USP 795 Compounding Standards Quiz

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Questions and Answers

USP (U.S. Pharmacopeia) sets standards for ______, and pharmacopeia is a list of medicinal drugs with preparation instructions

compounding

Non-Sterile: USP 795 Admin by mouth, via tube, rectally, vaginally, topically, nasally, ______

ear

Used to: prepare a formulation not commercially available, avoid an excipient, add a ______

flavor

3 categories based on complexity: Simple: follows ______

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Complex: requires special ______, equipment

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Flashcards

USP (U.S. Pharmacopeia)

Sets standards for compounding practices and provides a list of medicinal drugs with preparation instructions.

USP 795

USP chapter defining standards for non-sterile compounding.

Reasons for compounding

Used to create medications not commercially available, avoid specific inactive ingredients, or improve the taste of a medication.

Simple Compounding

Involves following straightforward instructions or recipes to create a compound.

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Complex Compounding

Demands specialized knowledge, training, facilities, or equipment to prepare a compound.

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Study Notes

USP Overview

  • The U.S. Pharmacopeia (USP) establishes standards for the quality of medicines and their ingredients.
  • Pharmacopeia serves as a reference, listing medicinal drugs accompanied by preparation instructions.

Non-Sterile Compounding: USP 795

  • Compounding is regulated under USP 795 for non-sterile preparations.
  • Administration routes include:
    • Oral (by mouth)
    • Enteral (via tube)
    • Rectal
    • Vaginal
    • Topical
    • Nasal
  • The primary purposes of compounding:
    • To create formulations not available commercially
    • To exclude certain excipients that may cause reactions or are undesirable
    • To incorporate beneficial additives as needed

Complexity Categories of Compounding

  • Compounded preparations are categorized based on complexity:
    • Simple:
      • Follows official monographs (standard preparation instructions)
    • Complex:
      • Requires special expertise
      • Involves specialized equipment for formulation and preparation

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