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Pharmacy Law > Federal Controlled Substance Law > Flashcards

Federal Controlled Substance Law Flashcards

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1
Q

What is the definition of “addict”?

A

Any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction.

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2
Q

What is the definition of “agent”?

A

An authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.

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3
Q

What is the definition of “controlled substance”?

A

A drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.

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4
Q

What is the definition of “dispense”?

A

To deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery. The term “dispenser” means a practitioner who so delivers a controlled substance to an ultimate user or research subject.

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5
Q

What is the definition of “distribute”?

A

To deliver (other than by administering or dispensing) a controlled substance or a listed chemical. The term “distributor” means a person who so delivers a controlled substance or a listed chemical.

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6
Q

What is the definition of “narcotic drug”?

A

Any of the following whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:
a. Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.
b. Poppy straw and concentrate of poppy straw.
c. Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine, and derivatives of ecgonine or their salts have been removed.
d. Cocaine, its salts, optical and geometric isomers, and salts of isomers.
e. Ecgonine, its derivatives, their salts, isomers, and salts of isomers.
f. Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in subparagraphs (A) through (E).

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7
Q

What is the definition of “opiate/opioid”?

A

Any drug or other substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction-sustaining liability.

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8
Q

What is the definition of “opium poppy”?

A

The plant of the species Papaver somniferum L., except the seed thereof.

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9
Q

What is the definition of “poppy straw”?

A

All parts, except the seeds, of the opium poppy, after mowing.

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10
Q

What is the definition of “practitioner”?

A

A physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research.

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11
Q

What is the definition of “ultimate user”?

A

A person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household.

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12
Q

What is the definition of “dispenser”?

A

An individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.

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13
Q

What is the definition of “individual practitioner”?

A

A physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.

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14
Q

What is the definition of “institutional practitioner”?

A

A hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.

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15
Q

What is the definition of “mid-level practitioner”?

A

An individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the State in which they practice.

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16
Q

What is the definition of “person”?

A

Any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.

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17
Q

What is the definition of “pharmacist”?

A

Any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.

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18
Q

What is the definition of “prescription”?

A

An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).

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19
Q

What is the definition of “reverse distributor”?

A

A registrant who receives controlled substances acquired from another DEA registrant for the purpose of:
1. Return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer’s behalf; or
2. Destruction.

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20
Q

What is the federal schedule of heroin?

A

C-I

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21
Q

What is the federal schedule of marijuana?

A

C-I

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22
Q

What is the federal schedule of bath salts?

A

C-I

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23
Q

What is the federal schedule of cocaine?

A

C-II

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24
Q

What is the federal schedule of morphine?

A

C-II

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25
Q

What is the federal schedule of codeine?

A

C-II

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26
Q

What is the federal schedule of meperidine?

A

C-II

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27
Q

What is the federal schedule of methamphetamine?

A

C-II

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28
Q

What is the federal schedule of amphetamine?

A

C-II

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29
Q

What is the federal schedule of lisdexamphetamine?

A

C-II

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30
Q

What is the federal schedule of methadone?

A

C-II

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31
Q

What is the federal schedule of hydrocodone?

A

C-II

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32
Q

What is the federal schedule of hydromorphone?

A

C-II

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33
Q

What is the federal schedule of oxymorphone?

A

C-II

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34
Q

What is the federal schedule of oxycodone?

A

C-II

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35
Q

What is the federal schedule of hydrocodone (dihydrocodeinone) in combination with a non-narcotic ingredient?

A

C-II

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36
Q

What is the federal schedule of methylphenidate?

A

C-II

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37
Q

What is the federal schedule of secobarbital?

A

C-II

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38
Q

What is the federal schedule of tapentadol?

A

C-II

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39
Q

What is the federal schedule of fentanyl?

A

C-II

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40
Q

What is the federal schedule of tincture of opium?

A

C-II

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41
Q

What is the federal schedule of sufentanil?

A

C-II

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42
Q

What is the federal schedule of dronabinol?

A

C-III

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43
Q

What is the federal schedule of anabolic steroids?

A

C-III

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44
Q

What is the federal schedule of buprenorphine?

A

C-III

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45
Q

What is the federal schedule of ketamine?

A

C-III

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46
Q

What is the federal schedule of codeine in combination with a non-narcotic ingredient?

