ProntoPass Oregon Facts 1 Flashcards
The feds encourage the USP to create standards for compounding sterile, hazardous, and non-sterile products. However, it is up to each state to incorporate these standards into state statutes.
Has Oregon implemented these standards and what are they?
Yes
USP 795 (Non-sterile)
USP 797 (Sterile)
USP 800 (Hazardous)
USP 825 (Radiopharmaceuticals)
USP Compounding Standards Required in Oregon to be followed by Oregon Pharmacists
Must follow all chapters.
USP 795 (Non-sterile)
USP 797 (Sterile)
USP 800 (Hazardous)
USP 825 (Radiopharmaceuticals)
Consequences for Non-Compliance with USP Standards in Oregon
Noncompliance shall be considered unprofessional conduct and may result in the loss of a pharmacist’s license.
A pharmacist in Oregon who compounds must be available to respond to patients’ and other healthcare practitioners’ needs.
Must have a 24-hour telephone line in case of emergencies for patients and practitioners.
Salient Features of USP Standards
A: Pharmacies preparing hazardous sterile products must have a dedicated Class II, Type A contained vertical flow biohazard cabinet.
B: Laminar Flow Hoods must exhaust to the outdoors and be HEPA-filtered prior to exhaust.
C: Laminar Flow Hoods and other sterile compounding equipment must be in a clean room compliant with an ISO Class 5 environment (air containing no more than 100 particles per cubic foot of a size at least 0.5 microns or larger).
D: Hoods must be in a separate room with HEPA-filters to create a sterile environment.
E: Annual training and certification for all personnel are required.
F: Personnel must use PPE (Personal Protective Equipment) including gloves, gowns, respirators, goggles, face shields, and other protective equipment for hazardous physical or chemical exposures.
G: Compounding records must be kept, documenting individual ingredients, lot numbers, expiration dates, and a chronologically documented compounding process.
H: Compounded hazardous prescriptions must have a distinctive warning label.
Who makes the rules and regulations?
Oregon State Board of Pharmacy
How many compliance officers and inspectors are there in Oregon?
9 compliance staff
Composition of the Oregon Pharmacy Board
5 Licensed Pharmacists (appointed by the Governor)
2 Licensed Pharmacy Technicians
2 Public Members
Requirements for Pharmacist Board Members
Must be actively practicing pharmacy in Oregon
Must have at least 5 years of experience in practice
Technicians must have at least 3 years of experience
Term Lengths for Board Members
Public members: 4-year term
Pharmacists: 4-year term
MPJE Requirement for Oregon
Yes, MPJE is required.
NOTE: One hour of continuing pharmacy education in pain management, provided by the Pain Management Commission of the Oregon Health Authority, is required prior to application for an Oregon Pharmacist License
If an applicant scores less than 75 on the NAPLEX or MPJE, they must wait:
At least 45 days to retake the NAPLEX
At least 30 days to retake the MPJE
Is NAPLEX Score Transferability allowed and how long
Yes, a NAPLEX score transfer is valid for 1 year
Internship Hours Requirement in Oregon
1,440 hours of practical experience required
- Does Oregon require that preceptors be licensed or registered?
Yes; Licensed as a preceptor with the board.
- Does Oregon require that interns be licensed or registered?
Yes; Licensed.
- If an intern has to be licensed: How long does the registration last?
Expires on November 30 every 2 years.
- What duties may a pharmacy intern perform?
Under the supervision of a licensed pharmacist, a pharmacy intern may:
Counsel patients
Perform DUR (Drug Utilization Review)
Oral receipt or transfer of a prescription
Administer immunizations (if properly trained and supervised by an immunization-qualified pharmacist)
Other activities approved by the board in writing
- Can a license be issued to a foreign-educated pharmacist?
Yes.
- For a foreign-educated pharmacist: Is an FPGEC certification required? How many hours of practical experience are required?
Yes; 1440 hours of practical experience are required.
An applicant may not count internship hours or pharmacist practice completed outside the United States toward Oregon’s internship requirement.
- Does a foreign graduate have to appear before the board before a license can be issued?
No.
- What board or regulatory agency issues the pharmacist license?
State Board of Pharmacy.
- What is the minimum age requirement to become a licensed pharmacist?
18 years of age.
- Can you be issued a temporary license in Oregon?
Yes; In an emergency, the board may issue a temporary license.
The temporary license shall be valid for no more than 6 months.
If the emergency lasts longer, the board may renew the temporary license for another 6 months.
- What are the requirements for transferring a license from another state to Oregon?
Must meet the following criteria:
Be at least 18 years old
Submit a written application
Have good moral character and habit
Have at least one year of pharmacy practice OR have met the internship requirements of the state (minimum of 1440 hours of work experience) within the one-year period immediately prior to the application date
Present proof of initial licensure in good standing
Pass the NAPLEX and MPJE (or equivalent exams) with a passing score of 75 or higher
Pay fees specified by the Board
- Are exam results from another state transferable to Oregon?
No; you must take the MPJE for this state.
If you do not score at least 75, you must wait 30 days to retake the exam.
- Is a board hearing required to transfer a pharmacist license from another state to Oregon?
No.
- How often must a pharmacist renew their license?
June 30th of each odd-numbered year.
- What agency is in charge of disciplining a pharmacist?
State Board of Pharmacy.
- What are the requirements to be a PIC (Pharmacist-in-Charge)?
Must have completed at least 1 year of pharmacy practice OR have completed PIC training course before appointment or within 30 days.
- What are the responsibilities of the PIC?
The PIC is responsible for all aspects of the operation related to the practice of pharmacy.
Become familiar with these aspects from the statutes.
