What You Need To Know about Compounded Medications

A compounded medication is a drug a healthcare provider prepares to meet your specific needs. It's made by combining, mixing, or altering ingredients of a drug.

Compounded medications are important for people who cannot be treated by or cannot access a drug approved by the United States Food and Drug Administration (FDA). Because they are custom-made, compounded medications aren't regulated the same way as regular prescription drugs.

Healthcare providers can create many different forms of drugs through compounding. Examples include capsules, solutions, and suspensions taken by mouth and creams and ointments applied to the skin. The most commonly compounded medications are those used for pain and hormone-replacement drugs.

Why Compounded Medications Are Needed

There are several reasons why you may need a compounded medication. A healthcare provider may custom-make a drug for the following reasons:

You Need a Specific Drug Combination

Your healthcare provider may prescribe a specific combination of drugs that isn't available as a commercial product to simplify your medication regimen or target multiple symptoms of your condition.

One common example is compounded mouthwashes for chemotherapy-related oral mucositis, which causes swelling, redness, and sores in the mouth. These mouthwashes combine several drugs to help with pain, inflammation, and infection.

Drugs that may be in a compounded mouthwash include:

• Benadryl (diphenhydramine)
• Lidocaine
• Nystatin
• Magnesium hydroxide
• Aluminum hydroxide
• Tetracycline
  

You Need a Certain Dose

You may need a specific dose of a medication that's not available. If a drug only comes in 5- or 10-milligram tablets, but you need a 1-milligram dose, your healthcare provider may prescribe a compounded medication with the exact dose required. A pharmacist can specially make the drug with the dose requested on your prescription.

You Need a Specific Dosage Form

There may be situations where you need a specific dosage form of an unavailable drug.

If a drug is only available as an oral tablet or capsule but you cannot swallow medications, your healthcare provider may prescribe a compounded drug in an alternate dosage form—such as an oral solution. This is particularly helpful for children and older adults who cannot swallow medications and need a liquid form.

Healthcare providers may also recommend a compounded medication if you dislike the taste or smell of a drug. This way, they can prepare an alternative that matches your preferences.

You Have an Allergy

The inactive ingredients in commercial drugs often cause allergies or intolerances. Potential allergens in a drug include dyes, sweeteners, preservatives, and milk products.

A compounded medication that excludes those ingredients may be a solution so you can take the medication you need without the risk of an allergic reaction.

A Commercial Drug Is Unavailable

There are certain situations when a commercial drug isn't available, such as a drug shortage or discontinuation. Compounded medications can help fill gaps in these situations so you can still access your medication.

Semaglutide (sold under brand names like Ozempic and Wegovy) and tirzepatide (sold under brand names like Mounjaro and Zepbound) have been affected by shortages.

These glucagon-like peptide-1 (GLP-1) medications are in high demand as options for weight loss, and many healthcare providers have been compounding these drugs to help people continue treatment.

Are Compounded Medications Safe?

The FDA recommends only taking a compounded drug if an FDA-approved drug cannot meet your medical needs. The FDA does not approve compounded medications, meaning the products are not evaluated for safety, effectiveness, or quality before being marketed.

While this doesn't necessarily mean compounded medications are unsafe, not having this level of safety check can expose you to serious health risks, including contamination of a drug or a drug containing inaccurate amounts of an active ingredient.

Possible Concerns

The FDA has highlighted concerns about taking compounded versions of GLP-1s like semaglutide and tirzepatide.

The first concern has to do with dosing. The FDA has received multiple reports of adverse events related to dosing errors with compounded injectable semaglutide. These included cases where people were measuring and self-administering incorrect doses of the drug and healthcare providers were miscalculating doses.

For both semaglutide and tirzepatide, there have been reports of prescriptions for doses that were higher than the recommended doses in FDA-approved labeling. The FDA also believes adverse events for compounded versions of these drugs are underreported.

Depending on the compounded medication type, extra precautions may be taken in its production to help ensure safety. Compounded drugs that will be injected, implanted, or used in the eye are made using aseptic (infection-preventing) techniques so that no germs get into the medication. This is known as sterile preparation.

