Pop Law Exam 2012

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1304: Records and Reports of Registrants Paper prescriptions for Schedule-II medications must be kept at the pharmacy
- True
- False

About This Quiz

Just a new way for me to study, hopefully it can help some others too. Facts not fully checked, learn at your own risk.

Quiz Preview

2.

Prescriptions must be dated for:
- The date the prescription is to be filled
- The date on which the prescription is written
- The date on which the medication will be available
Correct Answer

A. The date on which the prescription is written

Explanation

Presciptions must be dated for the date on which they are written, but can include the date on which the fill is allowed

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3.

DEA registration is required for the pharmacy, not the pharmacist.
- True
- False
Correct Answer

A. True

Explanation

DEA registration is a requirement for the pharmacy, not the individual pharmacist. The Drug Enforcement Administration (DEA) registration is necessary for pharmacies to legally handle and dispense controlled substances. It ensures that the pharmacy follows all regulations and protocols related to controlled substances. While individual pharmacists may also have their own licenses and certifications, DEA registration is specifically tied to the pharmacy itself. Therefore, the statement that DEA registration is required for the pharmacy, not the pharmacist, is true.

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4.

1304.11: Inventory Requirements Inventory While Schedule-II medications must have an exact count; while Schedule-III - V can be estimated (unless quantity >1,000)
- True
- False
Correct Answer

A. True

Explanation

Though in my notes, the 1,000 quantity thing wasn't very clear

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5.

Automated dispensing systems must have it's own DEA permit.
- True
- False
Correct Answer

A. True

Explanation

As FYI, this refers mainly to those dispensing systems in nursing homes

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6.

1301.22 Exemption of agents and employees Which of the following is FALSE about hospital DEA permits?
- Can cover Hospitalists (physicians)in the scope of their employement
- Includes a practitioner/internal code number as suffix to DEA number
- The hospital must have list of codes available upon request by law enforcement agencies
- All of the above are true
Correct Answer

A. All of the above are true

Explanation

All of the statements mentioned about hospital DEA permits are true. Hospital DEA permits can cover Hospitalists (physicians) in the scope of their employment. The permits include a practitioner/internal code number as a suffix to the DEA number. Additionally, the hospital is required to have a list of codes available upon request by law enforcement agencies.

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7.

Definitions If a drug is not approved for a treatment and not current approved (but is is still in clinical trials), it can still be used as a form of treatment through a "Compassionate use Investigational New Drug Application"
- True
- False
Correct Answer

A. True

Explanation

Compassionate Use INDA- way to get a drug that is still in clinical trials for patients that have no other treatment for their conditions, experimental treatment

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8.

A "commerical container" is what the customer recieves his/her medication in from the pharmacy.
- True
- False
Correct Answer

A. False

Explanation

A "commerical container" is what is received from the manufacturer

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9.

1301.76: Other Security Controls for Practitioners Which of the following forms must be filled out in the case of a significant loss, theft, or robbery?
- Form 222
- Incidence Reporting Form 3A
- Form 106
- TPS Report (with cover sheet)
Correct Answer

A. Form 106

Explanation

In the case of a significant loss, theft, or robbery, the form that must be filled out is Form 106. This form is likely a standardized document used to report such incidents and gather relevant information for further investigation or insurance purposes. The other options listed, Form 222, Incidence Reporting Form 3A, and TPS Report (with cover sheet), do not specifically pertain to reporting loss, theft, or robbery incidents.

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10.

Definitions A "New Drug" can refer to a drug that is on the market but is being used in the following way:
- Used in a different patient population than originally approved
- Administered in a different form
- Used for a different indication
- All of the above would apply to "New Drug"
Correct Answer

A. All of the above would apply to "New Drug"

Explanation

The given answer is correct because a "New Drug" can refer to a drug that is being used in a different patient population than originally approved, administered in a different form, or used for a different indication. In other words, any of these conditions would make a drug qualify as a "New Drug."

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11.

Definitions Which of the following applications would be most relevant to the approval of a generic drug?
- New Drug Application
- Abbreviated New Drug Application
- Approved Drug Application
- Investigational New Drug Application
Correct Answer

A. Abbreviated New Drug Application

Explanation

Abbreviated New Drug Applications must prove bioequivalence of generic to brand

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12.

