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MB JURISPRUDENCE > FDRL > Flashcards

FDRL Flashcards

1
Q

LIST OF CIV

A

List of Schedule IV controlled drugs:
______________________________

Tramadol (Ultram)
Alprazolam (Xanax)
Barbital (Barbitone)
Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol)
Carisoprodol (Soma)
Chloral hydrate (Noctec)
Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen)
Clonazepam (Klonopin, Clonopin)
Clorazepate(Tranxene)
Dexfenfluramine (Redux)
Propoxyphene dosage forms with other ingredients (Darvon, Darvocet, Dolene, Propacet)
Diazepam (Valium, Valrelease)
Dichloralphenazone (Midrin)
Difenoxin 1 mg/ Atropine 25 mcg (Motofen)
Estazolam (ProSom, Domnamid, Eurodin, Nuctalon)
Ethchlorvynol (Placidyl)
Fenfluramine (Pondimin, Ponderal)
Flurazepam (Dalmane)
Lorazepam (Ativan)
Mazindol (Sanorex, Mazanor)
Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan)
Midazolam (Versed)
Modafinil (Provigil)
Oxazepam (Serax, Serenid-D)
Pemoline (Cylert)
Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound)
Phenobarbital (Luminal, Donnatal, Bellergal-S)
Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl)
Prazepam (Centrax)
Quazepam (Doral, Dormalin)
Sibutramine (Meridia)
Temazepam (Restoril)
Triazolam (Halcion)
Zaleplon (Sonata)
Zolpidem (Ambien)
Eszopiclone (Lunesta)
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2
Q

LIST OF CII

A

Alfentanil (Alfenta) Amobarbital (Amytal, Tuinal) Amphetamine (Dexedrine, Biphetamine)

Coca Leaves Cocaine Codeine Dextropropoxyphene, bulk (non-dosage forms) Dihydrocodeine (Didrate, Parzone) Diphenoxylate Diprenorphine Ecgonine (Cocaine precursor, in Coca leaves) Ethylmorphine (Dionin) Fentanyl (Innovar, Sublimaze, Duragesic) Glutethimide (Doriden, Dorimide) Hydrocodone (dihydrocodeinone)

Hydrocodone and isoquinoline alkaloid

Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia)Hydromorphone (Dilaudid, dihydromorphinone) Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate)

Lisdexamfetamine (Vyvanse)Meperidine (Demerol, Mepergan, pethidine) Methadone (Dolophine, Methadose, Amidone) Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed) Methylphenidate (Ritalin) Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR) Opium poppy Opium tincture Opium, granulated Opium, powdered Opium, raw Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw Concentrate Remifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta)

Tapentadol (Nucynta)

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3
Q 
ALL IS REQUIRED ON MANDATORY DAILY HARD COPY PRINT OUT BY DATA PROCESSING SYSTEM EXCEPT: 
A. patient name.
B. quantity dispensed.
C. patient’s address.
D. date of issuing.
A

(d) Date of issuing, [21CFR1306.22(f)(3)-to-(4)].
1. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application.
2. If such an application provides a hard-copy printout of each day’s controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order.
3. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. Smith, or John H. Smith).
4. This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date.
5. This printout of the day’s controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing.
6. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the appropriately authorized refill.
7. Any such computerized application shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both).
8. Such a printout must include:

a. name of the prescribing practitioner,
b. name and address of the patient,
c. quantity dispensed on each refill,
d. date of dispensing (not issuing) for each refill,
e. name or identification code of the dispensing pharmacist, and
f. the number of the original prescription order.

In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its application by documentation (e.g., postmark).

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4
Q

WHAT IS LTCF?

A

The term Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients, [21CFR1300.01 Definitions-25].

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5
Q

WHAT IS SKILLED NURSING HOME?

A

A Skilled Nursing Facility is a nursing home that meets criteria for accreditation established by the sections of the Social Security Act that determine the basis for Medicaid and Medicare reimbursement for skilled nursing care.

Skilled nursing care includes rehabilitation and various medical and nursing procedures.

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6
Q

WHAT IS ICF?

A

An Intermediate Care Facility (ICF) is a nursing home that is recognized only under Medicaid.

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7
Q

WHAT ARE MID LEVEL PRACTIONERS

A 
ANYONE OTHER THAN
1. PHYSICIAN
2. DENTIST
3. VETERINARIAN
4. 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.
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8
Q

DEA 222 IS USED FOR?

