Compounding Pharmacies: What Are They and Are They Safe?

You might have heard about medicines like glucagon-like peptide 1 (GLP-1) agonists being made at special pharmacies. These drugs, used for weight loss and type 2 diabetes, have seen a huge demand in recent years. When regular pharmacies cannot keep up, compounding pharmacies step in.^1,2

But what exactly are these pharmacies? And are they safe? Continue reading to learn more about them and when to rely on them for your medicine needs.

What are compounding pharmacies?

Compounding pharmacies are different from your typical drugstore. Instead of dispensing pre-made medicines, they create personalized drugs. Compounding involves preparing medicines that are not commercially available in order to meet specific patient needs.^1,3

Reasons for compounding might include:^1,3

• Unavailable dosages or strengths
• Alternative dosage forms (for example, liquid instead of tablet)
• Allergen removal (for example, lactose or gluten)
• Flavoring for children
• Addressing drug shortages

Shortages of weight loss medicines like GLP-1s have led more and more people to go to compounding pharmacies for these drugs.^1,2

How do compounding pharmacies work?

A doctor prescribes a specific medicine. The compounding pharmacist then takes the raw ingredients and combines them.^1,3

Compounding pharmacies offer several benefits. They can create medicines for people who have allergies to certain ingredients. They can also create medicines that are not commercially available. For example, some children or pets need medicine in a liquid form, but it only comes in pills. Compounding pharmacies can make it into a liquid.^1,3

Are compounding pharmacies safe?

There is a degree of risk that you take when using compounded drugs. Compounded drugs are not approved by the US Food and Drug Administration (FDA) in the same way commercially available drugs are.^1,3

This means that the FDA does not verify the safety and effectiveness of compounded drugs before they are marketed. Instead, the FDA regulates the ingredients that are used as well as the facilities where compounding takes place.^1,3

Because compounded drugs are not FDA-approved, there is less oversight. And because there is less oversight, there is a chance of errors.^1,3

This can lead to issues with quality, potency, and safety. Sometimes, the ingredients might not be mixed correctly, or the medicine might be contaminated. This can be dangerous for people taking them.^1,3

Also, be extra cautious if buying compounded drugs online. For example, through an online pharmacy or a telehealth platform. These entities are not regulated by the FDA.^1,3

What to do if considering a compounding pharmacy for your medicine

If you are considering a compounding pharmacy – whether it is because you need a special formulation for a drug, a special dose that is not commercially available, or because of a drug shortage – here are steps you should take:^1,3

• Talk with your doctor – Always discuss compounded medicines with your doctor first. They can help you decide if it is the right option for you. They also may refer you to a compounding pharmacy that they know is reliable.
• Check the pharmacy – Make sure the compounding pharmacy is licensed and reputable. Ideally, you want a pharmacy where the pharmacists are board-certified sterile compounding pharmacists, or BCSCPs.
• Ask questions – Ask the pharmacist about the ingredients, the process, and their licensing. Here are some questions to consider:
• Are you licensed to dispense or ship to my state?
• Does a third-party lab test your compounded drugs?
• Are you accredited by the Pharmacy Compounding Accreditation Board (PCAB)? (This is considered the gold standard for compounding pharmacies.)
• Know the risks – Understand that compounded drugs are not FDA-approved and that there are potential risks involved.
• Report problems – If you experience any side effects or problems with a compounded medicine, tell your doctor and the FDA immediately.

To locate a compounding pharmacy near you, visit the Alliance for Pharmacy Compounding.

The bottom line

Compounding pharmacies can be a valuable resource for unique medicine needs or when a drug is not commercially available through a regular pharmacy. But it comes with some risks. Always seek reliable information from trusted sources.¹