Schedule 2 prescriptions can be communicated orally, but only in the case of "emergency".
- True
- False
Correct Answer

A. True

Explanation

Schedule 2 prescriptions can be communicated orally in emergency situations. This means that in urgent cases where immediate access to the medication is necessary, healthcare professionals can verbally communicate the prescription to the pharmacist, rather than providing a written prescription. This allows for quicker access to medication in emergency situations, ensuring that patients receive the necessary treatment promptly.

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13.

Labels and Labeling differ ONLY in that Labels also include the "package insert"
- True
- False
Correct Answer

A. False

Explanation

Label - display of written or printographic matter on the vial
Labeling - display of written or printographic matter on the vial + package insert

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14.

An intern is considered a pharmacist.
- True
- False
Correct Answer

A. True

Explanation

(I don't think it may be a direct quote, but something to the order of) Pharmacist - “any pharmacist licensed by a State to dispense controlled substances, and shall include any other person authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.”

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15.

Which of the following would not fall under "Schedule 2"
- Oxycodone
- Anabolic Steroids
- Amphetamines
- Methylphenidate
Correct Answer

A. Anabolic Steroids

Explanation

All anabolic steroids are under Schedule 3

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16.

1306.11 Prescriptions for Schedule II Drugs When providing Schedule II medications in an "Emergency Situation" which of the following is false?
- Pharmacist must fill out prescription and Form 106
- The quantity provided is suffice only to cover the "emergency period"
- Prescription from provider should be sent (postmarked in US) with "Authorization for emergency dispensing" within 7 days
- There must be an immediate need for administration, with no alternative treatment available
Correct Answer

A. Pharmacist must fill out prescription and Form 106

Explanation

In an emergency situation, the pharmacist is not required to fill out a prescription and Form 106.

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17.

1308 Schedules I-V Amphetamines is under which Schedule?
- I
- II
- III
- IV
- V
Correct Answer

A. II

Explanation

Stimulant for Diet Supression

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18.

When can a DEA permit be renewed?
- Within 30 days of expiry
- Within 60 days of expiry
- Within 90 days of expiry
- Within 120 days of expiry
Correct Answer

A. Within 60 days of expiry

Explanation

A DEA permit can be renewed within 60 days of expiry. This means that individuals or entities holding a DEA permit have a 60-day window after their permit expires to apply for its renewal. It is important to renew the permit within this timeframe to ensure that there is no lapse in authorization to handle controlled substances.

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19.

1305.07 Special Procedure for filling certain orders Which of the following is FALSE regarding Form 222?
- Forms are serially number
- Come in booklets of 7 or 14
- Formed are filled in triplicate
- Mistakes require single strike through NOT "blacking out" of information
Correct Answer

A. Mistakes require single strike through NOT "blacking out" of information

Explanation

Form 222 is a special procedure for filling certain orders. The statement that is FALSE regarding Form 222 is that mistakes require single strike through NOT "blacking out" of information. This means that if a mistake is made on Form 222, it should be corrected by using a single strike through, rather than blacking out the incorrect information. This ensures that the original information is still visible and the correction is clear.

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20.

1306 Prescriptions The following DEA number is valid: 1-2-3-4-5-6-4
- True
- False
Correct Answer

A. False

Explanation

Add 1st + 3rd + 5th digits = TOTAL (9)
Add 2nd+ 4th + 6th digits and multiply (*) by 2 = TOTAL (24)
Add two totals → last digit of sum should be 7th digit of DEA number (33; 7th digit should = 3)

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21.

Definitions The FDA controls ("oversees", "regulates", etc.) all advertising regarding prescription drugs, while the FTC controls advertising of OTC and dietary supplements
- True
- False
Correct Answer

A. True

Explanation

The explanation for the given correct answer is that the FDA is responsible for overseeing and regulating all advertising related to prescription drugs, while the FTC is responsible for controlling the advertising of over-the-counter drugs and dietary supplements. This means that the FDA has authority over the advertising of drugs that require a prescription, while the FTC has authority over the advertising of drugs that can be purchased without a prescription and dietary supplements. Therefore, the statement that the FDA controls advertising regarding prescription drugs and the FTC controls advertising of OTC and dietary supplements is true.

