Felis ISSN 2398-2950

Drug compounding (US)

Contributor(s): Elizabeth Wright, Gigi Davidson

Introduction

At time of writing, it is important to note that regulations for compounding for animals are radically different than those for compounding for humans. The reader is advised to consult local authorities to determine compounding rules and regulations for animals on a state by state basis.
  • Drug compounding can be defined as the formulation (or reformulation) of one or more FDA approved drugs or active pharmaceutical ingredients into a form which is ready to use for the special needs of an individual patient. 
  • This can be large scale drug compounding by FDA-registered outsourcing facilities, or small scale (one patient, one prescriber, one compound) by a licensed pharmacist or veterinarian in practice.
  • The term “preparation” is used to describe compounded drugs, and the term “product” is used to describe FDA-approved drug products (approved for either animals or humans).
  • Compounded preparations should not contain the same active ingredient at the same concentration, in the same dosage form (eg tablet, injection) as an FDA-approved product, unless the individual patient cannot tolerate an excipient in the approved dosage form (eg xylitol, polysorbate 80, propylene glycol).
  • Drug compounding is when a drug is altered in a way that is not described in the product labeling (eg crushing tablets to make an oral suspension) or when two or more drugs are mixed together prior to administration (eg mixing two sedatives in the same syringe prior to a procedure). Simply adding a flavor to an approved product prior to dispensing is also considered compounding.

Where do compounded preparations fit into the drug use algorithm?

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Who can compound and supply a compounded preparation?

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When is compounding appropriate?

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Quality assurance

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Considerations when compounding preparations

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Steps towards safer use of compounded drugs

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Further Reading

Publications

Refereed Papers


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