A

ORDERING CONTROL SUBSTANCES

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9
Q

DEA 224 IS USED FOR?

A

NEW REGISTRATION FOR DISPENSING

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10
Q

DEA 225 IS USED FOR?

A

NEW NEW REGISTRATION FOR EVERYTHING ELSE BUT DISPENSING MANUFACTURING, DISTRIBUTION, REVERSE DISTRIBUTION, IMPORTING, CHEMICAL ANALYSIS OR RESEARCH

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11
Q

DEA 363 IS USED FOR?

A

NEW REGISTRATION FOR NARCOTIC TREATMENT PROGRAM

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12
Q

DEA 224A

A

RENEWAL FOR DISPENSING

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13
Q

DEA 225A

A

RENEWAL OF EVERYTHING ELSE BUT DISPENSING

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14
Q

DEA 363A IS USED FOR?

A

RENEWAL OF NARCOTIC TREATMENT PROGRAM

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15
Q

DEA 41 IS USED FOR?

A

DESTRUCTION OF CONTROL SUBSTANCES.

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16
Q

WHAT IS THE SCHEDULE OF DIFENOXIN?

A

CI

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17
Q

WHAT IS THE SCHEDULE OF MESCALINE

A

CI

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18
Q

WHAT IS THE SCHEDULE OF PEYOTE

A

CI

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19
Q

HOW MUCH CODEINE SHOULD BE PRESENT IN A MIXTURE TO BE CLASSIFIED AS CIII

A

LESS THAN 1.8 GRAMS PER 100ML

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20
Q

WHAT IS THE CLASSFICATION OF LOMOTIL?

A

CV

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21
Q

WHAT IS THE CLASSIFICATION OF EZOGABINE

A

CV

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22
Q

WHAT SHOULD BE THE CONC OF CODEINE IN A MIXTURE TO BE CLASSIFIED AS CV?

A

NOT MORE THAN 200MG PER 100ML OR GM (ROBITTUSIN AC OR PHENERGAN WITH CODEINE)

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23
Q

WHAT SHOULD BE THE CONC OF DIFENOXIN IN A MIXTURE TO BE CLASSIFIED AS CV?

A

NOT MORE THAN 0.5MG DIFENOXIN + 25MCG OF ATROPINE SULFATE (MOTOFEN)

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24
Q

WHAT SHOULD BE THE CONC OF DIHYDROCODEINE IN A MIXTURE TO BE CLASSIFIED AS CV?

A

NOT MORE THAN 100MG PER 100ML OR GRAM

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25
Q

WHAT SHOULD BE THE CONC OF DIPHENOXALAT IN A MIXTURE TO BE CLASSIFIED AS CV?

A

NOT MORE THAN 2.5MG (DIPHENOXALATE) + 25MG ATROPINE (LOMOTIL OR LOGEN)

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26
Q

WHAT SHOULD BE THE CONC OF OPIUM IN A MIXTURE TO BE CLASSIFIED AS CV?

A

NOT MORE THAN 100MG PER 100ML OR GRAM

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27
Q

WHAT SHOULD BE THE CONC OF EHTYLMORPHINE IN A MIXTURE TO BE CLASSIFIED AS CV?

A

NOT MORE THAN 100MG PER 100ML OR GRAM

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28
Q

WHAT MIXTURE OR COMPOUNDS ARE CONSIDERED TO BE CV IF THEIR CONC IS LESS THAN OR EQUAL TO 1% (100MG PER 100ML OR GRAM)?

A
  1. DIHYDORCODEINNE PREPARATIONS (ROBITUSSIN AC, PHENERGAN WITH CODEINE)
  2. EHTYLMORPHINE PREPARATIONS
  3. OPIUM PREPARATIONS (PAREPECTOLINE, KAPECTOLIN PG, KAOLIN PECTIN PG)
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29
Q

WHAT IS THE SCHEDULE OF LYRICA

A

CV

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30
Q

WHAT IS THE SCHECULE OF VIMPAT

A

CV - LACOSAMIDE (VIMPAT)

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31
Q

WHAT IS THE SCHECULE OF POTIGA

A

CV - EXOGABINE

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32
Q

“DOUBLE CHECK, DO NOT DOUBLE UP” MESSAGE IS IN REFERENCE TO WHICH DRUG?

