Answered: According to USP Chapter <797>,…

Phlebotomy Essentials

6th Edition

ISBN:9781451194524

Author:Ruth McCall, Cathee M. Tankersley MT(ASCP)

Publisher:Ruth McCall, Cathee M. Tankersley MT(ASCP)

Chapter1: Phlebotomy: Past And Present And The Healthcare Setting

Section: Chapter Questions

Problem 1SRQ

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Question

According to USP Chapter <797>, allergenic extract preparation can be made in a doctor’s office facility by trained personnel only if the allergenic extract preparation:

a)Is compounded under a laminar air flow hood Is compounded by a pharmacist

b)Contains an antimicrobial preservative

c)Is used immediately after preparation

d)Is prepared only from plant origin material

Expert Solution

Step 1: What is the meaning of the term USP Chapter <797>, allergenic extract preparation?

The United States Pharmacopeia (USP) has created a set of rules and recommendations known as USP Chapter 797 to guarantee the efficacy, safety and quality of compounded sterile treatments, including allergenic extracts. In accordance with USP Chapter 797, the following is a definition of what allergenic extract preparation means:

An allergenic extract is a substance that is produced from substances that might cause allergic reactions in people, such as pollen, animal dander or venom. These extracts are frequently used in allergy immunotherapy (allergy injections) and diagnostic tests to treat allergies.
The process of making allergic extracts in a sterile, controlled environment to guarantee their efficacy and safety is known as "allergenic extract preparation." To develop standardized allergenic extracts for diagnostic or therapeutic purposes, the preparation may comprise combining and dilution of allergenic source materials, potential addition of preservatives and other procedures.
USP Chapter 797: This chapter provides detailed instructions and regulations for compounding sterile medications, including extracts containing allergens. To reduce the danger of contamination and guarantee the security of patients receiving these allergenic extracts, it encompasses elements like facility design, people qualifications, equipment and quality control methods.