La. Admin. Code tit. 46 § LIII-2533
Biological Safety Cabinet-a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49, or its successor.
Class 100 Environment-an atmospheric environment that contains fewer than 100 particles, of the size 0.5 microns or less in diameter, per cubic foot of air, according to Federal Standard 209E, or its successor.
Component-an ingredient used in the compounding of a drug product.
Compounding-the preparation, mixing, assembling, packaging, or labeling of a drug or device by a pharmacist for his patient as the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice, or including the preparation of drugs or devices in anticipation of prescription orders to be received by the compounding pharmacist based on routine, regularly observed prescribing patterns. Compounding does not include the compounding of drug products that are essentially copies of a commercially available product.
Cytotoxic-any pharmaceutical that has the capability of killing living cells.
Practitioner Administered Compounds-products compounded by a licensed pharmacist, upon the medical order of a licensed prescriber for administration by a prescriber for diagnostic or therapeutic purposes.
Preparation-a compounded drug dosage form or dietary supplement or a device to which a compounder has introduced a drug. This term will be used to describe compounded formulations.
Sterile Compounding-compounding performed using established aseptic technique and utilizing a laminar air flow hood or other device capable of providing a sterile compounding environment. Sterile compounding shall be used when compounding parenteral medications or products, ophthalmic preparations, or any other preparation requiring sterile techniques.
Sterile Product-any dosage form devoid of viable microorganisms including, but not limited to, parenterals, injectables, and ophthalmics.
La. Admin. Code tit. 46, § LIII-2533