Pharmacy Law Final Exam Study Guide - Spring 2025
Drug - correct answer Any article recognized in the USP/NF or HPUS intended for use in
diagnosis, cure, mitigation, treatment, or prevention of disease.
Labeling - correct answer Encompasses all written, printed, or graphic matter on the immediate
container or accompanying a drug.
Adulteration - correct answer A drug is considered adulterated if it contains filthy or
decomposed substances, is prepared under unsanitary conditions, or fails to meet quality
standards.
Misbranding - correct answer A drug is misbranded if its labeling is false/misleading, lacks
required information such as adequate directions, or is not packaged/labeled as required.
Dietary Supplements - correct answer Regulated under the Dietary Supplement Health and
Education Act (DSHEA); they are not approved by FDA before marketing but must be safe and
properly labeled.
Compounding - correct answer Traditional pharmacy compounding under section 503A must
comply with USP <795> (non-sterile) or <797> (sterile); 503B outsourcing facilities must register
and comply with cGMPs.
Prescription Drug Marketing Act (PDMA) - correct answer Restricts distribution of drug samples
to licensed prescribers and hospital pharmacies; prohibits sale/resale of drug samples.
Community pharmacies - correct answer Are not allowed to receive or distribute samples under
federal law.
Drug Quality and Security Act (DQSA) - correct answer Title I: Compounding Quality Act -
enhances FDA oversight of compounded drugs.
Drug Supply Chain Security Act (DSCSA) - correct answer Mandates tracking of prescription
drugs through supply chain using unique product identifiers, serialization, and documentation
of transfers.
Poison Prevention Packaging Act - correct answer Requires most prescription drugs to be
dispensed in child-resistant containers to prevent accidental poisoning.
Exceptions to Poison Prevention Packaging Act - correct answer SL nitroglycerin, certain oral
contraceptives, and patient/physician requested non-child-resistant containers.
Combat Methamphetamine Epidemic Act (CMEA) - correct answer Limits retail sales of
pseudoephedrine/ephedrine to 3.6 grams per day and 9 grams per 30 days.
,HIPAA (Health Insurance Portability and Accountability Act) - correct answer Permits
disclosures for treatment, payment, and healthcare operations without patient authorization.
OBRA '90 - correct answer Requires prospective Drug Utilization Review (DUR) before
dispensing to identify therapeutic duplications, interactions, etc.
Controlled Substances Act (CSA) - correct answer Drugs classified from Schedule I (high abuse,
no medical use) to Schedule V (lowest abuse potential).
DEA Form 222 - correct answer Triplicate or electronic form required to order Schedule II
medications.
Partial Dispensing - correct answer Permitted for Schedule II for terminally ill or LTCF patients;
remainder must be filled within 60 days.
Transfers - correct answer Schedule III-V can be transferred once unless pharmacies share a
real-time database.
MAPS - correct answer Michigan's prescription drug monitoring program; pharmacists must
check MAPS prior to dispensing certain controlled substances.
Pharmacy Intern Rules - correct answer Interns must hold a valid intern license and work under
the immediate supervision of a licensed pharmacist.
Pharmacist in Charge (PIC) Responsibilities - correct answer Responsible for ensuring pharmacy
compliance with all laws and regulations, maintaining records, and supervising staff.
Delegation and Technician Roles - correct answer Only pharmacists may counsel patients or
accept verbal prescriptions for controlled substances.
Customized Patient Medication Packages (CPMPs) - correct answer CPMPs must list drug name,
strength, quantity, directions, and expiration date (no more than 60 days).
Remote Pharmacy Regulations - correct answer Remote pharmacies must be affiliated with a
parent pharmacy, use telepharmacy technology, and have staffing safeguards. Limited in daily
prescription volume and must follow strict operational and security standards.
Record Retention Rules - correct answer Community pharmacy records must be retained for at
least 5 years; controlled substance records for 2 years. Hospital/institutional records must be
accessible within 48 hours upon request by the Board.
Prescription Requirements & Legality - correct answer Valid prescriptions must include patient
info, prescriber's name and license/DEA number, drug info, directions, and date. Fax and e-
prescriptions are allowed under certain conditions; verbal C-II orders only permitted in
emergencies.
