Historical Milestones in U.S. Drug Legislation: A Pharmacy Technician Quiz

1. What was the purpose of the 1906 Federal Food and Drug Act?

This act addressed environmental conservation efforts.

This act established guidelines for child labor laws.

This act focused on regulating the transportation of goods across state lines.

This act prohibits the sale of adulterated or mislabeled food, drinksand drugs

The 1906 Federal Food and Drug Act aimed to protect consumers by prohibiting the sale of adulterated or mislabeled food, drinks, and drugs, ensuring they meet certain safety and quality standards.

Explanation

The 1906 Federal Food and Drug Act aimed to protect consumers by prohibiting the sale of adulterated or mislabeled food, drinks, and drugs, ensuring they meet certain safety and quality standards.

2. What was the significance of the Harrison Narcotic Act in 1914?

This act banned the use of opium entirely.

This act limits the transport of opium. In order to purchase opium, a prescription is required.

This act legalized the use of opium for recreational purposes.

This act was intended to promote the sale of opium without any restrictions.

The Harrison Narcotic Act of 1914 aimed to control the distribution and use of opiates, specifically opium and coca leaves. It did not legalize opium for recreational use, but instead restricted its transport and required a prescription for purchase. The act was a response to the rising concern over addiction and abuse of these substances.

Explanation

The Harrison Narcotic Act of 1914 aimed to control the distribution and use of opiates, specifically opium and coca leaves. It did not legalize opium for recreational use, but instead restricted its transport and required a prescription for purchase. The act was a response to the rising concern over addiction and abuse of these substances.

3. What important regulations were established by the 1938 Food Drug and Cosmetic Act?

This act focused solely on regulating the cosmetic industry.

This act only applied to food products and not drugs or cosmetics.

This act removed all regulations on drug labeling and advertising.

4. What did the 1951 Durham Humphrey Amendment require regarding the labeling and supervision of drugs?

The 1951 Durham Humphrey Amendment required all drugs to be labeled with their active ingredients only.

The 1951 Durham Humphrey Amendment allowed over the counter drugs to be sold without any labeling requirements.

The 1951 Durham Humphrey Amendment prohibited the use of prescription drugs.

The 1951 Durham Humphrey Amendment was a landmark legislation that brought about crucial distinctions between legend drugs and over the counter drugs, requiring specific labeling requirements and physician supervision for legend drugs. The incorrect answers provided do not accurately represent the provisions of the amendment.

Explanation

The 1951 Durham Humphrey Amendment was a landmark legislation that brought about crucial distinctions between legend drugs and over the counter drugs, requiring specific labeling requirements and physician supervision for legend drugs. The incorrect answers provided do not accurately represent the provisions of the amendment.

5. What was the impact of the Kefauver-Harris Amendment of 1962?

The amendment imposed a ban on the production of all prescription drugs.

The amendment only focused on cosmetic testing and regulations.

The amendment allowed drug manufacturers to skip the approval process for new drugs.

The Kefauver-Harris Amendment of 1962 had a significant impact on drug regulation in the United States by requiring drugs to be proven safe and effective, increasing oversight on advertising, and implementing stricter approval and reporting requirements for manufacturers.

Explanation

The Kefauver-Harris Amendment of 1962 had a significant impact on drug regulation in the United States by requiring drugs to be proven safe and effective, increasing oversight on advertising, and implementing stricter approval and reporting requirements for manufacturers.

6. What was the significance of the 1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA)?

The act allowed for unrestricted access to all types of drugs.

The act designated only a single schedule for all controlled substances.

The act was primarily focused on legalizing recreational drug use.

The 1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA) was significant as it led to the formation of the Drug Enforcement Agency (DEA) and placed controlled substances into different schedules based on their abuse potential, ranging from Schedule I (highest abuse potential) to Schedule V (lowest abuse potential). This helped establish regulations for the manufacturing, distribution, and dispensing of various drugs.

Explanation

The 1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA) was significant as it led to the formation of the Drug Enforcement Agency (DEA) and placed controlled substances into different schedules based on their abuse potential, ranging from Schedule I (highest abuse potential) to Schedule V (lowest abuse potential). This helped establish regulations for the manufacturing, distribution, and dispensing of various drugs.

7. What was the significance of the 1970 Poison Prevention Packaging Act?

The act focused on increasing the availability of over-the-counter medications.

The act mandated warning labels on food products containing potentially harmful additives.

