Have you ever required a prescription medication that wasn’t available? Maybe the standard dosage was too high, or it contained an ingredient you were allergic to. In that case, your doctor may have suggested a using compounded medication instead.

Unlike the ready-made medications you pick up at the pharmacy, compounded medications are prepared with your unique needs in mind. Pets may also sometimes require compounded medications. But, as with anything custom-made, there are important things you need to know to ensure they’re safe and effective for you or your pets.

What are compounded medications?

Compounded medications are crafted by specially trained pharmacists who alter, mix, or combine ingredients to create a medication that’s tailored to a patient’s exact requirements. These medications offer a level of personalization not offered by standard prescription drugs. They are usually prescribed when a standard medication does not meet a patient’s needs. Roughly 1% to 3% of prescriptions written in the U.S. are for compounded drugs.¹

Nearly all forms of commercially available medications can be compounded, including capsules, tablets, oral liquids, creams, injections, and eye drops. Treatments for pain, hormonal therapies, and medications applied to the skin are some of the most commonly compounded medications.

Why are compounded medications in the news?

In recent years, compounded medications have become more popular among consumers who want personalized treatments related to weight loss, menopause (hormone replacement therapy, or HRT), and erectile dysfunction (ED).

For example, in early 2024, the FDA said it received reports of adverse events after patients used compounded semalutide—a drug belonging to a class of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. Semaglutide is the active ingredient in Wegovy, an injectable medication approved by the FDA as a treatment for obesity and excess weight. It is also found in the Ozempic injection and Rybelsus tablets, two medications approved to treat high blood sugar in adults with type 2 diabetes.

The FDA warned that some products sold as semaglutide may not contain the same active ingredient as FDA-approved semaglutide products on the market. Like with all compounded medications, patients should only use semaglutide-containing medications when prescribed by a licensed health care provider. In addition, these products should only be obtained from FDA-registered outsourcing facilities and pharmacies licensed by their state pharmacy boards.

Who needs a compounded medication?

A patient may need a compounded drug for a number of reasons:

• Specific dosage requirements: Sometimes, the commercially available dosage of a drug may not be suitable for a patient’s condition. Compounded drugs allow for precise dosage adjustments determined by the prescribing provider.
• Customized forms: People who have a hard time swallowing pills, such as children or some older adults, might need their medication in a different form (e.g., a liquid, suppository, or cream). In some cases, a medication can be flavored to make it more palatable. This increases the likelihood a patient will take their medication as prescribed and not skip any doses.   
• Allergies or sensitivities: Some people may be allergic to certain ingredients, such as dyes, preservatives, or fillers commonly found in mass-produced medications. Compounding allows these allergens to be avoided, making the medication safer for the patient.
• Drug availability: Sometimes medications are discontinued or in short supply. In that case, compounding pharmacies can create a similar formula to ensure patients still have access to the treatment they need.

Do I need a prescription for a compounded medication?

Most of the time, yes. A licensed health care provider, such as a doctor or a nurse practitioner, must prescribe a compounded medication and specify the exact formulation required. The prescription is then filled by a licensed pharmacist who prepares the medication according to the instructions provided.

In some cases, a compounded medication is made with over-the-counter ingredients (e.g., acetaminophen). You may not need a prescription for that, depending on the location of the pharmacy and your state’s regulations.

Where can I fill a prescription for a compounded medication?

You can fill a prescription for a compounded medication at a licensed pharmacy that specializes in compounding. Pharmacists who work in compounding pharmacies have generally received advanced training in compounding beyond their pharmacy school degree.

According to the American Pharmacists Association, there are roughly 7,500 pharmacies in the U.S. that specialize in compounding services. While some pharmacies focus solely on compounded prescriptions, others (such as retail, hospital, and community pharmacies) may have a team or department that handles compounding. If you have a favorite chain or independent pharmacy, it’s a good idea to call ahead of time and ask if they can fill a compounded prescription. If not, they may be able to recommend a local compounding pharmacy.

Are compounded medications FDA-approved?

No. Since compounded drugs are made on a case-by-case basis to meet the needs of individual patients—and they involve non-standard ingredients, dosages, and forms—they are not FDA-approved. Unlike FDA-approved medications, compounded drugs do not undergo the same strict testing for safety, efficacy, and quality before they become available to patients.

It's important to understand that lack of FDA approval does not mean a compounded drug is not safe or that it won’t work. Here are a few facts that may reassure you:

• Compounding pharmacies must use pharmaceutical-grade ingredients, made at an FDA-registered facility, when creating a compounded medication.
• While these medications are not subject to federal laws that regulate mass-produced drugs, compounding pharmacies in the U.S. are overseen by their state Board of Pharmacy. This requires them to meet certain safety standards.
• In 2013, a law called the Compounding Quality Act was passed after a 2012 fungal meningitis outbreak was traced back to a Massachusetts compounding pharmacy. This law created much tougher protocols for pharmacies that make compounded medications.

What are the risks associated with compounded drugs?

Since compounded medications aren’t subject to the same rigorous testing and approval process as commercially manufactured drugs, they may vary in quality and potency. That’s why it’s important to use a compounded medication only under the guidance of a licensed health care professional​.

You can also minimize any risks by choosing a trusted pharmacy to compound your medication. For example, look for pharmacies accredited by the Pharmacy Compounding Accreditation Board (PCAB) or the National Association of Boards of Pharmacy (NABP). You can also visit the Alliance for Pharmacy Compounding website to search for a reputable pharmacy in your area.

Can I order compounded medications online?

You can safely buy compounded medications online, but the FDA recommends that you research carefully and only buy from a reputable, licensed pharmacy. Purchasing a medication from an unregulated and/or unlicensed source may increase your risk of getting poor-quality and potentially harmful products.

First, check with your health care provider to make sure a compounded medication is necessary and appropriate for your condition. If you decide to order the medication online, keep these safety tips in mind:

• Look for online pharmacies that:
  • Are licensed by their state pharmacy board and accredited by organizations like the Pharmacy Compounding Accreditation Board (PCAB), the National Association of Boards of Pharmacy (NABP), or Verified Internet Pharmacy Practice Sites (VIPPS), which outline strict standards for safety and quality
  • Provide a physical U.S. address and telephone number
  • Require a doctor’s prescription
  • Have a licensed pharmacist on staff who can answer questions
• Be wary of online pharmacies that:
  • Do not require a doctor’s prescription
  • Offer unusually low prices or steep discounts
  • Do not provide written statements outlining how they protect your personal and financial information  

Will my insurance cover a compounded medication?

This depends on your specific insurance plan and the medication in question. Some insurance plans do cover compounded medications, especially if the compounded drug is considered medically necessary and no suitable commercially available alternative exists. Other plans might not cover these medications, or they may require a higher co-payment. In some cases, you may have to pay for the drug up front and then submit a claim later for reimbursement from your insurance company.

Compounded drugs may be covered by Medicare Part D. But Medicare only pays for compounded medications containing at least one ingredient that is a Part D-covered drug. The medication cannot contain any ingredients covered under Medicare Part B. Self-administered compounded drugs are not covered.

To find out if your insurance covers a compounded medication, contact the plan directly. Your pharmacist or health care provider may also be able to help you navigate insurance coverage for compounded medications.

Source

1.  Alliance for Pharmacy Compounding. Statement on rules governing compounding, what FDA guidance says about permissibility of compounding “essentially a copy” of an FDA-approved drug – and what those have to do with GLP-1s. Revised March 11, 2024. Found on the internet at https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf