Compounding
What is compounding?
the process in which we use bulk ingredients to prepare a prescribed medication that treats a specific patient’s medical condition
What is reconstitution?
process of adding a diluent liquid (such as distilled water) to a dry powder ingredient to make it into a suspension
Which chapter covers non-sterile compounding?
What does MFR stand for and what is it?
Master Formulation Record - aka your compound's recipe
What is BUD?
Beyond-use dating
Is a reconstitution considered a compounded product and why or why not?
No, because you are following the manufacturer's directions.
When is the reconstituted product prepared?
After the patient purchases it from the pharmacy.
What is GCPs?
Good compounding practices
When is a MFR created?
When a compounded product is being made for the first time
What is water activity?
The available water in the compound that can promote microbial growth and breakdown of the compound or its components
What are some examples of what is involved in compounding?
Preparing, mixing, assembling, altering, packing, and labeling a prescription according to the formulated recipe and prescription
What are some examples of ways to measure diluents?
Graduated cylinder, Reconstitube, or FillMaster
What are the differences of USP Chapters <795>, <797>, and <800>?
<795> - Covers non-sterile compounding
<797> - Covers sterile compounding
<800> - Covers hazardous drugs
What does CR stand for and what is it?
Compounded Record - Used to document any calculations and batch-specific information
What are water activity charts used for?
To determine water activity based on dosage form
What is the difference between a solute and a solvent?
Solute - The ingredient dissolved in the solvent
Solvent - The vehicle that makes up the largest part of the solution
How is the meniscus meant to be read?
Cylinder placed on a flat surface while you squat to be eye level with the meniscus, which is read from the bottom
Why is ascetic technique and sterility not required for non-sterile compounds?
Products used to create non-sterile products are not being injected directly into a vein
What does a CR contain?
- Name of compound, strength, and dosage form
- Master Formulation Record reference number
- Names and quantities of all ingredients (including MFG, LOT, NDC, EXP of each item)
- Total quantity made
- Name of person who made compound, performed quality control checks, and who approved product
- Date and time of compounding
- Assigned RX or lot number
- BUD assigned and storage requirements
- Description of final preparation appearance
- Results of quality control tests
- Documentation of and issues in quality control tests
1. Nonaqueous (low water activity aw < 0.6)
2. Aqueous (high water activity aw ≥ 0.6)
What is the difference between extemporaneous compounding and anticipatory compounding?
Extemporaneous compounding - When you are compounding for a specific patient's prescription after prescription is received by pharmacy
Anticipatory compounding - When a pharmacy prepares more than what they need at the moment to have some in stock for refills or for a similar presription
What are the steps to reconstituting a product?
1. Wash hands and don appropriate PPE
2. Tap unopened bottle of powder against counter or you palm to loosen powder before adding any liquid
3. Use graduated cylinder to measure total volume needed
4. Slowly pour half of the water into stock bottle, recap, shake vigorously, re-open and add remainder of water, re-cap and shake vigorously until powder is fully dissolved.
5. Pour reconstituted & flavored suspension into bottle and insert correct size PIBA
6. Affix medication label and auxiliary labels
Who shares the responsibility to ensure all GCPs are followed?
Pharmacist and pharmacy technicians
What does a MFR contain?
- Compound's name, strength, and dosage form
- Ingredients + quantities of each ingredient
- Detailing mixing instructions and calculations
- Equipment and supplies needed, including required dispensing container- Recommended BUD, storage, and labeling requirements
- Description of final product
- Quality control procedures and expected results
- Other information needed to describe compounding process to ensure repeatability
Why does an aqueous dosage form have shorter BUDs compared to nonaqoeous dosage forms?
Nonaqueous does not support microbial growth and breaks down slower while aqueous supports microbial growth and breaks down faster