Pharmacy Law CE Review Practice Exam Updated
2026 | Complete Study Guide with Verified
Questions and Detailed Rationales 🩺 | Federal and
State Pharmacy Laws, Controlled Substances
Regulations, DEA Schedules, Prescription
Requirements, Medication Dispensing Rules,
Recordkeeping and Documentation, Patient Privacy
(HIPAA), Legal and Ethical Standards, and
Regulatory Compliance for Pharmacy Continuing
Education Exam Success
Question 1: Under the federal Controlled Substances Act, which schedule
classification applies to a drug with currently accepted medical use in the United
States, a low potential for abuse relative to substances in Schedules III and IV, and
limited physical or psychological dependence liability?
A. Schedule I
B. Schedule II
C. Schedule III
D. Schedule IV
CORRECT ANSWER: D. Schedule IV
RATIONALE : Schedule IV substances are defined under 21 U.S.C. § 812 as having a
currently accepted medical use in treatment in the United States, a low potential for
abuse relative to Schedule III substances, and limited liability for physical or
psychological dependence. Examples include benzodiazepines such as alprazolam and
diazepam. Schedule I substances have no accepted medical use; Schedule II
substances have high abuse potential with severe dependence liability; Schedule III
substances have moderate to low physical dependence or high psychological
dependence.
Question 2: Which federal agency is primarily responsible for enforcing regulations
related to the manufacturing, distribution, and dispensing of controlled
substances in the United States?
A. Food and Drug Administration (FDA)
B. Centers for Medicare & Medicaid Services (CMS)
C. Drug Enforcement Administration (DEA)
D. Occupational Safety and Health Administration (OSHA)
CORRECT ANSWER: C. Drug Enforcement Administration (DEA)
RATIONALE : The Drug Enforcement Administration (DEA), a component of the U.S.
Department of Justice, is the primary federal agency responsible for enforcing the
Controlled Substances Act (CSA) and regulating the manufacture, distribution,
dispensing, importation, and exportation of controlled substances. The FDA regulates
,drug safety and efficacy; CMS administers Medicare and Medicaid; OSHA oversees
workplace safety.
Question 3: A pharmacist receives a prescription for oxycodone 5 mg, #30, with two
refills authorized. The prescription was written on March 1, 2024. Under federal
law, what is the latest date this prescription may be dispensed?
A. March 31, 2024
B. June 1, 2024
C. September 1, 2024
D. The prescription cannot be refilled under federal law
CORRECT ANSWER: D. The prescription cannot be refilled under federal law
RATIONALE : Oxycodone is a Schedule II controlled substance under the federal
Controlled Substances Act. Federal law (21 CFR § 1306.12) explicitly prohibits refills for
Schedule II prescriptions. A new prescription is required for each dispensing. While
partial fills are permitted under specific circumstances, refills are never authorized for
Schedule II substances regardless of prescriber instructions.
Question 4: Under the Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule, which of the following scenarios represents a permissible disclosure
of protected health information (PHI) without patient authorization?
A. Disclosing a patient's medication history to a pharmaceutical sales representative for
marketing purposes
B. Sharing a patient's prescription records with a law enforcement officer investigating a
non-drug-related crime without a warrant
C. Providing a patient's medication list to another healthcare provider involved in the
patient's treatment
D. Posting a patient's successful treatment outcome on the pharmacy's public social
media page
CORRECT ANSWER: C. Providing a patient's medication list to another healthcare
provider involved in the patient's treatment
RATIONALE : HIPAA permits disclosure of PHI for treatment, payment, and healthcare
operations without patient authorization (45 CFR § 164.506). Sharing medication
information with another treating provider falls squarely under "treatment." Disclosures
for marketing require explicit authorization; law enforcement disclosures require
specific legal process or exigent circumstances; public social media posts violate
privacy unless all identifiers are removed and patient consent is obtained.
Question 5: The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) mandates
that pharmacists perform which of the following activities for Medicaid patients
receiving new prescriptions?
