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FL 1* > Chapter 1 fed > Flashcards

Chapter 1 fed Flashcards

1
Q

Following deaths caused by sulfanilamide elixir in 1937, Congress passed the first legislation that required new drugs to be proven to be safe prior to marketing.

Which Act?

A

Food, Drug, and Cosmetic Act of 1938

pg 21

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2
Q

Which Act established the FDA and is the primary federal law dealing with food, drug, cosmetic, and medical device safety today (with many amendments).

A

Food, Drug, and Cosmetic Act of 1938

pg 21

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3
Q

Which amendment established two classes of drugs: prescription and OTC

A

Durham-Humphrey Amendment of 1951

pg 21

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4
Q

T or F:

Under Florida law, medical oxygen may be supplied to a patient by a medical oxygen retail establishment licensed by the FL department of business and professional regulation (DBPR) pursuant to a valid prescription.

A

TRUE

It is one of the few drugs in FL that can be dispensed by a business that does not have a pharmacy permit.

pg 21

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5
Q

Which amendment authorized verbal prescriptions and prescription refills?

A

Durham-Humphrey Amendment of 1951

pg 21

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6
Q

Which amendment required new drugs to be proven safe and effective for their claimed use?

A

Kefauver-Harris Amendments of 1962

Prior to this amendment, new drugs only had to be safe. This amendment required new drugs to also be effective for their stated use.

pg 21

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7
Q

Which amendment increased safety requirements for drugs and established Good Manufacturing Practices (GMPs) for manufacturing of drugs?

A

Kefauver-Harris Amendments of 1962

pg 22

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8
Q

Which amendment gave the FDA jurisdiction over prescription drug advertising?

A

Kefauver-Harris Amendments of 1962

pg 22

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9
Q

Which Act banned the re-importation of prescription drugs and insulin products produced in the United States (except by the manufacturer) and banned the sale, trade, or purchase of prescription drug samples?

A

Prescription Drug Marketing Act of 1987 (PDMA)

pg 22

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10
Q

T or F

Starter packs are subject to regulation as prescription drugs in the same manner as stock shipments of prescription drugs. Starter packs are NOT drug samples.

A

True

pg 22

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11
Q

What Act mandates the storage, handling, and record keeping requirements for prescription drug samples?

A

Prescription Drug Marketing Act of 1987 (PDMA)

Pg 23

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12
Q

Which Act does the following pertain to?

  • obtaining written requests for samples from practitioners and requiring signatures of practitioners upon receipt
  • samples may only be provided to practitioners or, upon request of a licensed practitioner, to an institutional pharmacy or to pharmacies of other healthcare facilities
    -community pharmacies should not possess prescription drug samples, except for prescription drugs that may be ordered by a pharmacist. The only exception to this would be a community pharmacy that is part of a healthcare entity such as a community pharmacy owned by a hospital
A

Prescription Drug Marketing Act of 1987 (PDMA)

Pg 23

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13
Q

In Florida, what permit is required to hold distribute, or dispose of prescription drug samples.

A

Complimentary Drug Distributor Permit from the Division of Drugs, Devices, and Cosmetics (DDDC) of the Department of business and professional regulation

required to by the Prescription Drug Marketing Act of 1987 (PDMA).

pg 23

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14
Q

Who may not be in possession of prescription drug samples?

A

A community pharmacy that is not affiliated with a healthcare entity

pg 23

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15
Q

Which Act prohibits, with certain exceptions, the resale of prescription drugs purchased by hospitals or healthcare facilities?

A

Prescription Drug Marketing Act of 1987 (PDMA)

*this is intended to prevent diversion of drugs due to price diversion because hospitals generally receive lower prices for drugs than community pharmacies

pg 23

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16
Q

The Drug Quality and Security Act of 2013 - these amendments to the FDCA addressed which two primary topics?

A

1) large-scale compounding by pharmacies
2) establishment of a frame-work for uniform track-and-trace system for prescription drugs throughout the supply chain to prevent counterfeit drugs

pg 23

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17
Q

Which Act passed in response to an outbreak of fungal meningitis in over 20 states in the fall of 2012, which was traced to a contaminated injectable steroid produced by the New England Compounding Center?

