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Pharmacy Laws & Regulations Flashcards

pg. 33-66 Chapter. 1: Federal Food, Drug, and Cosmetic Act (FDCA), Poison Prevention Packaging Act (PPPA), Federal Laws & Regulations, Privacy

1
Q

The drug approval process begins with pre-clinical testing with animals. If the pre-clinical testing on animals is promising, the next step would be to file an investigational new drug (IND) application. Who files the IND?

A

The Manufacturer

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2
Q

What law established the difference between Rx and OTC drugs?

A

Durham-Humphrey Amendment

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3
Q

A drug company is marketing an OTC drug as a product that will prevent colds. Which regulatory body is responsible for enforcing the accuracy of this claim?

A

Federal Trade Commission

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4
Q

What must be included on the label by manufacturers of legend drugs?

A

“Rx only” or “Caution: Federal law prohibits dispensing this drug without a prescription”

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5
Q

The Poison Prevention Packaging Act was enacted in order to (primarily) protect this group from an accidental drug overdose:

A

Young children

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6
Q

A manufacturer’s container of simvastatin 20 mg has an NDC of 68180-479-02, what do the numbers “68180” represent?

A

The manufacturer

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7
Q

A drug has the following National Drug Code: 0085-1264-02. What does the number “02” represent?

A

Packaging

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8
Q

What criteria does the drug need to meet in order to be considered an orphan drug?

A
  1. The targeted disease must affect less than 200,000 people

2. A drug in which there is no reasonable expectation that the sales will make up for the development costs.

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9
Q

What was the first law that required new drugs to be proven safe (if used as directed) before being marketed?

A

The Food, Drug and Cosmetic Act

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10
Q

A manufacturer’s container of SOMA has an NDC 62756-446-05, what do the numbers “446” represent?

A

The Drug

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11
Q

The FDA is responsible for approving prescription drugs before a drug is available on the market. When must a new drug application (NDA) be submitted to the FDA?

A

After phase III drug studies show promising results

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12
Q

Which clinical trial phase is the first to be conducted on human subjects?

A

Phase I

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13
Q

A pharmaceutical company has conducted animal and human clinical trials for a new biological drug to treat Alzheimer’s Disease. Which type of application must the pharmaceutical company submit to the FDA?

A

BLA

Biologics License Application for biologics

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14
Q

The definitions for food, drugs, dietary supplements and devices were each initially defined under this act:

A

The Food, Drugs and Cosmetics Act (FDCA)

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15
Q

The Drug Quality and Security Act of 2013 differentiated between these two areas:

A

Traditional compounding pharmacies vs Outsourcing facilities

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16
Q

A pharmaceutical company would like to market a new dosage for a drug. Which type of application must the company submit to the FDA?

A

Supplement New Drug Application (sNDA)

**to change a label, add a new medication, add a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental NDA.

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17
Q

The drug labeling information requirements for pregnancy and nursing were changed in 2015. The previous pregnancy categories of A, B, C, D and X are being phased out. What are the names of the sections that must be included in the new label?

A

Pregnancy
Lactation
Females & Males of Reproductive Potential

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18
Q

A drug company would like to make a generic version of a prescription drug product with an expired exclusivity period. Which type of application must the company submit to the FDA?

A

ANDA

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19
Q

Which of the following was the first law that required drugs to be proven effective (if used as directed) before being marketed?

A

Kefauver-Harris Amendment

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20
Q

A drug company is advertising a new prescription pain medication. Which of the following agencies will regulate the advertising?

A

The Food and Drug Administration

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21
Q

Which clinical trial phase is conducted after the drug is already approved by the FDA?

A

Phase IV

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22
Q

Name the Important Pharmacy Act of 2016.

What is it?

A

The Comprehensive Addiction and Recovery Act (CARA) of 2016

CARA is an amendment to the Controlled Substances Act and passed in response to the opioid crisis.

Increased availability of:

  • *Prevention/education
  • *Addiction treatments
  • *Naloxone

Allowed partial fill of schedule II drugs:

  • *Patient or prescriber can request
  • *Must be filled within 30 days of issue
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23
Q

Name the Important Pharmacy Act of 2014.

