USP 795 Objectives Flashcards

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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?

Moderate (correct)

Complex (correct)

Simple (correct)

Intermediate

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?

<ol> <li>Prep requires special calculations or procedures to determine quantities. 2. Stability data not known for the prep.</li> </ol> Signup and view all the answers

What defines a Complex Compounding Category?

Prep requires special training, environment, facilities, equipment, and procedures to assure therapeutic outcomes. Signup and view all the answers

What are the responsibilities of compounders?

<ol> <li>Acceptable strength, quality, and purity of prep. 2. According to Rx. 3. Following regulations. 4. Expand compounding knowledge and stay up to date. 5. Knowledgeable about USP 795.</li> </ol> Signup and view all the answers

Which chapters should a responsible compounder be familiar with?

797 - Sterile compounding, 1151 - Dosage forms, 1160 - Calculations in Rx compounding, 1163 - Quality assurance in compounding, 1176 - Balances and volumetric apparatus, 1191 - Stability considerations, 1265 - Written Rx drug informatics (guidelines). Signup and view all the answers

What should be checked during the compounding process?

Check dose, safety, intended use in terms of physical properties, dosage forms, therapeutic appropriateness, and legal limitations. Signup and view all the answers

How many preparations can be compounded at a time?

One. Signup and view all the answers

What should a compounding facility have?

Adequate space. Signup and view all the answers

What is the goal of the compounding area?

Designed, arranged, used, and maintained to prevent cross-contamination. Signup and view all the answers

What should the ambiance of the compounding area be like?

Well lighted, controlled temperature, and humidity. Signup and view all the answers

__ MUST be used for compounding non-sterile preparations when it is indicated to be used.

PURIFIED water Signup and view all the answers

What should storage areas provide?

Suitable environment to ensure quality and stability of bulk chemicals. Signup and view all the answers

Why should compounding equipment be cleaned?

To avoid cross-contamination. Signup and view all the answers

What should be considered regarding the design and size of compounding equipment?

Appropriate design and size. Signup and view all the answers

What does BUD stand for?

Beyond-Use-Date is the date after which the compounded prep shall not be used. Signup and view all the answers

What determines BUD?

The date the prep is compounded. Signup and view all the answers

When are preparations intended for administration?

Immediate or after short-term storage. Signup and view all the answers

What are the categories for BUD?

<ol> <li>Nonaqueous formulations 2. Water-containing oral formulations 3. Water-containing topical dermal liquids and semisolids.</li> </ol> Signup and view all the answers

What is the BUD for nonaqueous formulations?

No later than the time remaining until the earliest expiration date of any API or 6 months, whichever is sooner. Signup and view all the answers

What is the BUD for water-containing oral formulations?

14 days when refrigerated. Signup and view all the answers

What is the BUD for water-containing topical dermal liquids and semisolids?

30 days. Signup and view all the answers

What does documentation allow the compounder to do?

Enables the compounder to replicate the steps in a prep. Signup and view all the answers

What must documentation comply with?

State boards of pharmacy. Signup and view all the answers

What types of documents are important in compounding?

Master formulation record, compounding record, standard operating procedures (SOPs), Material Safety Data Sheets (MSDS) file. Signup and view all the answers

What is quality control for finished preparations?

<ol> <li>Does it look right? 2. Is it within acceptable error?</li> </ol> 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.

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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!