A

Drug Compounding Quality Act (DCQA)

*This outbreak resulted in the death of 60 patients and over 750 cases of infection

pg 23

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18
Q

Which Act allows outsourcing facilities, often referred to as 503B facilities to compound sterile products without receiving patient-specific prescriptions or medication orders?

A

Drug Compounding Quality Act (DCQA)

*these 503B facilities are primarily regulated by the FDA and are subject to FDA’s current Good Manufacturing Practices (cGMP) – there are currently only 70 registered outsourcing facilities in the entire country

pg 24

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19
Q

True or False
Outsourcing facilities that meet the Drug Compounding Quality Act are exempt from:
- premarket approval requirements for new drugs
-adequate directions for use requirements
-drug trace-and-track provisions

A

TRUE

pg 24

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20
Q

What is the difference between 503A and 503B?

A

503A pharmacies may only compound products pursuant to an individual prescription or medication order; permitted to do limited anticipatory compounding and primarily regulated by the states, and are subject to USP Chapter 797 quality standards for sterile compounding; NOT registered with the FDA as an outsourcing facility

503B no rx required; registered with the FDA

pg 24

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21
Q

Are outsourcing facilities exempt from good manufacturing practices?

A

No

pg 24

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22
Q

T or F

Outsourcing facilities MUST:

1) have a licensed pharmacist who provides direct oversight over the drugs compounded
2) register as an outsourcing facility
3) Report to the Secretary of HHS upon registering and every 6 months thereafter, the drugs sold in the previous six months
4) be inspected by FDA according to risk-based inspection schedule and pay annual fees to support it
5) report serious a/e experiences within 15 days and conduct a f/u investigation and reporting similar to current drug manufacturers
6) label products with a statement identifying them as a compounded drug and other specified information about the drug

A

True

pg 24

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23
Q

When are outsourcing facilities allowed to compound a drug product that includes a bulk drug substance?

A

1) the bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need
OR
2) the drug product compounded from such bulk drug substance appears on FDA’s drug shortage list at the time of compounding, distribution, and dispensing

pg 25

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24
Q

Section 503A limits interstate distribution of compounded drugs to __% unless the compounder is located in a state that has entered into a memorandum of understanding (MOU) with FDA addressing inordinate amounts of compounded drugs in interstate commerce and providing for appropriate investigation of complaints by a state

A

5%

pg 26

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25
Q

In states that have entered into an MOU with FDA, a pharmacy is considered to have distributed an inordinate amount of compounded drug products in interstate commerce if the number of prescription orders for compounded human drug products that the pharmacy distributed interstate during any calendar year is great than 50% of the sum of:
1)
2)

A

1) # of prescription orders for compounded human drug products that the pharmacy sent out of (or caused to be sent out of) the facility in which the drug products were compounded during that same calendar year
PLUS
2) the number of rx orders for compounded human drug products that were dispensed (eg picked up by patient) at the pharmacy during that same calendar year.

pg 26

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26
Q

T or F

In states that have not entered into an MOU with the FDA, a pharmacy may not distribute (or cause to be distributed) compounded drug products out of the state in which they are compounded in quantities that exceed 5% of the total prescription orders dispensed or distributed by such pharmacy

A

True

pg 26

NOTE: beginning Oct 2022, FL pharmacies may not distribute (or cause to be distributed) compounded drug products out of state in quantities that exceed 5% of the total prescription orders dispensed or distributed by such pharmacy ***this COULD change

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27
Q

Which Act?
1) provides for a uniform national framework for an electronic track-and-trace system for prescription drugs as they move through the supply chain, and sets national standards for state to license drug wholesaler distributers

2) applies to prescription drugs for human use in finished dosage form, but certain products are exempted, including blood and blood components, radioactive drugs, imaging drugs, certain IV products for fluid replacement, dialysis solutions, medical gases, compounded drugs, medical convenience kits containing drugs, certain combination products, sterile water, and products for irrigation

