Up to the final Flashcards
Beyond use date
used for compounded prescriptions
Expiration dates
used by pharmaceutical manufacturers
<795>
non sterile compounding
<797>
sterile compounding
<1178>
good repackaging practices
use suitable containers with an equivalent closure system
label has appropriate storage conditions and BUD
include lot number
<1191>
stability considerations in dispensing practice
Stability
capacity of a drug product to remain within specifications established to ensure its identity, strength, potency, quality and purity
Signs of lack of stability
change in performance or appearance
efficacy failure
Assay
strength
indicates the amount of API in dosage form
Does stability apply to homeopathic drugs, allergenic extracts, and new drugs for investigational use?
no
What from the environment affects stability?
pH, temp, light, oxygen, CO2
How do drugs and excipients affect stability?
particle size
relative purity of excipients
How does microbial contamination affect stability?
API, excipients, processing
Trace metals and catalysts can affect?
stability
How do closure systems affect stability?
moisture in containers
Chemical stability
each active ingredient retains its chemical integrity and labeled potency within the specified limits
Physical stability
the original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained
Microbiological Stability
Sterility or resistance to microbial growing is retained according to the specified requirements; retain effectiveness within the specified limits
Therapeutic Stability
therapeutic effect remains unchanged within shelf life
Toxicological stability
no significant increase in toxicity occurs
Common pathways for chemical degradation
hydrolysis, oxidation, photodegradation, dehydration, isomerization, decarboxylation
For official compounded preparations, use ingredients that meet requirements of ?
compendial monograph
USP or NF grade or what substances should be used for preparations?
Analytical Reagents
Certified American Chemical Society
Food Chemical Codex
Manufactured containers are labeled with the expiration date and?
batch control number
BUDs for compounded prescriptions are assigned based on?
Professional experience
careful interpretation of literature and laws
worksite policies and SOPs
NECC Case study
product caused fungal meningitis
resulted in a lot of deaths
14 people indicted
Drug Quality and Security Act
Amended FD&C Act to grant FDA more authority to regulate and monitor the manufacturing of compounded drugs
Compounded sterile preparations examples
injections, infusions
irrigations for internal body cavities
ophthalmic
preparations for pulmonary inhalation
baths/soaks for live organs and tissues
implants
Category 1 CSPs stored at CRT BUD
12 hours or less
Category 1 CSPs refrigerated BUD
24 hours or less
Category 2 CSPs stored at CRT BUD
more than 12 hours
Category 2 CSPs when refrigerated BUD
more than 24 hours
BUD is not to exceed
shortest expiration date or BUD of any components
Potassium Cyanide in Tylenol capsule is
hygroscopic, changes capsule appearance