Pharm. Laws

Question 1

1914 Harrison Narcotic Act

Answer 1

-Enacted because of the excessive number of opium
addicts in the United States
-People could no longer obtain opium without a
prescription

Question 2

-Defined the exact labeling for products and defined
misbranding and adulteration as being illegal

Answer 2

-Enacted because the 1906 Pure Food and Drug Act
was not worded strictly enough and did not include
cosmetics
-Basis for pharmacy law today
-New Drug Application required by FDA
-All narcotics were required to be labeled “Warning: May
be habit-forming”

Question 3

1951 Durham-Humphrey Amendment

Answer 3

-Made the initial distinction between legend drugs
(by prescription only) and non-prescription
(over-the-counter or OTC medications)
-Required legend drugs be labeled “Caution: Federal
law prohibits dispensing without a prescription”
-Must be prescription by a licensed practitioner

Question 4

1962 Kefauver-Harris Amendment

• FDA inspections
• Drug testing and approval required

Answer 4

-Enacted in an attempt to ensure the safety and
effectiveness of all new drugs on the market (both
legend and OTC)
-Prevented the sale of thalidomide in the United States because children were born with birth defects after use in pregnancy

Question 5

1970 Comprehensive Drug Abuse Prevention and Control Act

Answer 5

-The Drug Enforcement Agency (DEA) was formed
to enforce the laws concerning narcotics and their distribution
-Created controlled substance schedule I-V
-A closed system allowing distribution of controlled substances to only those registered with DEA
-Established strict recordkeeping guidelines

Question 6

1970 Poison Prevention Packaging Act (PPPA)

Answer 6

-Enacted to reduce accidental poisoning in children
-Requires most OTC and legend drugs be packaged
in child-resistant containers
-Exceptions to child-resistant containers

Question 7

Occupational Safety and Health Act of 1970 (OSHA)

Answer 7

-Ensures a safe and healthful workplace for all employees.
-Requires a reporting system for job-related injuries and illness.
-Attempts to reduce hazards in the workplace and conduct audits to ensure
compliance with the Act.
-Established universal precautions.
-Addresses air contaminants, flammable and combustible liquids, eye and skin protection, and hazard communication standards.
-OSHA requires the use of Safety Data Sheets (SDSs), which are to be
provided by the seller of a particular product to the purchaser.

Question 8

1972 Drug Listing Act: National Drug Code

Answer 8

-Implemented under the authority of the FDA
-Every drug has a unique 10-digit number divided
into three segments

Question 9

Orphan Drug Act of 1983

Answer 9

-Allowed drug companies to bypass the lengthy time
requirements of testing a new drug and the cost that
accompanied them to provide a medication to
persons who had rare disease(s) (disease that
affected 1 in every 200,000 people)

Question 10

1987 Prescription Drug Marketing Act

Answer 10

-Maintain legal supply channel from mfg. to
distributors and wholesalers.
-Prohibits sale or distribution of samples to anyone
other than who can prescribe them.
-Controlled the use of drugs in animals

Question 11

1990 Omnibus Budget Reconciliation Act (OBRA 90)

Answer 11

-Set limitations on Medicare & Medicaid reimbursement for medications
619

Question 12

Resource Conservation and Recovery Act (RCRA)

Answer 12

-General guidelines for the waste management
program envisioned by Congress.
-Hazardous waste – waste with properties that
make it dangerous or potentially harmful to human
health or the environment.

Question 13

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

Answer 13

-Deals with patient’s right to continuance of health
insurance even when changing employers

-Confidentiality: technician has direct knowledge of
patient’s medical information on a daily basis, so patients sign a consent form to grant access to this
information.
+Any information created or received by the pharmacy
+Any information relating to patients health, (mental, physical, past,
present or future)
+Information that may identify a patient

Question 14

2000 Drug Addiction Treatment Act (DATA 2000)

Answer 14

-Permits physicians to prescribe controlled substances
(pre-approved by the DEA) in schedules C-III, C-IV,
C-V to individuals suffering from opioid addiction for the purpose of maintenance or detoxification treatments.

Question 15

2003 Medicare Prescription and Modernization Act

Answer 15

-Medicare is a government-managed insurance program that provides assistance to people older than age 65 and Younger than 65 with disabilities and individuals
with end-stage renal failure
-Provides drug discount card to beneficiaries with low incomes who require pharmacy company assistance for obtaining medications

Question 16

Isotretinoin Safety and Risk Management Act of 2004

Answer 16

-Regulates the use of Accutane because it Can cause severe birth defects & adverse psychiatric effects
(depression/suicide)

Question 17

2004 Anabolic Steroid Control Act

Answer 17

-Placed anabolic steroids on Schedule III
-Harsher penalties for the abuse of anabolic steroids
and their misuse by athletes
-Amended in 2004 (stricter)

Question 18

2005 Combat Meth Act

• Daily sales limit of 3.6 grams / 9 g per 30 days
• Placement out of direct customer access
• Customer identification/recordkeeping

Answer 18

-Bill addresses all areas of manufacturing, law
enforcement, and sale of ephedrine and
pseudoephedrine, which is used as an ingredient in
the preparation of methamphetamine
-Strict guidelines: only a licensed pharmacist or
technician may dispense, sell, or distribute this drug

Question 19

2013 Drug Quality and Security Act

Answer 19

-Gives FDA greater oversight of bulk pharmaceutical
compounding and enhances the agency’s ability to track
drugs through the distribution process
-the Compounding Quality Act
-the Drug Supply Chain Security Act

Question 20

1906 Pure Food and Drug Act

Answer 20

-1st federal law regulating drugs
-Enacted to stop the sale of
inaccurately labeled drugs

Question 21

Biologics Price Competition and Innovation (BPCI) Act of 2009

Answer 21

-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.
-Permits the FDA to approve a biosimilar product
with a designation that is interchangeable with the
FDA-licensed reference biologic.

Question 22

Drug Supply Chain Security Act (DSCSA)

Answer 22

Outlines critical steps to build an electronic,
interoperable system to identify and trace certain
prescription drugs as they are distributed in the
United States

Question 23

2010 Patient Protection and

Affordable Care Act

Answer 23

-Makes preventive care more accessible and affordable for
many Americans

-Requires insurance companies to cover all applicants with
new minimum standards, including individuals with
preexisting conditions

Components of the ACA involve pharmacy professionals
+EHR incentives and e-prescribing
+MTM
+ACO
+The Home Demonstration Project(medication management
and Medicare Part D