April 6 - USP <795>

Question 1

What is the purpose of the USP?

Answer 1

USP standards serve to enhance patient safety and also protect the pharmacist

Question 2

What chapters in the USP affect compounding?

Answer 2

795 Pharmaceutical Compounding - Nonsterile Preparations
797 Pharmaceutical Compounding - Sterile Preparations
1075 Good Compounding Practices
1160 Pharmaceutical Calculations in Prescription Compounding

Question 3

What is the purpose of compounding?

Answer 3

Meet the unique needs of the patient (medication strength/dose not commercially available)

Question 4

Compounding is associated with specialty practice areas, such as?

Answer 4

Veterinary medicine
Dermatology
Hormone replacement therapy
Pain management
Hospice
Home care

Question 5

What does USP 795 discuss?

Answer 5

Responsibility of the compounder
Facility standards and equipment
Stability and beyond-use dates
Ingredient selection and quality
Checklist of considerations before compounding
Discussion of procedures for different dosage forms
Records and documentation
Quality control, verification and patient counseling

Question 6

What is the difference between compounding and manufacturing?

Answer 6

Pharmaceutical companies manufacture. Manufacturing is regulated by the federal government (Health Canada). In manufacturing, the product needs a DIN, there needs to be an established license and a notice of compliance
Healthcare professionals compound. Compounding is regulated by the territorial/provincial government. In compounding there needs to be compliance with regulations

Question 7

What is important with regards to the compounding environment? What is important with regards to the compounding equipment?

Answer 7

There should be adequate space (orderly placement and storage of equipment)
Temperature and lighting should be controlled
Should be clean
There should be a sink with hot and cold running water for hand washing and washing equipment
Equipment must be appropriate in design and size for intended purpose, always be cleaned immediately after use and properly maintained and calibrated
Must have separate and distinct areas for compounding sterile and non-sterile preparations

Question 8

What is important with regards to the stability of the preparations?

Answer 8

Primary packaging is important (e.g., light sensitive products, drugs that bind to the container)
Beyond-use date (BUD) or expiration date should be on the label of all medications

Question 9

How is the beyond-use date determined?

Answer 9

When no data is available, 795 provides the following guidelines:

• Solids and non-aqueous liquids prepared from commercially available dosage forms: 25% of the remaining expiration date of the commercial product, or 6 months, whichever is earliest
• Solids and non-aqueous liquids prepared from bulk ingredients - up to 6 months
• Water-containing formulations (prepared from ingredients in solid form) - up to 14 days when stored in a refrigerator
• All other formulations - up to 30 days or the intended duration of therapy, whichever is earliest

Question 10

How are ingredients selected?

Answer 10

USP or National Formulary (NF) chemicals are preferred.
Pharmacist responsible for selection
-chemicals must meet purity and safety standards
-should not use drug withdrawn from market by FDA (some exceptions with animals)
-if chemical grade obtain certificate of analysis
-spectroscopic or HPLC grade not necessarily pure

Question 11

What is important with compounded preparations?

Answer 11

The product should contain between 90% and 110% of labeled active ingredient
Guidelines specifically address these dosage forms: capsules, powders, lozenges, tablets, emulsions, solutions, suspensions, suppositories, creams, topical gels, ointments, pastes

Question 12

Describe the compounding process

Answer 12

The goal of compounding process is the “minimize error and maximize prescriber’s intent”
Pharmacists evaluate the appropriateness of order
Only one preparation should be compounded at a time (avoid errors and cross-contamination)

Question 13

What are 9 the steps in compounding?

Answer 13

1. Calculate the amount of ingredients for preparation
2. Identify equipment needed
3. Wash hands and wear proper attire
4. Clean compounding area and needed equipment
5. Collect all materials and ingredients
6. Compound preparation following formulation record
7. Document name on compounding record/log
8. Label final preparation appropriately
9. Properly clean and store all equipment

Question 14

What should the pharmacist be checking in the final check?

Answer 14

Pharmacist is responsible for checking final preparation
-weight variation
-proper mixing
-odor
-colour
-consistency
-pH if applicable
Pharmacist initials prescription and label (documenting/ensuring quality)

Question 15

What are the compounding records required?

Answer 15

USP requires pharmacies to maintain formulation record (master formula) and compounding record for each compounded preparation

Question 16

Describe the formulation record

Answer 16

Like a recipe
Filed alphabetically
Listing of: the ingredients, compounding equipment and instructions for preparing formula

Question 17

Describe the compounding record. What is the compounding record for? What does it include?

Answer 17

It’s a log of an actual compounded preparation

• batch may be prepared in anticipation of orders
• includes manufacturer, expiration date and lot numbers of chemicals
• date of preparation
• internal identification number (lot number)
• beyond-use date or expiration date
• names of individuals who prepared and verified

Question 18

What is important about compounded products with regards to patient counseling?

Answer 18

It should include:

• correct use
• storage
• beyond-use date or expiration
• evidence of instability on compounded medication

Question 19

What factors should be considered with regard to compounding/when to compound? (12)

Answer 19

Must be able to demonstrate that a patient-healthcare professional relationship exists.
May prepare drugs in very limited quantities in anticipation of a prescription.
Should only be done if there is a therapeutic need and lack of product availability.
Compounded product must not duplicate an approved drug product.
May compound when there is a shortage or no supply of a commercially available product.
Compounded products cannot be sold for resale to third parties but pharmacies not providing compounding services may contract this activity to another pharmacist.
Compounding of clinical trial drugs is only permitted if this activity is authorized in the clinical trial authorization.
Product should be compounded from an authorized drug or listed in a recognized Pharmacopoeia.
Those engaged in sterile compounding should be knowledgeable and obtain specialized technical training in this area.
Pharmacists providing compounding services to other hospitals should be within the same province, and operate under the same hospital management board.
Compounded products must comply with all relevant sections of the Food and Drugs Act.
Expiration date based on know stability date. If stability date is not available, use beyond-use dating.