Usp 797 guidelines beyond use dating

Usp 797 guidelines beyond use dating


PH. BACKGROUND The test for pH is to measure the acidity or basicity of an aqueous solution. The pH of water at 25 C is approximately 7.0. Solutions with a pH of. USP 1160 - USP Chapter 1160, Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations. USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. Batch preparation - A batch preparation is one in which multiple identical units are prepared in a single operation in anticipation of prescriptions. Therefore, USP 797 and USP 795 are considered enforceable, while USP 1075 and USP 1160 are simply considered guidelines for best practices. Automated compounding device (ACD) - An automated compounding device is a machine used to prepare CSPs (e.g., PN). A primary engineerirng control (PEC) such as a laminar airflow workbench would be located in this area. ISO Class - The International Organization for Standardization has established various levels of air cleanliness. Negative pressure room - If a pharmacy prepares more than a low). The Joint Commission (TJC) - The Joint Commission, formerly the Joint Commission on Accreditation of Healthcare Organizations (JCAHO ) is a nonprofit organization that accredits more than 20,000 healthcare organizations. 1.0 Pharmacist Licensure Requirements. 1.1 Definitions. Words and terms defined in Delaware Code Title 1, Section 302 and Title 24, Section 2502 of the Delaware Code. Antineoplastic agents - Antineoplastic agents are drugs that inhibit and combat the development of tumors. Sterile compounding processes Non-sterile compounding processes Terminology. Compounded sterile preparations (CSP) - Compounded sterile preparations are admixtures that need to be assembled under aseptic conditions to prevent contamination. Trituration - Trituration is a method to reduce particle size (comminution it may also include the grinding together of two or more substances in a mortar to mix them as. When using this method, the smallest quantity of active ingredient is mixed thoroughly with a proportion quantity of the diluent or base on the ointment slab. Levigating agents make incorporating solids easier, and they make a smooth, elegant preparation. HEPA filter - A HEPA filter is a high efficiency particulate air filter. Osmolarity - Osmolarity, also called osmotic pressure, is a characteristic of a solution determined by the number of dissolved particles in it. The ISO classes commonly discussed in sterile compounding are ISO Class 5 (3,520 particles of 0.5 micron or larger in a cubic meter ISO Class 7 (352,000 particles of 0.5. The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state. Currently we are mixing our own vaccines for allergen immunotherapy. Our hospital wants the mixing to be done by a pharmacist, that it is safer and more standardized. Nosocomial infection - A nosocomial infection is an infection acquired while in the hospital. The lower the number the fewer particles that are suspended in it and the cleaner the air is. More diluent (base) is added in amounts proportionate to the volume of the mixture on the ointment slab. This article is intended to provide a broad overview of sterile and nonsterile Compounding. Coring - Coring occurs when a needle damages the rubber closure of a parenteral container causing fragments of the closure to fall into the container and contaminate its contents. Responsibilities of all compounding personnel The basis for the classification of a CSP into a low-, medium-, and high-risk level, with examples of CSPs and their. Buffer area - An area that is required to be ISO class 7 or better. Hazardous drugs - Hazardous drugs are drugs that are known to cause genotoxicity, which is the ability to cause a change or mutation in genetic material; carcinogenicity, the ability to. Admixture - An admixture is the resulting solution when a drug is added to a parenteral solution. Effect of USP Compounding Guidelines on the Administration of Allergen Immunotherapy: Chapter 797. Board of Pharmacy (BOP) - Each state has its own board of pharmacy. This process is repeated until all of the ingredients are incorporated in the mixture. Aseptic techniques - Aseptic techniques are techniques or methods that maintain the sterile condition of products. Ante area - An area that is ISO class 8 or better where hand hygiene and garbing is performed. Levigation - Levigation is the process of reducing particle size of a solid by triturating it in a mortar or spatulating it on an ointment slab or pad with a. Primary engineering control (PEC) - A primary engineering control, which could include a room or device, provides an ISO Class 5 environment for compounding sterile products. Lipids may or may not also be present in parenteral nutrition. Material Safety Data Sheet (MSDS ) - OSHA -required notices on hazardous substances which provide hazard, handling, clean-up, and first aid information.