CPhT Blue Book - Chapter 10 Extemporaneous, Nonsterile Compounding

Compounding

a pharmacist or a technician uses bulk ingredients to prepare a prescribed medication that treats a specific patient’s medical condition

Sterile Compounding

aseptic technique to prepare solutions free of microorganisms for parenteral products or ophthalmic preparations

Compounded Sterile Preparations (CSPs)

including a clean room environment, correct aseptic technique, specialized equipment and training

Nonsterile Compounding

follows particular guidelines to keep medications as contamination-free as possible within a sanitized compounding space in a community or compounding pharmacy

Extemporaneous Compounding

compounding occurs for a specific need of the moment for a particular patient

Simple

following USP monograph directions/peer reviewed articles with specific quantities etc.

Moderate

requiring some special calculations

Complex

requiring special calculations, decision making, training etc.

Current Good Manufacturing Practices (CGMPs)

main regulatory standards for the manufacturing of pharmaceuticals

Pharmaceutically Elegant

it is aesthetically pleasing both in appearance and application

Anticipatory Compounding

pharmacies are allowed to prepare more than they need at that moment for refills or similar need

Accreditation Commission for Health Care (ACHC)

specializes in accrediting facilities and pharmacies particularly oriented toward home health care, hospice care, alternative healthcare institutions, and medical supplies

Pharmacy Compounding Accreditation Board (PCAB)

offers a certification process for those pharmacies that comply with all national standards and the best industry practices in nonsterile and sterile compounding

Continuous Quality Improvement (CQI)

to identify and resolve any problems in an ongoing way

Professional Compounding Centers of America (PCCA)

the knowledge and skills necessary to pass specialty compounding certification exams are presented as workshops and labs by this organization

Master Formulation Record

develops an appropriate delineated formula of instructions (recipe)

Compounding Record

create an individualized version for the specific patient’s batch that is generated

Hand Hygiene

using special alcohol-based rinses, gels, or foams that do not require water

Staging Area

assembly space

Autoclave

an intense heating appliance for chemical heat compounding processes; to sterilize instruments and measuring vessels and devices with steam heat and pressure

Sterilization

kills the germs on metal and glass surfaces

Mortar and Pestle

suited for hand grinding and pulverizing

Coarse-grained Mortar and Pestle

for triturating/pulverizing crystals, granules, and powders

Glass Mortar and Pestle

for mixing liquids and semisolid dosage forms

Electric Mortar and Pestle

used in a high-volume compounding pharmacy to reduce particle size and to mix the pharmaceutical compound more thoroughly

Three-roller Ointment

mixes and greatly reduces the particle size of ingredient powders used to compound a dermatological ointment or cream preparation

Ointment/Compounding Slab

plate made of ground glass that has a flat, hard, nonabsorbent surface ideal for mixing topical compounds

Spatula

an instrument used for transferring solid pharmaceutical ingredients to and from weighing pans

Nonvolumetric Glassware

inappropriate for precise volume measurements; to store, contain, and mix liquids

Hot Plates and Microwaves

melt down powders or mix ingredients with various solvents

Components

start with quality ingredients

Active Pharmaceutical Ingredient

any substance (or mixture of substances) in a compounded preparation that confers pharmacological activity

Added Substances

ingredients that are necessary to compound a preparation but do not confer pharmacological activity

Excipients

inactive ingredients

Vehicle

substance or solution that carries the active ingredient

Safety Data Sheet (SDS)

safe storage and handling that is required by OSHA for all bulk hazardous chemicals and drug substances

Controlled Substance Ordering System (CSOS)

ordering bulk narcotic ingredients through this online, identity-secure system

Sensitivity Range

potential range of error

Percentage of Error

range of potential error in the weight or measurement, compared to the desired quantity

Bioavailability Range

the percentage of how much of the substance is absorbed in the product form

Weighing Paper/Boat

hold the powder, protect the balance from damage, and avoid contact between the pharmaceutical ingredient and the metal tray

Tare Weight

the weight of this paper (or any weight container)

Class III Prescription Balance

has two mechanical balancing pans

Pharmaceutical Weights

in the right pan of the Class III Prescription balance

Forceps

tweezer-like instrument used for grasping and holding small, light objects

Class I and II

for high-precision laboratories

Arrest

lock

Subtherapeutic

below correct dosage

Bulk Counterbalance

weighing large amounts, from 100g to 5kg

Graduated Cylinder

glass or poly-propylene flask used for measuring liquids

Conical Graduates

wide bases and narrow tops, tapering from the bottom to top

Cylindrical Graduates

more accurate and have the shape of a uniform column