PTCB - Sterile and Non-Sterile Compounding Exam with
all Correct & 100% Verified Answers |Latest Update |
Already Graded A+
Extemporaneous compounding ✔Correct Answer-Process of mixing and preparing drug
components to meet a patient's need
Compounding ✔Correct Answer-The formulation of an individual compound made specifically
to meet a patient's need. It is not commercially available, and it is not available to be resold by
the patient or the prescriber
Manufacturing ✔Correct Answer-Batch compounding of FDA-approved compounds that are
then sold to pharmacies or health care practitioners
Sterile compounding ✔Correct Answer-•IV solutions
•Parenteral nutrition
•Ophthalmic formulations
•Reserved for injectable products, as well as medications to be instilled in the eye
•Must be formulated in a designated sterile compounding area. This area has to be distinct and
separate, and it may not be used for non-sterile compounding procedures
Controlled area or Buffer area ✔Correct Answer-•Area where sterile preparations are
formulated. Must be distinct and separate, and it may not be used for non-sterile compounding
procedures.
•Where the laminar flow workbench is located
Anteroom ✔Correct Answer-•Separate and distinct from the buffer area
•Used to decontaminate supplies and equipment
•Personnel must also use this area to perform hand washing and gowning procedures
Non sterile compounding ✔Correct Answer-•Tablets
•Capsules
•Creams
, •Ointments
•Suspensions
•Suppositories
•Transdermal applications
•Troches
United States Pharmacopeial Convention (USP) ✔Correct Answer-Leading authority in setting
standards for product safety and purity
USP-NF (National Formulary) ✔Correct Answer-Sets standards for chemical substances,
compounded products, dosage forms, medical supplies, and dietary supplements
USP - 797 ✔Correct Answer-Provides specific procedures and methods used for compounding
sterile preparations
USP - 795 ✔Correct Answer-Describes compounding practices and procedures for non-sterile
preparations
Low Risk CSP ✔Correct Answer-•Compounded using aseptic manipulations in an ISO Class 5
environment
•Compounding involves no more than 3 commercially available products and no more than 2
entries into any sterile container or bag
•Manipulations must follow aseptic guidelines when using ampules, syringes, or needles and
during the transfer of formulations
Medium Risk CSP ✔Correct Answer-•Pooling multiple vials or containers to prepare a CSP for
one or more patients
•Compounding involves more than one vial transfer
•A long compounding process is required (Dissolution)
•ex: Preparation of TPN using an automated device
High risk ✔Correct Answer-•Using non-sterile formulations to prepare CSPs (including those
intended for oral administration)
all Correct & 100% Verified Answers |Latest Update |
Already Graded A+
Extemporaneous compounding ✔Correct Answer-Process of mixing and preparing drug
components to meet a patient's need
Compounding ✔Correct Answer-The formulation of an individual compound made specifically
to meet a patient's need. It is not commercially available, and it is not available to be resold by
the patient or the prescriber
Manufacturing ✔Correct Answer-Batch compounding of FDA-approved compounds that are
then sold to pharmacies or health care practitioners
Sterile compounding ✔Correct Answer-•IV solutions
•Parenteral nutrition
•Ophthalmic formulations
•Reserved for injectable products, as well as medications to be instilled in the eye
•Must be formulated in a designated sterile compounding area. This area has to be distinct and
separate, and it may not be used for non-sterile compounding procedures
Controlled area or Buffer area ✔Correct Answer-•Area where sterile preparations are
formulated. Must be distinct and separate, and it may not be used for non-sterile compounding
procedures.
•Where the laminar flow workbench is located
Anteroom ✔Correct Answer-•Separate and distinct from the buffer area
•Used to decontaminate supplies and equipment
•Personnel must also use this area to perform hand washing and gowning procedures
Non sterile compounding ✔Correct Answer-•Tablets
•Capsules
•Creams
, •Ointments
•Suspensions
•Suppositories
•Transdermal applications
•Troches
United States Pharmacopeial Convention (USP) ✔Correct Answer-Leading authority in setting
standards for product safety and purity
USP-NF (National Formulary) ✔Correct Answer-Sets standards for chemical substances,
compounded products, dosage forms, medical supplies, and dietary supplements
USP - 797 ✔Correct Answer-Provides specific procedures and methods used for compounding
sterile preparations
USP - 795 ✔Correct Answer-Describes compounding practices and procedures for non-sterile
preparations
Low Risk CSP ✔Correct Answer-•Compounded using aseptic manipulations in an ISO Class 5
environment
•Compounding involves no more than 3 commercially available products and no more than 2
entries into any sterile container or bag
•Manipulations must follow aseptic guidelines when using ampules, syringes, or needles and
during the transfer of formulations
Medium Risk CSP ✔Correct Answer-•Pooling multiple vials or containers to prepare a CSP for
one or more patients
•Compounding involves more than one vial transfer
•A long compounding process is required (Dissolution)
•ex: Preparation of TPN using an automated device
High risk ✔Correct Answer-•Using non-sterile formulations to prepare CSPs (including those
intended for oral administration)