A

C-III

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47
Q

What is the federal schedule of alprazolam?

A

C-IV

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48
Q

What is the federal schedule of lorazepam?

A

C-IV

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49
Q

What is the federal schedule of diazepam?

A

C-IV

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50
Q

What is the federal schedule of temazepam?

A

C-IV

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51
Q

What is the federal schedule of zolpidem?

A

C-IV

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52
Q

What is the federal schedule of tramadol?

A

C-IV

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53
Q

What is the federal schedule of carisoprodol?

A

C-IV

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54
Q

What is the federal schedule of butorphanol?

A

C-IV

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55
Q

What is the federal schedule of eszopiclone?

A

C-IV

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56
Q

What is the federal schedule of phentermine?

A

C-IV

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57
Q

What is the federal schedule of pentazocine?

A

C-IV

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58
Q

What is the federal schedule of phenobarbital?

A

C-IV

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59
Q

What is the federal schedule of lorcaserin?

A

C-IV

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60
Q

What is the federal schedule of clorazepate?

A

C-IV

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61
Q

What is the federal schedule of chlordiazepoxide?

A

C-IV

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62
Q

What is the federal schedule of pregabalin?

A

C-V

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63
Q

What does the DEA stand for? What authority do they have?

A
  • Drug Enforcement Administration
  • Authority to enforce drug laws related to controlled substances on a federal level.
64
Q

What factors are considered when deciding whether a drug is a controlled substance?

A
  • Actual or relative potential for abuse
  • Scientific evidence of pharmacologic effect
  • Current scientific knowledge of substance
  • History and current patterns of abuse
  • Scope, duration, and significance of abuse
    *Risk to public health
  • Psychic or physiological dependence liability
  • Immediate precursor of a substance already controlled
65
Q

What are the characteristics of drugs in schedule I?

A
  • No currently accepted medical use in the U.S.
  • High potential for abuse
66
Q

What are the characteristics of drugs in schedule II?

A
  • Has a currently accepted medical use
  • High potential for abuse
  • May cause severe psychological or physical dependence
67
Q

What are the characteristics of drugs in schedule III?

A
  • Abuse potential
  • Moderate or low physical dependency
  • High psychological dependence
  • CII drugs in suppository form
68
Q

What are the characteristics of drugs in schedule IV?

A
  • Low potential for abuse
  • Limited physical or psychological dependence liability
69
Q

What are the characteristics of drugs in schedule V?

A
  • Low abuse potential compared to C-IV
  • Abuse leads only to physical or psychological dependency
  • Some OTC, some legend
70
Q

What are the ten types of federal DEA registrations?

A
  1. Manufacturing (C-I to C-V)
  2. Distribution (C-I to C-V)
  3. Reverse distribution (C-I to C-V) - accepting drugs for destruction
  4. Dispensing or instructing - pharmacies and physicians, others
  5. Research (C-I)
  6. Research (C-II to C-V)
  7. Narcotic treatment programs (C-II to C-V)
  8. Importing (C-I to C-V)
  9. Exporting (C-I to C-V)
  10. Chemical analysis (C-I to C-V)
71
Q

Which registration type characterizes the traditional community pharmacy?

A

Dispensing or instructing

72
Q

Who is legally allowed to possess a controlled substance?

A
  • Registrants
  • Patients
73
Q

Who is exempt from registration?

A
  • Pharmacist working in a pharmacy
  • Truck drivers
  • Plant employees
  • Others in the manufacturing/distributing line
74
Q

Who, or what, registers as a dispenser?

A
  • Practitioner (pharmacy) who so delivers a controlled substance to an ultimate user or research subject
  • An individual practitioner, institutional practitioner, pharmacy, or pharmacist who dispenses a controlled substance
75
Q

Can a dispensing pharmacy distribute controlled substances?

A

Yes. Can distribute (without being registered to distribute) to another practitioner for the purpose of general dispensing by the practitioner to patients IF:
* Practitioner is registered under the Act to dispense that controlled substance
* Distribution is recorded by the distributing practitioner
* If C-I or C-II, an order form is used
* 5% rule: total number of dosage units of all controlled substances distributed during each calendar year does not exceed five percent of the total number of dosage units of all controlled and noncontrolled substances distributed and dispensed during the same year.

76
Q

What two major factors are considered in the determination of DEA registration type?