, Controlled Substances - Partial Fills - correct answer C-II can be partially filled for
LTCF/terminally ill; documentation and total quantity limits apply.
Controlled Substances - Transfer Rules - correct answer C-III to C-V may be transferred once
unless pharmacies share a common, real-time database.
Controlled Substances - Emergency C-II - correct answer Allowed verbally in a true emergency;
prescriber must send written Rx within 7 days.
Controlled Substances - Multiple C-II Prescriptions - correct answer May be issued with future
'Do Not Fill Before' dates, not exceeding 90-day supply total.
Opioid Treatment (Suboxone/Methadone) - correct answer Requires X-DEA or DATA-waiver
registration; strict documentation needed.
Naloxone - correct answer Pharmacists can dispense without a script under Michigan's standing
order with appropriate documentation.
EpiPens for Schools/Camps - correct answer Facilities may receive stock prescriptions written to
the institution, not individuals.
Inventory Requirements - correct answer Exact counts required for C-IIs; inventory required
annually and upon PIC change.
FDCA (Food, Drug, and Cosmetic Act) - correct answer Definitions: drug, labeling, adulteration,
misbranding. Dietary supplements and FDA regulation. Compounding regulations.
Combat Methamphetamine Epidemic Act - correct answer Purchase limits. Logging
requirements.
Controlled Substances Act & DEA Regulations - correct answer Scheduling criteria (C-I to C-V).
Partial dispensing, transfers, and documentation. DEA 222 forms. MAPS reporting
requirements.
Non-US prescriber legality - correct answer Refers to the legality of prescriptions written by
prescribers outside the United States, such as Canadian MDs.
Partial fills - correct answer Refers to the allowance of dispensing a portion of a prescription for
controlled substances in cases of terminal illness or for patients in long-term care facilities
(LTCF).
Transfer rules - correct answer Regulations governing the transfer of controlled substances
from one pharmacy to another, specifically from C-III to C-V.
Emergency C-II procedures - correct answer Protocols that must be followed for the emergency
dispensing of Schedule II controlled substances.
Drug - correct answer Any article recognized in the USP/NF or HPUS intended for use in
diagnosis, cure, mitigation, treatment, or prevention of disease.
Labeling - correct answer Encompasses all written, printed, or graphic matter on the immediate
container or accompanying a drug.
Adulteration - correct answer A drug is considered adulterated if it contains filthy or
decomposed substances, is prepared under unsanitary conditions, or fails to meet quality
standards.
Misbranding - correct answer A drug is misbranded if its labeling is false/misleading, lacks
required information such as adequate directions, or is not packaged/labeled as required.
Dietary Supplements - correct answer Regulated under the Dietary Supplement Health and
Education Act (DSHEA); they are not approved by FDA before marketing but must be safe and
properly labeled.
Compounding - correct answer Traditional pharmacy compounding under section 503A must
comply with USP <795> (non-sterile) or <797> (sterile); 503B outsourcing facilities must register
and comply with cGMPs.
Prescription Drug Marketing Act (PDMA) - correct answer Restricts distribution of drug samples
to licensed prescribers and hospital pharmacies; prohibits sale/resale of drug samples.
Community pharmacies - correct answer Are not allowed to receive or distribute samples under
federal law.
Drug Quality and Security Act (DQSA) - correct answer Title I: Compounding Quality Act -
enhances FDA oversight of compounded drugs.
Drug Supply Chain Security Act (DSCSA) - correct answer Mandates tracking of prescription
drugs through supply chain using unique product identifiers, serialization, and documentation
of transfers.
Poison Prevention Packaging Act - correct answer Requires most prescription drugs to be
dispensed in child-resistant containers to prevent accidental poisoning.
Exceptions to Poison Prevention Packaging Act - correct answer SL nitroglycerin, certain oral
contraceptives, and patient/physician requested non-child-resistant containers.
Combat Methamphetamine Epidemic Act (CMEA) - correct answer Limits retail sales of
pseudoephedrine/ephedrine to 3.6 grams per day and 9 grams per 30 days.
