Acts and Amendments

Question 1

What is the Pure Food and Drug Act (1906) and why was it enacted?

Answer 1

Prohibits interstate commerce of misbranded and adulterated drugs and food. It was enacted by the shockingly unsanitary conditions in the meat-packing industry.

Question 2

What is the Federal Food, Drug, and Cosmetic Act (1906) and what agency did it essentially create?

Answer 2

Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application before marketing them. It essentially created the FDA.

Question 3

What is the Durham-Humphrey Amendment (1951)?

Answer 3

Defines two specific categories for drug products: legend drugs (prescription-only) and over-the-counter (OTC) medication.

Question 4

What is the label that legend drugs must have per the Durham-Humphrey Amendment (1951)?

Answer 4

Legend drug labels must indicate “Caution: Federal law prohibits dispensing without a prescription.”

Question 5

What is the Kefauver-Harris Amendment (1962)?

Answer 5

Established a framework that requires drug manufacturers to scientifically prove that a medication is not only safe but effective. Prior to this amendment, drug manufacturers only had to prove that a drug was safe (not misbranded or adulterated).

Question 6

What is the Poison Prevention Packaging Act (PPPA) (1970)?

Answer 6

Aims to protect young children from poisonings and deaths that can occur if they gain access to hazardous products including medications.

Question 7

What are some products that are exempt from the PPPA?

Answer 7

Some products are exempt from the PPPA, such as sublingual nitroglycerin, effervescent acetaminophen, effervescent aspirin, oral contraceptives, and hormone replacement therapy.

Question 8

What requirements does the PPPA establish?

Answer 8

Requires that most over-the-counter and legend drugs be packaged in child-resistant containers.

Requires that child-resistant packaging be designed to make it significantly difficult for children under five years of age to open within a reasonable time, but not too difficult for the majority of the adult population

Question 9

What is the Controlled Substances Act (CSA) (1970)?

Answer 9

The CSA is the federal drug policy that regulates the manufacture, importation, possession, use, and distribution of controlled substances: certain narcotics, stimulants, depressants, hallucinogens, and anabolic steroids.

Question 10

How does the CSA classify controlled substances?

Answer 10

The CSA classifies controlled substances into five schedules represented by Roman numerals: Schedules I, II, III, IV, and V.

Question 11

How does Schedule I define controlled substances?

Answer 11

C-I drugs have a high potential for abuse and physical/psychological dependence. They currently have no accepted medical use and are considered investigational or illicit drugs.

Question 12

How does Schedule II define controlled substances?

Answer 12

C-II drugs have a high potential for abuse and physical/psychological dependence. However, unlike C-I drugs, C-II drugs are considered medically acceptable and necessary. The CSA sets forth more strict regulations on the prescribing, distribution, and dispensing of C-II controlled substances in comparison to CIII–V.

Question 13

How does Schedule III define controlled substances?

Answer 13

C-III drugs have moderate to low potential for physical dependence but a high potential for psychological dependence.

Question 14

How does Schedule IV define controlled substances?

Answer 14

C-IV drugs have a low potential for abuse and dependence. However, C-IV drugs could still lead to addiction and have dangerous effects, especially if combined with other substances of abuse.

Question 15

How does Schedule V define controlled substances?

Answer 15

C-V drugs have a low potential for abuse and dependence. These products may contain limited quantities of certain narcotics.

Question 16

Per the CSA, how long does a non-controlled substance prescription valid for before it expires.

Answer 16

Prescriptions for non-controlled substances expire one year after the date written.

Question 17

Per the CSA, if federal or state laws are different, which one should pharmacies follow?

Answer 17

When federal and state laws are different, pharmacies are expected to follow the more stringent law.

Question 18

What is DEA Form 41 used for?

Answer 18

For reporting the destruction of CS.

Question 19

What is DEA Form 104 used for?

Answer 19

For reporting pharmacy closure or surrender of a pharmacy permit.

Question 20

What is DEA Form 106 used for?

Answer 20

For reporting loss or theft of CS.

Question 21

What is DEA Form 222 used for?

Answer 21

For ordering C-I and C-II CS.

Question 22

What is DEA Form 222a used for?

Answer 22

For ordering more of Form DEA 222.

Question 23

What is DEA Form 224 used for?

Answer 23

For applying for a DEA registration number.

Question 24

What is DEA Form 224a used for?

Answer 24

For a DEA registration renewal; must be renewed every three years.

Question 25

Letters A, B, and F are used for who in a DEA number?

