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Questions and Answers
What is the BUD for a Category 1 compounded sterile preparation at controlled room temperature?
What is the BUD for a Category 1 compounded sterile preparation at controlled room temperature?
The primary engineering control (PEC) must provide an ISO class air 7 environment.
The primary engineering control (PEC) must provide an ISO class air 7 environment.
False
What type of cleaning supplies must be used in the primary engineering control (PEC)?
What type of cleaning supplies must be used in the primary engineering control (PEC)?
Low lint disposable or reusable tools that are dedicated for specific areas.
The buffer area must provide ____ class 7 air throughout the room.
The buffer area must provide ____ class 7 air throughout the room.
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Match the compounding category with the correct BUD requirements:
Match the compounding category with the correct BUD requirements:
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What is the required cleaning frequency for the PEC during compounding?
What is the required cleaning frequency for the PEC during compounding?
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Separate master formulation records (MFR) must be created for compounded sterile preparations prepared for more than one patient.
Separate master formulation records (MFR) must be created for compounded sterile preparations prepared for more than one patient.
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The positive pressure ante room must provide an ISO class ____ air environment.
The positive pressure ante room must provide an ISO class ____ air environment.
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What is the purpose of a master formula record in pharmacy compounding?
What is the purpose of a master formula record in pharmacy compounding?
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Non-sterile compounding must occur in a separate room from sterile compounding at all times.
Non-sterile compounding must occur in a separate room from sterile compounding at all times.
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What kind of water should be used in compounding when the formula calls for water?
What kind of water should be used in compounding when the formula calls for water?
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The label on a compounded preparation must include the ______ and a statement that it is a compounded preparation.
The label on a compounded preparation must include the ______ and a statement that it is a compounded preparation.
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Which of the following must be documented for each compounding record?
Which of the following must be documented for each compounding record?
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Match the following components with their respective descriptions:
Match the following components with their respective descriptions:
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It is acceptable to use distilled water in compounding as long as it meets purified water requirements.
It is acceptable to use distilled water in compounding as long as it meets purified water requirements.
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What is a requirement for standard operating procedures (SOPs) in compounding?
What is a requirement for standard operating procedures (SOPs) in compounding?
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What is the maximum batch size for all compounded sterile preparations (CSPs) requiring sterility testing?
What is the maximum batch size for all compounded sterile preparations (CSPs) requiring sterility testing?
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Sterility testing is required for category 1 preparations.
Sterility testing is required for category 1 preparations.
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What should the labeling on dispensed compounded sterile products indicate?
What should the labeling on dispensed compounded sterile products indicate?
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Personnel handling hazardous drugs must be trained before handling them and reassessed every _____ months.
Personnel handling hazardous drugs must be trained before handling them and reassessed every _____ months.
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Match the compounding categories with their requirements:
Match the compounding categories with their requirements:
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What is the highest allowed storage duration for multidose compounded sterile products after puncture?
What is the highest allowed storage duration for multidose compounded sterile products after puncture?
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Non-preservative topical ophthalmic CSPs require antimicrobial effectiveness testing.
Non-preservative topical ophthalmic CSPs require antimicrobial effectiveness testing.
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What must be documented for any notification and recall of CSPs with out of specification limits?
What must be documented for any notification and recall of CSPs with out of specification limits?
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The maximum storage time for a single-dose compounded sterile product before making other sterile products is _____ hours.
The maximum storage time for a single-dose compounded sterile product before making other sterile products is _____ hours.
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What factors determine beyond-use dates (BUDs) for compounded preparations?
What factors determine beyond-use dates (BUDs) for compounded preparations?
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Study Notes
Oregon Law - Pharmacy Responsibilities
- Pharmacists and non-pharmacist personnel are responsible for all operational aspects of pharmacy
- Policies and procedures must reduce errors
- Annual self-inspections are required
- Staff oversight is mandatory
- Preventative measures for diversion of inventory required
- Annual and quarterly inventory controls of C2 drugs (every 93 days) and quality assurance plan required
- Maintenance of medication files is mandatory
- Notification of violations to the board required
- Pharmacist in charge (PIC) may oversee up to 3 pharmacies at a time
- PIC must complete 1 year of practice training
- Changing PICs within 15 days requires board notification of change with self-inspection and CS inventory.
- Max of 4 interns for direct patient care activities, more permitted for non-patient activities
- Consultant pharmacists can store records at a licensed pharmacy or become a licensed "drugless" pharmacy.
Qualifications and Scope of Duties
- Technician identification to the public as a technician is mandatory
- Technicians cannot access pharmacy without the presence of a pharmacist
- Technicians may: perform final drug verification, affix labels, reconstitute drugs, accept oral refills with no changes, repackage multi dose drugs but not use discretion or judgment.
- Cannot access pharmacy when no pharmacist is on duty
- Receive/transfer prescriptions with prior pharmacist verification
- Cannot counsel patients or prescribe any medications
Qualifications and Scope of Duties (continued)
- Techs may not counsel patients or prescribe medications
- No maximum pharmacist-to-technician ratio; the pharmacist can supervise as many as they deem reasonable and safe.
Intern Licensing and Renewals
- Intern license renewal requires 2 hours of CE in cultural competency, annual background check.
- Needed 1440 hours of school-based rotational internship, 1 hour of CE in pain management, criminal background check with fingerprints, disclosure of arrests/convictions
- Interns may perform most pharmacist tasks except for prescribing
- Pharmacist licensure expires June 30 of odd-numbered years and must be renewed biennially
- Pharmacists require 30 hours of CE in the previous 2 years.
Prescription/Drug Orders and Regulations
- All prescriptions must be for legitimate medical purposes and within the prescriber’s scope of practice.
- Patient-provider relationship is required for all prescriptions
- Pharmacist has liability for prescriptions not properly prepared
- Pharmacists can refuse prescriptions if there is a concern
- Transferring prescriptions between pharmacies must be done electronically for C2 prescriptions, but not hard copy.
- C3,4,5 prescriptions can be transferred 1 time only.
Reporting and Participation in Programs Addressing Inability to Practice
- Individuals who have problems or who need assistance should report to and participate in programs to address the inability to practice
- The program is at least 2 years, potentially longer if the board deems necessary
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Description
Test your knowledge on the responsibilities and qualifications required for pharmacists in Oregon. This quiz covers operational aspects, inventory controls, and oversight duties essential for pharmacy management. Stay informed about the legal framework and essential policies to ensure compliance in the pharmacy sector.