The act aimed to regulate the packaging of household cleaning products to prevent accidental ingestion.

The 1970 Poison Prevention Packaging Act primarily focused on childproof packaging for drugs and certain exemptions were in place for emergency drugs and small quantities unlikely to harm young children.

Explanation

The 1970 Poison Prevention Packaging Act primarily focused on childproof packaging for drugs and certain exemptions were in place for emergency drugs and small quantities unlikely to harm young children.

8. What does the 1983 Orphan Drug Act enable the FDA to do?

Regulate the use of generic drugs in the market.

Oversee the clinical trials of all new pharmaceutical products.

This act enables the FDA to promote the research and marketing of drugs needed for the treatment of rare diseases.

Set pricing regulations for all prescription medications.

The 1983 Orphan Drug Act specifically focuses on promoting research and marketing of drugs for rare diseases, rather than regulating generic drugs, overseeing all clinical trials, or setting pricing regulations.

Explanation

The 1983 Orphan Drug Act specifically focuses on promoting research and marketing of drugs for rare diseases, rather than regulating generic drugs, overseeing all clinical trials, or setting pricing regulations.

9. What was the significance of the 1988 Food and Drug Administration Act?

This act abolished the FDA and transferred its responsibilities to the Department of Agriculture.

The act prohibited any reporting of adverse drug reactions to the FDA.

The 1988 Food and Drug Administration Act focused solely on regulating food safety standards.

The 1988 Food and Drug Administration Act was mainly concerned with regulating prescription drug prices.

The 1988 Food and Drug Administration Act played a key role in establishing the FDA as an agency under the Department of Health and Human Services and emphasizing the importance of reporting adverse drug reactions to the FDA for regulation and monitoring purposes.

Explanation

The 1988 Food and Drug Administration Act played a key role in establishing the FDA as an agency under the Department of Health and Human Services and emphasizing the importance of reporting adverse drug reactions to the FDA for regulation and monitoring purposes.

10. What did the Prescription Drug Marketing Act of 1988 ban?

This act banned the sale, trade, or purchase of drug samples

The promotion of generic drugs.

The distribution of free drug samples.

The regulation of over-the-counter medications.

The Prescription Drug Marketing Act of 1988 specifically banned the sale, trade, or purchase of drug samples to ensure proper regulation and control over prescription medications.

Explanation

The Prescription Drug Marketing Act of 1988 specifically banned the sale, trade, or purchase of drug samples to ensure proper regulation and control over prescription medications.

11. What is the purpose of the Health Insurance Portability and Accountability Act (HIPAA) enacted in 1996?

This act was designed to regulate the import and export of health insurance plans between countries.

This act was put in place to standardize the price of health insurance premiums across the United States.

This act was enacted to establish guidelines for licensing medical professionals in different states.

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 primarily focuses on increasing the privacy and security of patient health information, providing limitations on who can access and share this information, making health insurance portable for individuals changing jobs, and mandating standardized electronic submissions of claim information to make healthcare processing more efficient and cost-effective.

Explanation

The Health Insurance Portability and Accountability Act (HIPAA) of 1996 primarily focuses on increasing the privacy and security of patient health information, providing limitations on who can access and share this information, making health insurance portable for individuals changing jobs, and mandating standardized electronic submissions of claim information to make healthcare processing more efficient and cost-effective.

12. What does the 2006 Combat Methamphetamine Epidemic Act (CMEA) limit the purchase of pseudophedrine (pse) products to?

2.0g of pse per day or 6g per 30 days

4.2g of pse per day or 10g per 30 days

This act limits the purchase of pseudophedrine(pse) products to 3.6g of pse per dat or 9g per 30 days

5.0g of pse per day or 15g per 30 days

The 2006 Combat Methamphetamine Epidemic Act (CMEA) restricts the purchase of pseudophedrine (pse) products to 3.6g of pse per day or 9g per 30 days in order to combat the production of methamphetamine.

Explanation

The 2006 Combat Methamphetamine Epidemic Act (CMEA) restricts the purchase of pseudophedrine (pse) products to 3.6g of pse per day or 9g per 30 days in order to combat the production of methamphetamine.

13. What does a Class I Recall indicate?

A Class I Recall is solely for administrative purposes within the pharmaceutical company.

A Class I Recall indicates a minor issue with the drug that requires no action from patients.

A Class I Recall means that the drug has been proven to be completely safe with no side effects.

