Part 13 Sterile Products Flashcards
Any licensed pharmacy which compounds sterile products EXCEPT HOSPITALS pharmacies compounding for inpatients, SHALL on a ____ basis submit to the BOP a report listing the quanitity of high risk or batch sterile products.
A. quarterly
B. Biannually
C. Annually
D. Biennially
A. quarterly
Any licensed pharmacy which compounds and dispenses sterile products SHALL provide upon request of the BOP the following information for ANY Sterile drug product compounded
A. Name, Strength, and dosage form.
B. Quantity compounded, dispensed, traded, sold or otherwise distributed
C. Expiration date
D. Storage requirements
E. All components and an accurate statement of the WEIGHT or measure of each component
F. The beyond-use date
G. Labels and labeling
A. Name, Strength, and dosage form.
B. Quantity compounded, dispensed, traded, sold or otherwise distributed
D. Storage requirements
E. All components and an accurate statement of the WEIGHT or measure of each component
F. The beyond-use date
G. Labels and labeling with appropriate beyond-use date and instructions for storage and use
Any licensed pharmacy which compounds and dispenses sterile products must ensure that the following information is on file at the practice site and readily accessible for sterile products
A. Documentation of the name and strength of all drug products compounded over the past 2 years
B. The source and lot numbers of the components used in thsoe products
C. The beyond-use date every compounded in the past 2 years
D. The total number of dosage units compounded over the past 2 years
E. The name of the person who prepared the drug product
F Storage requirements of everything compounded over the past 2 years
G. The name of the pharmacist who approved the drug product
H. The name of the practitioner or the name of the patient or healthcare entity who received the compounded drug product
I. The results of any sampling, testing or other quantitative evaluation conducted for the purpose of quality control for any sterile compounded products, compounded over the past 2 years
A. Documentation of the name and strength of all drug products compounded over the past 2 years
B. The source and lot numbers of the components used in thsoe products
D. The total number of dosage units compounded over the past 2 years
E. The name of the person who prepared the drug product
G. The name of the pharmacist who approved the drug product
H. The name of the practitioner or the name of the patient or healthcare entity who received the compounded drug product
I. The results of any sampling, testing or other quantitative evaluation conducted for the purpose of quality control for any sterile compounded products, compounded over the past 2 years
All sterile product compounding must be performed with
A. Class 100 laminar flow hood
B. Class 101 laminar flow hood
C. Biologic safety cabinet (Class II, type A)
D. Biologic safety cabinet (Class II, type B)
E. Class 100 clean room
F. Class 101 clean room
A. Class 100 laminar flow hood
C. Biologic safety cabinet (Class II, type A)
E. Class 100 clean room
The laminar flow hood, biologic safety cabinet (Class II, Type A) or class 100 clean room SHALL be kept running continuously. However, if the hood is turned off, the hood SHALL be functioning for how long before it can be used?
A. 10 minutes B. 30 minutes C. 1 hour D. 2 hours E. 4 hours
B. 30 minutes
Prefilters in the laminar flow hoods SHALL be changed how often?
A. quarterly B. Biannually C. Annually D. Biennially E. 30 days F. 60 days
A. quarterly
Any licensed facility which engages in sterile compounding SHALL conduct a ___ review of its policy and procedure manual, and shall update its policy and procedure manual as necessary.
A. quarterly B. Biannually C. Annually D. Biennially E. 30 days F. 60 days
C. Annually
At the TIME of dispensing of the sterile product, the dispensing container MUST bear a LABEL which contains the following for OUTPATIENT USE
A. The chemical form B. Patients Name C. Prescriber's Name D. Pharmacy practice site name, address, and phone number E. If a liquid, the volume F. Identification of the pharmacist who compounded the sterile product G. The Beyond use time H. When applicable, identification of the pharmacy intern or pharmacy technician who assisted in the compounding of the sterile product I. name and amount of drug added J. the expiration time K. Date of compounding L. Directions for use M. appropriate auxiliary labels N. Strength of the medication
B. Patients Name
C. Prescriber’s Name
D. Pharmacy practice site name, address, and phone number
F. Identification of the pharmacist who compounded the sterile product G. The Beyond use time ?? H. When applicable, identification of the pharmacy intern or pharmacy technician who assisted in the compounding of the sterile product I. name and amount of drug added J. the expiration time K. Date of compounding L. Directions for use M. appropriate auxiliary labels
At the TIME of dispensing of the sterile product, the dispensing container MUST bear a LABEL which contains the following for INPATIENT USE
A. The chemical form B. Patients Name C. Prescriber's Name D. Pharmacy practice site name, address, and phone number E. If a liquid, the volume F. Identification of the pharmacist who compounded the sterile product G. The Beyond use time H. When applicable, identification of the pharmacy intern or pharmacy technician who assisted in the compounding of the sterile product I. name and amount of drug added J. the expiration time K. Date of compounding L. Directions for use M. appropriate auxiliary labels N. Strength of the medication
B. Patients Name ?
C. Prescriber’s Name ?
F. Identification of the pharmacist who compounded the sterile product
G. The Beyond use time ??
H. When applicable, identification of the pharmacy intern or pharmacy technician who assisted in the compounding of the sterile product
I. name and amount of drug added
J. the expiration time
K. Date of compounding
M. appropriate auxiliary labels
What is the minimally acceptable compounding site for the routine compounding of HAZARDOUS sterile products?
A. Class 100 laminar flow hood
B. Class I, Type A contained vertical flow biohazard cabinet
C. Class II, Type A contained vertical flow biohazard cabinet
D. Class III, Type A contained vertical flow biohazard cabinet
E. Class I, Type B contained vertical flow biohazard cabinet
F. Class II, Type B contained vertical flow biohazard cabinet
G. Class III, Type B contained vertical flow biohazard cabinet
C. Class II, Type A contained vertical flow biohazard cabinet
Hazardous sterile products SHALL be
A. segregated within the pharmacy practice site
B. placed in an appropriate out wrap
C. placed in a freezer until time to be used
A. segregated within the pharmacy practice site
B. placed in an appropriate out wrap
All PICs, pharmacist, pharmacy interns and pharmacy technicians involved in compounding Hazardous sterile products, must have a ___ certification
A. quarterly
B. Biannual
C. Annual
D. Biennial
C. Annual
A Hair cover and a mask SHALL be required unless a __ is utilized
A. Class 100 laminar flow hood
B. Class I, Type A contained vertical flow biohazard cabinet
C. Class II, Type A contained vertical flow biohazard cabinet
D. Class III, Type A contained vertical flow biohazard cabinet
E. Class I, Type B contained vertical flow biohazard cabinet
F. Class II, Type B contained vertical flow biohazard cabinet
G. Class III, Type B contained vertical flow biohazard cabinet
C. Class II, Type A contained vertical flow biohazard cabinet
As part of its quality assurance program, any licensed facility which engages in sterile compounding SHALL perform a ___ pursuant to guidelines adopted by the BOP. ANY EXCEPTIONS or serious Deficiencies SHALL be reported to the ___?
Shall perform a GAP ANALYSIS, Exceptions and serious Deficiencies SHALL be reported to the Board of Pharmacy