What is it?

A

Pregnancy and Lactation Labeling Final Rule (PLLR)

Changed the pregnancy categories made it easier to understand.

  1. 1 Pregnancy (incl. Labor & Delivery)
  2. 2 Lactation (incl. Nursing Mothers)
  3. 3 Females & Males of Reproductive Potential
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24
Q

Name the Important Pharmacy Act of 2013.

What is it?

A

Drug Quality and Security Act (DQSA)

Compounding Quality Act

  • *FDA gained authority to regulate compounding
  • *Separate traditional compounders (503A) and outsourcing facilities (503B)

Drug Supply Chain Security Act: “Track and Trace” all transactions of prescription drug products

25
Q

Name the Important Pharmacy Act of 2010.

What is it?

A

Affordable Care Act

Improved access to quality care while decreasing cost

  • ——-Quality Care——–
  • Accountable Care Organizations (ACOs)
  • Valued-Based Purchasing
  • Essential Health Benefits
  • Integrated Care Models
  • Care Transitions
  • MTMs
26
Q

Name the Important Pharmacy Act of 2019.

A

The Biologics Price Competition and Innovation Act

27
Q

Biosimilars must have the same:

A
  1. MOA
  2. Dosage form
  3. Strength
  4. Indication
28
Q

What color is the biologics book?

29
Q

What color is the generics book?

30
Q

Name the Important Pharmacy Act of 2007.

What is it?

A

FDA Amendments Act

Enhanced drug safety through Risk Evaluation and Mitigation Strategies (REMS)

31
Q

Name the Important Pharmacy Act of 2000.

What is it?

A

The Drug Addiction and Treatment Act (DATA 2000)

Physicians can dispense and prescribe opioid addiction treatments in the office setting

32
Q

Name the Important Pharmacy Act of 1997.

What is it?

A

FDA Modernization Act (FDAMA)

Extension of the Controlled Substances Act

Legend shorted to “Rx Only”

33
Q

Name the Important Pharmacy Act of 1994.

What is it?

A

Dietary Supplement Health and Education Act (DSHEA)

Structure function claim:

  1. Address a nutrient deficiency
  2. Support overall health
  3. Be linked to body functions

Disclaimer: “Not FDA approved, not intended to treat, diagnose, cure or prevent any disease.”

34
Q

Name the Important Pharmacy Act of 1990.

What is it?

A

Omnibus Budget Reconciliation Act

Passed in an effort to decrease he inefficient use of government money spent on healthcare.

  1. Rph must perform DUR
  2. Counsel
  3. State retrospective DUR programs (TX PMP)
35
Q

Name the Important Pharmacy Act of 1987.

What is it?

A

Prescription Drug Marketing Act (PDMA)

No reimportation of drugs from outside the US except by manufacturer.

36
Q

Name the Important Pharmacy Act of 1984.

What is it?

A

Hatch-Waxman Act
(Drug Price Competition and Patent Term Restoration Act)

Generic drug approvals (Orange Book)

37
Q

According to the Prescription Drug Marketing Act (PDMA), patients cannot buy drugs in other countries and bring them into the US under these conditions:

A
  1. ≤ 90-day supply for the patient’s own use
  2. Effective treatment is not available in the U.S.
  3. Condition is serious
  4. Drug has no unreasonable risk
  5. Sales of drug samples and coupons prohibited
  6. Limited reselling of drugs by hospital
  7. Wholesalers must be registered in each state
38
Q

Name the Important Pharmacy Act of 1983.

What is it?

A

Orphan Drug Act

  1. Encouraged development of drugs for rare diseases
  2. < 200,000 people in US affected
  3. Tax credits & 7-year exclusivity for manufacturers
39
Q

Name the Important Pharmacy Act of 1982.

What is it?

A

Federal Anti-Tampering Act

“Chicago Tylenol Murders” - laced with potassium cyanide

Tamper-resistant features on OTC meds

40
Q

What are the product exceptions to the Federal Anti-Tampering Act?

