Study Notes
Nonsterile Pharmaceutical Compounding
The Need for Compounding / compounding
sterile compounding
nonsterile compounding / Why is there a need for compounding? There is still a need for a prescribed med made from a bulk product for a specific medical disease, product is not commercially available
Sterile Compounding / Where is most sterile compounding performed? Sterile is aseptic for parenteral or ophthalmic preparations performed in the “clean room environment” CSP- compounded sterile preparations
Nonsterile Compounding / Where does most nonsterile compounding occur? Pharmacy area
Gives examples of when nonsterile compounding might be required. Smaller dose than commercially available, topical formulation when oral had adverse effect, customization
Solutions / • Define solution- liquid dosage form
, solvent- dissolved in a solution, and solute- Active ingredient.
Suspensions / • What is the difference between a solution and a suspension? Suspension – active ingredient not dissolved but dispersed
What is the purpose of a suspending agent? Prevents settling
Ointments and Creams / Distinguish between ointments-water/oil, creams-oil/water
Powders / Why are powders no longer dispensed in bulk form-inaccurate dosing
How do pharmacists describe powders? Finely divided combination, or a mixture, of drugs and or chemicals ranging in size from extremely fine to very coarse
Suppositories / How are suppositories prepared? Melting base material, adding active ingredient and pouring the resultant liquid into a mold
Capsules / What are reasons for compounding capsules?
Unusual doses maybe less of an active ingredient
Bio-Identical Hormones / hormone replacement therapy (HRT)
estrogen replacement therapy (ERT) / What is the advantage of compounded bio-identical hormones? Cream, it is safer than the oral medication
Laws, Regulations, and Standards for Compounding / good compounding practices (GCP)
anticipatory compounding / Who or what regulates compounding pharmacies?
USP, FDA Modernization Act of 1997
USP Chapter 795 / manufactured products
compounded preparations / What is USP Chapter 795?
US Pharmacopeia, the develop standards for CGMP
Product Inventory / Material Safety Data Sheet (MSDS) / How do pharmacists in a compounding pharmacy assure the quality of the ingredients they use? USP
Beyond-Use Dating / beyond-use dating
stability / How is beyond-use dating calculated? Aqueous solutions 14-30 days; solids 6months or less
Under what circumstances might the beyond-use dating be extended? Depends on the stability- extent to which a product retains the same properties and characteristics possessed at the time of preparation
Accreditation of Compounding Pharmacies / Pharmacy Compounding Accrediting Board (PCAB)
continuous quality improvement (CQI) / Why do compounding pharmacies seek accreditation?
Marketing/reimbursement
Certification of Pharmacy Technicians / What requirements must a pharmacy technician meet in order to work in a compounding pharmacy? Additional training/certification
Documentation of Nonsterile Compounding / What must be documented in a compounding pharmacy? Master Control Record- formula/recipe for the drug
The Master Control Record / master control record / How is a master control record like a recipe used in cooking? Record and prepare quality preparation for a legal prescription
The Compounding Log / compounding log
prescription record / How is a compounding log like a master control record? How is it different? MCR is about drug only, CL has info on drug and the patient
Describe procedures for C-II compounds.
Calculations in the Compounding Pharmacy / Give an example of how a technician uses calculations in a compounding practice.
Equipment for Weighing, Measuring, and Compounding
Weights and Balances / Class III prescription balance
counterbalance
weighing paper
digital electronic analytical balance / Which type of balance is required equipment in every pharmacy?
Counterbalance
Pharmaceutical Weights / pharmaceutical weights / Describe a typical weight set. 1-2 pans, polished brass metric and apothecary weights
Forceps and Spatulas / forceps
spatula / Why is it important to use forceps to pick up weights? Medicine cant be touched with bare skin because moisture /oil affect their accuracy
How are spatulas used in the pharmacy? Transfer solid pharmaceutical ingredients to and from weighing pans
Compounding Slab / compounding slab / What can be used in place of a compounding or ointment slab? Special disposable nonabsorbent parchment paper
Mortar and Pestle / mortar and pestle / What are different types of mortar and pestle and how is each used? Electric-used in high volume compounding; glass/ porcelain - triturating or pulverizing;
Graduate Cylinders, Pipettes, and Beakers / graduate cylinder
pipette / How do conical-wide tops narrow base and cylindrical- uniform column graduates differ in appearance?
Other Equipment / Describe equipment used to make tablets and capsules. Convection oven, autoclave, balance, graduated cylinders, pipettes, mortar, pestle, beakers, flasks, slabs, molds
Technique for Weighing, Measuring, and Compounding
Attire and Preparation Requirements / What are minimum attire standards for nonsterile compounding? Lab coat; gloves; and hairnet
Technique for Weighing Pharmaceutical Ingredients / Which type of balance is preferred in the compounding pharmacy?
Why is using a Class III balance more difficult?
Calculating Percentage of Error / percentage of error / How is percentage of error calculated? Amount of error/quantity desired x 100 = % of error ( range should be less than 5%)
Technique for Measuring Liquid Volumes / meniscus / What is a general rule of thumb for selecting a container for volumetric measurement? Always select the device that yields the most accurate volume
Techniques for Mixing Compounded Drugs / How does the technician know which technique to use for mixing compounded drugs? Master control record or the pharmacist
Comminution and Blending / comminution
blending
trituration
levigation
pulverization
spatulation
sifting
tumbling / When performing trituration what technique produces the best results? Minimal pressure rotate pestle rapidly
When mixing solids and liquids, how can you make the solid dissolve more quickly and uniformly? Gently heating the liquid to reduce particle size
What is a levigating agent? Castor oil; glycerin, mineral oil
Compounding Ointments and Creams / When compounding ointments and creams, how can you achieve a smooth end product? Use a spatula press against slab to provide a shearing force
Compounding Powders / diluent powder / How are oral solid pediatric doses prepared? Pulverize, or triturate tablet mix resultant powder with diluent and use that powder to fill capsule
Filling Capsules / punch method / What are three ways to fill capsules? Punch method; capsule machine, hand fill
Geometric Dilution Method / geometric dilution method / What is the procedure for combining drugs using the geometric dilution method? Use mortar/pestle to gradually combine several drugs and inactive ingredients
The Compounding Process / Why is it important to follow the USP Chapter 795 steps in compounding prescriptions?
Selecting Medication Containers / What is the appropriate container for each of these products: tablets and capsules-amber-colored prescription vials, ointments and creams-white ointment jar, suppositories-cardboard box?
Labeling and Cleanup / What information should be on the medication container label? Ingredients and amounts; beyond use date; lot number and date of compounding
What is correct cleanup procedure for ingredients containing hazardous chemicals? Discard in sealed bag then place in bio bag; verified and signed off by pharmacist; outside vendor takes and discards
Final Check by the Pharmacist / pharmaceutical elegance / What does the final check by the pharmacist include? Final product; master control and calculations
Patient Counseling by the Pharmacist / What information should the pharmacist communicate to the patient? Individually prepared and compounded and make sure they understand information
Reimbursement / Why is the number of specialized compounding pharmacies growing? More need for specialized meds
Page 2 of 6