Mpje: Non-Controlled Federal Law Review

Front 1

Nitroglycerin PPPA limits

Back 1

N/a; SL dosage forms

Front 2

Isosorbide DN PPPA limits

Back 2

NMT 10 mg sublingual/ chewable

Front 3

Anhydrous cholestyramine PPPA limits

Back 3

N/a; in powder form

Front 4

Sodium fluoride products PPPA limits

Back 4

NMT 110 mg NaF

NMT 50 mg F-

Front 5

Methylprednisolone PPPA limits

Back 5

NMT 84 mg

Front 6

Mebendazole (vermox) PPPA limits

Back 6

NMT 600 mg

Front 7

Betamethasone PPPA limits

Back 7

NMT 12.6 mg

Front 8

Potassium PPPA limits

Back 8

NMT 50 mEq per unit dose packs

Front 9

Erythromycin granules for oral suspension PPPA limits

Back 9

NMT 8 mg

Front 10

Colestipol PPPA limits

Back 10

NMT 5 mg per packet in powder form only

Front 11

Aerosol containers PPPA limits

Back 11

N/a

Front 12

Pancrelipase PPPA limits

Back 12

N/a

Front 13

Prednisone tablets PPPA limits

Back 13

NMT 105 mg

Front 14

OCP PPPA limits

Back 14

N/a as long as administered in mfgr memory aid dispenser

Front 15

Conjugated estrogen tablets PPPA limits

Back 15

NMT 32 mg in mnemonic dispenser

Front 16

Medroxyprogesterone PPPA limits

Back 16

N/a tablets

Front 17

Norethindrone tablets PPPA limits

Back 17

NMT 50 mg in mnemonic dispenser

Front 18

Sacrosidase (sucrase) PPPA limits

Back 18

n/a

Front 19

HRT that rely solely on activity of one or more progestogen or estrogen substances PPPA limits

Back 19

n/a

Front 20

Effervescent ASA or APAP PPPA limits

Back 20

<= 15%

Front 21

ASA OTC PPPA

Back 21

any

Front 22

Iron OTC PPPA

Back 22

>=250mg

Front 23

APAP OTC PPPA

Back 23

>= 1 gram

Front 24

Diphenhydramine OTC PPPA

Back 24

>= 66mg

Front 25

Ibuprofen OTC PPPA

Back 25

>=1 gram

Front 26

Loperamide OTC PPPA

Back 26

>=0.045mg

Front 27

Lidocaine OTC PPPA

Back 27

>5.0 mg

Front 28

Dibucaine OTC PPPA

Back 28

>0.5 mg

Front 29

Mouthwashes OTC PPPA

Back 29

>= 3 g of etoh/ package

Front 30

Naproxen OTC PPPA

Back 30

>=250 mg

Front 31

Ketoprofen OTC PPPA

Back 31

>=50mg

Front 32

Minoxidil OTC PPPA

Back 32

>=14 mg

Front 33

Flouride OTC PPPA

Back 33

>=50 mg

Front 34

OTC products previously available per rx only OTC PPPA

Back 34

any amount

Front 35

Bar codes are required for 3 types of drug products. Name them.

Back 35

1. Rx drugs sold to/ used in hospitals
2. OTC drugs dispensed pursuant to an inpatient order or sold to hospitals
3. biological products

Front 36

The bar code requirement applies to whom?

Back 36

Manufacturers
Distributors
Re-packers
Labelers
Re-labelers

Front 37

At a minimum, what must the bar code contain?

Back 37

NDC number

Front 38

What are the 4 exemptions to the tamper-reistant packaging?

Back 38

1. Dentifrices
2. Dermatological
3. Insulin
4. Lozenges

Front 39

Can a waiver for PPPA be oral? or does it have to be written.

Back 39

OK to be oral.

Front 40

How may drug samples be distributed?

Back 40

Upon physicians WRITTEN request. A receipt must be issued. Can be stored in a hospital pharmacy, not a retail pharmacy.

Front 41

What are the 3 exceptions to the PDMA that would allow a charitable institution, hospital, or health care facility to sell, purchase, or trade prescription drugs?

Back 41

1. Another hospital in a the GBO

2. Retail pharmacy that is getting screwed due to temporary shortage

3. Sales due to outpatient prescriptions w/in the hospital

Front 42

The pedigree requirement is required of:

Back 42

Secondary wholesalers.

Basically anyone who isn't a mfgr or authorized distributor of record for the drug must show pedigree

Front 43

Class I recalls

Back 43

Most severe

Likely to cause death/ serious harm

Front 44

Class II recalls

Back 44

Temporary or reversible side effects

Front 45

Class III recalls

Back 45

Not likely to cause adverse health effects

Front 46

How can hospitals comply with patient package insert requirements?