A

Drugs Supply Chain Security Act (DSCSA) (Track and Trace)

Pg 27

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28
Q

Per ______ Act, manufacturers are required to provide “Transaction Data” for each product sold. Wholesalers are required to receive transaction data upon purchase and subsequently provide transaction data to buyer (pharmacies or other wholesalers), and pharmacies are required to receive transaction data and pass this information along if they further distribute the product

A

Drugs Supply Chain Security Act (DSCSA) (Track and Trace)

**transaction data INCLUDES:
> transaction information (product’s name, strength, dosage form; NDC #; container size and number of containers; date of transaction; and name and address of the person from whom ownership is being transferred and to whom ownership is being transferred. A unique product identifier or serialized numerical identifier (SNI) will also be required that identifies an individual bottle or unit of sale),

> transaction history (a paper or electronic statement that includes prior transaction back to the manufacturer)

> AND a transaction statement (a paper or electronic statement by the seller that the seller is authorized (licensed), received the product from an authorized person (licensed), received the transaction info and transaction history from the prior owner if required, did not knowingly ship a suspect or illegitimate product, has systems and processes to comply with verification requirements, and did not knowingly provide false transaction information)

pg 27

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29
Q

How long must transaction data be maintained for by each supply chain partner?

A

6 years

pg 28

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30
Q

When pharmacies are investigating any suspect or illegitimate product, a pharmacy must verify the product identifier of at least __#__ products or ___% of the suspect product, whichever is greater, or all of the packages if there are fewer than _#__.

A

= at least 3 products, or 10%

pg 28

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31
Q

What form do pharmacies use when notifying the FDA of an illegitamate product?

A

Form FDA 3911 and notify trading partners within 24 HOURS

pg 29

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32
Q

Drug Supply Chain Security Act (DSCSA - Track and Trace)

What are the 4 exceptions to having a distribution license and passing transaction data?

A

1: when the distribution is between two entities that are affiliated or under common ownership
2: when a dispenser is providing product to another dispenser on a patient-specific basis
3: when a dispenser is distributing under emergency medical reasons
or
4: when a dispenser is distributing “minimal quantities” to a licensed practitioner for office use

pg 29

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33
Q

Adulterate or misbranded?

the drug contains any filthy, putrid, or decomposed substance

A

adulterated

pg 29

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34
Q

Adulterate or misbranded?

the drug has been prepared or held under insanitary conditions where it may have been contaminated

A

adulterated

pg 29

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35
Q

Adulterate or misbranded?

the methods of manufacture do not conform to current good manufacturing practices

A

adulterated

pg 30

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36
Q

Adulterate or misbranded?

the drug has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory/warehouse/establishment delays, denies, or limits and inspection or refuses to permit entry or inspection

A

Adulterate

pg 30

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37
Q

Adulterate or misbranded?

the container is composed of any poisonous or deleterious substance which may contaminate the drug

A

adulterated

pg 30

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38
Q

Adulterate or misbranded?

the drug contains an unsafe color additive

A

adulterated

pg 30

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39
Q

Adulterate or misbranded?

it purports to be a drug in an official compendium and its strength differs from or its quality or purity falls below the compendium standard, unless the difference is clearly stated on the label

aka the product claims to meet USP standards and its strength or quality does not meet those standards

A

adulterated

pg 30

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40
Q

Adulterate or misbranded?

it is not in a compendium and its strength differs from or its quality falls below what it represents

aka even if the product does not claim to meet USP standards, if the strength or quality differs or falls below what is stated on its label or labeling, it is…… _______________

A

adulterated

pg 30

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41
Q

Adulterate or misbranded?

the drug is mixed or packed with any substance that reduces its strength or quality, or the drug has been substituted in whole or in part

A

adulterated

pg 30

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42
Q

Adulterate or misbranded?