A

Skin products
Insulin
Lozenges
Toothpaste

41
Q

Name the Important Pharmacy Act of 1972.

What is it?

A

Drug Listing Act

All drugs must be registered with FDA and assigned a National Drug Code (NDC)

42
Q

Name the 2 Important Pharmacy Acts of 1970.

What is it?

A

Controlled Substances Act (CSA)

  • Created 5 “schedules” based on potential for abuse
  • Estab. a closed system to reduce drug diversion

Poison Prevention PAckaging Act (PPPA)

  • Child-Resistant (C-R) Packaging
  • To avoid accidental poisoning in young children
43
Q

Name the Important Pharmacy Act of 1962.

Why?

A

Kefauver-Harris Amendment

Passed in response to thalidomide tragedy - sleeping agent but used to treat morning sickness in pregnancy –> babies born with loss of limbs

Now: Drugs must be safe & effective!!

44
Q

Name the Important Pharmacy Act of 1951.

What is it?

A

Durham-Humphrey Amendment

Rx vs OTC

Legend: “Caution: Federal law prohibits dispensing without a prescription”

45
Q

Define the 3 conditions making a drug available by prescription only due to the Durham-Humphrey Amendment.

A
  1. Habit-forming
  2. Unsafe unless used under expert supervision
  3. Limited under an NDA
46
Q

Define Adulteration

A

Some is wrong with the drug

  1. Product is filthy, putrid, decomposed, or contaminated.
  2. Prepared or stored under unsanitary conditions
  3. Lack or quality controls or purity testing or lack of CGMPs
  4. Strength of quality is different than official standing or labeling
47
Q

Define Misbranding.

A

Some is wrong with the labeling

  1. Label is lacking required information or illegible
  2. False or misleading label or advertising
  3. Improper packaging
  4. Ingredients differ from USP monograph standards
48
Q

When something is wrong with the drug and label this is called?

A

Adulteration & Misbranded

49
Q

Name the Important Pharmacy Act of 1906.

What is it?

A

The Pure Food and Drug Act
“Wiley Act”

Food/drug label cannot be false or misleading - no adulterated or misbranded drugs

50
Q

Name the Important Pharmacy Act of 1937.

What is it?

A

The Food, Drug and Cosmetic Act

Manufacturer required to prove a drug is safe

due to Sulfanilamide Elixir was produced using a solvent, diethylene glycol (antifreeze) which resulted in 107 deaths (mostly kids)

51
Q

According to the FDCA, labeling requirements are

A
  1. Adequate directions for use
  2. All ingredients lists
  3. Claims accurate
52
Q

Prescription Drug Approval Process

Pre-clinical testing

A

Rodent/non-rodent testing for acute toxicity

Relative safety

Therapeutic potential

53
Q

Prescription Drug Approval Process

Phase I

A

20-100 healthy volunteers or people with disease

Safety, SE, PK/PD

54
Q

Prescription Drug Approval Process

Phase II

A

100-300 with the disease;

efficacy/safety
SE
Optimal dose/dose range

55
Q

Prescription Drug Approval Process

Phase III

A

300-3000 people with the disease

efficacy compared to placebo or standard of care

ADRs

56
Q

Prescription Drug Approval Process

Phase IV

A

Post-marketing surveillance

Long-term safety & efficacy

High-risk patient monitoring

Other populations and new uses

57
Q

What does ANDA stand for? What is it?

A

Abbreviated New Drug Application (ANDA)

Generic Drug Approval:

  1. Drug is a copy of the reference drug
  2. Must be proven bioequivalent
  3. 505 (b)(2) application [similar to a traditional NDA]
58
Q

A manufacturer is seeking approval of a generic drug via an ANDA. What must be the same as the branded drug?

A

Active ingredient
Dosage form
Route of Administration
Strength

59
Q

What is the purpose of The Food and Drug Approval Process?

A
  1. Drug approval based on safety and efficacy
  2. Post-marketing safety
  3. Oversight of manufacturers and prescription drug advertising

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