,Q1 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
A Washington pharmacy's automated dispensing system (ADS) cabinet is
restocked by a certified pharmacy technician without a pharmacist's final
verification. Under WAC 246-945-XXX (or current equivalent), which legal principle
best determines whether this restocking violates the standard of practice?
A. The ADS is exempt from pharmacist verification if the technician is certified and the cabinet is
in a licensed pharmacy.
B. Restocking is a non-discretionary task that may be delegated, but the pharmacist-in-charge
retains ultimate responsibility for accuracy and must establish a system of checks. CORRECT
C. Only a pharmacist may physically place any drug into an ADS, regardless of the drug's
schedule or packaging.
D. The violation depends solely on whether the drug is a controlled substance; non-controlled
drugs may be restocked freely.
RATIONALE: Washington law allows delegation of non-discretionary tasks to trained personnel,
but the pharmacist-in-charge is legally responsible for the accuracy and security of the ADS.
Option A is incorrect because pharmacist verification is not universally exempted. Option C is too
absolute; technicians may restock under specific conditions. Option D is wrong because even
non-controlled drugs require proper oversight to ensure patient safety.
Page 2
,Q2 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
Which of the following best describes the legal authority of a Washington
pharmacy intern who has not yet obtained a license but is enrolled in an
ACPE-accredited program?
A. The intern may practice independently if supervised by a pharmacist who is physically present
at all times.
B. The intern may perform all pharmacist functions except final verification and counseling,
provided they are registered as a pharmacy intern with the Board. CORRECT
C. The intern may only perform clerical tasks and cannot handle controlled substances until
licensed.
D. The intern may practice without registration as long as they are enrolled in an accredited
program and supervised by a pharmacist.
RATIONALE: Washington requires pharmacy interns to be registered with the Board; they may
perform many pharmacist functions under supervision but cannot perform final verification or
provide patient counseling independently. Option A is incorrect because independent practice is
not allowed. Option C is too restrictive; interns can handle controlled substances under
supervision. Option D is wrong because registration is mandatory.
Q3 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
A Washington pharmacy is considering implementing a telehealth protocol for
dispensing controlled substances. Which federal law most directly governs the
prescribing of controlled substances via telemedicine without a prior in-person
exam?
A. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008
B. The Controlled Substances Act (CSA) as amended by the SUPPORT Act CORRECT
C. The Health Insurance Portability and Accountability Act (HIPAA)
D. The Federal Food, Drug, and Cosmetic Act (FDCA)
RATIONALE: The Ryan Haight Act generally requires an in-person exam before prescribing
controlled substances via telemedicine, but the SUPPORT Act and subsequent DEA flexibilities
have modified this. However, the CSA as amended by the SUPPORT Act is the primary federal
law governing telemedicine prescribing of controlled substances. HIPAA and FDCA do not
directly address controlled substance prescribing.
Page 3
, Q4 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
Under Washington's Prescription Monitoring Program (PMP), which of the
following is a mandatory requirement for pharmacists before dispensing a
controlled substance?
A. Review the patient's PMP report for every controlled substance prescription, including
Schedule V.
B. Review the PMP report only for Schedule II and III opioids, with exceptions for hospice and
end-of-life care. CORRECT
C. Review the PMP report only if the patient exhibits drug-seeking behavior.
D. Review the PMP report only for the first fill of a controlled substance and then annually.
RATIONALE: Washington law requires pharmacists to review the PMP before dispensing
Schedule II and III opioids, with exceptions for hospice, palliative, and end-of-life care. Option A
is too broad; Schedule V is not included. Option C is subjective and not the legal standard.
Option D is incorrect; review is required at each dispensing, not just first fill.
Q5 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
A Washington pharmacy compounds a sterile preparation that is not a
FDA-approved drug. Which regulatory framework primarily governs the
compounding and distribution of this preparation?
A. FDA's Drug Efficacy Study Implementation (DESI) program
B. Section 503A of the FDCA and Washington State compounding rules CORRECT
C. Section 503B of the FDCA and FDA outsourcing facility requirements
D. The DEA's registration requirements for manufacturers
RATIONALE: Section 503A of the FDCA governs traditional compounding by licensed
pharmacists and physicians, and Washington has additional compounding rules. Section 503B
applies to outsourcing facilities that compound sterile preparations without patient-specific
prescriptions. DESI and DEA manufacturer rules are not the primary framework.
