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pht 100

chapter 8 part 2

the higher grade purity of a product is ensured by an analysis certificate be the American Chemical Society
material safety data sheet must be filed for all stored ingredients
the material safety data sheet is MSDS
the msds has info on hazards and accidental exposure treatment procedures
the msds also has info on hazard/flammability of compound chemicals
the beyond use date documents the date after which the compound expires
stability is the extent to which a compound has the same properties possessed at preparation time
the usp chpt. 795 provides an estimate for beyond use date
refridgerated aqueous solutions may last about 14 days
solids may last up to 6 mos.
others may last for 30 days
when manufactured materials are used, take the ealier date of expiration
25% of the remaining expiration date may last 6 mos.
techs should have pharmacists check beyond use dates
sterile compound beyond use dates is stricter, about 24-72 hrs. & stability/sterility is documented
many compounding pharm]s seek mat'l acreditatio which protects patients & businesses legal boundaries
nat'l accreditation differentiates a practice from other pharm] practices
the pharm] compounding accrediting board, accredites pharm]s
for accreditation, pharm]s must follow the continuous quality improvement process
the continuous quality improvement process includes periodic spot checks of tech's work & random product selection to be analyzed at an outside lab
the pharm] compounding accrediting board provides quality standards for compounding pharm]s through voluntary accreditation
continuous quality improvements is a process of written procedures designed to spot problems & give answers
techs must pass a broad nat'l certification exam as well as mini certifications & lab training
nonsterile compouding documents include a master control record which is a recipe for rx compounds
the master control record is prepared by a pharmacist or given by a compounding service
the master control record also includes recipes for preps, mixing instructions, & beyond use dates
a compounding log is generated for each rx
pharmacists use a compounding log to complete initial calculations & to document them
the log copy (called the rx record) is filed & used for refills
a compounding log is a print out of the rx that has details of ingredients & compounding instructions used by techs for preps
a rx record is a computed version of the compounding log
the compounding log lists ingredients, manufacturers, wholesaler sources, lot #'s ndc #'s, expiration, qualitity made, compounding date, & initials of pharmacist & tech
techs must have aptitude for calculation performing
pharmacists are legally responsible for techs calculations
double checking is a good practice
C2 rx balancing needs a 2 pan balance, used weigh small amounts (120g or less), sensitivity requirement around +/- 6 mg, pharmaceutical weights to offset ingredient weights
Created by: wildap



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