Back 46

1. PPI with each dispensing

2. PPI at 1st dispensing & in 30 days

Front 47

Phase I trials: patient disposition? sample size? primary objective?

Back 47

1. Healthy
2. 20-80 patients
3. Toxicology not efficacy

Front 48

Phase II trials: patient disposition? sample size? primary objective?

Back 48

1. Have dz
2. 100-300
3. Efficacy

Front 49

Phase III trials: patient disposition? sample size? primary objective?

Back 49

1. Have dz
2. Thousands
3. Efficacy, then submit NDA to FDA

Front 50

Requirements to use an investigational drug for patients in the general population?

Back 50

1. Life threatening dz
2. Pursuant to treatment protocol submitted to FDA
3. No other available tx
4. Patient is not charged
5. Informed consent
6. Currently in clinical trials or trials have completed and mfgr is pursuing market approval

Front 51

What form must a physician fill out to obtain in individual patient IND for investigational use in the general population?

Back 51

FDA 1571

Front 52

If the FDA expedites the approval of a drug what is now mandated?

Back 52

Phase IV trials

Front 53

OTCs may be marketed for approval in 3 different ways.

Back 53

1. NDA
2. Abbreviated NDA
3. OTC monograph

Front 54

A drug will become "new" and again subject to the the NDA approval process if what occurs?

Back 54

Basically if ANYTHING about the drug changes:

dose, coatings, excipients, indication, application, proportion of ingredients, etc.

Front 55

May a MFGR market a drug for off label use?

Back 55

No. But may distribute literature regarding the off label use.

Front 56

Waxman-Hatch amendment

Back 56

Made it easier for generic mfgr's to bring drug to market. Only need to show the drug is bioequivalent and bioavailable to the innovator. Also grants certain market exclusivity rights.

Front 57

Who regulates OTC drug advertising?

Back 57

FTC

Front 58

Who regulates Rx drug advertising?

Back 58

FDA

Front 59

What class device?

Needles

Back 59

I

Front 60

What class device?

Scissors

Back 60

I

Front 61

What class device?

Stethoscope

Back 61

I

Front 62

What class device?

Toothbrush

Back 62

I

Front 63

What class device?

Soft contacts for daily use

Back 63

II

Front 64

What class device?

Hard contacts for daily use

Back 64

II

Front 65

What class device?

Electric heating pad

Back 65

II

Front 66

What class device?

Diagnostic reagent

Back 66

II

Front 67

What class device?

Thermometer

Back 67

II

Front 68

What class device?

Insulin syringe

Back 68

II

Front 69

What class device?

Pacemaker

Back 69

III

Front 70

What class device?

Soft contacts for extended use

Back 70

III

Front 71

What class device?

Hard contacts for extended use

Back 71

III

Front 72

What class device?

Heart valves

Back 72

III

Front 73

What class device?

Requires premarket approval

Back 73

III

Front 74

What class device?

Life sustaining or supporting

Back 74

III

Front 75

What class device?

General controls are adequate to ensure safety

Back 75

I

Front 76

FDA is authorized to require a MFGR to recall a device in question. True or false?

Back 76

TRUE. Unlike DRUG RECALLS, where the FDA cannot do this.

Front 77

A hospital finds that the heart valve it was using for surgery is defective and people have been dying. To whom must this be reported and when should this be reported?

Back 77

MFGR or FDA (if MFGR isnt known)

Within 10 days

Front 78

For permanently implantable devices MFGR must do 2 things. Name them.

Back 78

1. Have a tracking method
2. Conduct post marketing surveillance

Front 79

Can tax-free alcohol be sold to outpatients?

Back 79

No

Front 80

Can a compound with tax free alcohol be sold for in-patient use?

Back 80

Yes

Front 81

Can tax free alcohol be used for food or drink?

Back 81

No

Front 82

Form to purchase large volumes of tax-free alcohol?

Back 82

ATF 1447

Front 83

Form to purchase tax-free alcohol for general compounding?

Back 83

ATF-11

Front 84

Ipecac OTC limits?

Back 84

1 fl oz (30 mL)

Front 85

Ipecac doseage?

Back 85

15 mL >1 yr old

Front 86

Ipecac warning label

Back 86

Do not use in:

unconsious ppl

lye

acids

cleaning fluid

petroleum distillates

Front 87

Expiration date for a compounded non aqueous liquid or solid

Back 87

NMT 25% of time remaining or MAX 6 months, whichever is less

Front 88

Expiration date fore aqueous solns

Back 88

14 days if refrigerated

Front 89

BUD for multiple use container

Back 89

Exp date on MFGR container or 1 yr from the dispensing date, whichever sooner

Front 90

BUD for unit dose container

Back 90

1 yr or less, unless stability data indicate otherwise