A
  • Schedules of drugs handled
  • Activity
77
Q

How does one go about checking the validity of a DEA number?

A

Ex: NDC BS6548234
1. 6 + 4 + 2 = 12
2. 5 + 8 + 3 = 16 x 2 = 32
3. 32 + 12 = 44 (last number is 4, meaning that 4 should be the last number of the NDC)

78
Q

What does the first letter mean at the beginning of a DEA number?

A

Level of practitioner
* A, B, C = practitioner (not a pharmacist)
* M = mid-level practitioner

79
Q

What does the second letter mean at the beginning of a DEA number?

A

First letter of last name or first letter of company name

80
Q

How can a DEA number that does not match a company name or practitioner last name be legitimate?

A

Marriage, change of name, change of company name (getting bought out), etc.

81
Q

Who is eligible for a registration exemption? How is their DEA number different?

A
  • Any agent or employee of a person who is registered to engage in any group of independent activities if the person is acting in the usual course of his/her business or employment.
  • Individual practitioner who is an agent or employee of another practitioner registered to dispense controlled substances may administer or dispense controlled substances if authorized to do so by place of employment under the registration of the employer.
  • Individual practitioner who is an agent or employee of a hospital or other institution may administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution, provided that:
    a. Dispensing, administering, or prescribing is done in the usual course of professional practice
    b. Authorized or permitted by the jurisdiction in which they are practicing
    c. Hospital or other institution has verified that the individual is permitted to dispense, administer, or prescribe within the jurisdiction
    d. Acting only within their scope of employment
    e. Hospital/institution authorizes the individual under the hospital registration and designates a specific internal code number for each authorized practitioner (numbers, letters, or a combo of both and shall be suffix to DEA # preceded by a hyphen)
    f. Current list of internal codes and corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request
82
Q

Is a pharmacist a practitioner?

A

No

83
Q

How often must pharmacies re-register with the DEA?

A

Every three years

84
Q

When manufacturers label for controlled substances, where must the symbol on the label be located?

A

Predominately located on the label/labelling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. Should be clear and large enough to afford easy identification of the schedule without removal from the shelf.

85
Q

True/false: Each commercial container of a controlled substance shall have printed on the label the symbol designating the schedule.

A

True

86
Q

Does the word “schedule” need to be explicitly used in manufacturer labeling for controlled substances?

A

No. No distinction between narcotic and non-narcotic needs to be made either.

87
Q

In what situation would a symbol indicating schedule not be required?

A
  • 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
  • Not required on commercial container too small or unable to accommodate a label if the symbol is printed on the box or package from which the commercial container removed upon dispensing to the ultimate user
  • Not required on commercial container or labeling if being utilized in clinical research involving blind/double blind studies
88
Q

What storage arrangements are permitted for controlled substances in pharmacies?

A

C-I: Securely locked, substantially locked cabinet
C-II to C-V: Securely locked, substantially locked cabinet or may disperse throughout the stock of noncontrolled substances in such a manner to obstruct theft or diversion of controlled substances

89
Q

What storage arrangements are permitted for controlled substances with individual practitioners?

A

All must be kept locked up

90
Q

What is the difference between a prescription order and a medication order?

A
  • Prescriptions: outpatient; an order for a medication which is dispensed to or for an ultimate user
  • Medication order: institutional care; immediate administration to the ultimate user
91
Q

What does it mean to issue a prescription?

A

It is a decision-making process

92
Q

Who is entitled to issue prescriptions?

A

Practitioners

93
Q

What is “corresponding responsibility”?

A

Shared by a practitioner and pharmacist to be certain a prescription is legitimate and complete

94
Q

What is the difference between dispensing, administering, and prescribing?

A
  • Dispensing: to deliver a controlled substance to an ultimate user or research subject; includes prescribing, administering, packaging, labeling, or compounding
  • Administering: direct application of a substance (injection, inhalation, ingestion, or any other means) to the body of the patient or research subject
  • Prescribing: issuing an order for a medication which is dispensed to or for an ultimate user (does not include an order for medication which is dispensed for immediate administration to the ultimate user)
95
Q

Can a controlled substance prescription be issued for general office dispensing?

A

No. Can just sell to the office given they are registered with the DEA and follow the 5% rule

96
Q

What can be changed on/added to a C-II Rx by a pharmacist?

