Pharmacy USP Guidelines Quiz

<p>USP Chapter &lt;800&gt; (A)</p> Signup and view all the answers

<p>Assist practitioners in selecting suitable IV admixtures and ensuring compatibility. (B)</p> Signup and view all the answers

<p>Aseptic processes must be followed. (B)</p> Signup and view all the answers

<p>Unused contents must be discarded after preparation for the patient. (C)</p> Signup and view all the answers

<p>3 different sterile products (C)</p> Signup and view all the answers

<p>They may utilize diluents not included in the approved labeling. (C)</p> Signup and view all the answers

<p>A label with the exact beyond-use time. (C)</p> Signup and view all the answers

<p>Microbial contamination risk (D)</p> Signup and view all the answers

<p>14 days (C)</p> Signup and view all the answers

<p>Passing sterility and endotoxin tests (D)</p> Signup and view all the answers

<p>Potential microbial stability (A)</p> Signup and view all the answers

<p>180 days (D)</p> Signup and view all the answers

<p>Food ingredients (D)</p> Signup and view all the answers

<p>35 days (B)</p> Signup and view all the answers

<p>Type of packaging used (C)</p> Signup and view all the answers

<p>Identify, measure, dilute, and mix CSPs accurately (A)</p> Signup and view all the answers

<p>Items are stored under appropriate restricted access when necessary (B)</p> Signup and view all the answers

<p>CSPs must maintain labeled strength within ±10% if not specified (A)</p> Signup and view all the answers

<p>The maintenance of CSP strength and stability (D)</p> Signup and view all the answers

<p>The item is compatible. (D)</p> Signup and view all the answers

<p>The Merck Index (D)</p> Signup and view all the answers

<p>6 hours (B)</p> Signup and view all the answers

<p>Compounding protocols must conform to the correct sequence and quality (D)</p> Signup and view all the answers

<p>Remington: The Science and Practice of Pharmacy (C)</p> Signup and view all the answers

<p>Quarterly (A)</p> Signup and view all the answers

<p>To validate proper techniques and reduce errors (D)</p> Signup and view all the answers

<p>Methods of validation of strength and purity (A)</p> Signup and view all the answers

<p>To ensure stability and safety of compounded products (C)</p> Signup and view all the answers

<p>Compendium of Pharmaceutical Excipients (D)</p> Signup and view all the answers

<p>The item is incompatible. (B)</p> Signup and view all the answers

<p>Contains information on drug delivery methods (A)</p> Signup and view all the answers

<p>They can be stored for a maximum of 12 hours. (C)</p> Signup and view all the answers

<p>Both Category 1 and Category 2 (B)</p> Signup and view all the answers

<p>They have shorter storage durations compared to those processed terminally. (D)</p> Signup and view all the answers

<p>Increased training and cleaning requirements. (D)</p> Signup and view all the answers

<p>Longer beyond-use dates overall. (D)</p> Signup and view all the answers

<p>It must include an ISO Class 5 PEC. (D)</p> Signup and view all the answers

Guidelines set by the United States Pharmacopeia (USP) that provide specific instructions and standards for the preparation of sterile medication.

A system used to classify compounded sterile products based on their risk of microbial contamination.

Two resources that provide detailed information on the compatibility of drugs and their safe administration in sterile solutions.

Special requirements and regulations that apply to compounding sterile products that are hazardous or radioactive in nature.

The time a compounded sterile preparation maintains its quality and purity after preparation.

The amount of time a compounded sterile preparation maintains its quality and purity after preparation.

A system that categorizes compounded sterile products based on their risk of microbial contamination.

A written protocol that ensures the accuracy, precision, identity, purity, and stability of compounded sterile products.

Procedures that must be followed for preparing, storing, and dispensing compounded sterile products.

The evaluation of the potential harm and effect on bioavailability of combining different drugs in a sterile solution.

Ensuring that the compounding environment maintains sterility and purity.

The verification that sterilization methods are effective while maintaining the strength and stability of the compounded sterile product.

The responsibility of compounding personnel to correctly identify, measure, dilute, and mix compounded sterile products.

USP beyond use dates only consider microbial contamination, so chemical and physical stability must be assessed separately.

The process of evaluating potential sources of contamination during sterile compounding.

A compounding protocol that involves multiple steps, specialized equipment, or a lengthy process.

Compounded sterile products prepared using aseptic techniques in a controlled environment.

A controlled environment designed to minimize microbial contamination during sterile compounding.

A compounding protocol that involves aseptic techniques, but not in a cleanroom.

Resources like King's Guide and Handbook on Injectable Drugs that provide compatibility and stability information about sterile products.

A resource that provides information on the compatibility of drugs in sterile solutions.

A reference book that contains information on the stability and compatibility of medications in parenteral form.

A comprehensive resource that provides information on pharmaceutical excipients, their properties, and their uses in drug formulations.

A reference book that provides detailed information on various drugs and their uses.

A comprehensive resource that provides information on pharmacy practice, including pharmaceutical compounding, manufacturing, and analysis information.

A resource that provides information on pharmaceutical excipients and methods of validation for strength and purity.

A reference book that provides detailed information on various drugs and their uses.

A resource that provides information on drug delivery systems and pharmaceutical dosage forms.

A compounded sterile preparation (CSP) that is made in poorer than ISO Class 5 air quality but used within 4 hours, meeting specific criteria such as aseptic technique, compatibility, and limited ingredients.

A CSP made from a single-dose container must be discarded after preparing one dose for a patient. The container cannot be used for multiple patients.

A CSP that is made within 4 hours and is ready to be administered to the patient.

The beyond-use date (BUD) for CSPs prepared as 'Immediate Use' products is 4 hours from the start of preparation.

A proprietary bag and vial system that is prepared according to the manufacturer's instructions is not considered compounding and is not subject to USP Category requirements.

A compounded sterile product (CSP) is a medication that is made by a pharmacist to meet a patient's specific needs. It is prepared in a controlled environment, typically a cleanroom, using aseptic techniques to ensure sterility.

The Beyond Use Date (BUD) is the time limit for which a compounded sterile product is considered safe and effective. It is based on factors such as the compounding method, storage conditions, and the ingredients used.

The USP Categories are a system used to classify compounded sterile products based on their risk of microbial contamination and the associated BUD limits.

Category 1 is the safest category for CSPs, representing the lowest risk of contamination and therefore allows for the longest BUDs. Compounds in this category are made in a cleanroom.

Category 2 CSPs are compounded in a controlled environment that may not be a cleanroom, posing a higher risk of contamination. They have shorter BUDs than Category 1 products.

Category 3 represents a new addition to the USP guidelines, allowing for extended BUDs with greater training requirements and additional testing. This category is for complex preparations requiring more expertise and rigor.

This category is defined by the compounding method and storage temperature. Aseptically processed CSPs are made using aseptic techniques to minimize contamination, while terminally sterilized CSPs undergo a sterilization process after compounding.

Aseptically processed CSPs are made using aseptic techniques in a controlled environment, while terminally sterilized CSPs undergo a sterilization process after compounding. For example, an autoclave can be used for terminal sterilization.

Source ingredients are the raw materials that are used to prepare a CSP. They must be of high quality and meet purity and sterility standards to ensure the safety and effectiveness of the final product.

Compounding personnel must be highly trained and skilled to prepare CSPs safely and effectively, adhering to strict guidelines and protocols.