Introduction Flashcards
The creation of a pharmaceutical preparation by a licensed pharmacist to meet the unique needs of an individual patient when a commercially available drug does not meet those needs.
Compounding.
Combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug product or bulk drug substance to create a nonsterile preparation. (USP 795)
Non-Sterile Compounding
USP 795
Non-Sterile Compounding
USP 797
Sterile Compounding
Combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile medication. (USP 797)
Sterile Compounding
Why do we need sterile compounding?
When the route of medication administered BYPASSES the body’s natural defense mechanisms.
In what three situations would we compound a product for a patient?
- Drug or dosage form not commercially available.
- Dose Unavailable
- Formulation inappropriate for patient.
Can we compound a medication to save money?
No, it is not permissible to compound a preparation only because it is cheaper if there is a commercially available product.
Are compounded products FDA-approved?
No, therefore they do not have the same safety, quality, and effectiveness requirements as FDA-approved drugs.
What act amended the Federal Food, Drug, and Generic ACT (FD&C) leading to the formation of 503 A and 503 B facilities?
Drug Quality and Security Act of 2013.
What was the intent of the Drug Quality and Security Act of 2013?
To prevent compounding pharmacies from functioning like drug manufacturers.
In a 503 A facility, under what 3 scenarios may a pharmacist compound a drug product in a state-licensed pharmacy or federal facility?
- The compounded drug is for an identified individual patient.
- Drugs are distributed pursuant to a valid patient-specific prescription.
- Drugs compounded in advance of receiving prescriptions are compounded only in limited quantities.
___________ pharmacies are exempt from Current Good Manufacturing Practices (CGMPs)
503A
What contains the minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of the drug product; ensure that the product is safe for use, verify ingredients and the strength of the product.
Current Good Manufacturing Practices (CGMPs).
These are dictated by the FDA.
Under what circumstances may pharmacists and physicians compound bulk substances at a 503A facility?
- Substance complies with an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph if one exists, and the USP chapter on pharmacy compounding.
- Are components of FDA-approved drug products if an applicable USP or NF monograph does not exist.
- Appear on FDA’s list of bulk drug substances that may be used in compounding if such a monograph does not exist and the substance is not a component of an FDA-approved drug product. In addition, bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with the FDA under section 510 of the FD&C Act.
