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MPJE Law > Federal Part 2 > Flashcards

Federal Part 2 Flashcards

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1
Q

What is the food and rug act 1908?

A

Food and drugs labels should not be:
* False or misleading
* Adulterated or misbranded

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2
Q

What are the short comings of the Wiley act?

A
  1. Did not prevent false or misleading efficacy claims
  2. Failed to regulate cosmetics and devices
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3
Q

Provided that no new drug could be marketed until proven safe and approved by the new FDA

A

Food, Drug and Cosmetic Act of 1938

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4
Q

What is adulteration

A
  1. filthy, putrid, or decomposed substance
  2. prepared, packed, or held under unsanitary conditions
  3. Bad manufactering practice
  4. Container is poisonous
  5. Color additives are unsafe
  6. Unrecognizable label
  7. Substitutions in active drug
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5
Q

What is misbranding?

A
  1. Label is false or misleading
  2. Imporper pckaging
  3. Lack of required info for packaging
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6
Q

What created The first time that a clear distinction was made between OTC and prescription drugs?

A

Durham-Humphrey Amendment of 1951

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7
Q

What are the 3 conditions that should be on Rx drug?

A
  1. Habit forming
  2. Unsafe -> toxicity
  3. Limited Rx use under a manufacturer’s NDA
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8
Q

Another name for Rx drugs?

A

Legend drugs: needs script to dispense

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9
Q

What did kefauver-harris accomplish?

A
  1. Approval for safety and efficacy
  2. Evidence of effectiveness
  3. Post-market requires reports of serious ADRs
  4. Infomred consent for clinical trials
  5. Current good manufacturing practices
  6. Oversight to regulate ads f Rx drugs
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10
Q

What agency regulates the advertising of OTC drugs?

A

FTC

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11
Q

Jurisdiction of DESI?

A

Drugs marketed fter 1938

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12
Q

Established the regulations surrounding controlled substances that all manufacturers, importers, exporters, distributors, researchers, hospitals, pharmacies, prescribers and pharmacists must follow

A

Controlled Substances Act of 1970

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13
Q

How enforces PPPA?

A

Consumer product safety commission

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14
Q

What did the PPPA achieve

A

Requires a number of household substances and drugs to be packaged in child-resistant packaging

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15
Q

Amended the FDAC to require all drugs to be registered with the FDA

A

Drug Listing Act of 1972

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16
Q

Describe the NDC code?

A

First 4-5 digits: labeler code
Second 3-4 digits: Porduct code
Thrid 1-2 digit: Package code

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17
Q

What is Federal Anti-Tampering Act of 1982?

A

1.Federal crime to tamper OTC
2.Products require tamper resistant feautres

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18
Q

How long is the exclusivity of an orphan drug?

A

7 years with incentives and tax credit

19
Q

What is an orphan drug?

A
  1. Dx affects <200,000 people
  2. No reasonable expectation that the sales revenue will recover the cost of research and development
20
Q

What are requires initiated by Hatch-waxman?

A
  1. Proof of safetyand efficacy are not required for generics
  2. Only required proof of bioequivalence and proof of acceptable manufacturing methods
  3. Brand name drug manufacturers given exclusivity as incentive
21
Q

Patients cannot buy drugs in other countries and bring them into the US, except under these conditions

Prescription Drug markting act

A
  1. <90 day supply
  2. An effective tx is not available in the US
22
Q

Requires pharmacists to perform a prospective drug utilization review (DUR) and counseling for all Medicaid beneficiaries before dispensing the prescription to the patient

A

Omnibus

23
Q

Enacted to reduce public health risks from adulterated, misbranded, counterfeit or expired drugs

A

Prescription Drug Marketing Act of 1987

24
Q

According to Omnibus, states are required to implement?

A

Retrospective DUR for patterns of fraud, abuse, overuse, and medically unnecessary care

25
Q

Allowed FDA to hire extra reviewers

A

Prescription Drug User Fee Act (PDUFA) of 1992

26
Q

Established regulations for dietary supplements that were different from those for drugs or conventional foods

A

DSHEA

27
Q

Differentiate drug from supplement?

A

Drug: claims to cure, prevent, and teat dx
Supplement: address a nutrient deficiency to support health

28
Q

Protects individuals’ medical records and personal health information (PHI) held by covered entities, such as healthcare providers, health plans, and healthcare clearinghouses

A

HIPAA

29
Q

Required the establishment of a registry for clinical trials

A

FDA Modernization Act of 1997(FDAMA)

30
Q

What simplified D-humphrey?

A

FDAMA
* Rx only
* Warning: may be habit forming

31
Q

Permitted physicians to prescribe and dispense controlled substances in an office-based setting to treat opioid dependence

A

The Drug Addiction Treatment Act of 2000(DATA 2000)

32
Q

Can NPs and PAs prescribe controls?

A

Yes, under the CARA

33
Q

Medicare Prescription Drug Improvement and Modernization Act of 2003

A

Created Medicare Part D to cover Rx drugs

34
Q

Estblished REMS?

A

FDA Amendments Act of 2007(FDAAA)

35
Q

Set up a marketplace where individuals and small businesses can compare and purchase health insurance plans and offers subsidies to lower-income individuals to make insurance more affordable

A

Affordable Care Act of 2010

35
Q

Created an abbreviated licensure pathway for biological products that are demonstrated to be biosimilar to or interchangeable with an FDA-approved product

A

The Biologics Price Competition and Innovation Act of 2009

36
Q

Gave the FDA increased authority to regulate compounding

A

Drug Quality and Security Act of 2013

37
Q

What is a traditional compounder?

A

Compound for an individual patient based on a prescription

38
Q

What is an outsourcing facility?

A

Typically make larger batches of sterile compounds that are distributed to hospitals and other facilities

39
Q

Requirements of outsourcing pahrmacies?

A
  1. CGMP requemnts
  2. Under the supervision of licensed pharmacist
  3. Inspected by FDA
  4. No Rx requirements
40
Q

Changed the drug labeling requirements for pregnancy and nursing

A

Pregnancy and Lactation Labeling Final Rule 2014

41
Q

What are the new classes of pregnancy and lactation labeling?

A
  1. Pregnancy
  2. Lactation
  3. Females and males of reporductive potential
42
Q

An amendment to the Controlled Substances Act:
* Authorized prevention and education
* MAT and anloxone programs

A

The Comprehensive Addiction and Recover Act (CARA)

43
Q

Permits pharmacist to partially fill CII prescriptions subject to state law

A

CARA

MPJE Law (2 decks)

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