Good Compounding Practices and Techniques

69問 • 5ヶ月前

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Study that concern itself with the physical, chemical, and biological factors which influenced the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms

Pharmaceutics

An agent intended for use in diagnosis, mitigation, treatment, cure, and prevention of disease in man or animal

Drug

Dosage forms in which drugs are prepared by the pharmacists for administration in the treatment of disease

Pharmaceutical preaparations

This may be done extemporaneously compounded or manufactured for immediate distribution

Pharmaceutical preparations

Dosage forms are also known as

Pharmaceuticals

It is prepared by adding an active ingredient (API / therapeutic ingredients / pharmacological active ingredients ) and a non-therapeutic ingredient (inert or inactive ingredients) which comprises a vehicle or formulation matrix

Dosage forms

Other term for non-therapeutic / inert / inactive ingredients

excipients

Means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis

Manufacturing

Preparation of components into a drug product as the result of a practitioner's prescription drug order based on the practitioner/patient/pharmacist relationship in the course of professional practice

Compounding

Preparation of components into a drug product for the purpose of, or as an incident to, research, teaching, or chemical analysis and not for sale or dispensing

Compounding

What compedium chap. 795 stated that compounding is the preparation, mixing, assembling, altering, packaging and labeling of a drug, drug delivery device, or device in accordance with a licensed practitioner’s prescription, medication order, or initiative based on the practitioner-patient-pharmacist-compounder relationship in the course of professional practice

United States Pharmacopeia

Pharmacists may _____, in reasonable quantities, dmg preparations that are commercially available in the marketplace if a pharmacist-patient-prescriber relationship exists and a valid prescription is presented

compound

Pharmacists may compound _____ medications in commercially available dosage forms or in alternative dosage forms to accommodate patient needs as allowed by individual state boards of pharmacy

non prescription

Pharmacists may _____ drugs in limited quantities prior to receiving a valid prescription, on the basis of a history of receiving valid prescriptions that have been generated solely within an established pharmacist-patient–prescriber relationship, and provided that the prescriptions are maintained on file for all such preparations dispensed at the pharmacy

compound

Pharmacists should not offer _____ medications to other pharmacies for resale; however, a practitioner may obtain compounded medication to administer to patients, but it should be labeled with the following: “For Office Use Only,” date compounded, use-by date, and name, strength, and quantity of active ingredients. An exception to this may be the outsourcing of some compounded preparations by hospitals to contract compounding pharmacies

compounded

_____ pharmacies and pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services

Compounding

It is devised to make possible the administration of medication in measured prescribed amount

Dosage forms

Device that holds a drug and is or may be, in direct contact with the drug

Containers

In direct contact with the drug at all times; e.g. closure

Immediate container

It protects the content from extraneous solids and from loss of the article under ordinary conditions of handling, shipment, storage, and distribution

Well closed container

It protects the contents from contamination by extraneous liquids, solids, or vapors, from loss of the article and from efflorescence, deliquescence, or evaporation under the ordinary or customary conditions of handling, shipment, storage, and distribution, and is caple of tight reclosure

Tightly closed container

it is impervious to air or any other gas under the ordinary or customary conditions of handling, shipment, storage, and distribution

Hermetic container

Intended for injection or parenteral preparation

Hermetic container

Known as unit dosage package

Single dose container

One that holds a quantity of drug intended and cannot be resealed when opened with assurance that sterility has been maintained

Single dose container

One that contains more dose of the medication and permits the withdrawal of successive portions without changing the strength or endangering the quality or purity of the remaining portion

Multiple dose container

Used primarily for liquid dosage forms

Round bottle

Used for dispensing liquids of low viscosity

Rx bottle

Used for bulk powders or large quantity of tablets or capsules

Wide mouth bottle

Used for applying liquid medication to a wound or skin surface

Application bottle

Used for powders to be applied by sprinkle

Sifter-top containers

Used for ophtalmic and otic preparation

Dropper bottle

Used to dispense semi-solid dosage forms (2 answers)

Ointment jar, Collapsible tube

Used to dispense liquid contents as a mist or foam

Aerosol container

Labelling includes desired condition to ensure the stability of a pharmaceutical preparation for the period of its intended shelf life

Storage

Storage condition hot exceeding 8°C

Cold

Storage condition between 8-15°C

Cool

Temperature prevailing in working area

Room temperature

Storage condition between 15-30°C

Controlled room temp

Storage condition between 30-40°C

Warm temp

Storage condition above 40°C

Excessive heat

Refers to the length of time that a drug produced may remain on the pharmacist’s shelf in the original packages and under usual environmental condition

Shelf life

Retain an acceptable level of its original potency and overall quality

Shelf life

If storage condition are not met, either physical degradation or chemical deterioration may occur

Shelf life

Latest date at which the product is expected to be stable physically, chemically, therapeutically, identity, strength, quality, and purity until that date if storage condition are met

Expiry date / Beyond Use date

Manufacturer's shelf life of solid dosage forms (e.g. tab & cap)

5 years from the date of preparation

Manufacturer's shelf life of liquid dosage forms

shorter shelf life

Manufacturer's shelf life of dispersed systems-aerosols, emulsions, and semi-solid (eg. ointments & suppositories)

shorter shelf life

Extemporaneous compounding shelf life of non-preserved aqueous

14 days

Extemporaneous compounding shelf life of preserved aqueous

35 days

Extemporaneous compounding shelf life of nonaqueous dosage forms

90 days

Extemporaneous compounding shelf life of solid dosage forms

180 days

Nomenclature of drug's proprietary name

brand name

Nomenclature of drug's proprietary name

trade name

Nomenclature of drug's non-proprietary name

generic name

Uses yellow prescription

Dangerous drugs

Prohibited and regulated drugs

Dangerous drugs

Prescription or legend drugs are also called _____ drugs

ethical

Requires Rx label

Prescription / Legend drugs

Can be bought w/o prescription

OTC drugs

Swallowing via mouth

per oral

Injected into the body

parenteral

Inserted into the rectum

rectal

Applied to a certain area of the skin

topical

Inserted into the vagina

vaginal

Inhaled through mouth or nose

inhalation

Under the tongue

oral-sublingual

Beside the cheek

oral-buccal

Administered by application to the tongue

oral-perlingual

M#5 Section and Title v2

ユーザ名非公開 · 32問 · 13日前

M#5 Section and Title v2