Lecture 10: USP

Question 1

Why do USP standards exist?

Answer 1

To enhance patient safety and protect pharmacists

Question 2

What is special about prescription compounding?

Answer 2

Meets unique needs of the patient

Question 3

What 6 specialty practice areas is compounding associated with?

Answer 3

1) Veterinary medicine
2) Dermatology
3) Hormone replacement therapy
4) Pain management
5) Hospice
6) Home care

Question 4

With compounding, is there a demonstrated patient-healthcare professional relationship?

Answer 4

Yes

Question 5

With compounding, is there a third party reselling the product outside of the patient-healthcare professional relationship?

Answer 5

No

Question 6

With compounding, is the activity regulated by the province?

Answer 6

Yes

Question 7

With compounding, is there an inordinate amount of product produced on a regular basis?

Answer 7

No

Question 8

With compounding, is an identical product commercially available?

Answer 8

No

Question 9

With compounding, is the product and/or compounding service promoted or advertised to the general public?

Answer 9

No

Question 10

Why is a sink with hot and cold running water essential for compounding?

Answer 10

For hand washing and equipment cleaning

Question 11

What are 3 criteria that equipment must meet when being used for compounding?

Answer 11

1) Appropriate in design and size for intended purpose
2) Must always be cleaned immediately after use
3) Must be properly maintained and calibrated

Question 12

True or false: sterile and non-sterile products can be compounded in the same area

Answer 12

False, the pharmacy must have separate and distinct areas for compounding sterile and non-sterile products

Question 13

What is required to be on the label of all medications (besides legal information)?

Answer 13

Expiration date

Question 14

How is expiration date determined?

Answer 14

• Aqueous or non-aqueous
• Expiration dates of ingredients
• Storage temperature
• References with stability data

Question 15

What does the USP 795 say about expiration dating for solids and non-aqueous liquids prepared from commercially available dosage forms?

Answer 15

25% of the remaining expiration date of the commercial product, or 6 months, whichever is earliest

Question 16

What does the USP 795 say about expiration dating for solids and non-aqueous liquids prepared from bulk ingredients?

Answer 16

Up to 6 months

Question 17

What does the USP 795 say about expiration dating for water-containing formulations prepared from ingredients in solid form?

Answer 17

Up to 14 days when stored in refrigerator

Question 18

What does the USP 795 say about expiration dating for all other formulations?

Answer 18

Up to 30 days or the intended duration of therapy, whichever is earliest

Question 19

What selecting ingredients, what is preferred?

Answer 19

USP or National Formulary chemicals

Question 20

Who is responsible for the selection of ingredients?

Answer 20

Pharmacist

Question 21

What 2 considerations should be made when selecting ingredients for compounding?

Answer 21

• Chemical must meet purity and safety standards

- Should not use drug withdrawn from market by FDA

Question 22

What is needed if selecting ingredients that are chemical grade?

Answer 22

Certificate of analysis

Question 23

What type of ingredients are not necessarily pure?

Answer 23

Spectroscopic or HPLC grade

Question 24

How must active ingredient should compounded preparations contain?

Answer 24

90-110% of amount on label

Question 25

What 12 dosage forms does USP 795 address?

Answer 25

Capsules, powders, lozenges, tablets, emulsions, solutions, suspensions, suppositories, creams, topical gels, ointments, and pastes

Question 26

What is the goal of the compounding process?

Answer 26

Minimize error and maximize prescribers intent

Question 27

How many preparations can be compounded at once and why?

Answer 27

Only one to avoid errors and cross-contamination

Question 28

Who is responsible for the final check of a compounded product?

Answer 28

Pharmacist

Question 29

Who initials the prescription and label?

Answer 29

Pharmacist

Question 30

What are pharmacies required to maintain according to USP 795?

Answer 30

Formulation record and compounding record for each compounded preparation

Question 31

What is a formulation record?

Answer 31

An individual record that includes ingredients, compounding equipment, and instructions for preparing the formula (like a recipe)

Question 32

What is a compounding record?

Answer 32

Log of an actual compounded preparation that includes manufacturer, expiration date, lot numbers of chemicals, preparation date, and names of individuals who prepared and verified

Question 33

What 4 things should be included when counselling a patient?

Answer 33

1) Correct use 2) Storage 3) Expiration date 4) Evidence of instability in compounded medication

Question 34

What are 5 factors that should be considered regarding compounding?

Answer 34

1) Must be able to demonstrate that a patient-HCP relationship exists 2) May prepare drugs in very limited quantities in anticipation of a prescription 3) Should only be done if there is a therapuetic need and lack of product availability 4) Compounded product must not duplicate an approved drug product 5) May compound when there is a shortage or no supply of a commercially available product

Question 35

When is compounding of clinical trial drugs permitted?

Answer 35

Only if this activity is authorized in the clinical trial authorization

Question 36

What should compounded products be compounded from?

Answer 36

An authorized drug

Question 37

What are guidelines for pharmacists that provide compounding services to other hospitals?

Answer 37

Should be within the same province and operate under the same hospital management board