A

ACETAMINOPHEN

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33
Q

CAN A SUPPLIER FILL A PARTIAL DEA222 FORM

A

YES, THE REMAINING QUANTITY SHOULD BE SUPPLIED WITHIN 60 DAYS.

34
Q

FOR AN EMERGENCY ORAL PRESCRIPTION OF CII MEDICATION THE PRESCRIBER MUST SUPPLY THE HARD COPY WITHIN?

A

7 DAYS

35
Q

CAN A PHARMACIST FILL A CII PRESCRIPTION PARTIALLY?

A

YES, BUT THE REMAINING QTY MUST BE FILLED WITHIN 72 HOURS OTHERWISE IT BECOMES VOID.

36
Q

CAN A PHARMACIST PARTIALLY FILL A CII PRESCRIPTION WITHOUT THE 72 HOUR RULE?

A

YES, FOR PATIENTS IN LTCF OR TERMINALLY ILL PATIENTS.

37
Q

AAOA

A

ALLIED AGAINST OPIOID ABUSE

38
Q

WHO DEVELOPED THE PHARMACY TOOK KIT IN ASSOCIATION WITH BOARD OF PHARMACIES TO HELP PHARMACIST ENGAGE, EDUCATE PATIENTS ABOUT PAIN MEDICATIONS.

A

ALLIED AGAINST OPIOID ABUSE - AAAOA

39
Q

HOW LONG AFTER EXPIRATION YOU ARE ALLOWED TO REINSTATE YOUR DEA LICENSE

A

1 MONTH

40
Q

WHAT IS A STANDING ORDER?

A

A PRESCRIPTION ORDER WRITTEN BY A PRESCRIBER THAT IS NOT SPECIFIC TO AND DOES NOT IDENTIFY A PARTICULAR PATIENT.

41
Q

WHAT IS ARCOS?

A

AUTOMATION OF REPORTS AND CONSOLIDATED ORDER SYSTEM

42
Q

WHAT IS MAT?

A

MEDICATION ASSISTED TREATMENT: USE MEDICATION IN COMBINATION IWTH COUNSELING AND BEAHVIOUR THERAPY.

43
Q

Form FDA 2632

A

Application for Approval for Use of Narcotic Drugs in a Narcotic Addiction Treatment Program

44
Q

Form FDA 2633

A

Medical Responsibility Statement for Use of Narcotic Drugs in a Treatment Program

45
Q

Form FDA 2635

A

Consent to Treatment with an Approved Narcotic Drug

46
Q

Form FDA 2636

A

Hospital Request for Methadone Detoxification Treatment

47
Q

Form FDA 482

A

Notice of Inspection (sample)

48
Q

Form FDA 2438b

A

Routine Notice to Observe Patient Identifying Information

49
Q

Form FDA 483

A

Inspectional Observations

50
Q

SCHEDULE OF BUPRE-NORPHINE?

A

CIII

51
Q

CAN BUPRENEX (Buprenorphine) BE PRESCRIBED TO TREAT NARCOTIC ADDICTION?

A

NO, IT IS ONLY FDA APPROVED FOR TREATMENT OF PAIN

52
Q

WHICH DOSAGE FORMS OF BURPRENORPHINE ARE ALLOWED FOR TREATMENT OF NARCOTIC ADDICTION?

A 
SUBOXONE (Buprenorphine + Naloxone)
AND SUBUTEX (Buprenorphine)
53
Q

DOES A 222 FORM REQUIRED FOR TRANSFER OF CII FILLED PRESCRIPTIONS FROM A CENTRAL FILL PHARMACY TO RETAIL PHARMACY

A

NO

54
Q

TAMPER EVIDENT PACKAGING IS REQUIRED FOR?

A

ALL OTC PACKAGES EXCEPT

  1. DERMATOLOGICAL
  2. DENTRIFICE
  3. INSULINE
  4. LOZENGE
55
Q

OTC ARE CLASSIFIED IN HOW MANY CATEGORIES

A

3
CATEGORY I
CATEGORY II
CATEGORY III

56
Q

WHAT ARE CATEGORY I OTC

A

CONTAINING INGREDIENTS THAT ARE GENERALLY SAFE, EFFECTIVE AND NOT MISBRANDED.

