Transcript Nonsterile compounding

Nonsterile compounding-USP ch 795
USP <795> outlines the responsibilities of the compounder,
which can be summarized as being responsible for compounding
preparations of acceptable strength, quality, and purity with appropriate packaging
and labeling in compliance with requirements established by applicable laws and
agencies (eg, state boards of pharmacy). Specifically, the responsibilities of the
compounder include the following general principles:
Personnel are capable and qualified to perform their assigned duties.
Compounding ingredients of the appropriate identity, quality, and purity
are purchased from reliable sources.
All equipment used in compounding is clean, properly maintained, an
used appropriately.
Only authorized personnel are allowed in the immediate vicinity of the
drug compounding operations.
There is assurance that processes are always carried out as intended or
specified and are reproducible.
The compounding environment is suitable for its intended purpose and to
prevent errors.
Adequate procedures and records exist for investigating and correcting
failures or problems in compounding, in testing, or in the
preparation itself.
USP ch 795
• USP 795 carries the force of law. Its provisions can be, and
are, enforced by U.S. Food and Drug Administration agents
and state board of pharmacy officials. All states have
adopted USP 795 as the baseline for safe and legal
nonsterile compounding
• It is the most common kind of drug compounding done by
pharmacists and pharmacy technicians in community and
hospital pharmacies.
• Preventing contamination is important when doing
nonsterile compounding, but compounders do not have to
work in completely sterile environments like cleanrooms.
• "the production of solutions, suspensions, ointments and
creams, powders, suppositories, capsules and tablets."
USP ch 795
• extemporaneous compounding----making a drug dosage
not made by manufacturer.
• simple, moderate and complex categories.
• Simple nonsterile compounding involves mixing
medications according to established formulas, or
"recipes," and creating liquid versions of drugs usually sold
only as tablets or capsules.
• Used in doses smaller than ones in commercially produced
products.
• 125 simple nonsterile compounds in USP.
• It gives APIs and nonpharmaceutical ingredients to use, as
well as how to measure and mix the ingredients, label the
finished drug product and determine an expiration date
USP ch 795
• Moderate nonsterile compounding involves making dosages
containing potentially harmful medications or preparations
that require special handling.
• Fentanyl troches, which are better known as lollipops, and
ointments that can only be safely applied with gloves fall into
this category.
• Mostly from dentists, oncologists and dermatologists
• Few pharmacies perform complex nonsterile compounding,
which requires advanced training and special equipment to
make products like extended-release capsules and
transdermal patches.
• Sterile compounding is ---Medication intended for injection,
infusion or application to the eye must be compounded
according the rules and standards for sterile compounding
due to bacteria or fungi.