Page 4
TO RESOLVE COMPLEX PRACTICE DILEMMAS
A Washington pharmacy's automated dispensing system (ADS) cabinet is
restocked by a certified pharmacy technician without a pharmacist's final
verification. Under WAC 246-945-XXX (or current equivalent), which legal principle
best determines whether this restocking violates the standard of practice?
A. The ADS is exempt from pharmacist verification if the technician is certified and the cabinet is
in a licensed pharmacy.
B. Restocking is a non-discretionary task that may be delegated, but the pharmacist-in-charge
retains ultimate responsibility for accuracy and must establish a system of checks. CORRECT
C. Only a pharmacist may physically place any drug into an ADS, regardless of the drug's
schedule or packaging.
D. The violation depends solely on whether the drug is a controlled substance; non-controlled
drugs may be restocked freely.
RATIONALE: Washington law allows delegation of non-discretionary tasks to trained personnel,
but the pharmacist-in-charge is legally responsible for the accuracy and security of the ADS.
Option A is incorrect because pharmacist verification is not universally exempted. Option C is too
absolute; technicians may restock under specific conditions. Option D is wrong because even
non-controlled drugs require proper oversight to ensure patient safety.
Page 2
,Q2 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
Which of the following best describes the legal authority of a Washington
pharmacy intern who has not yet obtained a license but is enrolled in an
ACPE-accredited program?
A. The intern may practice independently if supervised by a pharmacist who is physically present
at all times.
B. The intern may perform all pharmacist functions except final verification and counseling,
provided they are registered as a pharmacy intern with the Board. CORRECT
C. The intern may only perform clerical tasks and cannot handle controlled substances until
licensed.
D. The intern may practice without registration as long as they are enrolled in an accredited
program and supervised by a pharmacist.
RATIONALE: Washington requires pharmacy interns to be registered with the Board; they may
perform many pharmacist functions under supervision but cannot perform final verification or
provide patient counseling independently. Option A is incorrect because independent practice is
not allowed. Option C is too restrictive; interns can handle controlled substances under
supervision. Option D is wrong because registration is mandatory.
Q3 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
A Washington pharmacy is considering implementing a telehealth protocol for
dispensing controlled substances. Which federal law most directly governs the
prescribing of controlled substances via telemedicine without a prior in-person
exam?
A. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008
B. The Controlled Substances Act (CSA) as amended by the SUPPORT Act CORRECT
C. The Health Insurance Portability and Accountability Act (HIPAA)
D. The Federal Food, Drug, and Cosmetic Act (FDCA)
RATIONALE: The Ryan Haight Act generally requires an in-person exam before prescribing
controlled substances via telemedicine, but the SUPPORT Act and subsequent DEA flexibilities
have modified this. However, the CSA as amended by the SUPPORT Act is the primary federal
law governing telemedicine prescribing of controlled substances. HIPAA and FDCA do not
directly address controlled substance prescribing.
Page 3
, Q4 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
Under Washington's Prescription Monitoring Program (PMP), which of the
following is a mandatory requirement for pharmacists before dispensing a
controlled substance?
A. Review the patient's PMP report for every controlled substance prescription, including
Schedule V.
B. Review the PMP report only for Schedule II and III opioids, with exceptions for hospice and
end-of-life care. CORRECT
C. Review the PMP report only if the patient exhibits drug-seeking behavior.
D. Review the PMP report only for the first fill of a controlled substance and then annually.
RATIONALE: Washington law requires pharmacists to review the PMP before dispensing
Schedule II and III opioids, with exceptions for hospice, palliative, and end-of-life care. Option A
is too broad; Schedule V is not included. Option C is subjective and not the legal standard.
Option D is incorrect; review is required at each dispensing, not just first fill.
Q5 APPLY WASHINGTON STATE AND FEDERAL PHARMACY STATUTES AND REGULATIONS
TO RESOLVE COMPLEX PRACTICE DILEMMAS
A Washington pharmacy compounds a sterile preparation that is not a
FDA-approved drug. Which regulatory framework primarily governs the
compounding and distribution of this preparation?
A. FDA's Drug Efficacy Study Implementation (DESI) program
B. Section 503A of the FDCA and Washington State compounding rules CORRECT
C. Section 503B of the FDCA and FDA outsourcing facility requirements
D. The DEA's registration requirements for manufacturers
RATIONALE: Section 503A of the FDCA governs traditional compounding by licensed
pharmacists and physicians, and Washington has additional compounding rules. Section 503B
applies to outsourcing facilities that compound sterile preparations without patient-specific
prescriptions. DESI and DEA manufacturer rules are not the primary framework.
Page 4