If a products strength is less than what is represented on its label

A

it could be BOTH misbranded and adulterated

pg 30

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43
Q

Adulterate or misbranded?

the labeling is false or misleading in any particular way

A

misbranding

pg 30

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44
Q

Adulterate or misbranded?

it is a prescription drug and the manufacturer’s labeling fails to contain the following information:

-the name and address of the manufacturer, packer or distributor
-brand and/or generic name of the drug or drug product
-the net quantity (weight, quantity, or dosage units)
-the weight of active ingredient per dosage unit
-the federal legend “rx only”
-if not taken orally, the specific routes of administration
-special storage instructions, if appropriate
-manufacturers control number (lot number)
-expiration date
-adequate information for use. for rx drugs, this is the package insert and medication guide or patient package insert if required. this also includes other information required (certain products, including opioids and benzos, required black box warnings to alert healthcare professionals about essential info about the product)

A

misbranded

pg 30

NOTE: these labeling requirements are for the manufacturer; when a pharmacist dispenses a drug to a patient pursuant to a valid prescription, the label does not have to contain all of these elements. refer to the state prescription labeling requirements

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45
Q

Adulterate or misbranded?

It is an OTC drug and fails to contain the following:
a. A principle display panel, including a statement of identity of the product
b. The name and address of the manufacturer, packer or distributer
c. net quantity of contents
d. cautions and warning needed to protect user
e. adequate directions for safe and effective use
f. content and format of OTC product labeling in drug facts panel format (active ingredients, purpose, uses/indications, warnings, directions, other info, inactive ingredients, questions+telephone #)

A

misbranded

pg 31

*pharmacists should know labeling requirements for OTC drugs

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46
Q

Adulterate or misbranded?

It is a drug liable to deterioration unless it is packaged or labeled accordingly

A

misbranded

pg 31

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47
Q

Adulterate or misbranded?

The container is made, formed, or filled as to be misleading

A

misbranded

pg 31

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48
Q

Adulterate or misbranded?

the drug is an exact imitation of another drug or offered for sale under the name of another drug

A

misbranded

pg 31

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49
Q

Adulterate or misbranded?

it is dangerous to health when used in the dosage or manner suggested in the labeling

A

misbranded

pg 32

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50
Q

Adulterate or misbranded?

it is packaged or labeled in violation of the Poison Prevention Packaging Act

A

misbranded

pg 32

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51
Q

Dispensing a prescription without authorization causes the drug to be ____________ even if it is labeled correctly by the pharmacist. This is because a prescription drug product is only exempt from the manufacturers labeling requirements when it is dispensed pursuant to a valid prescription

Adulterate or misbranded?

A

misbranded

pg 32

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52
Q

Misfiling a prescription with the wrong drug, strength, or directions for use will always cause the drug to be _____________.

if a misfiled prescription involves the wrong strength of the drug prescribed, it would also be ___________.

Adulterate or misbranded?

A

misbranded

adulterated – this is because the definition of adulteration includes when the strength differs from or quality falls below that which it represents

pg 32

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53
Q

If a drug is subject to REMS and it is prescribed or dispensed without meeting the requirements of the REMS, it is ______________

Adulterate or misbranded?

A

misbranded – because the REMS program is part of the official labeling of the drug

pg 32

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54
Q

The advertising or promotion of a compounded drug that is false or misleading would be ______________

Adulterate or misbranded?

A

misbranding

pg 32

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55
Q

An expired drug product in a manufacturer’s bottle is adulterated because after the expiration date, the strength cannot be assured. If a prescription is filled using an expired product, it may also be ______________ if the pharmacist placed a BUD that is after the expiration date of the drug

Adulterate or misbranded?

A

misbranded

pg 33

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56
Q

If a pharmacist stores inventory in a room or refrigerator where the temp is not adequately controlled, the products would be ______________

Adulterate or misbranded?

A

adulterated

pg 33

57
Q

If a pharmacist stores stores a specific product incorrectly, such as stocking a medication on a pharmacy shelf instead of in the refrigerator as required, this would lead to the product being ______________
Adulterate or misbranded?

