PTCB: Compounding

act of reducing a substance to small, fine particles

comminution

to scatter or incorporate the particles of one substance into another

dispense

the act of dissolving a substance into a liquid

dissolution

a sweetened hydroalcoholic solution which may contain an active ingredient or serve as a vehicle for another medication; binder/filler to mask the actual taste of the medication

Elixir

A mixture of two liquids that are not soluble in each other. when shaken, one phase will form globules in the other.

Emulsions

inert substances added to another substances in order to attain suitable consistency, shape or form (tablets fillers and binders

excipients

used to combine one drug with another in a mortar and pestle.place the smaller amount, usually the active ingredients into mortar then add the same amount of the next ingredient

geometric dilution

a water loving substance

hydrophilic

water hating or oil loving substance

hydrophobic

using a spatula to mix, smooth, or dispense a solid, semisolid, or liquid into an ointment base

levigation

a semisolid dosage with a petroleum or fatty bee meant for topical application

ointment

substances added that are intended to maintain sterility by killing or inhibiting growth of bacteria or other organism

preservatives

method for filling capsules in which the body of a capsule is repeatedly punched into a cake of medication until the capsule is full

punch method

a liquid dosage form in which active ingredient are dissolved in a liquid vehicle

solution

to add slowly

sprinkle

mixing a substance using a stir rod or other appropriate tool, without the use of a stir bar

stir by hand

mixing or agitation a substance using a stir bar and magnetic stir function of the hot plate

stirring

surface acting agent. a substance used to lower the surface tension of a liquid to facilitate compounding

surfactant

insoluble substance held in dispersion by an agent to prevent separation or settling

suspension

controlled sucrose solution suitably flavored and intended as a vehicle or base or the active ingredient. Must be preserved with an antibacterial anti fungal ingredient

syrup

to reset the balance to zero

tare

grinding or mixing dry powders in a mortar and pestle to reduce particle size

trituration

a whorled arrangement, design, or pattern created by the spin bar and the magnetic stir function of the hot plate

vortex

two pan balance, used weight small amounts

class III prescription balance

two pan balance, used for larger weights

counterbalance

single pan, easier to operate than two pan balance, more accurate

digital electronic balance

used with two-pan balances to offset ingredients weight; made of polished brass with noncorrosive coating

pharmaceutical weights

used to transfer solid ingredients to weighing pans, ointments and creams, remove material from mortar pestle

spatulas

glass

stirring rod

used for grasping objects; used with pharmaceutical weights to avoid transferring moisture or oil from hands

forceps

plate made of ground glass; disposable nonabsorbent parchment paper

compounding slab

used in measuring liquids;

used to measure liquid

used for grinding and mixing ingredients

mortar and pestle

used for storing ingredients and final products

freezers and refrigerators

protection when working with powders

container hood, mask, and gowns

used for combining tablet ingredients

tablet press

used for making larger quantities of capsules

capsule machine

other equipment

tong, hot plate, ointment jar, troche mold, suppository mold, thermometer, braun, homogenizer

Many compounding pharmacy seek national accreditation

protects patient, protect business, differentiate their practice from other pharmacies

responsible for accrediting pharmacies

PCAB

to be accredited must follow all specific standards

1.must follow continuous quality improvement process including periodic spot checks, random selection of product to be analyzed at an outside lab 2. certification of pharmacy technician

certification of pharmacy technician in compounding

1. pass PTCB; 2. complete mini-certifications and laboratory training; 3. all compounding task must be supervised and checked by the pharmacist.

USP chapter 795

only USP or National formulary ingredients should be used; pharmacist balance cost of ingredients with quality;3. pharmacist must have multiple sources of ingredients

Material Safety Data Sheet must be filed with for all stored ingredients; contain information on:

1. hazard and flammability, how to clean up spills, procedures for treating accidental ingestion or exposure

estimated for beyond-use dating

refrigerated solutions: 14 days solids and solutions: 6 months or less; all other formulations: 30 days

* if using other ingredients and may expire sooner than 6 months, that will be the expiration date

manufactured or bulk materials

25% of the remaining expiration date; 6 months earlier

a patient-specific medication prepared on-site by the technician, under the supervision of the pharmacist, from individual ingredients

compounded preparations

products prepared off-site by a manufacturer, mass production

manufactured products

recipe for maing the compound prescriptions

master control record - prepared by pharmacist or compounding service

master control record list:

drug's name, strength, dosage form, ingredients and quantities, mixing instructions, recommended beyond use dating, storing and labeling requirements

ff

generated foe each prescription; use by pharmacist to complete initial calculation and documenting them

compounding log;

copy of the log

prescription record

compounding log list

ingredients, manufacturer, wholesaler source, assigned lot number, NC number, expiration date of ingredients; quantity made, date of compounding, initials of pharmacist and compounding technicians