Federal Part 2

Question 1

What is the food and rug act 1908?

Answer 1

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

Question 2

What are the short comings of the Wiley act?

Answer 2

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

Question 3

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

Answer 3

Food, Drug and Cosmetic Act of 1938

Question 4

What is adulteration

Answer 4

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

Question 5

What is misbranding?

Answer 5

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

Question 6

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

Answer 6

Durham-Humphrey Amendment of 1951

Question 7

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

Answer 7

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

Question 8

Another name for Rx drugs?

Answer 8

Legend drugs: needs script to dispense

Question 9

What did kefauver-harris accomplish?

Answer 9

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

Question 10

What agency regulates the advertising of OTC drugs?

Answer 10

FTC

Question 11

Jurisdiction of DESI?

Answer 11

Drugs marketed fter 1938

Question 12

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

Answer 12

Controlled Substances Act of 1970

Question 13

How enforces PPPA?

Answer 13

Consumer product safety commission

Question 14

What did the PPPA achieve

Answer 14

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

Question 15

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

Answer 15

Drug Listing Act of 1972

Question 16

Describe the NDC code?

Answer 16

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

Question 17

What is Federal Anti-Tampering Act of 1982?

Answer 17

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

Question 18

How long is the exclusivity of an orphan drug?

Answer 18

7 years with incentives and tax credit

Question 19

What is an orphan drug?

Answer 19

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

Question 20

What are requires initiated by Hatch-waxman?

Answer 20

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

Question 21

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

Prescription Drug markting act

Answer 21

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

Question 22

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

Answer 22

Omnibus

Question 23

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

Answer 23

Prescription Drug Marketing Act of 1987

Question 24

According to Omnibus, states are required to implement?

Answer 24

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

Question 25

Allowed FDA to hire extra reviewers

Answer 25

Prescription Drug User Fee Act (PDUFA) of 1992

Question 26

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

Answer 26

DSHEA

Question 27

Differentiate drug from supplement?

Answer 27

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

Question 28

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

Answer 28

HIPAA

Question 29

Required the establishment of a registry for clinical trials 

Answer 29

FDA Modernization Act of 1997 (FDAMA)

Question 30

What simplified D-humphrey?

Answer 30

FDAMA * Rx only * Warning: may be habit forming

Question 31

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

Answer 31

The Drug Addiction Treatment Act of 2000 (DATA 2000)

Question 32

Can NPs and PAs prescribe controls?

Answer 32

Yes, under the CARA

Question 33

Medicare Prescription Drug Improvement and Modernization Act of 2003

Answer 33

Created Medicare Part D to cover Rx drugs

Question 34

Estblished REMS?

Answer 34

FDA Amendments Act of 2007 (FDAAA)

Question 35

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

Answer 35

Affordable Care Act of 2010

Question 35

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

Answer 35

The Biologics Price Competition and Innovation Act of 2009 

Question 36

Gave the FDA increased authority to regulate compounding

Answer 36

Drug Quality and Security Act of 2013

Question 37

What is a traditional compounder?

Answer 37

Compound for an individual patient based on a prescription

Question 38

What is an outsourcing facility?

Answer 38

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

Question 39

Requirements of outsourcing pahrmacies?

Answer 39

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

Question 40

Changed the drug labeling requirements for pregnancy and nursing

Answer 40

Pregnancy and Lactation Labeling Final Rule 2014 

Question 41

What are the new classes of pregnancy and lactation labeling?

Answer 41

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

Question 42

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

Answer 42

The Comprehensive Addiction and Recover Act (CARA)

Question 43

Permits pharmacist to partially fill CII prescriptions subject to state law

Answer 43

CARA