A

adulterated

pg 33

58
Q

If a pharmacist fails to dispense a medication in a child-resistant container when required, this would be ________________
Adulterate or misbranded?

A

misbranding

pg 33

59
Q

STUDY TIP!

You are more likely to encounter questions related to adulteration and misbranding based on scenarios in a pharmacy

A

:)

60
Q

Special Warning Requirements for OTC products in the FDCA

FD&C Yellow No. 5 (tartrazine) and No.6 (21 CFR 201.20):

A

Must disclose presence and provide warning in “precautions” section of label that may cause allergic reaction in certain susceptible persons

pg 33

61
Q

Special Warning Requirements for OTC products in the FDCA

Aspartame (21 CFR 201.21):

A

Must contain warning in pre-cautions” section of labeling to the following effect: phenylketonuria’s: contains phenylalanine __mg per (dosage unit)

pg 33

62
Q

Special Warning Requirements for OTC products in the FDCA

Sulfites (21 CFR 201.22):

A

Prescription drugs containing sulfites (often used as a preservative) must contain an allergy warning in the “warnings: section of the labeling

pg 33

63
Q

Requires warning to only be taken at bedtime and not be used in infants unless under advice of a physician. Label also cannot encourage use during pregnancy

A

Mineral oil

64
Q

Any drug containing more than 5% of ______ ________ (often used as a flavoring agent) must include warning that any use other than directed may be dangerous and that the article should be kept out of reach of children

A

Wintergreen Oil (methyl salicylate)

65
Q

Limits the amount of sodium phosphates oral solution to not more than ___ ml per OTC container

A

90 ml

66
Q

Requires warning not to exceed dose prescribed and to contact physician if difficulty breathing persists

A

isoproterenol inhalation preparations

67
Q

requires warning regarding non specific small bowel lesions consisting of stenosis, with or without ulceration, associated with administration of enteric-coated thiazides with potassium salts

A

potassium salt preparations for ORAL ingestions

68
Q

the following statement (boxed and in RED letters) must appear: “For emergency use to cause vomitting in poisoning. Before using, call physician, the poison prevention center, or hospital emergency room immediately for advice”
- the following warning must appear “ warning: keep out of reach of children. do not use in unconscious persons”
-

A

Ipecac syrup

69
Q

The dosage of Ipecac syrup must appear on the label. the usual dosage is __________ in individuals over 1 year of age and may only be sold in ________ ml containers

A

1 tablespoon (15 ml)

1 oz (30 ml) containers

70
Q

Must contain warning about possible kidney damage when taken in large amounts or for along period of time

A

phenacetin (acetophenetidin)

71
Q

Must have special warnings for use in children, including warning regarding Reyes syndrome. Retail containers of one-fourth (pediatric dose) cannot be sold in containers holding more than _____ tablets.

A

Aspirin/salicylates
36 tablets

72
Q

Any OTC product label that states “For the temporary relief of minor sore throats” must include this warning

“warning- severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult physician promptly. do not use more than __ days or administer to children under 3 years of age unless directed by physician”

A

2 days

73
Q

Internal analgesics and antipyretics, including APAP, ASA, ibuprofen, naproxen, ketoprofen, etc. are required Mohave a warning for persons consuming ___ or more alcoholic beverages per day and to consult with a doctor before taking

A

three

74
Q

OTC drugs for vaginal contraceptive and spermicide use containing nontoxynol 9 as the active ingredient must include what warning requirements

A

STDs, does not protect against HIV/AIDs

75
Q

What warnings must acetaminophen have on the label?

A
  • name prominently displayed
  • liver toxiciity
  • warn not to use with other products containing apap and to talk to a doctor or pharmacist before taking with warfarin
76
Q

What warnings must NSAIDs have?

A
  • must include “NSAID” prominently on label
  • must contain stomach bleeding warning
77
Q

OTC Products containing iron in solid oral dosage form must have on label

A
  • accidental overdose warning, leading cause of fatal poisoning in children under 6
  • keep product away from children
78
Q

What OTC products are exempt from tamper-evident packaging?