A. Conduct a comprehensive medication therapy management (MTM) session
B. Offer counseling regarding proper use, side effects, and storage of the medication
,C. Obtain written informed consent before dispensing any new medication
D. Submit prior authorization requests to the patient's insurance plan
CORRECT ANSWER: B. Offer counseling regarding proper use, side effects, and
storage of the medication
RATIONALE : OBRA '90 requires pharmacists to offer counseling to Medicaid patients
about new prescriptions, including information on proper use, dosage, route, duration,
side effects, precautions, and storage. While MTM services may be provided under
other programs, OBRA '90 specifically mandates the offer of counseling, not its
completion. Written consent is not required for routine dispensing, and prior
authorization is an insurance process, not a pharmacist obligation under OBRA '90.
Question 6: Which provision of the Drug Supply Chain Security Act (DSCSA)
requires pharmaceutical manufacturers to affix a product identifier to each
package and homogeneous case of a prescription drug distributed in the United
States?
A. Product tracing requirement
B. Product verification requirement
C. Product identifier requirement
D. Authorized trading partner requirement
CORRECT ANSWER: C. Product identifier requirement
RATIONALE : The DSCSA (enacted as part of the Drug Quality and Security Act of 2013)
mandates that manufacturers affix a product identifier—containing the standardized
numerical identifier (serial number), lot number, and expiration date in both human-
readable and machine-readable (2D barcode) format—to each package and
homogeneous case of prescription drugs. This supports the electronic, interoperable
system to identify and trace prescription drugs distributed in the U.S. Product tracing
involves transaction information exchange; verification confirms product legitimacy;
authorized trading partner defines eligible entities in the supply chain.
Question 7: Under federal law, what is the maximum number of days' supply of a
Schedule III or IV controlled substance that may be dispensed pursuant to a single
prescription, including refills?
A. 30 days
B. 90 days
C. 180 days
D. There is no federal limit on days' supply
CORRECT ANSWER: B. 90 days
RATIONALE : Federal regulations (21 CFR § 1306.22) permit Schedule III and IV
controlled substance prescriptions to be refilled up to five times within six months from
the date of issue, with the total quantity dispensed not exceeding a 90-day supply.
While state law may impose stricter limits, the federal maximum is 90 days. Schedule II
, prescriptions have no refill authorization and are generally limited to a 30-day supply
under many state laws, though federal law does not specify a days' supply limit for
Schedule II.
Question 8: A pharmacy compounder operating under Section 503A of the Federal
Food, Drug, and Cosmetic Act is permitted to compound medications under which
of the following conditions?
A. For wholesale distribution to other pharmacies without patient-specific prescriptions
B. In anticipation of receiving prescriptions before any individual patient prescription is
received
C. For a specific patient based on a valid prescription or in limited quantities before
receipt of a prescription based on a history of receiving valid prescriptions
D. Using bulk drug substances that are not components of FDA-approved drugs
CORRECT ANSWER: C. For a specific patient based on a valid prescription or in
limited quantities before receipt of a prescription based on a history of receiving
valid prescriptions
RATIONALE : Section 503A compounding pharmacies (traditional compounders) may
compound medications for identified individual patients based on valid prescriptions,
or in limited quantities before receiving a prescription if there is a history of receiving
valid prescriptions for that compound. They cannot compound for wholesale
distribution (prohibited under 503A), cannot compound in anticipation of prescriptions
without such history, and generally must use bulk drug substances that comply with
USP standards or are components of FDA-approved drugs, unless specific exemptions
apply.
Question 9: Which federal law requires pharmacists to verify the identity of
purchasers of pseudoephedrine-containing products and maintain sales records
for inspection by law enforcement?
A. Controlled Substances Act
B. Combat Methamphetamine Epidemic Act of 2005
C. Ryan Haight Online Pharmacy Consumer Protection Act
D. Drug Enforcement Administration Modernization Act
CORRECT ANSWER: B. Combat Methamphetamine Epidemic Act of 2005
RATIONALE : The Combat Methamphetamine Epidemic Act (CMEA) of 2005, enacted as
part of the USA PATRIOT Act reauthorization, regulates over-the-counter sales of
pseudoephedrine, ephedrine, and phenylpropanolamine products. It requires retailers
to verify purchaser identity, maintain a logbook of sales, impose daily and monthly
purchase limits, and place products behind the counter. The CSA regulates scheduled
drugs; the Ryan Haight Act addresses online prescription dispensing; the DEA
Modernization Act is not a recognized federal statute.
