Drug Compounding

Creating Drugs to Make a Unique Formulation

Phamacist sorting pills
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Compounding medications is an often-forgotten practice, but one that is still very much in demand and can be a great service for patients.Pharmacists capable of creating compounded drugs are highly sought after. It is a complicated science requiring specialized education and training. 

Common Questions About Compounded Drugs

  • What are compounded drugs? Compounded drugs are medication that have been mixed together according to a recipe to make a formulation that’s not readily available or approved by the Food and Drug Administration, to suit a particular patient’s needs. For instance, some medications can cause stomach issues, so some doctors will recommend a compounded drug that uses an antacid to sooth the stomach.
  • What are compounded drugs made from? Compounded drugs are typically made by mixing ingredients, using both prescription and over-the-counter medications.
  • Who needs compounded drugs? Many people need compounded drugs for different reasons. For instance, babies and children, particularly those born premature, need medications in extremely small doses and often need them to treat gastroesophageal reflux disease (GERD). People with allergies to commercial drugs, which often contain lactose, may need a special formulation. Another common need is for elderly patients who have trouble swallowing pills, and so need their medication in a liquid form instead.
  • How are compounded drugs developed? Compounded medicines are developed from recipes or formulations. Doctors will usually provide the recipe, but pharmacists will double check the recipe in standard drug information books for accuracy.
  • How does a pharmacist know that the drug they compound is safe? Pharmacists typically check that the recipes they use are safe – and each has their own resources they use to check the stability and efficacy of a compound. Some resources include:
      • Lexi Comp, which produces drug information books and in recent years has started to include recipes for medications commonly compounded under the drug names monograph.
    • The Professional Compounding Centers of America (PCCA)
    • The physician who wrote the prescription.
    • Hospitals, since they do a lot of liquid compounds.
    • Retail/community pharmacies can call a compounding pharmacy to seek help.
  • Is compounding regulated? Yes, on a state-by-state basis, but standards set by the United States Pharmacopeia, (USP) are also integrated into the practice of pharmacy compounding. Pharmacies that compound a large volume of drugs can be accredited through national standards developed by The Pharmacy Compounding Accreditation Board (PCAB).
  • Why doesn’t the FDA regulate compounded drugs? The FDA has its hands full. The approval of drugs takes many years and there is already a huge backlog. Since compounded drugs are typically made for just one person, regulation of that one product is not feasible—nor practical for a patient requiring medication quickly.
  • Does a pharmacist need a qualification to practice compounding and if so, what? Qualifications are generally in the form of formalized training, such as PCCA’s Comprehensive Compounding Course or Aseptic Training Course, for all aspects of compounding that the pharmacist plans to engage in.
  • Where can I get more information? For more information, contact the following organizations:
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