A

Dermatological, dentifrice, insulin, lozenge products

OTC products not packaged properly would be considered misbranded AND adulterated

79
Q

If a pharmacist is repackaging OTC products, would they still be subject to cGMP requirements, to include manufacturer labeling and tamper-evident packaging, if offered for sale to the public?

A

Yes (but not if it is an rx)

80
Q

FDA Drug and Device Recall Classifications

Reasonable probability product will cause either serious adverse effects on health or death

A

Class I

81
Q

FDA Drug and Device Recall Classifications

May cause temporary or medically reversible adverse effects on health or where probability of serious adverse effects is remote

A

Class 2`

82
Q

FDA Drug and Device Recall Classifications

Not likely to cause adverse health consequences

A

Class 3

83
Q

Prescription drug advertising is regulated by

A

FDA

84
Q

OTC drug advertising is regulated by

A

Federal Trade Commission (FTC)

85
Q

The advertising of prescription drug prices is considered ___________ advertising under FDA regulations

A

reminder advertising

86
Q

Reminder advertising is exempt from the FDA advertising regulations provided the following conditions are met (4 items)

A

1) the only purpose of the advertising is to provide information on price (NOT info on drug’s safety, efficacy, or indications for use)
2) contains the proprietary name (if any), the generic name of the drug, the drug’s strength, the dosage form, price charged for a specific quantity
3) may include: availability of professional or other types of services, as long as its not misleading
4) the price stated in the advertising shall include ALL charges (mailing and delivery fees may be stated separately)

87
Q

Florida law prohibits pharmacies from advertising or promoting the sale of __________ ____________

A

controlled substances

88
Q

If a pharmacy makes any therapeutic claims regarding compounding products, they would be subject to…

A

FDA’s rules on advertising

89
Q

Patient package inserts are required for

A

oral contraceptives
estrogen-containing products

90
Q

For hospitalized, institutionalized patients, and nursing homes, a patient packet insert must be provided to a patient prior to the FIRST administration of the drug and every ___ days thereafter

FAILURE to provide a PPI for these drugs would cause them to be….

A

30 days

misbranded!

91
Q

FDA Requires Medication Guides for all new and refill prescriptions dispensed in the community setting when:

(3)

A

1) patient labeling could prevent serious adverse effects
2) product has serious risks relative to benefits
3) patient adherence to directions is crucial

92
Q

Which drugs requires med guides (as listed in the book)

A

Accutane (isotretinoin)
Coumadin (warfarin)
Antidepressants in children and teenagers
Epogen (epoetin alfa)
Forteo (teriparatide)
Lindane shampoo and lotion
Lotronex (alosetron hcl)
Nolvadex (tamoxifen)
NSAIDs
Remicade (infliximab)
Trizivar (abavacir sulfate, lamivudine, and zidovudine)
Opioid analgesics and cough products
Benzos

93
Q

Failure to provide a Med Guide when dispensing a drug that requires one would cause the drug to be

A

misbranded

94
Q

Who must be registered with iPLEDGE before dispensing isotrentinoin (Accutance)?

A

Doctors, patients, and pharmacies, and pharmacists (in order to dispense)

95
Q

Females of reproductive potential have a ___-day window to get an isotretinoin prescription filled

A

7 day window

96
Q

Isotretinoin (Accutane) is dispensed in a blister package that cannot be broken. What is the maximum quantity that can be dispensed?

A

30 day supply

NO refills allowed

97
Q

What is the max supply of thalidomide {REMs w/ Celgene}

A

4 weeks (28 day supply)

no automatic refills or telephone prescriptions

pharmacy has to be certified through Celgene

98
Q

T or F

Thalidomide prescriptions can only be accepted with an authorization number and patient risk category

A

True

99
Q

Thalidomide authorization numbers are valid for ___ days from the date of the last pregnancy test for females of reproductive potential and 30 days from the dated issue for other patients

A

30 days

100
Q

For thalidomide, the pharmacy must obtain a confirmation number prior to dispensing via toll-free number or online. the confirmation number is valid for ___ hours and must be entered on the prescription.