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22.

A maintenance treatment can include dispensing in excess of 21 days (meaning it overlaps with Detoxification).
- True
- False
Correct Answer

A. True

Explanation

A maintenance treatment can go on forever

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23.

1301.51 New permits as a result of moves/name chages must be done before the change takes place.
- True
- False
Correct Answer

A. True

Explanation

When it comes to moves or name changes, new permits must be obtained before the change actually takes place. This implies that the necessary permits and paperwork should be completed prior to the move or name change occurring. Therefore, the statement "New permits as a result of moves/name changes must be done before the change takes place" is true.

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24.

1307.11 What is the percent of total dosage units distributed of Controlled Substances that cannot be exceeded in one calendar year? (i.e. What's the max % of distributed drugs that can be Controlled Substances?)
- 3%
- 5%
- 7%
- 10%
Correct Answer

A. 5%

Explanation

The correct answer is 5%. This means that the maximum percentage of distributed drugs that can be Controlled Substances is 5%. This suggests that there are regulations or guidelines in place to limit the distribution of Controlled Substances to ensure their proper use and prevent abuse or misuse.

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25.

1301.52: Termination Registration can be terminated for all of the following reasons EXCEPT:
- Medicare fraud
- Violation of controlled substances act
- Death
- Closure of a pharmacy
- All of the above are valid reasons
Correct Answer

A. All of the above are valid reasons

Explanation

The correct answer is "All of the above are valid reasons." This means that all of the reasons listed (Medicare fraud, violation of controlled substances act, death, closure of a pharmacy) can lead to the termination of registration, except for the option "All of the above."

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26.

1301.90: Screening employees A person with no felony convication, but a history of sucessful rehabilitation for chemical dependency, can be hired by a pharmacy.
- True
- False
Correct Answer

A. True

Explanation

A person with no felony conviction but a history of successful rehabilitation for chemical dependency can be hired by a pharmacy because they have demonstrated the ability to overcome their addiction and have not been involved in any serious criminal activity. This shows that they have taken the necessary steps to address their past issues and can be trusted to handle the responsibilities of working in a pharmacy.

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27.

1304: Records and Reports of Registrants Within what timeframe must central records be able to reach a pharmacy location?
- 24 hours
- 2 days
- 1 week
- Central pharmacies are not allowed to keep records
Correct Answer

A. 2 days

Explanation

Central records must be able to reach a pharmacy location within 2 days. This ensures that the necessary records and reports of registrants are readily available for the pharmacy's operations and compliance purposes. A shorter timeframe would be too restrictive, while a longer timeframe could potentially hinder the pharmacy's ability to access important information in a timely manner.

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28.

1302: Labeling and Packaging of controlled substances On the date when a medication is newly scheduled or moved to a new schedule, the manufacturer must have proper marking in place (i.e. the Symbol identifying C-II, C-III, C-IV) before any prescription for that medication can be filled.
- True
- False
Correct Answer

A. True

Explanation

When a medication is newly scheduled or moved to a new schedule, the manufacturer must have proper marking in place before any prescription for that medication can be filled. This ensures that the medication is properly labeled and packaged as a controlled substance, and helps to prevent any errors or confusion in dispensing the medication. Therefore, the statement "True" is correct.

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29.

1305.17 - Preservation Form 222's are the exception to the "2 year" rule-of-thumb and must be kept for 3 years
- True
- False
Correct Answer

A. False

Explanation

Form 222's must be kept at pharmacy (retail locations) for 2 years

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30.

Who is not included in the "closed system" of Controlled substances?
- Manufacturers
- Patients
- Delivery Personnel
- Distributors
- Dispensers
- Prescribers
- All of the above are included
Correct Answer

A. Delivery Personnel

Explanation

Delivery personnel are not included in the "closed system" of controlled substances. The closed system refers to the strict regulations and monitoring of the manufacturing, distribution, prescription, and dispensing of controlled substances. While manufacturers, distributors, prescribers, and dispensers are all part of this closed system and have specific responsibilities and regulations to follow, delivery personnel are not directly involved in the handling or administration of controlled substances. Their role is primarily focused on transportation and delivery of medications rather than the actual control and monitoring of these substances.