57
Q

WHAT ARE CATEOGRY II OTC

A

CONTAINING INGREDIENTS THAT ARE NOT GENERALLY SAFE AND EFFECTIVE OR THAT ARE MISBRANDED

58
Q

CATEGORY III OTC

A

CONTAIN INGREDIENTS FOR WHICH DATA AVAILABLE ARE INSUFFICIENT TO PERMIT CLASSIFICATION

59
Q

IPECAC SYRUP CAN BE DISPENSED OTC ONLY FOR _____ ML OF VOLUME?

A

30ML

60
Q

WHAT IS THE DOSE OF IPECAC SYRUP FOR POISONING?

A

1 TABLE SPOON IN PERSON OVER 1 YEARS OF AGE

61
Q

WHAT NEEDS TO BE SUBMITTED TO FDA BEFORE START OF HUMAN TRIALS BY THE MANUFACTURER?

A

INVESTIGATIONAL NEW DRUG APPLICATION (IND)

62
Q

WHEN IS ABBREVIATED NEW DRUG APPLICATION USED (ANDA)

A

FOR A GENERIC MEDICATION.

63
Q

WHAT IS MEASURED IN PHASE I TRIALS

A

SAFETY OF A NEW DRUG

64
Q

WHAT IS MEASURED IN PHASE II TRIALS

A

THERAPEUCTIC EFFECTIVENESS

65
Q

WHAT IS MEASURED IN PHASE III TRIALS

A

EFFECTIVENESS AND EFFICIENCY OF A NEW DRUG AGAINST THE PLACEBO.

66
Q

WHAT IS SNDA USED FOR?

A

TO CHANGE PACKAGING AND LABELING REQUIREMENTS OF ALREADY MARKETED DRUGS

67
Q

FIRST SET OF DIGITS IN NDC REPRESENTS?

A

4 OR 5 DIGITS REPRESENT MANUFACTURER

68
Q

SECOND SET OF DIGITS IN NDC REPRESENTS?

A

3 OR 4 DIGITS REPRESENT STRENGTH, DOSAGE FORM, FORMULATION

69
Q

THIRD SET OF DIGITS IN NDC REPRESENTS?

A

1 OR 2 DIGITS REPRESENT PACKAGE SIZE.

70
Q

NPI NUMBER CONTAINS HOW MANY DIGITS?

A

10

71
Q

WHAT ARE CLASS I DRUG RECALLS?

A

SERIOUS OR LIFE THREATENING CONSEQUENCES

72
Q

WHAT ARE CLASS II DRUG RECALLS?

A

MAY CAUSE TEMPORARY OR MEDICALLY REVERSIBLE ADVERSE HEALTH EFFECTS

73
Q

WHAT ARE CLASS III DRUG RECALLS

A

MAY NOT CAUSE ADVERSE HEALTH CONSEQUENCES

74
Q

PPPA IS ENFORCED BY

A

CONSUMER PRODUCT SAFETY COMMISSION CPSC

75
Q

WHAT CONTAINERS ARE REQUIRED TO BE REPLACED WHEN REFILLING A PRESCRIPTION

A

ONLY PLASTIC CONTAINERS AND CLOSURES

76
Q

WHAT DURGS REQUIRE PPI (INSERTS)?

A
  1. ISOTRENTINOIN
  2. ESTROGEN AND PROGESTERONE CONTAINING PRODUCTS.
  3. ORAL CONTRACEPTIVES.
77
Q

MEDICAID PROVIDES HEALTH COVERAGE TO WHAT TYPE OF INDIVIDUALS?

A
  1. MEDICALLY INDIGINANT PEOPLE LIKE, bLIND, DISBALED AND AGED.
  2. CERTAIN LOW INCOME INDIVIDUALS AND FAMILIES.
78
Q

PROSPECTIVE DRUG REVIEW (PDR) IS REQUIRED WHAT TYPE OF PATIENTS?

A

FOR RETAIL OR OUT PATIENT PRESCRIPTIONS

79
Q

PDR STANDS FOR?

A

PROSPECTIVE DRUG REVIEW

80
Q

PDR IS MANDATED BY?

A

OBRA - 90

81
Q

ARE NDC NUMBERS REQUIRED ON DRUG LABELS?

A

NO

MB JURISPRUDENCE (13 decks)

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