Questions and Answers
What is the purpose of USP Pharmaceutical Compounding - Nonsterile Preparations?
To provide compounders with guidance on applying good compounding practices for the preparation of nonsterile compounded formulations for dispensing and/or administration to humans or animals.
Which of the following are compounding categories?
What defines a Simple Compounding Category?
- Making a prep that has USP monograph. 2. Making a prep that appears in a review journal. 3. Reconstituting or manipulating commercial products. 4. Included specific quantities, procedures, and equipment with stability data with BUD.
What are the characteristics of the Moderate Compounding Category?
Signup and view all the answers
What defines a Complex Compounding Category?
Signup and view all the answers
What are the responsibilities of compounders?
Signup and view all the answers
Which chapters should a responsible compounder be familiar with?
Signup and view all the answers
What should be checked during the compounding process?
Signup and view all the answers
How many preparations can be compounded at a time?
Signup and view all the answers
What should a compounding facility have?
Signup and view all the answers
What is the goal of the compounding area?
Signup and view all the answers
What should the ambiance of the compounding area be like?
Signup and view all the answers
__ MUST be used for compounding non-sterile preparations when it is indicated to be used.
Signup and view all the answers
What should storage areas provide?
Signup and view all the answers
Why should compounding equipment be cleaned?
Signup and view all the answers
What should be considered regarding the design and size of compounding equipment?
Signup and view all the answers
What does BUD stand for?
Signup and view all the answers
What determines BUD?
Signup and view all the answers
When are preparations intended for administration?
Signup and view all the answers
What are the categories for BUD?
Signup and view all the answers
What is the BUD for nonaqueous formulations?
Signup and view all the answers
What is the BUD for water-containing oral formulations?
Signup and view all the answers
What is the BUD for water-containing topical dermal liquids and semisolids?
Signup and view all the answers
What does documentation allow the compounder to do?
Signup and view all the answers
What must documentation comply with?
Signup and view all the answers
What types of documents are important in compounding?
Signup and view all the answers
What is quality control for finished preparations?
Signup and view all the answers
Study Notes
USP 795 Overview
- USP 795 provides guidelines for good compounding practices for nonsterile preparations intended for humans or animals.
Compounding Categories
- Compounding is categorized as simple, moderate, or complex based on the preparation requirements.
Simple Compounding
- Involves preparations with an existing USP monograph.
- Includes preparations from review journals or reconstituting commercial products.
- Requires defined quantities, procedures, and equipment, along with stability data and Beyond-Use Date (BUD).
Moderate Compounding
- Entails special calculations or procedures to determine quantity.
- Stability data for the preparation is typically unknown.
Complex Compounding
- Requires specialized training, equipment, facilities, and procedures to ensure effective therapeutic outcomes.
Responsibilities of Compounders
- Ensure acceptable strength, quality, and purity of preparations.
- Follow prescriptions and comply with regulations.
- Continuously expand compounding knowledge and maintain familiarity with USP 795.
Essential USP Chapters for Compounders
- Familiarity with Chapter 797 (sterile compounding) and 1151 (dosage forms).
- Understanding of Chapters 1160 (calculations), 1163 (quality assurance), 1176 (balances), 1191 (stability), and 1265 (written drug informatics).
Compounding Process
- Involves verifying dose, safety, intended use, dosage forms, therapeutic appropriateness, and legal limitations.
Compounding Capacity
- Only one preparation should be compounded at a time to maintain quality control.
Compounding Facility Requirements
- Should have adequate space and designed to prevent cross-contamination.
Ambiance of Compounding Area
- Must be well-lit with controlled temperature and humidity for optimal conditions.
Use of Purified Water
- Purified water must be used when indicated for non-sterile preparations.
Storage Area Standards
- Should ensure a suitable environment for the quality and stability of bulk chemicals.
Equipment Cleaning Protocol
- All compounding equipment must be thoroughly cleaned to avoid cross-contamination.
Equipment Design and Size
- Equipment should be appropriately designed and sized to fit the compounding process.
Beyond-Use-Date (BUD)
- BUD is defined as the date after which a compounded preparation should not be used.
BUD Determination
- Determined by the date the preparation is compounded.
Administration Timeline
- Preparations are intended for immediate use or after a short-term storage.
BUD Categories
- Nonaqueous formulations, water-containing oral formulations, and water-containing topical dermal liquids and semisolids.
BUD Specifications
- Nonaqueous formulations: BUD is either the earliest API expiration date or 6 months, whichever is sooner.
- Water-containing oral formulations: BUD is 14 days when refrigerated.
- Water-containing topical dermal products: BUD is 30 days.
Documentation Importance
- Essential for replicating the compounding steps and ensuring traceability.
Compliance with Documentation
- Must adhere to regulations set by state boards of pharmacy.
Types of Documentation
- Essential documents include master formulation record, compounding record, standard operating procedures (SOPs), and Material Safety Data Sheets (MSDS).
Quality Control Measures
- Quality assessment includes visual inspection and confirming it meets acceptable error margins.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Description
Test your knowledge on the objectives and categories of the USP 795 guidelines for pharmaceutical compounding. This quiz covers key concepts such as compounding categories and their definitions, tailored for professionals in the field. Perfect for students and practitioners alike!