A Class I Recall is the most serious type of recall and is issued when there is a reasonable probability that the use of the drug will cause serious adverse health consequences or death. Patients must be notified immediately to prevent harm.

Explanation

A Class I Recall is the most serious type of recall and is issued when there is a reasonable probability that the use of the drug will cause serious adverse health consequences or death. Patients must be notified immediately to prevent harm.

14. What is a Class II recall?

The recall is initiated due to minor labeling issues that do not pose any serious health risks.

Class II recalls are always issued at the customer level, directly affecting the end consumers.

The probability of serious harm is high and the effects are permanent. This recall typically involves issues with food safety.

Class II recalls are classified as such when there is a low probability of serious harm and the effects are usually temporary or reversible. The recalls are typically due to consistency of potency issues and do not reach the customer level.

Explanation

Class II recalls are classified as such when there is a low probability of serious harm and the effects are usually temporary or reversible. The recalls are typically due to consistency of potency issues and do not reach the customer level.

15. What is a Class III recall?

A recall that solely involves cosmetic defects in the product.

A recall that is initiated by the customer due to dissatisfaction with the product.

A recall that is limited to specific geographical regions and does not affect the overall market.

A recall that involves a product that may cause serious adverse health consequences or death.

Not likely to cause any serious adverse effects and does not go to the customer level

Class III recalls are considered to be the least severe type of recall as they are not likely to cause serious adverse effects and do not reach the level of the customer.

Explanation

Class III recalls are considered to be the least severe type of recall as they are not likely to cause serious adverse effects and do not reach the level of the customer.

16. What information must OTC labeling contain?

Caution/warning labels and directions for use only

Expiration date only

Product Name and net contents only

OTC labeling must contain a comprehensive list of information including product name, manufacturer address, net contents, all ingredients, habit-forming drugs, caution/warning labels, and directions for use.

Explanation

OTC labeling must contain a comprehensive list of information including product name, manufacturer address, net contents, all ingredients, habit-forming drugs, caution/warning labels, and directions for use.

17. What information is required on prescription drugs according to the Food, Drug, and Cosmetic Act?

Patient's favorite color and zodiac sign

List of all movies watched by the doctor and patient

Weather forecast for the day of use

The Food, Drug, and Cosmetic Act specifies the necessary information that should be present on prescription drugs to ensure safe dispensing and usage.

Explanation

The Food, Drug, and Cosmetic Act specifies the necessary information that should be present on prescription drugs to ensure safe dispensing and usage.

18. What information must package inserts contain?

Drug pricing information, Side effects only, Marketing slogans, Brand name only

Package inserts provide critical information about the drug including its description, clinical pharmacology, indications, contraindications, warnings, dosage, and the most recent label revision date. Other information such as drug pricing, side effects only, marketing slogans, or brand name only would not provide a comprehensive overview of the drug.

Explanation

Package inserts provide critical information about the drug including its description, clinical pharmacology, indications, contraindications, warnings, dosage, and the most recent label revision date. Other information such as drug pricing, side effects only, marketing slogans, or brand name only would not provide a comprehensive overview of the drug.

19. Which drug classes must have package inserts distributed with them?

Antibiotics

Antihistamines

Oral contraceptives, estrogen-containing and progestational drugs, intrauterine contraceptive devices, diethylstilbestrol products, accutane, metered-dose inhalers

Vitamins

Package inserts are required for drug classes where detailed information is necessary for safe and effective use. While antibiotics, antihistamines, and vitamins may also require information, the specified drug classes have specific risks and precautions that necessitate the distribution of package inserts.

Explanation

Package inserts are required for drug classes where detailed information is necessary for safe and effective use. While antibiotics, antihistamines, and vitamins may also require information, the specified drug classes have specific risks and precautions that necessitate the distribution of package inserts.

20. What does the National Drug Code (NDC) identify?

NDC is a code used by pharmacies to track medication usage by patients.

The NDC number is composed of two sets of numbers that identify the drug and its dosage.

National Drug Code is a code used to identify patient information in medical records.

The National Drug Code (NDC) uniquely identifies each medication and is composed of three sets of numbers to identify the manufacturer, drug, and pack size. It is not used to identify patient information, track medication usage by pharmacies, or composed of two sets of numbers.

Explanation

The National Drug Code (NDC) uniquely identifies each medication and is composed of three sets of numbers to identify the manufacturer, drug, and pack size. It is not used to identify patient information, track medication usage by pharmacies, or composed of two sets of numbers.