Answer 25

Physicians, dentists, veterinarians, pharmacies, and hospitals.

Question 26

The letter M is used for who in a DEA number?

Answer 26

Allied health (“mid-level”) practitioners such as physician assistants and nurse practitioners.

Question 27

Letters P and R are used for who in a DEA number?

Answer 27

Manufacturers, distributors, narcotic treatment programs, and researchers.

Question 28

What is the Federal Anti-Tampering Act (1983) and why was it enacted?

Answer 28

Mandates that over-the-counter (OTC) drug products must have a tamper-evident seal.

Sometimes called the “Tylenol Act.” It was passed in response to the deaths of seven people who took Tylenol capsules that had been laced with cyanide in Chicago.

Question 29

Prescription Drug Marketing Act (1987)?

Answer 29

Prohibits the selling, purchasing, and trading of prescription drug samples. Limits the distribution pf drug samples only to those licensed to prescribe them, if requested.

Question 30

What is the Omnibus Budget Reconciliation Act (OBRA) (1990)?

Answer 30

Commonly called “OBRA ‘90,” this Act established three key pharmacy provisions: drug utilization review, patient counseling standards, and patient record maintenance.

Question 31

What are the three key pharmacy divisions established by OBRA ‘90?

Answer 31

Drug utilization review, patient counseling standards, and patient record maintenance.

Question 32

What is a DUR?

Answer 32

A DUR requires pharmacists to review if the prescription is necessary and appropriate.

Question 33

What are the two types of DUR?

Answer 33

Prospective and retrospective

Question 34

What factors should be considered in a prospective DUR?

Answer 34

Therapeutic duplications, drug interactions, drug allergies, over/underutilization, and potential misuse.

Question 35

What is a retrospective DUR?

Answer 35

A retrospective DUR is preformed after the patient has received the medication and is often used to detect prescribing or dispensing patterns.

Question 36

What is the Dietary Supplement Health and Education Act (DSHEA) (1994)?

Answer 36

Under this act, dietary supplements such as vitamins and herbal supplements are considered “food.” Therefore, dietary supplements do not have to be approved or authorized for investigation as a new drug by the FDA.

Question 37

What is the Health Insurance Portability and Accountability Act (HIPAA) (1996)?

Answer 37

Limits the use and disclosure of protected health information (PHI) to the “minimum necessary.”

Question 38

True or False: HIPPAA provides an option for the patient to obtain a copy of their health record and request corrections.

Answer 38

True/False: If PHI is exposed to unauthorized parties, the affected individuals must be notified.

Question 39

What is the Food and Drug Administration Modernization ACT (FDAMA) (1997)?

Answer 39

This act eliminates certain labeling requirements.

Question 40

What is the Drug Addiction Treatment Act (DATA) (2000)?

Answer 40

Allows qualified prescribers to complete training and register for NADEAN (Narcotic Addiction DEA Number).

Question 41

What is a NADEAN?

Answer 41

Narcotic Addiction DEA Number, a special DEA number that begins with the letter “X”. It enables them to prescribe Schedule III, IV, and V controlled substances indicated for the treatment of opioid use disorder (OUD) outside of an addiction treatment center.

Question 42

What is the most commonly prescribed medication for Opioid Use Disorder?

Answer 42

Buprenorphine

Question 43

What is the Combat Methamphetamine Epidemic Act (CMEA) (2005)?

Answer 43

Regulates the sale of OTC products containing pseudoephedrine (PSE) and ephedrine, which can be used to illegally manufacture methamphetamine.

Question 44

What do customers have to present to purchase PSE-containing products?

Answer 44

Customers must present a valid, government-issued ID.

Question 45

Combat Methamphetamine Epidemic Act (CMEA) (2005) limits the purchase of OTC products containing pseudoephedrine to how many grams per day?

Answer 45

Daily limit of 3.6 gram per day per customer.

Question 46

Combat Methamphetamine Epidemic Act (CMEA) (2005) limits the purchase of OTC products containing pseudoephedrine to how many grams every 30 days?

Answer 46

No more than 9 grams per 30 days if purchased in-store.

Question 47

Pharmacies must keep a written or electronic record of all OTC sales of PSE and ephedrine products. The records must be maintained for how long?

Answer 47

Pharmacies must keep a written or electronic record of all OTC sales of PSE and ephedrine products, and must be maintained for at least two years.

Question 48

What should records of OTC PSE sales contain?

Answer 48

Product name and quantity sold

Name, address, and signature of the purchaser

Date and date of the sale