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Pharmaceutics 1 > Pharmacy Law > Flashcards

Pharmacy Law Flashcards

1
Q

Food and Drug Act 1906

A

First federal law to regulate drugs

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2
Q

Sherley Amendment

A

Therapeutic claims regulated

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3
Q

Federal Food, Drug, Cosmetic Act 1938

A

Requires thorough toxicologic testing
FDA created to enforce laws
Prohibits distribution of new drug w/o New Drug Application (NDA) and FDA approval

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4
Q

Durham-Humphrey Amendment

A

Legal distinction between OTC and prescription
‘Rx Only’
New drugs require a prescription
Prescription can’t be refilled w/o prescribers consent

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5
Q

Drug Abuse Control Amendment and Comprehensive Drug Abuse Prevention and Control Act

A

Prevent drug abuse

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6
Q

Kefauver-Harris Amendment

A

Congress strengthened laws
Ensures greater degree of safety for approved drugs
Requires proof of safety and effectiveness before FDA approval
Investigational New Drug Application (IND) before human trials
FDA authority to issue Good Manufacturing Practice (GMP)

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7
Q

Comprehensive Drug Abuse Prevention and Control Act of 1970

A

Controlled substance act

Consolidate and codify control authority over drugs of abuse

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8
Q

Schedule I

A

No accepted medicinal use

Any non-medical substance being abused

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9
Q

Schedule II

A

Accepted medical use, high potential for abuse

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10
Q

Schedule III

A

Accepted medical use, potential of abuse less than I or II

Moderate psychological or physical dependence

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11
Q

Schedule IV

A

Accepted medical use, low potential of abuse, limited dependence

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12
Q

Schedule V

A

Accepted medical use, low potential of abuse, limited dependence relative to IV

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13
Q

Pregnancy Cat. A

A

Failed to demonstrate risk to fetus in 1st trimester, no risk in later trimesters

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14
Q

Pregnancy Cat. B

A

Animal reproduction studies failed to demonstrate risk, no adequate and well-controlled studies in pregnant women

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15
Q

Pregnancy Cat. C

A

Animals have adverse effect, no adequate/well-controlled studies in pregnant women
Potential benefits may warrant use despite risk

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16
Q

Pregnancy Cat. D

A

Positive evidence of human fetal risk

Potential benefits may warrant use despite risk

17
Q

Pregnancy Cat. X

A

Animals and humans demonstrate fetal abnormalities and/or human fetal risk, risk outweigh potential benefit

18
Q

Black Box Warning

A

Adverse reaction serious in proportion to benefit, consider in assessing

19
Q

Orphan Drug Act

A

For rare diseases and conditions, tax credits and designated years of marketing exclusivity

20
Q

Drug Price Competition and Patent Term Restoration Act of 1984

A

Speed generic approval and extending innovating patents
Generics get Abbreviated New Drug Application (ANDA)
Patent extensions for FDA review time, 1/2 testing phase not to exceed usual 20 yr patent term

21
Q

Prescription Drug Marketing Act

A

New safeguards on integrity to reduce risk of adulterated, misbranded, repackaged, or mislabeled drugs through 2nd sources
Reimportation, Sales Restrictions, Distribution of Samples, Wholesale Distributors

22
Q

Prescription Drug User Fee Act

A

FDA can accept user fees from companies in return to commit to review new drug within time frames

23
Q

Dietary Supplement Health and Education Act

A

Supplements can’t have claims to prevent or cure specific diseases and have a disclaimer
Submit to FDA to being truthful and not misleading
GMP for dietary supplements

24
Q

FDA Modernization Act

A

FDA sets policy, establishes standards, issues guidelines, enforces rules
Gatekeeper to new drugs, tests, medical devices by application and review

25
Q

Development to approval

A

Discovery, Pre-clinical, IND, FDA review, Clinical, NDA?BLA Pre-approval inspection, FDA response

26
Q

Phase 1 Clinical Trials

A

Healthy Patients

27
Q

Phase 2 Clinical Trials

A

Efficiency and short term safety

28
Q

Phase 3 Clinical Trials

A

Safety and Efficiency with risk/benefit assessment

29
Q

Phase 4 Clinical Trials

A

Long term effects (after marketing)

30
Q

Recall Class I

A

Kills people

31
Q

Recall Class 2

A

Probability of reversible or temporary effects

32
Q

Recall Class 3

A

No adverse effects

33
Q

Solid State Degradation

A
  1. Loosening at reaction site
  2. Bond breaking/making
  3. Solid solution formation of degradation product
  4. Separation and crystallization of degradation product within parent solid
34
Q

CoCrystals

A

homogeneous with fixed stoichiometry

35
Q

Amorphous Solids

A

No order, defined by glass transition temperature, more soluble than crystal

36
Q

Colligative Properties

A 
Depend on number of solute particles
Vapor pressure lowering
Boiling point elevation
Freezing point depression
Osmotic pressure

Pharmaceutics 1 (6 decks)

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