A

24 hours

this means the prescription must be dispensed within 24 hours of obtaining the confirmation number.

101
Q

Who can counsel on thalidomide?

A

a certified thalidomide REMs counselor, counseling must be documented

Rxs cannot be transferred to another pharmacy without prior authorization from Celgene.

102
Q

If a dietary supplement or medical device has an NDC number on its label, it would be _____________

A

misbranded

103
Q

The primary source for determining generic equivalency of drugs

A

FDA Orange Book

104
Q

To be considered generically equivalent, a drug must be both _____________ equivalent and _____________ equivalent to the reference drug product (brand/generic)

A

pharmaceutically equivalent and therapeutically equivalent to the reference drug product

105
Q

_________________ equivalents are drug products in identical dosage forms and routes of administration that contain identical amounts of the identical active drug ingredient

A

pharmaceutical equivalents (aka same drug)

106
Q

_____________ equivalents are approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated

A

Therapeutic equivalents (aka same clinical effect)

107
Q

in the orange book, what letter = generic equivalent?

A

A

108
Q

in the orange book, what letter = NOT generic equivalent?

A

B

109
Q

This FDA book lists biological products that are considered biosimilars and provides interchangeability evaluations for these products

A

FDA purple book

110
Q

What is an interchangeable product?

A

a product that has been shown to be biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient

111
Q

T or F

ONLY biological products that have been designated “interchangeable” may be substituted for the original reference product by a pharmacist

A

True

Biosimilar products would require prescriber intervention in order to substitute

112
Q

Class ___ devices are deemed to be low risk and are therefore subject to the least regulatory controls

A

Class I (ie dental floss)

113
Q

Class __ devices are higher risk and require greater regulatory controls

A

Class II (syringes)

114
Q

Class __ devices are generally the highest risk devices and are subject to the highest level of regulatory control and those that pose a significant risk of illness of injury require premarket approval by the FDA

A

Class III (heart valve)

115
Q

The Poison Prevention Packaging Act of 1970 is administered by

A

Consumer Product Safety Commission (CPSC)

116
Q

Which act requires child-resistant containers for all prescription drugs and for certain non-prescription drugs, drug classes, preparations and dietary supplements?

A

The Poison Prevention Packaging Act of 1970

117
Q

Which drugs REQUIRE child-resistant containers

A

Aspirin; Naproxen >250mg; Ketoprofen >50 mg; Ibuprofen >1 g/pckg; Methyl salicylate (oil of wintergreen); containing >5%

Controlled drugs

Methyl alcohol (methanol) >4%

Iron-containing drugs/supplements >250mg elemental iron

Tylenol >1g in a single package

Benadryl >66mg

Loperamide >0.045mg/pckg

Lidocaine >5mg/pckg ; Dibucaine >0.5mg

Fluoride >50 mg elemental, >0.5% fluoride
minoxidil >14mg
Imidazolines >0.08mg

ANY drug switched from Rx to OTC status

118
Q

Exemptions from child resistant containers?

A

1) Request of the patient (blanket statement ok) or physician; Verbal request ok
2) Bulk containers not intended for household use
3) Drugs distributed to institutionalized pts
4) Rx drugs packaged for residents of LTCFs and other institutional setting if the facility personnel will administer the meds to pts
5) One package size of OTC drugs designed for elderly

119
Q

What specific Rx and non prescription drug are exempt from child resistant containers/the Poison Prevention Packaging Act?

