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Pharmacy Law 2022 > Food, Drug, and Cosmetic Act > Flashcards

Food, Drug, and Cosmetic Act Flashcards

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1
Q

Which act required new drugs to be proven safe?

A

Food, drug, and cosmetic act

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2
Q

Which act provided a distinction between prescription and OTC drugs?

A

Durham-Humphrey Amendment of 1951

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3
Q

Which act made manufactures print on prescription drugs “Federal law prohibits dispensing without a prescription”?

A

Durham-Humphrey Amendment of 1951

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4
Q

Which act made drugs be proven safe AND effective?

A

Kefauver-harris act

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5
Q

What are the federal requirements for labeling of prescription drugs?

A

-Patient name

-Prescription number

-Date when prescription written or dispensed

-Name of prescriber

-Name and address of the pharmacy

-Cautionary statements

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6
Q

What did the Food, Drug, and Cosmetic Act of 1938 do?

A

Requires new drugs must be proven safe.

Defined what a new drug was approved for human use.

Required adequate use instruction and warnings for abuse.

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7
Q

What did the Durham-Humphrey Amendment of 1951 do?

A
  • Created a distinction between “OTC” and “Legend Drugs”
  • Legend Drugs can only be dispensed with a valid Prescription and by an authorized person
  • Allowed prescribers to authorize refills and oral scripts
  • The emphasis on this act was to insure safety thru qualified medical supervision.
  • Made manufacturers print on label: “Federal law prohibits dispensing without a prescription”
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8
Q

What are the patient label requirements in louisiana?

A

1) Patient name
2) Prescriber name
3) Pharmacist initials/name
4) Pharmacy name, address, and phone #
5) Medication: Name, Strength, directions, RX #, Date dispensed, and warnings

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9
Q

What did the poison prevention act of 1970 do?

A

Special packaging for medications were now required to make is difficult for not more than 20% of children to open but not more than 10% of adults can not use

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10
Q

Who can make exclusions to the poison prevention act?

A
  • A prescriber can make a one time exclusion
  • The pharmacist can not make an exclusion
  • The patient can make single or blanket exclusions
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11
Q

What are the medications excluded from the poison prevention act?

A
  • Nitroglycerin SL
  • Isosorbide dinitrate SL 10 mg or less
  • Erythromycin ethylsuccinate (EES) granules: not more than 8 grams
  • Erythromycin ethylsuccinate tablets: not more than 16 grams
  • Cholestyramine powder
  • Potassium supplements
  • Betamethasone tablets
  • Prednisone
  • Sodium fluoride
  • Mebendazole tab
  • Methylprednisone
  • Colestipol
  • Pancrelipase
  • Cyclically PO contraceptives
  • conjugated estrogen tabs
  • Norethindrone acetate tabs in mnemonic dispenser
  • medroxyprogesterone acetate tabs
  • sacrosdiase
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12
Q

Products that have proof they are ok start with _.

A

A
This means they are substitutable for something else, data exists and meets bioequivalence

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13
Q

AA

A

Products in conventional dosage forms

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14
Q

AN

A

Solutions and powders for aerolization

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15
Q

AO

A

Injectable oil solutions

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16
Q

AP

A

Injectable aqueous solutions and certain IV non-aqueous solutions

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17
Q

AT

A

Topical products

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18
Q

Products that are not suitable for generic products start with _.

A

B
They require further FDA investigation and review to determine equivalency

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19
Q

BC

A

Extended release dosage forms

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20
Q

BD

A

Active ingredients and dosage forms with documented bioequivalence problems

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21
Q

BE

A

Delayed release oral dosage forms

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22
Q

BN

A

Aerosol-neb

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23
Q

BP

A

Active ingredients with POTENTIAL bioequivalence problems

24
Q

BR

A

suppositories or enemas

25
Q

BS

A

Products having drug standard deficiencies

26
Q

BT

A

Topical with bioequiv issues

27
Q

BX

A

drug products where data are insufficient to determine equivalence

28
Q

How long does a patent last?