A

Professional judgement

97
Q

What can be changed on/added to a C-III to C-V Rx by a pharmacist?

A
  • Change patient address upon verification
  • Dosage form, drug strength, drug quantity (only after consultation and agreement of prescribing practitioner)
  • Directions for use, issue date
98
Q

What must be documented after a change is made to a controlled substance Rx?

A
  • The change that was authorized
  • Name or initials of the individual giving authorization
  • Initials of the pharmacist
99
Q

What is the difference between the “issue” and “writing” of a prescription?

A

Anyone can write a prescription, but it must be issued by someone who is entitled to issue

100
Q

What factors are required to make a prescription for a controlled substance satisfy the “purpose of issue” of a prescription?

A
  • Legitimate medical purpose
  • Individual practitioner
  • Usual course of practice
  • Corresponding responsibility
101
Q

In addition to a prescriber signature, what 12 items are required on a written controlled substance prescription?

A
  1. Name of patient (full name)
  2. Address of patient
  3. Date of issuance
  4. Drug name
  5. Strength (if applicable)
  6. Dosage form of drug
  7. Quantity prescribed
  8. Direction for use
  9. Name of prescriber
  10. Address of prescriber
  11. DEA registration number of the prescriber
  12. Signature if written
102
Q

Who is entitled to fill prescriptions?

A

Pharmacists in pharmacies

103
Q

Is electronic prescribing of controlled substances allowed by federal law? Under what circumstances?

A

Yes. Involves certification on prescriber and dispenser ends.

104
Q

What is an “emergency” such that a telephone prescription is allowed for a C-II drug?

A
  • Immediate administration of the prescribed drug is necessary for proper treatment of the patient
  • No appropriate alternative exists, including a non C-II or noncontrolled drug
  • Not reasonably possible for the prescribing practitioner to provide a written Rx prior to the dispensing
105
Q

What governs the number of dose units dispensed for the patient pursuant to an “emergency”?

A

Quantity prescribed can only be for the emergency use period

106
Q

What is a “covering prescription” and when must it be “delivered” to the pharmacy?

A
  • Identical to the phone prescription, written down by the pharmacist except it is signed by the practitioner
  • Must say “authorization for emergency dispensing” on the face of the covering Rx
107
Q

What is the meaning of “post-dating”? Is it allowed for controlled substance prescriptions?

A
  • Prescription written to be filled at a later date
  • Date of issue is the date it is written
  • This is not allowed for controlled substance prescriptions!
108
Q

Can multiple prescriptions for a C-II medication be written by a prescriber on the same day?

A
  • “Regulations permit writing and signing identical C-II Rx on the same day, writing to the pharmacist not to fill them early, and giving the date of earliest authorized filling”
  • Date of issue is the date it is written
  • Total day supply authorized is 90 days of therapy
109
Q

Under what circumstances can a C-II drug prescription be faxed to the pharmacy and the faxed copy serve as the original?

A
  • Can be faxed if the original manually signed Rx is presented to the pharmacist for review prior to the actual dispensing of controlled substance
  • Fax can serve as original when:
    a. Schedule II narcotic compounded for the direct administration to a patient by parenteral, IV, IM, SQ, or intraspinal infusion
    b. Schedule II substance for LTCF
    c. Schedule II narcotic for patient enrolled in hospice care program certified and paid for by Medicare
110
Q

How many refills are allowed on C-II prescriptions?

A

None

111
Q

Are partial fills of C-II prescriptions allowed?

A
  • Initial partial filling is always allowed
  • If pharmacist “unable to supply”/only has a few:
    a. Dispense what they have, complete fill within 72 hours (pharmacy must have the balance of prescription ready for dispensing prior to 72 hour limit, patient not required to pick up balance within 72 hours)
  • If patient or prescriber requests a partial fill:
    a. Dispense what is requested
    b. Remainder can be filled within 30 days of date written/issued
    c. After 30 days, no dispensing allowed!
  • Emergency: 72 hour limit
112
Q

Are partial fills allowed for LTCF patients or patients with terminal illnesses?

A
  • There are exceptions for partial filling
  • Rules are:
    1. No more than face amount of Rx
    2. No dispensing past 60 days of date of issue
    3. Write “terminally ill” or “LTCF patient” on Rx
    4. Keep accurate records of all dispenses
113
Q

What information is required on a C-II prescription label?