2026 | Complete Study Guide with Verified
Questions and Detailed Rationales 🩺 | Federal and
State Pharmacy Laws, Controlled Substances
Regulations, DEA Schedules, Prescription
Requirements, Medication Dispensing Rules,
Recordkeeping and Documentation, Patient Privacy
(HIPAA), Legal and Ethical Standards, and
Regulatory Compliance for Pharmacy Continuing
Education Exam Success
Question 1: Under the federal Controlled Substances Act, which schedule
classification applies to a drug with currently accepted medical use in the United
States, a low potential for abuse relative to substances in Schedules III and IV, and
limited physical or psychological dependence liability?
A. Schedule I
B. Schedule II
C. Schedule III
D. Schedule IV
CORRECT ANSWER: D. Schedule IV
RATIONALE : Schedule IV substances are defined under 21 U.S.C. § 812 as having a
currently accepted medical use in treatment in the United States, a low potential for
abuse relative to Schedule III substances, and limited liability for physical or
psychological dependence. Examples include benzodiazepines such as alprazolam and
diazepam. Schedule I substances have no accepted medical use; Schedule II
substances have high abuse potential with severe dependence liability; Schedule III
substances have moderate to low physical dependence or high psychological
dependence.
Question 2: Which federal agency is primarily responsible for enforcing regulations
related to the manufacturing, distribution, and dispensing of controlled
substances in the United States?
A. Food and Drug Administration (FDA)
B. Centers for Medicare & Medicaid Services (CMS)
C. Drug Enforcement Administration (DEA)
D. Occupational Safety and Health Administration (OSHA)
CORRECT ANSWER: C. Drug Enforcement Administration (DEA)
RATIONALE : The Drug Enforcement Administration (DEA), a component of the U.S.
Department of Justice, is the primary federal agency responsible for enforcing the
Controlled Substances Act (CSA) and regulating the manufacture, distribution,
dispensing, importation, and exportation of controlled substances. The FDA regulates
,drug safety and efficacy; CMS administers Medicare and Medicaid; OSHA oversees
workplace safety.
Question 3: A pharmacist receives a prescription for oxycodone 5 mg, #30, with two
refills authorized. The prescription was written on March 1, 2024. Under federal
law, what is the latest date this prescription may be dispensed?
A. March 31, 2024
B. June 1, 2024
C. September 1, 2024
D. The prescription cannot be refilled under federal law
CORRECT ANSWER: D. The prescription cannot be refilled under federal law
RATIONALE : Oxycodone is a Schedule II controlled substance under the federal
Controlled Substances Act. Federal law (21 CFR § 1306.12) explicitly prohibits refills for
Schedule II prescriptions. A new prescription is required for each dispensing. While
partial fills are permitted under specific circumstances, refills are never authorized for
Schedule II substances regardless of prescriber instructions.
Question 4: Under the Health Insurance Portability and Accountability Act (HIPAA)
Privacy Rule, which of the following scenarios represents a permissible disclosure
of protected health information (PHI) without patient authorization?
A. Disclosing a patient's medication history to a pharmaceutical sales representative for
marketing purposes
B. Sharing a patient's prescription records with a law enforcement officer investigating a
non-drug-related crime without a warrant
C. Providing a patient's medication list to another healthcare provider involved in the
patient's treatment
D. Posting a patient's successful treatment outcome on the pharmacy's public social
media page
CORRECT ANSWER: C. Providing a patient's medication list to another healthcare
provider involved in the patient's treatment
RATIONALE : HIPAA permits disclosure of PHI for treatment, payment, and healthcare
operations without patient authorization (45 CFR § 164.506). Sharing medication
information with another treating provider falls squarely under "treatment." Disclosures
for marketing require explicit authorization; law enforcement disclosures require
specific legal process or exigent circumstances; public social media posts violate
privacy unless all identifiers are removed and patient consent is obtained.
Question 5: The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) mandates
that pharmacists perform which of the following activities for Medicaid patients
receiving new prescriptions?
