How to choose a compounding pharmacy

In pharmacy compounding, a pharmacist creates a customized medication for an individual patient when a doctor or other prescriber determines it’s necessary. Using active pharmaceutical ingredients and other components that meet applicable quality standards, the pharmacist can prepare a medication in the strength and dosage form the patient needs — a pill, capsule, liquid, lozenge, or even a patch or suppository.

When a compounded medication is based on a drug that is commercially available, federal law generally allows it in two circumstances:

The commercial drug isn’t appropriate. Manufactured drugs don’t come in strengths and dosage forms appropriate for everyone. Some people can’t take pills, for example, or are allergic to one of the preservatives or dyes in a commercial drug. Children might need a lower dose that’s not available commercially — or simply need a flavored, liquid version.

When a prescriber determines that a commercial drug isn’t suitable for a particular patient, they can write a prescription for a specific compounded formulation to meet that patient’s needs.

The commercial drug isn’t available. Drug shortages are common, and the law recognizes that patients’ care shouldn’t suffer when an FDA-approved drug is unavailable. It allows providers to prescribe compounded versions of commercial drugs when the drug is on the FDA Drug Shortages List.

Important takeaways

• Patient-specific needs and drug shortages are the principal circumstances in which pharmacies may compound versions of commercially available drugs.
• A prescriber determines when a compounded formulation is needed for a patient. Patients can’t simply request a compounded version of a commercially available drug as a matter of preference. A traditional compounding pharmacy generally dispenses a compounded medication pursuant to a prescription for an identified individual patient.

How to choose a compounding pharmacy

The most important factor in choosing a compounding pharmacy is making sure it’s a legitimate, state-licensed pharmacy — not a shady fly-by-night operation that a friend of a friend told you about (or, worse, that you heard about on social media).

You can verify a pharmacy’s license with a quick search of your state board of pharmacy’s website. We make that easier: Visit a4pc.org/isitlegit and you can jump directly to the site for your state.

Once you’re sure the compounding pharmacy is licensed in your state, there are some questions you might want to ask the compounding pharmacist.

Ask about accreditation

The Accreditation Commission for Health Care and the Coalition for Compounding Excellence offer specialized accreditation programs for compounding pharmacies, known as PCAB and CCE accreditation. Accreditation involves an independent assessment of a pharmacy’s practices, quality systems, and compliance with applicable standards. PCAB or CCE accreditation is a strong indication of a pharmacy’s commitment to quality and continuous improvement.

Ask about the training of the compounding staff

Ask about certifications the staff holds and any specialized training or continuing education they’ve completed. The more of that, the better.

Ask about quality standards

Verify that the pharmacy complies with applicable USP compounding standards — the official quality standards that govern pharmacy compounding — and that it sources active pharmaceutical ingredients from facilities that meet applicable federal requirements. And ask whether an independent, outside laboratory tests its compounded medications when appropriate.

Ask how your medication is compounded

A great compounding pharmacist won’t hesitate to explain the process and make sure you feel comfortable with the medication being prepared for you. If your medication is an eye drop or injection — known as a “sterile compound” — ask about the pharmacy’s sterility-testing and potency-testing policies.

Use the Compounding Pharmacy Locator

Your compounding pharmacist shouldn’t hesitate to answer these questions, and you should feel comfortable with the answers. If you aren’t, you can find a legal, state-licensed compounding pharmacy with the Alliance for Pharmacy Compounding’s “Find a Compounder” tool: a4pc.org/findacompounder.