Pharmacy Law

Question 1

1906 Pure food and drug act

Answer 1

1st federal law regulating drugs

-enacted to stop the sell of inaccurately labeled drugs

Question 2

1914 Harrison Narcotic act

Answer 2

• enacted because of the excessive amount of opium addicts

- no longer obtain opium without a prescription

Question 3

1938 food drug and cosmetic act

Answer 3

• enacted to replace the 1906 act so as to include
• basis for modern pharmacy law
• New drug application required by fda
• all narcotics required to be labeled Warning: may be habit forming
• Require adequate directions for use (package insert)
• defined exact labeling requirements and defined mislabeling (false or misleading, lacking warnings) and adulteration (Unsafe, unsanitary) as illegal

Question 4

1951 Durham Humphrey amendment

Answer 4

• Made description between legend (prescription only) drugs and over the counter (non-prescription) drugs
• Requires legend drugs be labeled Warning: federal law prohibits dispensing without a prescription
• must be prescribed by a licensed practitioner

Question 5

1962 Kefauver-Harris amendment

Answer 5

• enacted to ensure safety and effectiveness in new drugs
• burden put on manufacturing companies to have good manufacturing practices: FDA inspections, Drug testing and approval needed
• prevented sale of thalidomide due to birth defects caused by it

Question 6

1970 comprehensive drug abuse prevention and control act

Answer 6

• The drug enforcement agency (DEA) formed to enforce laws concerning distribution of narcotics
• created controlled substance classification
• closed distribution of controlled substances to only those registered with the DEA
• strict recordkeeping guidelines

Question 7

1970 poison prevention packaging act

Answer 7

• enabled to reduce accidental poisoning of children
• requires most OTC and legend drugs to be packaged in childproof containers (80% under 5 should not be able to open while 90% adults can)
• Exception to childproof containers allowed: upon request, institutionalized patients, certain emergency medications

Question 8

Occupational safety and health act of 1970 (OSHA)

Answer 8

-Ensures safe and healthful workplace for employees
-requires reporting system for workplace incidents
-attempts to reduce hazards
-established universal precautions
-Establishes air contaminants, flammable and combustible liquids, eye and
skin protection, and hazard communication standards
-requires Safety data sheets (SDS).

Question 9

1972 drug listing act national drug code

Answer 9

• implemented by the FDA

- every drug has a unique 10 digit number divided into three segments (Labeler, Product code, Package code)

Question 10

Orphan drug Act of 1983

Answer 10

• Allowed companies to bypass the lengthy time requirements to test a new drug and the cost accompanying them to provide medications for rare diseases (diseases that affect 1 in every 200,000 people)
• Also covers diseases that affect >200,000 if it can be proven that the cost of testing could not be made back by sales

Question 11

Prescription drug marketing act of 1987

Answer 11

-Required the labeling “Caution: Federal law restricts
this drug to use by or in order of a licensed
veterinarian”
-controlled use of drugs on animals
-prohibits sale and distribution of samples to anyone other than those who can prescribe it
-maintains legal supply channel between mfg and distributors and wholesalers

Question 12

1990 Omnibus budget reconciliation act (OBRA 90)

Answer 12

-Set limitations for medicare and medicaid reimbursements for prescriptions
-created need for pharmacy technicians
-all medications prescribed must be reviewed for appropriateness
-Pharmacist MUST COUNSEL all patients that receive new prescriptions
-All patients must be given information on the drug they are taking (the name, when to take it, how
long to take it, and any side effects or possible
interactions)

Question 13

Resource Conservation and
Recovery Act (RCRA)

Answer 13

• general guidelines for the waste management program
• Hazardous waste falls into 2 categories
• -Listed waste that shows up on any of the EPA’s 4 lists, K list, F list, P list and U list
• -Characteristic wastes that exhibit one or more of four characteristics; ignitability, corrosivity, reactivity and toxicity

Question 14

Health Insurance Portability and

Accountability Act of 1996 (HIPAA)

Answer 14

• patients rights to continued health insurance even after changing employers
• confidentiality, patient information (identifying info, health info, and info from or received by the pharmacy) requires the patient’s consent in order to be accessed

Question 15

2000 Drug Addiction Treatment Act

DATA 2000

Answer 15

-allows prescribing of controlled substances in schedules C-III, C-IV,
C-V to those suffering opioid addiction for maintenance or detoxification purposes

Question 16

2003 Medicare Prescription and

Modernization Act

Answer 16

• Medicare provides help and benefits to those 65 and older and those younger than 65 with disabilities or end stage renal failure
• provides drug discount card to beneficiaries with low income

Question 17

Isotretinoin Safety and Risk Management

Act of 2004

Answer 17

• Regulates use of accutane
• -mandatory registration and education for physicians, pharmacists, and patients
• only in person prescriptions
• female patients must do a monthly pregnancy test before the prescription is filled

Question 18

2004 Anabolic Steroid Control

Act

Answer 18

• places anabolic steroids on schedule III
• harsher penalties for the abuse of anabolic steroids
• amended in 2004 to be stricter

Question 19

2005 Combat Meth Act

Answer 19

-Addresses all areas of manufacturing, law enforcement and sale of ephedrine and
pseudoephedrine
-strict guidelines: only a licensed pharmacist or technician may dispense, sell or distribute this drug
–Daily sales limit of 3.6 grams / 9 g per 30 days

Question 20

Biologics Price Competition and

Innovation (BPCI) Act of 2009

Answer 20

-created an abbreviated pathway for approval of
biological products demonstrated to be biosimilar
to or interchangeable with an FDA-licensed
reference biological product.
-Lowers cost and provides patient access to crucial
biological therapies that they need.

Question 21

Drug Supply Chain Security Act

DSCSA

Answer 21

-outlines critical steps to build an electronic system to identify and trace certain prescription drugs as they are distributed in the united states

Question 22

2010 Patient Protection and

Affordable Care Act

Answer 22

-makes preventive care more accessible and affordable for many Americans
-requires insurance companies to cover all applicants with
new minimum standards, including those with
preexisting conditions
–parts of this act include Pharmacy professionals, specifically EHR incentives and e-prescribing, MTM, ACO, The Home Demonstration Project(medication management)
and Medicare Part D

Question 23

2013 Drug Quality and Security Act

Answer 23

-gives FDA greater oversight of bulk pharmaceutical
compounding and enhances their ability to track
drugs through the distribution process
–comprised of two separate acts
— the compounding quality act: created a new class of manufacturers that voluntarily register with the FDA as an “outsourcing facility”
—the drug supply chain security act: requires the FDA to create and implement a national tracking system
to be used by manufacturers