Non-Sterile/Sterile Compounding

Question 1

Non-Sterile Compounding

Answer 1

May be compounded in anticipation of future prescriptions based on routine and regularly observed prescribing patterns
Commercially available products can be compounded if not reasonably available
CANNOT compound essentially copies of commercially available products unless the prescribing practitioner specifically orders the strength and dosage form and specifies why the patient needs the product compounded
A pharmacy may enter in agreement to compound and dispense for another pharmacy if the pharmacy complies with the centralized prescription dispensing rule

Question 2

Pharmacist Compounding Non-Sterile Preparations

Answer 2

Must obtain continuing education appropriate for the type of compounding done by the pharmacist
Inspect and approve all components, drug product containers, closure, labeling, and all other material involved in the compounding process
Review all compounding records for accuracy and conduct in process and final checks to ensure the errors have not occurred in the compounding process
Be responsible for the proper maintenance, cleanliness, and use of all equipment used in the compounding process

Question 3

Non-Sterile Equipement

Answer 3

Class a prescription balance for analytic balance and weights which are subject inspection by the TSBP

Question 4

Compounding labeling requirements

Answer 4

Normal labeling requirements as well as the name or names of printable active ingredients of the compounded preparation and the statement that the preparation has been compounded by the pharmacy

Question 5

Non-Sterile Standard Operating Procedures(SOPs)

Answer 5

Designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process

Question 6

Office use compounding

Answer 6

For distribution the physicians, classy pharmacies, or veterinarians requires a written agreement with the practitioner pharmacy.
Label must state “for institutional her office use only – not for resale”

Question 7

Control Substance Compounds

Answer 7

Schedule II-V narcotic compounds are allowed so long as the concentration does not exceed 20% of the final solution, compound or mixture

Question 8

Sterile Compounding Requirements

Answer 8

USP Chapter 797
May be compounded for prescriptions, medication orders, anticipation of prescriptions or medication orders, as an incident to research/teaching/chemical analysis and not for sale or dispensing, for office use
Commercially available products can be compounded if not reasonably available
CANNOT compound essentially copies of commercially available products unless the prescribing practitioner specifically orders the strength and dosage form and specifies why the patient needs the product compounded
A pharmacy may enter in agreement to compound and dispense for another pharmacy if the pharmacy complies with the centralized prescription dispensing rule

Question 9

Sterile Compounding Training Requirements

Answer 9

All compounding personnel must receive didactic and experiential training that includes: ascetic technique, critical area contamination factors, environmental monitoring, facilities, equipment supplies, sterile pharmaceutical calculations and terminology, sterile pharmaceutical compounding documentation, quality assurance procedures, aseptic preparation procedures, handling cytotoxic and hazardous drugs and general conduct in controlled areas

Question 10

Pharmacist Training Requirements

Answer 10

20 hours of instruction through either a college of pharmacy or an ACPE approved course and complete on the job training at the pharmacy which cannot be transferred

Question 11

Pharmacist Renewal/CE Requirements***

Answer 11

2 hours of CE related sterile compounding if engaged in compounding low and medium risk preparations
OR
4 hours of CE related to sterile compounding if engaged in high risk preparations

Question 12

Tech and Tech Trainee Training Requirements

Answer 12

Must complete 40 hours of instruction through either an ACPE approved course or a training program accredited by the American Society for Heath System Pharmacists and complete structured on the job training which provides 40 hours of instruction and experience

Question 13

Tech and Tech Trainee Renewal/CE Requirements

Answer 13

2 hours of CE related sterile compounding if engaged in compounding low and medium risk preparations
OR
4 hours of CE related to sterile compounding if engaged in high risk preparations

Question 14

Sterile Compounding Evaluation and Testing

Answer 14

All personnel must be trained and pass media-fill test for assessing aseptic technique
Must be conducted at pharmacy
Must be conducted during orientation and training and at least annually for low or medium risk and twice a year for high risk products

