 years AND minimum $5,000 fine
Under the _____, if law enforcement violates the 4th amendment, any evidence obtained cannot be used in the court against the defendant.
The DEA may inspect/search a pharmacy by what three methods?
Notice of inspection
Administrative Inspection Warrant (AIW)
_____ requires the consent of the owner or the pharmacist-in-charge before the inspection can be carried out.
Notice of Inspection
The Notice of Inspection must include what statements?
Owner or PIC has a constitutional right to refuse consent
Any incriminating evidence may be seized and used in criminal prosecution
Notice of inspection has been presented
Consent is voluntary and not coerced
Consent may be withdrawn at any time during the inspection
Upon receiving consent for the inspection, the DEA inspector may ______, ______, and _____.
inspect the premises
examine and copy all records and reports (except financial/pricing data)
Take an inventory of controlled substances
Consent is _____ when the DEA presents an Administrative Inspection Warrant (AIW).
An AIW is issued by _____ based on ______.
judge, probable cause
Under the CSA, probable cause standard is defined as ______ and is a relatively easy standard to meet.
"valid public interest"
The Administrative Inspection Warrant must contain what?
Name and address of the premises to be inspected
Statement of the statutory authority for the inspection
Statement of the nature and extent of the inspection, including specific items to be seized
Statement of the last date of the premises were inspected or a statement that the premises have never been inspected
An Administrative Inspection Warrant may be served when?
regular business hours
Refusing entry to a DEA inspector with an AIW is a subject to ______, ______ or ______.
imprisonment for up to 1 year
fine of up $25,000
A search warrant may be served when?
T/F: The probable cause requirement for an AIW is more stringent that that of a search warrant.
False (less stringent)
An AIW or a search warrant is not needed in what situations?
Initial inspection of a new pharmacy
Records ordered by subpoena
Consent given by owner or a PIC
Situation presenting imminent danger to public health and safety
Exception situations where obtaining a warrant would be impractical because of lack of time or opportunity
When warrant is not constitutionally required (incident to lawful arrest, inspection of commercial premises open to public, evidence in plain sight)
Under CSA, ______ may not in the usual course of professional practice, prescribe or administer controlled substances in order to maintain or detox an addicted patient.
________ therapy is dispensing an opioid agonist at stable dosage level for a period of time in excess of 21 days for the purpose of maintaining an addicted patient.
_______ therapy is dispensing an opioid agonist in decreasing doses to alleviate adverse physiological of psychological effects incidence to withdrawal as a method of bringing the patient to a drug-free state.
________ authorized the administration of certain drugs to maintain or detox opioid dependent patients in opioid treatment programs (methadone clinics)
Narcotic Addict Treatment Act
Opioid treatment programs must register with the ____ and renew _____.
Opioid treatment programs must be certified by ____ every ____.
Substance Abuse and Mental Health Services Administration (SAMHSA), 3 years
SAMHSA is a branch of the ______.
US Department of Health and Human Services
Only what is approved for use in OTP?
Any pharmacy may dispense methadone for ____, but only OTP may dispense methadone for ______.
________ amended the CSA to permit qualified physicians to prescribe/dispense C-III opioids approved by the FDA for detox/maintenance of opioid-dependent patients.
Drug Addiction Treatment Act (DATA)
DATA defines a qualified physician as what?
Board certified in addiction psychiatry or addiction medicine
Has completed at least 8 hours of authorized training in the treatment and management of opioid-dependent patients (CE class)
________ extends the authority to prescribe C-III opioids for detox/maintenance purposes to nurse practitioners and PAs.
Comprehensive Addiction and Recovery Act (CARA)
In order for nurse practitioners and PAs to prescribe opioids for detox/maintenance, they must what?
Completed at least 24 hours of authorized training in treatment and management
Are supervised by a "qualified physician"
Prescribers for opioid dependent patients may treat up to _____ patients at a time for the first year.
30 (on the books at a time)
After one year, the prescribers for opioid dependent patients may obtain permission from _____ to treat up to ____ patients at a time.
The special DEA registration number for prescribers of opioid dependent patients begins with what?
T/F: The prescribers special DEA registration number replaces the prescriber's original DEA registration number.
False (does not)
What are the C-III through C-V approved products for opioid-dependent patients?
Subutex (buprenorphine SL)
Suboxone (buprenorphone SL tablet/film)
Zubsolv (buprenorphone/naloxone SL tablet)
Bunavail (buprenoprhine/naloxone film)
Sublocade (buprenorphine ER injection - only available in prescriber's office)
What is the purpose of naloxone in buprenorphine products?
Prevent tampering with the dosage form
The Controlled Substance Registrant Protection Act mandates that a federal investigation be carried out in the event of a burglary or robbery of a DEA registrant if what?
Replacement cost of controlled substances taken exceeds $500
Death or significant injury occurs during the commission of the crime
Interstate or foreign commerce is involved in planning or execution of the crime
______ is illegal entry into a building with the intent to commit a crime.
______ is illegal taking of property by force of threat of force.
The penalty for robbery or burglary is what?
Imprisonment up to 20 years
Fine up to $25,000
The penalty of robbery or burglary using a dangerous weapon is what?
Imprisonment up to 25 years
Fine up to $35,000
The penalty for robbery or burglary resulting in death is what?
Imprisonment for life
Fine up to $50,000
The Combat Methamphetamine Epidemic Act regulates the sale and purchase of products containing ______, ______, and _____.
PSE, ephedrine, and PPA are identified in the legislation as _______.
scheduled listed chemical products (SLCP)
Alabama law restricts the sale of SLCP to _______.
Federal law requires SLCP to be stored either ______ or _____.
behind the counter
in a locked cabinent
Alabama law requires SLCP to be stored where?
behind the counter
T/F: Federal law does not impose an age requirement on purchasers of SLCP.
Alabama law requires purchasers of SLCP to be at least _____.
Both federal law and AL law limit purchases of SLCP to _____ per purchaser per day.
Federal law limits retail purchases of SLCP to _____ per purchaser per 30 days.
Federal law limits mail-order purchases of SLCP to ____ per purchaser per 30 days.
Alabama law limits retail and mail-order purchases of SLCP to ____ per purchaser per 30 days.
Federal law requires sale of SLCP to be recorded in _______ or ______.
Alabama law requires the sale of SLCP to be recorded in a _____.
Alabama law requires what information to be recorded when someone purchases SLCP?
Quantity sold (in grams0
Name and address of purchaser
Date and time of sale
T/F: Controlled substances may not be mailed through the US postal service.
When mailing controlled substances, the inner container must contain what?
name and address of the pharmacy, practitioner, or other person dispensing the prescription
When mailing controlled substances, the inner container must be placed in _____ or wrapped in _______.
plain outer container, plain paper
When mailing controlled substances, the outer container/wrapper must be free of what?
markings that would indicate the nature of the contents
This set is often in folders with...
Law: New Drug Application (exam 2)
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