KNOW

A

Oral contraceptives

Medroxyprogesterone acetate tablets

SL NTG, SL/chewable isosorbide dinitrate of <10mg

ASA and APAP in effervescent tablets or granules

K+ supps in unit-dose packaging

NaF containing not more than 264mg

anhydrous cholestyramine and colestipol packets

erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing no more than 8g of erythromycin {tablets - <16g}

prednisone tablets <105mg

methylprednisolone tablets <84 mg

mebendazole tabs <600 mg

betamethasone tabs <12.6mg

aerosol containers intended for inhalation

pancrealipase prepation

HRT

120
Q

T or F

A pharmacy is permitted to reuse a glass container if a new safety cap is provided with each fill

A

True

the law requires dispensing medications in a new vial/bottle and safety cap with each prescription filled

121
Q

When pharmacists don’t comply with the poison prevention packaging act, in addition to violating the PPPA (remember CPSC enforces), it is also a ___________ violation of the FDCA

A

misbranding

122
Q

The Federal Hazardous Substances Act of 1966 is enforced and administered by

A

Consumer product safety commission (CPSC)

123
Q

This Act is intended to protect consumers from hazardous and toxic substances

A

Federal Hazardous Substances Act

*note, this act does not apply to drugs regulated by the FDA, but many apply to other products sold in a Pharmacy such as bleach, cleaning fluids, antifreeze

124
Q

The Hazard Communication Standard is administered and enforced by

A

OSHA

(SDS/MSDS forms)

125
Q

______ requires that all written prescriptions meet certain tamper-resistant requirements to prevent unauthorized copying and to prevent counterfeiting (with some exceptions)

A

CMS

126
Q

CMS regulations require a consultant pharmacist to perform a Medication Regimen Review for all long-term care patients every ___ days.

A

30

the rph must report any irregularities to the attending physician, the facilities medical director, and facility’s director of nursing; reports must be acted upon.

127
Q

When pharmacy services are used at LTCF as PRN, psychotropic drugs must be limited to ___ days

A

14 days

UNLESS practitioner documents rationale for extending

128
Q

To reduce medication waste, pharmacies may not dispense more than a ___ day cycle of medications to LTCD residents

A

14 days

129
Q

What medications can be delivered by mail? by common carrier?

A

1) non-controlled rx
2) controlled rx {can be mailed to other DEA registrants - practitioners, pharmacies, distributors, or drug disposal firms}

any prescription drug may be delivered from a pharmacy to a pt by common carrier; this includes ALL schedules of CS and dangerous drugs. NOT subject to postal regulations.

130
Q

What requirements are necessary when mailing controlled substances?

A

1) the rx container must be labeled in compliance with rx labeling rules
2) the outer wrapper or container in which the prescription is placed must be free of markings that would indicate the nature of the contents (including the name of the pharmacy as part of the return address on the mailing package)
3) no markings of any kind may be placed on the package to indicate the nature of contents

131
Q

T or F

Pharmacies may use and disclose PHI to provide treatment for payment and for healthcare operations WITHOUT authorization from the patient.

A

True

132
Q

T or F

Pharmacies may use and disclose PHI for certain governmental functions without authorization from the patient.

A

True

this includes
- public health activities (reporting a/e to the FDA)
- health oversight agencies (BOPs, state monitoring programs)
- LAW enforcement agencies!!

133
Q

Patients have a right to access and obtain a copy of their PHI. Pharmacies must comply with a request within ___ days, but may extend time by no more than ___ additional days if they notify the individual of the reason for the delay.

A

30 days; 30 days

134
Q

Patients have a right to amend their PHI records and request and accounting of disclosures of their PHI made by a pharmacy under certain circumstances.

Pharmacies must comply with a request to amend or request for an accounting disclosures within ___ days, but may extend it by no more than ___ additional days if they notify the individual of the reason for the delay.

A

60 days; 30 days

135
Q

What did the HITECH Act add to HIPAA?

A

added a breach notification requirement

136
Q

HITECH ACT-
Covered entities are required to notify individuals of a breach of their “unsecured” PHI within ___ calendar days after the breach is discovered

A

60 days

137
Q

HITECH Act-
For breaches affecting fewer than 500 individuals, covered entities must maintain a log of these breaches and notify HHS of these breaches … how often?

A

annually

138
Q

HITECH Act-
For breaches affecting more than 500 individuals, the Secretary of HHS and prominent local media must be notified in addition to the affected individuals within ___ days after the breach is discovered.

A

60 days

FL 1* (4 decks)

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