21. What do the first set of NDC numbers (five numbers) indicate?

Manufacturer

Dosage strength

Expiration date

Quantity dispensed

The first set of NDC numbers typically indicate the manufacturer of the medication. This helps identify the company that produced the drug.

Explanation

The first set of NDC numbers typically indicate the manufacturer of the medication. This helps identify the company that produced the drug.

22. What does the NDC second set/middle set (four numbers) indicate?

Dosage strength of the drug.

Expiration date of the drug.

Manufacturer of the drug.

Specific drug - each drug has its own number

The correct answer is 'Specific drug - each drug has its own number.' The NDC second set/middle set of four numbers represent a specific drug, with each drug having its unique identifier within the National Drug Code system.

Explanation

The correct answer is 'Specific drug - each drug has its own number.' The NDC second set/middle set of four numbers represent a specific drug, with each drug having its unique identifier within the National Drug Code system.

23. What do the NDC last two numbers indicate?

Package size - (100 tablets may be 01, 500 tablets may be 05)

Dosage - (01 for 10mg, 05 for 50mg)

Distribution center location - (01 for East coast, 05 for West coast)

Expiration date - (01 for January, 12 for December)

The NDC last two numbers indicate the package size of the medication. For example, if the last two numbers are 01, it could represent a package size of 100 tablets, while 05 could indicate a package size of 500 tablets.

Explanation

The NDC last two numbers indicate the package size of the medication. For example, if the last two numbers are 01, it could represent a package size of 100 tablets, while 05 could indicate a package size of 500 tablets.

24. What is the classification of Schedule I drugs in the United States?

These drugs have multiple accepted medical uses and low abuse potential.

These drugs have NO accepted medical use in the united states. These drugs have the highest abuse potential

These drugs have limited medical use and a moderate abuse potential.

These drugs are commonly used for medical purposes but have a high abuse potential.

Schedule I drugs are classified as substances with no accepted medical use in the United States and have the highest potential for abuse according to the Drug Enforcement Administration (DEA).

Explanation

Schedule I drugs are classified as substances with no accepted medical use in the United States and have the highest potential for abuse according to the Drug Enforcement Administration (DEA).

25. What are Schedule II drugs?

Schedule II drugs are over-the-counter medications available without a prescription.

Schedule II drugs have a low potential for abuse and dependence.

Schedule II drugs can be easily refilled without restrictions.

Schedule II drugs are tightly controlled substances due to their high potential for abuse and dependence. They can NOT be refilled, require specific forms for ordering and returning, and have strict regulations surrounding their use.

Explanation

Schedule II drugs are tightly controlled substances due to their high potential for abuse and dependence. They can NOT be refilled, require specific forms for ordering and returning, and have strict regulations surrounding their use.

26. What are Schedule III drugs?

Schedule III drugs fall under the highest category of controlled substances.

These drugs have the highest potential for abuse/dependence compared to other drug schedules.

Schedule III drugs can only be prescribed by specialized doctors.

Schedule III drugs cannot be refilled under any circumstances.

Schedule III drugs are classified as such because they have a moderate to low potential for physical and psychological dependence. They can be refilled up to 5 times within a six month period, unlike Schedule I and II drugs which have stricter refill limitations.

Explanation

Schedule III drugs are classified as such because they have a moderate to low potential for physical and psychological dependence. They can be refilled up to 5 times within a six month period, unlike Schedule I and II drugs which have stricter refill limitations.

27. What regulations apply to Schedule IV drugs?

These drugs can only be obtained with a prescription from a specialist.

Patients can purchase Schedule IV drugs over-the-counter without any restrictions.

Schedule IV drugs are classified as having the highest potential for abuse/dependence.

Schedule IV drugs have specific regulations regarding refills and are considered to have lower potential for abuse compared to other schedules.

Explanation

Schedule IV drugs have specific regulations regarding refills and are considered to have lower potential for abuse compared to other schedules.

28. What are Schedule V drugs?

These drugs have less potential for abuse than schedule II, III, and IV drugs.

Schedule V drugs are the most dangerous and addictive drugs.

Schedule V drugs are completely legal and available over the counter.

Schedule V drugs have the same potential for abuse as schedule II drugs.

Schedule V drugs are classified as substances with the least potential for abuse among prescription medications, which is why they are subject to the least strict regulations compared to other schedules.

Explanation

Schedule V drugs are classified as substances with the least potential for abuse among prescription medications, which is why they are subject to the least strict regulations compared to other schedules.