A

20 years

29
Q

What is the duration of market exclusivity of a generic drug patent?

A

180 days

30
Q

Can you continue to refill an OTC after the refills go away?

A

Yes, but if the directions are above the OTC labeling, you take responsibility

31
Q

What are the requirements for OBRA 90?

A

DUR
Counseling
Patient medication histories

32
Q

What must you counsel on?

A

1) Name and description of medication
2) Dosage form, dose, route, and duration of therapy
3) Special directions for preparation, administration, or use by patient
4) Common severe SEs, adverse effects, interactions, or CIs
5) self-monitoring techniques
6) Storage and refill info
7) What to do if dose missed

33
Q

What should patient medication use histories include?

A

1) Name, address, phone number, age, DOB, gender
2) Significant disease states
3) known allergies or prior drug reactions
4) list of drugs and devices previously used by patient
5) pharmacist’s comments relevant to individual’s therapy

34
Q

What is the difference between adulteration and misbranding?

A

Adulteration is when a drug contains filthy, putrid, or decomposed substance (contains unapproved drug, color additive, or deleterious substance). It is prepared in unsanitary conditions.

Misbranding is when the labeling is false or misleading. It’s missing data like manufacturer, active drug, missing quantity.

35
Q

What are the labeling requirements for manufacturers?

A

1) Name and address of manufacturer
2) Established name of product
3) “net” quantity
4) Weight of each active ingredient
5) Federal legend
6) Specific route
7) Storage requirements
8) Manufacturer Lot #
9) Expiration date

36
Q

Aspartame warning

A

Phenylketonuric

37
Q

Sulfite

A

Preservative- allergy

38
Q

Sodium phosphate warning

A

No more than 90 ml per container

39
Q

Isoproterenol inhalation warning

A

Call doc if symptoms persist

40
Q

Acetphenetidin warning

A

long time dosing kills your kidneys

41
Q

What are the restricted access programs for some medications?

A

1) Thalidomide - STEPS
2) iPLEDGE
3) Lotronex -PPL
4) Clozaril - CNR
5) Xyrem

42
Q

What are the regulations for thalidomide?

A

7 days post preggo test or 30 days for males
the scripts are good for 28 days
WRITTEN Rx

43
Q

What are the regulations for Isotretinoin?

A
  • Escribed or phoned in
  • Registration in database
  • 2 forms of BC
  • Monthly preggo tests
  • 30 day limit on Rx
  • Need authorization number prior to filling
44
Q

What are the regulations for clozapine?

A
  • Blood drawn first 6 months weekly
  • Next 6 months is every 2 weeks
  • After that it is once a month
45
Q

What programs use specialty pharmacies?

A
  • Exjade
  • Fosamax for pagets
  • IRESSA (Gefitinib)
  • Xyrem
46
Q

What is a class I recall?

A

Reasonable probability that the product will cause serious illness or death

47
Q

What is a class II recall?

A

Reasonable probability of temporary or reversible adverse events, death is unlikely

48
Q

What is a class III recall?

A

are not likely to cause adverse health consequences

49
Q

Does the FDA have authority to regulate compounded drugs?

A

Yes because they are considered new drugs

50
Q

What are the BUDs in the absence of stability data?

A

Non aq liquids: time left of soonest ingredient or 6 months
Aq solutions: 14 days at cold temp
Everything else: duration of therapy or max 30 days

51
Q

What is a low risk sterile product?

A

made using closed system transfers

52
Q

What is a high risk category I sterile product?

A

Made with complex procedures or mult procedures

53
Q

What is a category II product?

A

non-sterile agents used or open systems

54
Q

What are the rules of regulation for HIPAA?

A

Keep for six years.
Patient should sign only on the first time and a third party may sign.
Privacy policies must be posted somewhere.

55
Q

Where should you not disclose patient info?

A

Mailings or phone calls

56
Q

Are foreign prescriptions allowed for controlled substances?

A

No but it could be allowed if the foreign prescriber had a US DEA registration

Pharmacy Law 2022 (8 decks)

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