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31.

Due to a controversy with methyphenidate (Ritalin) in the early 1990's, the DEA has no limits on manufacturing drugs which are in Schedule I or II as long as all sales are properly documents
- True
- False
Correct Answer

A. False

Explanation

Manufacturers of of Schedule I and II must submit quota request to the DEA, which never rejects a quota request (due to methylphenidate issue)

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32.

For how long is a DEA permit valid for pharmacies?
- 1 year
- 2 years
- 3 years
- 4 years
Correct Answer

A. 3 years

Explanation

A DEA permit is valid for pharmacies for a period of 3 years. This means that once a pharmacy obtains a DEA permit, they are authorized to handle and dispense controlled substances for a duration of 3 years. After this period, the pharmacy will need to renew their permit to continue operating legally and handling controlled substances.

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33.

1304: Records and Reports of Registrants Which of the following is not an acceptable file choice:
- Three Files: Schedule II Drugs, Schedule III-V Drugs, Non-Controlled Drugs
- Two separate Files: Schedule 2-5 drugs (adequate computer system OR Red “c” in lower right-hand corner of all 3-5) and Non-controlled drugs
- Two separate Files: Schedule II drugs, Schedule III-V and non-controlled drug (Adequate computer system or red “C” in lower right corner of all Schedule III-V drugs)
- All are acceptable
Correct Answer

A. All are acceptable

Explanation

All of the file choices mentioned in the options are acceptable. There is no option that is not acceptable.

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34.

Pharmacists are generally not considered "Individual Practitioners"
- True
- False
Correct Answer

A. True

Explanation

Except in the 7 states with allow pharmacists to write for controlled substances (collaborative practice agreements)

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35.

What is the length at which "detoxification" programs are considers long-term (any less is considered short-term)?
- 14 days - 6 months
- 28 days - 6 months
- 28 days - 12 months
- 30 days - 6 months
Correct Answer

A. 30 days - 6 months

Explanation

Detoxification programs are considered long-term if they last for a period of 30 days to 6 months. This means that any program that lasts less than 30 days is considered short-term.

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36.

At the creation of the Controlled Substances Act, who were considered "prescribers"?
- Physicians
- Podiatrists
- Veterinarians
- Nurse Practitioners
- Dentist
Correct Answer(s)

A. Physicians
A. Podiatrists
A. Veterinarians
A. Dentist

Explanation

physicians, dentists, veterinarians, podiatrists

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37.

While recognized as a practice of medicine by different insurance companies, the DEA does not consider "Telemedicine" to be a practice of medicine.
- True
- False
Correct Answer

A. False

Explanation

The DEA does consider "telemedicine" to be a practice of medicine....I actually don't know if insurance companies do or not

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38.

1306.35 Transfers for 3, 4, 5 (for refills) Which of the following regarding transfers is FALSE?
- A prescription can be transferred no more times than refills allotted (i.e. 3 refills = 3 refills MAX)
- Must be directly communicated between two licensed pharmacists
- "Void" must be be written on the prescription
- "Transfer" must be be written on the prescription
- On the back of the prescription must be written: pharmacy address, DEA number, name of pharmacist, date of transfer
Correct Answer

A. A prescription can be transferred no more times than refills allotted (i.e. 3 refills = 3 refills MAX)

Explanation

A prescription can be transferred no more times than refills allotted (i.e. 3 refills = 3 refills MAX). This statement is false because a prescription can only be transferred once, regardless of the number of refills allotted. Once a prescription is transferred, it becomes void at the original pharmacy and can no longer be refilled or transferred again.

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39.

1308 Schedules II-V Pregabalin (Lyrica) is under which Schedule?
- II
- III
- IV
- V
Correct Answer

A. V

Explanation

Pregabalin (Lyrica) is classified under Schedule V. Schedule V drugs have a lower potential for abuse compared to drugs in Schedules II-IV. They are considered to have a currently accepted medical use and may have limited physical or psychological dependence when compared to drugs in higher schedules.

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40.

DEA has full control over who can be considered a prescriber.
- True
- False
Correct Answer

A. False

Explanation

"Original Four" described in Federal Control Substances Act- physicians, dentists, veterinarians, podiatrists. States can add mid-level practitioners (e.g. collaborative practice)

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41.