Question 15

Media Fill Test Exception

Answer 15

No preparation intended for patient use shall be compounded before this test
Pharmacist may temporarily compound sterile preparations and supervise a pharmacy technician compounding sterile preparations without media fill test provided the pharmacist completes the on-site media fill test within seven days of commencing work at the pharmacy

Question 16

Define Low Risk Sterile Compounds

Answer 16

Within ISO Class 5 or better
Single transfers of steroid dosage forms from ampules, bottles, and files using sterile syringe is and needles; manually measuring no more than three manufacturer products to compound drug admixtures and nutritional solutions

Question 17

Low Risk Storage and Expiration

Answer 17

May be stored 48 hours at room temperature, 14 days of cold, or 45 days if frozen

Question 18

Define Medium Risk Sterile Compounds

Answer 18

Multiple individual or small dosage of steel products are combined to prepare a product admixture to multiple patients or one patient on multiple occasions; usually requires long compounding processes.
I.e. TPN fluids with multiple injections, filling reservoirs and infusion devices with multiple sterile products, transfers of volumes for multiple ampules or vials into a single final sterile product

Question 19

Medium Risk Storage and Expiration

Answer 19

May be stored 30 hours at room temperature, seven days if cold 45 days if frozen

Question 20

Define High Risk Sterile Compounds

Answer 20

Non-Sterile ingredients are used

I.e. Dissolving nonsterile bulk drug powder to make solutions which will be terminally sterilized

Question 21

High Risk Storage and Expiration

Answer 21

Maybe store 24 hours at room temperature, three days if cold, or 45 days if frozen

Question 22

Sterile Preparation Environment

Answer 22

Shall be compounded in a primary engineering control device which is capable of maintaining at least ISO class 5 conditions

Question 23

Primary engineering control devices include:

Answer 23

Laminar airflow hoods
Biological safety cabinet
Compounding aseptic isolators
Compounding aseptic containment isolators

Question 24

Laminar airflow hoods

Answer 24

Must be certified at least every six months

Question 25

Biological safety cabinet

Answer 25

Must be class II or III vertical cabinet and be located in an ISO class 7 area. 
If being used for nonhazardous preparations, they must be located in a buffer area

Question 26

Compounding aseptic isolators

Answer 26

Must be placed in an ISO class 7 buffer area unless certain conditions are met

Question 27

Compounding aseptic containment isolator

Answer 27

If used for low and medium risk products, it may be placed in an ISO Class 7 buffer area unless specific conditions are met.
If use for high-risk hazardous preparations, it must be placed in an area room with at least ISO Class 8 conditions

Question 28

Low and Medium Risk Compounding

Answer 28

Must have a clean room meeting specific requirements including having an anteand buffer area

Question 29

High Risk Compounding

Answer 29

In addition to the requirements for low and medium risk compounding, the primary engineering devices must be located in a buffer area that provides a physical separation through the use of walls, doors, and pass-throughs and has a minimum differential positive pressure of 0.02 to 0.05 inches water column

Question 30

Sterile Product Labeling

Answer 30

In addition to normal labeling
Generic or official name of principal active ingredient
A beyond use date determined as outlined in USP chapter 797
A statement for outpatient prescriptions that the sterile preparation was compounded by the pharmacy

Question 31

Compounding process

Answer 31

All significant procedure will be covered in written standard operating procedures (SOPs)
Personal cleansing and garbing
Quality restaurants programs must include media fill test procedures, filter integrity testing, finished preparation release and checks, and environmental monitoring
Quality Control Program to monitor environment and quality of preparations

Question 32

Immediate Use of Compounded Sterile Products

Answer 32

Provides an exemption for low risk compounding requirements in an emergency or for immediate use where meeting the requirements would subject the patient to additional risk due to delay
Specific conditions must be met including that the perforation time does not exceed one hour and a ministration begins no later than one hour after compounding