Help
Options
Didn't know it?
click below
click below
Knew it?
click below
click below
Don't Know
Remaining cards (0)
Know
retry
shuffle
restart
0:00
Embed Code - If you would like this activity on your web page, copy the script below and paste it into your web page.
Normal Size Small Size show me how
Normal Size Small Size show me how
Compunding
| Question | Answer |
|---|---|
| Non sterile compounding | Solutions and suspensions, Ointments and creams, suppositories and capsules |
| Why compound | cannot swallow pills, oral medication may harm stomach, may be allergic to preservatives or colorings |
| Compounding Pharmacies | must be licensed by the state, Federal and state laws and national standards guide safety practices. |
| GCP-Good Compounding Practices | created by the USP-United States Pharmacopia |
| Grade Chemical compounded | USP and National Formulary |
| Food and Drug Administration Modernization Act of 1997 | Allows pharmacists to compound non sterile ond or sterile medications for an individual patient if these medications meet established USP standards. Compounding pharmacies overseen by state board of pharmacy. |
| FDA | compounding a commercially available product is prohibited |
| FDA | if community pharmacy selling products to healthcare professions or out of state pharmacy, must apply for manufacturing license. |
| USP Chapter 795 | Agencies Responsible-Accreditation of compounding pharmacies Certificate of pharmacy technicians Pharmacy Compounding PCAB is responsible for accrediting pharmacies. |
| To be accredited: | Pharmacy must meet all standards for sterile and non-sterile compounding. |
| Chapter 795 | Non sterile |
| Chapter 797 | Sterile |
| Chapter 800 | hazardous and chemo |
| Chapter 795 | only USP and national Formulary grade ingredients should be used. Pharmacist must balance cost of ingredients with quality.. |
| Chapter 795 | American chemical society ensures that an ingredient is a high grade purified product. |
| Material safety data sheet Chapter 795 | must be filed for all stored ingredients |
| Compounded products have beyond dose dating | not called expiration date-date is initiated at the time of compounding. product stability must be documented |
| Compounded Quality Act | Distinguishes traditional compounders Track and trace-requires ability to track medications from manufacturer to patient. |
| outsourcing facilities | promotes voluntary registration |
| Beyond dose dating | applies to compound preparations |
| Stability | The extent to which a compounded product retains the same physical and chemical properties and characteristics it possessed at the time of preparation. |
| Chapter 795 | Refrigerated aqueous (water based) =14 days Solids and non aqueous solutions =6 months or less all other formulations-30 days |
| USP Chapter 795 | Beyond use date for prescription with two or more active ingredients take the earlier of these. 25% of the remaining expiration or 6 months |
| How to calculate | Take all ingredients and figure out which one expires first. Calculate how many months to the date-,ex-19 months then times it by 25 will figure out months and if less then 6 mos that is the date you come up with. |
| Documentation of Non sterile Compounding | master control record, the compounding log, calculations in the compounding pharmacy |
| Master Control record | A recipe for a compound preparation that lists the name of the ingredients |
| Master Control Record | Prepared by the pharmacist or prepared by a compounding pharmacist |
| Compound Log | generated for each prescription Pharmacist uses it to complete the initial calculations and document item Copy of the log is called the prescription record and is filed and used for refills. |
| On the log | all ingredients, manufacturer, wholesale source, assigned lot number, NDC number |
| On Log | expiration date for each ingredient, quantity made, date of compounding, initials of pharmacist and compounding technician |
| Pharmacist | responsible for all calculations made by technicians |
| Scales | class A (111) prescription balance required in every pharmacy. Weighs from 6mg to 120 g Weights on right side, drugs on left |
| Weights | Always use forceps to transfer weights Always stored in original case |
| Spatulas | used to transfer drug or to mix medications during compounding |
| Motar and Pestle | used for Trituration(grinding) |
| Glass | preferable for liquids and semi soft dosages forms |
| Porcelain or Wedgewood | preferred for mixing crystals, tablets, or large particles |
| Ointment slabs | ground glass plates used to compound creams ointments |
| Capsules | sizes range from 000 to 9 with 9 being the smallest |
| Graduates | used to measure liquids. Always use the smallest graduate capable of holding intended measurement. |
| Graduates | measure liquid from the bottom of the meniscus(a concave shape that bulges downward) Volume should be no less then 20% or more than 90% of capacity of volumetric container. |
| Cylindrical | most accurate |
| Conical | easiest to clean |
| Beakers | do not use to measure limited accuracy |
| Graduate Cylinders, Pipettes and Beakers | A pipette is a long thin hollow tube Used to transfer liquid less volume less then 1.5 ml |
| The acceptable range of error | 120 mg on class A balance |
| Geometric Dilution | When mblingixing ingredients add the most potent drug first, then equal amount of next potent drug and so on. |
| Comminution | the act of reducing a substance to small fine particles, including trituration, levigation, pulverization, spatulation, sifting and tumbling. |
| Levigation | mixing the powder with a vehicle like mineral oil, castor oil, to reduce particles size in order to produce a smooth product |
| Trituration | the process of rubbing, grinding, or pulverizing a substance to create fine particles generally by means of a mortar and pestle. |
| pulverization | reduces particle size by adding a violatile solvent(Camphor, Alcohol, Iodine, or Ether, after which the solvent is then permitted to evaporate. |
| Spatulation | using a spatula to combine and mix sifting |
| Tumbling | placing powders into a container and shaking. |
| Blending | the act of combining two substances |
| books | Remington-The Science and Practice of Pharmacy Professional Compounding Centers of America-PCCA-this entitles pharmacies to recipes |
Created by:
linmariej