Compounded medications used orally or on the skin are usually nonsterile preparations. While the room is clean, the preparers might not necessarily use infection-preventing methods.

How Compounded Medications Are Regulated

While the FDA doesn't approve compounded medications, they still have oversight. How they are regulated depends on where the medication is prepared. Compounded medications are prepared in pharmacies or outsourcing facilities—facilities registered directly with the FDA that engage in compounding sterile drugs.

Pharmacies are regulated by the state boards of pharmacy, meaning regulations for compounding pharmacies may vary by state.

Outsourcing facilities are regulated at the federal level, so regulations for compounding medications at outsourcing facilities are the same regardless of location. Outsourcing facilities must register with the FDA, undergo FDA inspections, report adverse events, and report compounded drugs to the FDA.

The facilities must also comply with Current Good Manufacturing Practices (CGMP)—regulations that ensure the quality of pharmaceutical products. The FDA enforces CGMP regulations, and compliance with CGMP assures the identity, strength, quality, and purity of drug products. CGMP requirements include obtaining quality raw materials, maintaining reliable testing laboratories, and investigating product quality issues.

For all these reasons, outsourcing facilities typically have a higher degree of oversight than compounding pharmacies.

Where To Find Compounded Medications

Most pharmacies offer a basic level of compounding services and may be able to prepare simple formulations, but most compounded medications need to be made and picked up at a pharmacy specializing in compounding medications. Compounding pharmacies are better equipped to prepare a range of products, including higher-risk medications such as injections or eye drops.

That means that if you are given a prescription for a compounded medication, you may have to go to a pharmacy different from your usual one. You can ask your healthcare provider where the nearest compounding pharmacy is, search the internet, or use the Alliance for Pharmacy Compounding's Find a Compounder search tool.

In pharmacies, compounded drugs are made by a licensed pharmacist or physician once they receive a particular prescription. Pharmacies may also prepare products in small quantities in anticipation of prescriptions.

Compounded medications may also be available in hospitals, clinics, and doctors' offices. In these cases, the medications come from outsourcing facilities, which compound and ship drugs in large volumes across state lines.

How to Purchase Compounded Medications

The most common way to purchase a compounded medication is from a pharmacy.

If you have a prescription for a compounded medication, ask your healthcare provider or pharmacist where to fill it. For example:

• Chain pharmacies usually have select locations that offer compounding services.
• Many independent pharmacies offer some compounding, but it's best to call and check if they can prepare your medication.
• Compounded medications may be sold online. Always research online pharmacies before purchasing from them, as many are unregulated and unlicensed. Buying compounded drugs from an unsafe online pharmacy can expose you to poor-quality products.

Insurance does not always cover compounded medications. Some insurance plans may cover these medications, especially if they are considered medically necessary. Other plans may not cover them. Check with your insurance provider to determine if your plan covers compounded drugs.

FDA Recommendations

The FDA has warned people about illegal online sales of compounded semaglutide. The FDA has identified illegally marketed drugs that may be counterfeit, contain incorrect or harmful ingredients, or contain the wrong amount or none of the active ingredient (what makes the drug work) at all.

The FDA encourages you to be vigilant when purchasing drugs online and to only purchase from safe online pharmacies. Signs of a safe online pharmacy include:

• Having a licensed pharmacist on staff to answer questions
• Licensing with a state board of pharmacy
• Having a physical address and telephone number in the U.S.
• Always requiring a prescription for medications
  

A Quick Review

Compounded medications are drugs a healthcare provider prepares to meet your specific needs. They may be prescribed when a certain dosage form, dose, or drug combination isn't commercially available.

A compounded drug may also be prescribed if you are allergic to a certain ingredient of a commercial drug or a commercial drug is unavailable, like when there is a drug shortage.

Compounded drugs aren't FDA-approved, meaning they aren't evaluated for safety or effectiveness. If you're looking to fill a prescription for a compounded medication, it's best to find a local, in-person pharmacy that specializes in compounding.