1301.27 Automated dispensing at LTCF No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long term care facility.
- True
- False
Correct Answer

A. True

Explanation

This statement is true because according to the given information, only a registered retail pharmacy is allowed to install and operate an automated dispensing system at a long term care facility. This implies that no other person or entity is authorized to perform this task. Therefore, the correct answer is true.

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42.

Definitions What describes a pharmcist's "freedom of fault" regarding the written guarentee they recieve from manufacturers that drugs purchased are neither adultered or misbranded?
- Limited Liability Clause
- Freedom from Misbranding Act
- Subsequent Safety
- Safe Harbor Provision
Correct Answer

A. Safe Harbor Provision

Explanation

The correct answer is "Safe Harbor Provision." A pharmacist's "freedom of fault" refers to the protection they have from legal liability when they rely on the written guarantee provided by manufacturers that the drugs purchased are not adulterated or misbranded. The Safe Harbor Provision offers this protection to pharmacists, allowing them to trust the guarantee and distribute the drugs without fear of being held responsible if any issues arise.

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43.

In governmental organization, under what organization/agency/branch/etc. does the DEA fall?
- Justice Department
- CIA
- FBI
- A and C
- All of the above
Correct Answer

A. A and C

Explanation

Executive branch → Justice department (attorney general) → FBI → DEA

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44.

1304: Records and Reports of Registrants Which of the following are records which must be kept at the pharmacy?
- Form 222 (executive order forms)
- Inventories
- Manufacturer invoices
- Paper prescription
Correct Answer(s)

A. Form 222 (executive order forms)
A. Inventories
A. Paper prescription

Explanation

Form 222 (executive order forms), Manufacturer invoices, Paper prescription must be kept

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45.

1304.11: Inventory Requirements Minimally, inventory must be taken at least bi-annually.
- True
- False
Correct Answer

A. True

Explanation

The statement is true because the phrase "at least bi-annually" means that inventory must be taken at least twice a year. This ensures that the inventory is regularly checked and updated, allowing the company to have an accurate record of its stock levels. By conducting inventory at least bi-annually, the company can identify any discrepancies, such as missing or excess items, and take appropriate actions to maintain an efficient inventory management system.

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46.

1306.14 Labeling and Filling A Schedule II prescription can be transmitted electronically between a retail pharmacy and a central as long as it says "Central Fill" on the prescription.
- True
- False
Correct Answer

A. True

Explanation

A Schedule II prescription can be transmitted electronically between a retail pharmacy and a central as long as it says "Central Fill" on the prescription. This means that if a prescription for a Schedule II drug includes the designation "Central Fill," it can be sent electronically from a retail pharmacy to a central location for filling. This allows for more efficient and streamlined processing of prescriptions, ensuring that patients receive their medications in a timely manner.

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47.

Which of the following are NOT considered Long Term Care Facilities (LTCF)
- Nursing Homes
- Facilities with resident patients
- Assisted living facilities
- All of the above are not considered LTCF
Correct Answer

A. Assisted living facilities

Explanation

Assisted living facilities don't really provide medical care (as I understand). They are more like "hotels".

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48.

Which category registration is requied for someone to be defined as a "compounder"?
- Category 1
- Category 2
- Category 5
- Category 7
Correct Answer

A. Category 7

Explanation

Compounder means any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.

Category 7 registration is for Narcotic Treatment Programs

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49.

1301.26 Exporting/Importing Individuals may not enter/leave the U.S. with any more than 50 doses of each medication they are traveling with.
- True
- False
Correct Answer

A. False

Explanation

The maximum amount of units that can be brought in is 50 TOTAL. Meaning 50 unites of Med A, OR 25 units of MedA + 25 units of Med B

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Pop Law Exam 2012

1304: Records and Reports of Registrants Paper prescriptions for Schedule-II medications must be kept at the pharmacy

Quiz Preview

Prescriptions must be dated for:

DEA registration is required for the pharmacy, not the pharmacist.

1304.11: Inventory Requirements Inventory While Schedule-II medications must have an exact count; while Schedule-III - V can be estimated (unless quantity >1,000)

Automated dispensing systems must have it's own DEA permit.

