Pharmacy Law

Question 1

1906 Pure Food and Drug Act

Answer 1

Stopped the sale of mislabeled drugs

Question 2

1914 Harrison Narcotic Act

Answer 2

People can no longer purchase opium without a perscription

Question 3

1938 Food, Drug, and Cosmetic Act

Answer 3

Required adequate directions for use
All narcotics are to be labeled with “Warning: may be habit-forming”
Defined exact labeling for products
Misbranding and adulteration now is illegal

Question 4

1951 Durham-Humphrey Amendment

Answer 4

Makes the distinction between prescription drugs and over-the-counter medications
Requires legend drugs to be labeled: “Caution, Federal law prohibits dispensing without a prescription”
Certain drugs must be prescribed by licensed practitioner

Question 5

1962 Kefauver-Harris Amendment

Answer 5

Burden of good manufacturing practices on manufacturing companies
Prevents the sale of thalidomide

Question 6

1970 Comprehensive Drug Abuse Prevention and Control Act

Answer 6

DEA is formed for enforcing narcotic laws and their distribution
Creates the control substance categories
Establish strict recordkeeping guidelines

Question 7

1970 Poison Prevention Packaging Act (PPPA)

Answer 7

Requires most OTC and legend drugs have a child-resistant container

Question 8

Occupational Safety and Health Act of 1970 (OSHA)

Answer 8

Ensures a safe workplace for workers
Attempts to reduce hazards in the workplace
Requires for there to be a report system for job-related injuries and illnesses
Requires the use of Safety Data Sheets (SDS)

Question 9

1972 Drug Listing Act: National Drug Code

Answer 9

Every drug now has a unique 10 digit code that is divided into 3 segments

Question 10

Orphan Drug Act of 1983

Answer 10

Allows companies to bypass the time requirements of testing a new drug to provide medication to those with rare diseases

Question 11

1987 Prescription Drug Marketing Act

Answer 11

Prohibits the sale or distribution of samples to anyone other than those who can prescribe them
Controls the use of drugs for animals
Required the label: “Caution: Federal law restricts
this drug to use by or in order of a licensed
veterinarian”

Question 12

1990 Omnibus Budget Reconciliation Act (OBRA 90)

Answer 12

Set limitations on reimbursements on Medicaid and Medicare for medication
All prescribed medication will be evaluated for appropriateness
Pharmacists must counsel all patients who receive new medications
Patients must be given all information about their medication

Question 13

Resource Conservation and Recovery Act (RCRA)

Answer 13

Guidelines for waste management

Question 14

Health Insurance Portability and Accountability Act of 1996 (HIPPA)

Answer 14

Patient’s right to privacy

Technicians must uphold confidentiality

Question 15

2000 Drug Addiction Treatment Act (DATA 2000)

Answer 15

Allows physicians to prescribe controlled substances to those with an opioid addiction for detoxify treatments

Question 16

2003 Medicare Prescription and Modernization Act

Answer 16

A program started to help people who are either
older than 65 or those who are younger with disabilities
Provides drug discounts

Question 17

Isotretinoin Safety and Risk Management Act of 2004

Answer 17

Regulates the use of Accutane
Registration and education for physicians, pharmacists and patients
Female patients must take pregnancy test before prescription filled

Question 18

2004 Anabolic Steroid Control Act

Answer 18

Placed anabolic steroids on CIII

Harsher penalties for those who abused/misused steroids, especially athletes

Question 19

2005 Combat Meth Act

Answer 19

Focuses on ephedrine, which is used to make meth

Strict guidelines on how much technicians and pharmacists can dispense, sell or distribute it

Question 20

Biologics Price Competition and Innovation (BPCI) Act of 2009

Answer 20

Lowers cost and provides patients with needed biological therapies
Permits the FDA approve biosimilar products

Question 21

Drug Supply Chain Security Act (DSCSA)

Answer 21

Gives an outline for an electronic interoperable system to identity and trace the distribution of certain drugs within the U.S.

Question 22

2010 Patient and Affordable Care Act

Answer 22

Makes preventative care easier and more affordable for Americans
Requires insurance companies to cover all applicants with new minimum standards

Question 23

2013 Drug Quality and Security Act

Answer 23

Gives FDA better oversight over pharmaceuticals and it’s ability to track drugs through the distribution process
Creates new class of manufacturing that are an “outsourcing facility”
Requried the FDA to create and implement a national tracking system