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Drug Compounding

Compounding 101

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Drug Compounding

Compounding medications is almost taking a step back in time, to the way drugs used to be prepared for patients, but it is also a great way to improve the relevance and business in any pharmacy today.

Pharmacists still have many questions about this complicated science. Here we provide some answers.

What are compounded drugs?

Compounded drugs are drugs that have been mixed together according 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.

What are compounded drugs made from?

Compounded drugs are typically made by mixing ingredients (prescription and/or over-the-counter) together to mix a formulation that’s not readily available or approved by the FDA.

Who needs compounded drugs?

- Babies and children, especially preemies, who need medications in extremely small doses, and often need them to treat gastroesophageal reflux disease (GERD).

- Children, who might need something that’s more palatable (fruity flavors can be added).

- People with allergies to commercial drugs, which often contain lactose.

- Patients who need a dose that’s not commercially available.

- Pets, who need them to treat pain, stomach acid problems, thyroid issues and potassium deficiencies.

- Patients (often elderly) who need medication in a different form—a liquid because they have trouble swallowing, for example.

How are compounded drugs developed?

Compounded medicines are developed from recipes/formulations. Often, says Heather Free, pharmacist at BioScrip Pharmacy Store, Washington, D.C., doctors will include a recipe on the prescription, but she always double checks it.

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, says Free. 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?

- PCCA, The Professional Compounding Centers of America,—membership costs

PCCA offers ACPE-accredited hands-on training classes and continuing

education classes for its members.

- International Academy of Compounding Pharmacists,

- Columbus Children’s Hospital in Columbus, Ohio.,

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