1301.22 Exemption of agents and employees Which of the following is FALSE about hospital DEA permits?

Definitions If a drug is not approved for a treatment and not current approved (but is is still in clinical trials), it can still be used as a form of treatment through a "Compassionate use Investigational New Drug Application"

A "commerical container" is what the customer recieves his/her medication in from the pharmacy.

1301.76: Other Security Controls for Practitioners Which of the following forms must be filled out in the case of a significant loss, theft, or robbery?

Definitions A "New Drug" can refer to a drug that is on the market but is being used in the following way:

Definitions Which of the following applications would be most relevant to the approval of a generic drug?

Schedule 2 prescriptions can be communicated orally, but only in the case of "emergency".

Labels and Labeling differ ONLY in that Labels also include the "package insert"

An intern is considered a pharmacist.

Which of the following would not fall under "Schedule 2"

1306.11 Prescriptions for Schedule II Drugs When providing Schedule II medications in an "Emergency Situation" which of the following is false?

1308 Schedules I-V Amphetamines is under which Schedule?

When can a DEA permit be renewed?

1305.07 Special Procedure for filling certain orders Which of the following is FALSE regarding Form 222?

1306 Prescriptions The following DEA number is valid: 1-2-3-4-5-6-4

Definitions The FDA controls ("oversees", "regulates", etc.) all advertising regarding prescription drugs, while the FTC controls advertising of OTC and dietary supplements

A maintenance treatment can include dispensing in excess of 21 days (meaning it overlaps with Detoxification).

1301.51 New permits as a result of moves/name chages must be done before the change takes place.

1307.11 What is the percent of total dosage units distributed of Controlled Substances that cannot be exceeded in one calendar year? (i.e. What's the max % of distributed drugs that can be Controlled Substances?)

1301.52: Termination Registration can be terminated for all of the following reasons EXCEPT:

1301.90: Screening employees A person with no felony convication, but a history of sucessful rehabilitation for chemical dependency, can be hired by a pharmacy.

1304: Records and Reports of Registrants Within what timeframe must central records be able to reach a pharmacy location?

1302: Labeling and Packaging of controlled substances On the date when a medication is newly scheduled or moved to a new schedule, the manufacturer must have proper marking in place (i.e. the Symbol identifying C-II, C-III, C-IV) before any prescription for that medication can be filled.

1305.17 - Preservation Form 222's are the exception to the "2 year" rule-of-thumb and must be kept for 3 years

Who is not included in the "closed system" of Controlled substances?

Due to a controversy with methyphenidate (Ritalin) in the early 1990's, the DEA has no limits on manufacturing drugs which are in Schedule I or II as long as all sales are properly documents

For how long is a DEA permit valid for pharmacies?

1304: Records and Reports of Registrants Which of the following is not an acceptable file choice:

Pharmacists are generally not considered "Individual Practitioners"

What is the length at which "detoxification" programs are considers long-term (any less is considered short-term)?

At the creation of the Controlled Substances Act, who were considered "prescribers"?

While recognized as a practice of medicine by different insurance companies, the DEA does not consider "Telemedicine" to be a practice of medicine.

1306.35 Transfers for 3, 4, 5 (for refills) Which of the following regarding transfers is FALSE?

1308 Schedules II-V Pregabalin (Lyrica) is under which Schedule?

DEA has full control over who can be considered a prescriber.

1301.27 Automated dispensing at LTCF No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long term care facility.

Definitions What describes a pharmcist's "freedom of fault" regarding the written guarentee they recieve from manufacturers that drugs purchased are neither adultered or misbranded?

In governmental organization, under what organization/agency/branch/etc. does the DEA fall?

1304: Records and Reports of Registrants Which of the following are records which must be kept at the pharmacy?

1304.11: Inventory Requirements Minimally, inventory must be taken at least bi-annually.

1306.14 Labeling and Filling A Schedule II prescription can be transmitted electronically between a retail pharmacy and a central as long as it says "Central Fill" on the prescription.

Which of the following are NOT considered Long Term Care Facilities (LTCF)

Which category registration is requied for someone to be defined as a "compounder"?

1301.26 Exporting/Importing Individuals may not enter/leave the U.S. with any more than 50 doses of each medication they are traveling with.