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Drug compounding for veterinary patients.

Mark G Papich1

  • 1Veterinary Clinical Pharmacology, North Carolina State University, College of Veterinary Medicine, Raleigh, NC 27606, USA. mark_papich@ncsu.edu

The AAPS Journal
|December 16, 2005
PubMed
Summary

Veterinary drug compounding is permitted case-by-case under new guidelines but must avoid bulk substances and manufacturing. Veterinarians and pharmacists must ensure drug stability, purity, and potency.

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Area of Science:

  • Veterinary Pharmacy
  • Pharmaceutical Compounding
  • Regulatory Compliance

Background:

  • Drug compounding has been a long-standing necessity in routine veterinary practice.
  • Evolving regulations and compliance policy guidelines (CPGs) impact veterinary drug compounding.
  • A significant CPG was issued by the Food and Drug Administration (FDA) in July 2003.

Purpose of the Study:

  • To summarize the FDA's limitations on compounding veterinary drugs.
  • To highlight the conditions under which veterinary drug compounding is permissible.
  • To emphasize the responsibilities of veterinarians and pharmacists in ensuring compounded drug quality.

Main Methods:

  • Review and summarization of the July 2003 FDA CPG on veterinary drug compounding.
  • Identification of key restrictions and allowances within the guideline.
  • Analysis of implications for veterinary professionals.

Main Results:

  • The guideline prohibits compounding drugs from bulk substances.
  • Compounding must not be construed as the manufacture of a new animal drug.
  • Case-by-case drug compounding is permitted under the CPG.

Conclusions:

  • Veterinary drug compounding is allowed provided it adheres to specific FDA limitations.
  • Practitioners must be vigilant about potential incompatibilities affecting drug quality.
  • Ensuring drug stability, purity, and potency is crucial for safe and effective veterinary care.

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