A
  • Date of fill
  • Pharmacy name
  • Pharmacy address
  • Rx number
  • Name of patient
  • Name of prescribing practitioner
  • Directions for use and cautionary statements
  • “Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
114
Q

What information is required on a C-III to C-V prescription labels?

A
  • Date of initial fill
  • Pharmacy name
  • Pharmacy address
  • Rx number
  • Name of patient
  • Name of prescribing practitioner
  • Directions for use and cautionary statements
  • C-III and C-IV only: “Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
115
Q

When are the labeling requirements for controlled substances different for institutionalized patients?

A
  • Less than or equal to a 7 day supply
  • Not in possession of ultimate user
  • Institutional safeguards
  • Can identify supplier, drug, patient, directions, cautionary statements if any
116
Q

What is the “no transfer” label? For which schedules is it required?

A
  • “Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed”
  • C-II, C-III, and C-IV
117
Q

How can C-III through C-V prescriptions be communicated to a pharmacy? Which delivery methods must be signed by the prescriber?

A
  • Called, faxed, electronically sent: no original needed
  • Written and faxed must be signed by prescriber
118
Q

How are partial fills and refills handled on C-III, C-IV, and C-V prescriptions?

A
  • Partial fills must add up to total allowed
  • Maximum of 5 refills
  • Time limit: 6 months from date of issue
119
Q

How long are C-III, C-IV, and C-V prescriptions valid?

A

6 months

120
Q

How long are C-II prescriptions valid?

A
  • 30 days
  • LTCF or terminally ill: 60 days
121
Q

May scheduled prescriptions be transferred to another pharmacy? Under what circumstances? How many times? Which schedules?

A
  • Can be transferred ONE TIME ONLY
  • If real-time on-line database shared by pharmacies: multiple transfers permitted
    a. Remaining refills transferred with Rx
    b. Communicated b/w pharmacists
  • CANNOT transfer original unfilled prescription received in paper (including fax) or oral form to another pharmacy; after filled once, can be transferred
122
Q

If have real-time on-line database shared by pharmacies and are transferring, what must the transferor record?

A
  • Write “VOID” on hard copy or add info to e-script
  • Record receiver info on back of hard copy Rx
    a. Pharmacy name
    b. Address
    c. DEA#
    d. Pharmacist name
    e. Date of transfer
123
Q

If have real-time on-line database shared by pharmacies and are transferring, what must the receiver record?

A
  1. Original date of issuance
  2. Original refill #
  3. Date of original dispensing
  4. Refills remaining and dates/locations of previous refills
  5. Pharmacy name, address, DEA #
  6. Rx number
  7. Pharmacist name
  8. Original fill pharmacy info
124
Q

What are the rules for dispensing a C-V drug without a prescription? Are there limits on these purchases?

A
  • Purchaser must be at least 18 yo
  • Must “know” the purchaser or see an ID
  • Pharmacist can only authorize, someone else must ring up
  • Only 120mL (4oz) of any codeine-containing drug to an individual purchaser in any 48-hour period
125
Q

What is a “central fill” pharmacy?

A
  • A centralized prescription filling system where a central pharmacy location is responsible for dispensing medications to multiple retail/community pharmacies
  • Retail can fax or submit electronically to central fill, must write “Central Fill” on Rx and record lots of additional info
  • Retail retains original for 2 years
126
Q

What is the minimum time period for which controlled substance records should be maintained?

A

2 years

127
Q

What is a Form 222?

A

Form required for all pharmacy purchases and non-prescription transfers of C-II drugs

128
Q

Who gets (and maintains) copies of the executed Form 222?

A
  • Ordering pharmacy keeps a copy
  • DEA gets a copy
  • Original will go to supplier
129
Q

Who is legally allowed to sign Form 222s?

A
  • Most recent signer of registration/re-registration is the person with authority to sign
  • Authority can be delegated via power of attorney form
130
Q

What schedules can be ordered on a 222?

A

C-II

131
Q

How are a paper Form 222 and CSOS the same and different?

A

CSOS is a digital signature issued to purchaser by the DEA

132
Q

For how many days is a completed 222 valid?

A

60 days

133
Q

What is meant by “central recordkeeping”?