A. Conduct a comprehensive medication therapy management (MTM) session
B. Offer counseling regarding proper use, side effects, and storage of the medication
,C. Obtain written informed consent before dispensing any new medication
D. Submit prior authorization requests to the patient's insurance plan
CORRECT ANSWER: B. Offer counseling regarding proper use, side effects, and
storage of the medication
RATIONALE : OBRA '90 requires pharmacists to offer counseling to Medicaid patients
about new prescriptions, including information on proper use, dosage, route, duration,
side effects, precautions, and storage. While MTM services may be provided under
other programs, OBRA '90 specifically mandates the offer of counseling, not its
completion. Written consent is not required for routine dispensing, and prior
authorization is an insurance process, not a pharmacist obligation under OBRA '90.
Question 6: Which provision of the Drug Supply Chain Security Act (DSCSA)
requires pharmaceutical manufacturers to affix a product identifier to each
package and homogeneous case of a prescription drug distributed in the United
States?
A. Product tracing requirement
B. Product verification requirement
C. Product identifier requirement
D. Authorized trading partner requirement
CORRECT ANSWER: C. Product identifier requirement
RATIONALE : The DSCSA (enacted as part of the Drug Quality and Security Act of 2013)
mandates that manufacturers affix a product identifier—containing the standardized
numerical identifier (serial number), lot number, and expiration date in both human-
readable and machine-readable (2D barcode) format—to each package and
homogeneous case of prescription drugs. This supports the electronic, interoperable
system to identify and trace prescription drugs distributed in the U.S. Product tracing
involves transaction information exchange; verification confirms product legitimacy;
authorized trading partner defines eligible entities in the supply chain.
Question 7: Under federal law, what is the maximum number of days' supply of a
Schedule III or IV controlled substance that may be dispensed pursuant to a single
prescription, including refills?
A. 30 days
B. 90 days
C. 180 days
D. There is no federal limit on days' supply
CORRECT ANSWER: B. 90 days
RATIONALE : Federal regulations (21 CFR § 1306.22) permit Schedule III and IV
controlled substance prescriptions to be refilled up to five times within six months from
the date of issue, with the total quantity dispensed not exceeding a 90-day supply.
While state law may impose stricter limits, the federal maximum is 90 days. Schedule II
, prescriptions have no refill authorization and are generally limited to a 30-day supply
under many state laws, though federal law does not specify a days' supply limit for
Schedule II.
Question 8: A pharmacy compounder operating under Section 503A of the Federal
Food, Drug, and Cosmetic Act is permitted to compound medications under which
of the following conditions?
A. For wholesale distribution to other pharmacies without patient-specific prescriptions
B. In anticipation of receiving prescriptions before any individual patient prescription is
received
C. For a specific patient based on a valid prescription or in limited quantities before
receipt of a prescription based on a history of receiving valid prescriptions
D. Using bulk drug substances that are not components of FDA-approved drugs
CORRECT ANSWER: C. For a specific patient based on a valid prescription or in
limited quantities before receipt of a prescription based on a history of receiving
valid prescriptions
RATIONALE : Section 503A compounding pharmacies (traditional compounders) may
compound medications for identified individual patients based on valid prescriptions,
or in limited quantities before receiving a prescription if there is a history of receiving
valid prescriptions for that compound. They cannot compound for wholesale
distribution (prohibited under 503A), cannot compound in anticipation of prescriptions
without such history, and generally must use bulk drug substances that comply with
USP standards or are components of FDA-approved drugs, unless specific exemptions
apply.
Question 9: Which federal law requires pharmacists to verify the identity of
purchasers of pseudoephedrine-containing products and maintain sales records
for inspection by law enforcement?
A. Controlled Substances Act
B. Combat Methamphetamine Epidemic Act of 2005
C. Ryan Haight Online Pharmacy Consumer Protection Act
D. Drug Enforcement Administration Modernization Act
CORRECT ANSWER: B. Combat Methamphetamine Epidemic Act of 2005
RATIONALE : The Combat Methamphetamine Epidemic Act (CMEA) of 2005, enacted as
part of the USA PATRIOT Act reauthorization, regulates over-the-counter sales of
pseudoephedrine, ephedrine, and phenylpropanolamine products. It requires retailers
to verify purchaser identity, maintain a logbook of sales, impose daily and monthly
purchase limits, and place products behind the counter. The CSA regulates scheduled
drugs; the Ryan Haight Act addresses online prescription dispensing; the DEA
Modernization Act is not a recognized federal statute.