,HIPAA (Health Insurance Portability and Accountability Act) - correct answer Permits
disclosures for treatment, payment, and healthcare operations without patient authorization.
OBRA '90 - correct answer Requires prospective Drug Utilization Review (DUR) before
dispensing to identify therapeutic duplications, interactions, etc.
Controlled Substances Act (CSA) - correct answer Drugs classified from Schedule I (high abuse,
no medical use) to Schedule V (lowest abuse potential).
DEA Form 222 - correct answer Triplicate or electronic form required to order Schedule II
medications.
Partial Dispensing - correct answer Permitted for Schedule II for terminally ill or LTCF patients;
remainder must be filled within 60 days.
Transfers - correct answer Schedule III-V can be transferred once unless pharmacies share a
real-time database.
MAPS - correct answer Michigan's prescription drug monitoring program; pharmacists must
check MAPS prior to dispensing certain controlled substances.
Pharmacy Intern Rules - correct answer Interns must hold a valid intern license and work under
the immediate supervision of a licensed pharmacist.
Pharmacist in Charge (PIC) Responsibilities - correct answer Responsible for ensuring pharmacy
compliance with all laws and regulations, maintaining records, and supervising staff.
Delegation and Technician Roles - correct answer Only pharmacists may counsel patients or
accept verbal prescriptions for controlled substances.
Customized Patient Medication Packages (CPMPs) - correct answer CPMPs must list drug name,
strength, quantity, directions, and expiration date (no more than 60 days).
Remote Pharmacy Regulations - correct answer Remote pharmacies must be affiliated with a
parent pharmacy, use telepharmacy technology, and have staffing safeguards. Limited in daily
prescription volume and must follow strict operational and security standards.
Record Retention Rules - correct answer Community pharmacy records must be retained for at
least 5 years; controlled substance records for 2 years. Hospital/institutional records must be
accessible within 48 hours upon request by the Board.
Prescription Requirements & Legality - correct answer Valid prescriptions must include patient
info, prescriber's name and license/DEA number, drug info, directions, and date. Fax and e-
prescriptions are allowed under certain conditions; verbal C-II orders only permitted in
emergencies.
, Controlled Substances - Partial Fills - correct answer C-II can be partially filled for
LTCF/terminally ill; documentation and total quantity limits apply.
Controlled Substances - Transfer Rules - correct answer C-III to C-V may be transferred once
unless pharmacies share a common, real-time database.
Controlled Substances - Emergency C-II - correct answer Allowed verbally in a true emergency;
prescriber must send written Rx within 7 days.
Controlled Substances - Multiple C-II Prescriptions - correct answer May be issued with future
'Do Not Fill Before' dates, not exceeding 90-day supply total.
Opioid Treatment (Suboxone/Methadone) - correct answer Requires X-DEA or DATA-waiver
registration; strict documentation needed.
Naloxone - correct answer Pharmacists can dispense without a script under Michigan's standing
order with appropriate documentation.
EpiPens for Schools/Camps - correct answer Facilities may receive stock prescriptions written to
the institution, not individuals.
Inventory Requirements - correct answer Exact counts required for C-IIs; inventory required
annually and upon PIC change.
FDCA (Food, Drug, and Cosmetic Act) - correct answer Definitions: drug, labeling, adulteration,
misbranding. Dietary supplements and FDA regulation. Compounding regulations.
Combat Methamphetamine Epidemic Act - correct answer Purchase limits. Logging
requirements.
Controlled Substances Act & DEA Regulations - correct answer Scheduling criteria (C-I to C-V).
Partial dispensing, transfers, and documentation. DEA 222 forms. MAPS reporting
requirements.
Non-US prescriber legality - correct answer Refers to the legality of prescriptions written by
prescribers outside the United States, such as Canadian MDs.
Partial fills - correct answer Refers to the allowance of dispensing a portion of a prescription for
controlled substances in cases of terminal illness or for patients in long-term care facilities
(LTCF).
Transfer rules - correct answer Regulations governing the transfer of controlled substances
from one pharmacy to another, specifically from C-III to C-V.
Emergency C-II procedures - correct answer Protocols that must be followed for the emergency
dispensing of Schedule II controlled substances.