A

Allows certain registered entities to maintain their records at a central location rather than at each individual site where controlled substances are handled

134
Q

What records can NOT be sent to a central location (ie, they must be kept at the registered location)?

A
  • Form 222s
  • POA
  • Receipts and invoices for CIII – CV
  • Inventories
  • Records of distribution (selling to another registrant)
  • Records of controlled substances dispensed (Rxs, log book for OTC)
  • 106s
  • DEA registration certificate
135
Q

What is the purpose of the red C? If it is required, where is the red C stamped on the prescription?

A
  • To help find C-III, C-IV, C-V prescriptions amidst non-controls
  • Placed on Rx in bottom right corner (no less than 1 inch high)
136
Q

What 4 search characteristics must be available in a data processing system to eliminate the need for the red C on a prescription?

A
  • Prescriber’s name
  • Patient’s name
  • Drug dispensed
  • Date filled
137
Q

What storage (filing) systems/schemes are permitted for controlled substance prescriptions?

A
  • A drawer for C-II only
  • C-III to C-V can be on their own or mixed in with non-controls
138
Q

What is a “biennial inventory”?

A

Every 2 years

139
Q

When is the first controlled substances inventory in a pharmacy required to be recorded?

A

The day the business opens for the first time

140
Q

What is the maximum time period permitted between official biennial inventories?

A

2 years

141
Q

What drug schedules must be counted/measured accurately, and what schedule drugs may be estimated – and what is the exception to that second group?

A
  • C-II: must be accurately/exactly counted or measured
    a. Including liquids, powders to nearest metric unit volume/weight
  • C-III, C-IV, C-V: must be accurately/exactly counted if original container had more than 1000 tabs/caps
  • C-III, C-IV, C-V: can be estimated if original container had less than 1000 tabs/caps
142
Q

Are more frequent inventories permitted with the most recent being the “official” inventory?

A

Yes

143
Q

What is a standard record for receiving controlled substances? How about for dispensing?

A

Prescriptions and invoices are records of receiving and dispensing in the interim

144
Q

What is required if a non-controlled drug on hand in the pharmacy is changed to a controlled drug between inventories?

A

Add newly controlled drugs to inventory

145
Q

What is the significance of recording “opening” or “closing” on the inventory?

A

Whether the numbers recorded reflect drugs on hand at open or close

146
Q

What is a “perpetual” or “running” inventory and is that required by law?

A
  • A method of keeping track of controlled substances in a continuous/ongoing manner
  • This is not required by DEA but is considered a best practice
147
Q

How is a biennial inventory used to determine a loss or theft of a controlled substance?

A

Used to identify discrepancies

148
Q

What DEA form is used to record destruction of scheduled drugs? Who usually destroys the drugs?

A
  • Form 41: Registrant’s Inventory of Drugs Surrendered (completed by reverse distributor)
  • Reverse distributor
149
Q

Under what circumstances is a Form 222 also required for destruction?

A

Transfers – sending in for destruction

150
Q

What DEA form is used to report theft or significant loss of controlled substances?

A

Form 106

151
Q

What is a “collector”? Can pharmacies serve as collectors? How does controlled substance disposal differ for registrants and non-registrants?

A
  • “Manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, retail pharmacies, LTCFs w/ registered hospitals/clinics or retail pharmacies authorized to maintain collection receptacles”
  • Three options for registrants:
    a. Destroy on-site (2 destroyers/witnesses) – pharmacy stock
    b. Send for destruction via reverse distributor (reverse distributor will complete Form 41)
    c. Request assistance from regional DEA Special Agent
  • Non registrants:
    a. Law endorcement
    b. Authorized collectors
    c. Mail-back or collection receptacles (collection receptacles and inner liners have lots of stipulations)
152
Q

What are the scheduled listed chemical products (SLCPs)?

A

Products behind counter or in locked cabinet (ex. ephedrine, pseudoephedrine, phenylpropanolamine)

153
Q

What are the federal ID requirements for purchasing SLCPs?

A

Must ID purchaser (unexpired photo ID issued by state or government)

154
Q

What information must be recorded upon the sale of SLCPs?

A
  • Record purchaser name, address, signature, product sold, quantity, date, time
  • Maintain logbook for 2 years
155
Q

What are the federal daily and 30-day quantity limits for SLCP sales?

A
  • 3.6 g daily
  • 9 g in 30 days

Pharmacy Law (3 decks)

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