Federal Legislation & Agencies

Question 1

Pure Food & Drug Act of 1906

Answer 1

Prohibited the adulteration & misbranding of foods & drugs in interstate commerce

Question 2

What were the loopholes to the Pure Food & Drug Act of 1906

Answer 2

• Labels not required to list ingredients
• Misbranding provisions did not prevent false or misleading efficacy claims, it only prevented false statements as to the drug’s identity (i.e., strength, quality and purity)
• Did not provide authority to ban unsafe drugs
• Did not regulate cosmetics or medical devices

Question 3

The 1906 Pure Food and Drugs Act only authorized two methods of enforcement to remove violative products from the market:

Answer 3

Seizure & Criminal prosecution

Question 4

Food, Drugs & Cosmetics Act of 1938

Answer 4

Requires that new drugs cannot be marketed until proven safe for use under the conditions described on the label and approved by the FDA

Expanded misbranding and adulteration definitions

Labels must contain adequate directions for use and warnings about habit-forming properties (if applicable)

Expanded coverage to cosmetics and devices

Question 5

Unites States Pharmacopeia (USP)

Answer 5

Official compendia established in 1820 which contains monographs of active ingredients which include the approved titles, definitions, descriptions, and standards for identity, quality, strength, purity, packaging, stability, and labeling for a drug

Question 6

NF (National Formulary)

Answer 6

Monographs of inactive ingredients

Question 7

Homeopathic Pharmacopeia of the United States (HPUS)

Answer 7

An official compendium for homeopathic products

Question 8

Durham-Humphrey Amendment (1951)

Answer 8

Authorized oral prescriptions and refills, and established two classes of drugs:

• Prescription drugs (a.k.a. “legend drugs”)
• OTC or non-prescription drugs

Question 9

Under the Durham-Humphrey Amendment (1951), prescription drugs must contain

Answer 9

• “adequate information for use”: (indications, effects, dosages, routes, methods, frequency, warnings, hazards, contraindications, side-effects, etc.)
• “Caution: Federal law prohibits dispensing without a prescription”

Question 10

Under the Durham-Humphrey Amendment (1951), OTC drugs must contain

Answer 10

“adequate directions for use” for the layperson: purposes for use, dose, frequency of administration, duration of use, route, etc.

Question 11

Kefauver-Harris Amendment of 1962

Answer 11

• Required drugs be proven safe and also effective
• Established good manufacturing practices
• Established new drug approval process
• Established advertising oversight: FDA over legend drugs, FTC over OTC drugs

Question 12

Medicare Part A

Answer 12

Hospital (inpatient)

Question 13

Medicare Part B

Answer 13

Medical (Outpatient)

Question 14

Medicare Part C

Answer 14

Advantage (Gap coverage)

Question 15

Medicare Part D

Answer 15

Prescription Drug

Question 16

Anti-Kickback Statute

Answer 16

it is a crime to knowingly and willfully offer remuneration for patient referrals

Question 17

Stark Law

Answer 17

Prohibits physicians from referring patients for designated services to an entity which the physician has a financial relationship

Question 18

Poison Prevention Packaging Act of 1970

Answer 18

Requires all OTC and prescription drugs utilize child-resistant containers, with some exceptions (i.e. nitroglycerin)

Question 19

Child resistant packaging not required if:

Answer 19

(1) prescriber authorizes OR

(2) patient requests

Question 20

Orphan Drug Act

Answer 20

Provided tax and licensing incentives for manufacturers to develop and market drugs or biologicals for the treatment of “rare disease or conditions” affecting less than 200,000 people is US

Question 21

Prescription Drug Marketing Act of 1987

Answer 21

Regulated the use of drug samples

Required drug distributors to have a state license

Question 22

Omnibus Budget Reconciliation Act of 1990 3 main components

Answer 22

• Rebate programs (Best price on pharmaceuticals to Medicaid)
• Demonstration projects (Encourage innovative therapy programs to save money)
• Drug Utilization Review (DUR) Programs (Prospective review DUR, education programs, retrospective DUR)

Question 23

What is prospective DUR under OBRA 90

Answer 23

Screening prescriptions prior to dispensing (DDI, drug disease interaction, drug allergy, therapeutic duplication, right dose and duration, evidence of abuse or misuse)

Question 24

Pharmacist requirements under OBRA 90

Answer 24

Patient counseling
Documenting patient info (demographics, contact info, medical conditions, allergies and ADR history, comprehensive med list)

Question 25

Dietary Supplement Health Education Act of 1994

Answer 25

• Defined dietary supplements as products that are intended to supplement the diet including vitamins, minerals, herbs, botanicals, and amino acids
• Allowed certain claims of benefit (i.e. nutritional deficiencies, descriptions of the role of the supplement in maintaining structure or function of the body)
• Requires labeling to include: This statement has not been reviewed by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.

Question 26

HIPAA (1996)

Answer 26

Governs the privacy and security of patients’ protected health information by covered entities

Question 27

What is a covered entity

Answer 27

Healthcare providers, health plans, healthcare clearinghouses, and business associates

Question 28

What is the HIPAA privacy rule

Answer 28

addresses the use and disclosure of information between covered entities and requires covered entities to provide patients with a notice of privacy practices

Question 29

What is the HIPAA security rule

Answer 29

addresses the security of electronic protected health information that a covered entity creates, receives, maintains, or transmits

Question 30

Drug Quality & Safety Act of 2013

Answer 30

Provided FDA additional authority to regulate and monitor compounded medications and to track and trace prescription drugs through the distribution chain