What Is a Compound Drug?

Compounded medications are drugs made by combining or altering the ingredients of existing drugs for an individual patient or a specific need. Compound medications are made in compounding pharmacies by licensed pharmacists or physicians. They are not manufactured in facilities owned by large pharmaceutical companies like Eli Lilly, Pfizer or Novo Nordisk.

Compound medications serve a few purposes:

• Some individual patients can’t be treated with FDA-approved medications. Compounded drugs allow physicians to tailor drugs to a patient’s needs. For example, if a patient is allergic to a binding ingredient or flavoring in an approved drug, a compounding pharmacy can make a formulation without the allergen.
• There may be other reasons why a medication isn’t medically appropriate for some patients, and hospitals may need to compound a quantity of a drug to treat those patients.
• The FDA may approve compounding when a drug is on the FDA Drug Shortages List.

Are compounded drugs the same as generic drugs?

No, compounded medications are not the same as generic drugs. A generic drug is an FDA-approved drug previously sold under patent. Once the patent expires, the generic drug can be sold by any licensed manufacturer. 

Generic drugs must be tested by the FDA and confirmed to be “bioequivalent” to the brand-name drug.

Are compounded drugs the same as off-label drugs?

Off-label use means a doctor prescribes an FDA approved-drug to an individual for a non-FDA-approved use. A compounded drug, on the other hand, isn’t tested, reviewed or approved by the FDA for any use. Off-label use and compounded drugs are both legal, but can come with risks.

A compounding pharmacy is a pharmacy that makes and sells custom-made medications. Most compounding pharmacies are privately run, but about 40% are retail or hospital pharmacies known as “community pharmacies.” These community pharmacies sell brand-name and generic drugs but may also make compound drugs if needed.

Not all compounding pharmacies can make the same types of medications. Community pharmacies may not have all the ingredients to make all compounds, so customers may need to visit a compounding pharmacy for certain mixtures. 

When a compounding pharmacy makes a compound drug, it must use pharmaceutical-grade ingredients manufactured in an FDA-registered facility. However, compounding pharmacies themselves aren’t licensed by the FDA. States license and inspect pharmacies, but federal agencies like the FDA and Drug Enforcement Administration (DEA) can conduct for-cause inspections if needed.

Are compounding pharmacies as safe as regular pharmacies?

Compounding pharmacies can be as safe as dispensing pharmacies when they’re making and providing small amounts of drugs for individual patients. 

However, it’s important to know that the compound drugs made at a compounding pharmacy aren’t FDA-approved, and oversight of the facilities isn’t as rigorous as it is for approved medications. The FDA advises physicians and patients to be cautious when using compounded medications for any purpose.

Why are pharmacies making compound semaglutide and tirzepatide?

Some pharmacies started making compounded semaglutide and tirzepatide due to shortages of these drugs in pharmacies. As of October 2024, semaglutide injectable remains on the FDA Drug Shortages List.

Since the demand is high and few other options are available, compounding pharmacies have stepped into the gap. Semaglutide and tirzepatide are also becoming incredibly popular to help people lose weight or maintain a lower weight. So, these drugs present an attractive opportunity for profit for compounding pharmacies and telehealth providers.

Semaglutide drugs have been on the Drug Shortages List since 2022. Tirzepatide drugs were on the list from December 15, 2022, to October 2, 2024.

The FDA has released several alerts warning of the dangers associated with compound drugs. Other reports have warned about dangers in connection with unsafe facilities and poor compounding practices.

Some of the dangers the FDA has mentioned include:

• Dosing errors, when compounded medications use different measurements or differently sized syringes to draw up medication
• Bacterial or viral contamination of products due to non-sterile facilities
• Unnecessary or unsafe ingredients used to prepare the compounded medications

Most medications prepared by state-licensed compounding pharmacies are as safe as any other medication. The FDA warns consumers to use caution when purchasing any medication that’s not FDA-approved.

Are compounded semaglutide and tirzepatide safe?

According to the FDA, compounded drugs may be less safe than drugs produced by their manufacturer and reviewed by the FDA. Normally, compounded drugs are made for individual patients being treated by a physician. Compounded semaglutide and tirzepatide may contain ingredients that haven’t been tested or that may not work for some people.

The FDA has received reports of compounded semaglutide containing other ingredients, including:

• Vitamin B12, vitamin B6 and L-carnitine: These additives are said to reduce nausea and enhance the effects of weight loss. The FDA hasn’t studied or approved compounding any vitamin with semaglutide or tirzepatide.
• Semaglutide sodium and semaglutide acetate: These are salt forms of semaglutide that haven’t been approved for use by the FDA. The active ingredient in the salt form is different from the ingredient in the base form used in the approved medications.
• Other contaminants: Nonsterile ingredients, amino acids and testosterone have been found in vials in compounding pharmacies making off-brand semaglutide and tirzepatide.

Drug manufacturers have sued compounding pharmacies for patent infringement. The patent for tirzepatide is currently held by Eli Lilly, while Novo Nordisk owns the patent for semaglutide. The two pharmaceutical giants are suing compounding pharmacies and wellness companies for patent infringement and false advertising.

Both companies have filed multiple lawsuits against telehealth companies, spas, weight-loss clinics and compounding pharmacies for deceptive marketing.

These lawsuits focus on claims made by the compounding companies, which call their products “sourced” from the original manufacturers or compare the compounded drugs to the brand-name versions.

Are compound drugs part of the semaglutide lawsuits?

These are different types of lawsuits. Both involve Eli Lilly and Novo Nordisk and semaglutide and tirzepatide, but they’re not the same legal action.

Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RAs) Liability Litigation

The two types of lawsuits here are completely different. Although the same companies and drugs are involved, the types of claims and the nature of the cases have almost nothing in common.

The issues involved with the compounded drugs pertain to the interests of the pharmaceutical companies and the safety of the compounded drugs themselves. The pharmaceutical companies claim that the knock-off drugs may be contaminated or unsterile.

The issues involved with the MDL involve failure on the part of the pharmaceutical companies to let patients know about all the possible risks of using their drugs. Drugs included in the MDL include Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Trulicity, Victoza and Saxenda. 

If any compounded medication makes you sick, you should contact your healthcare provider immediately. Tirzepatide and semaglutide both are alleged to have serious side effects. It’s important that you inform your doctor of any unusual or severe side effects right away. Only a qualified healthcare professional can tell you what your next medical steps should be.

The FDA has a reporting system for medication and side effects. MedWatch lets consumers, along with doctors and other industry professionals, report the adverse effects of drugs and other medical products so the FDA can review them for safety. The general public can access adverse event reporting numbers on the FDA Adverse Event Reporting System (FAERS) Public Dashboard.

*Reports by themselves are not an indicator of a drug’s safety profile. In addition, FAERS may include duplicate reports or may significantly undercount injuries. 

Taking legal action

Unfortunately, if you become ill from using one of the compounded GLP-1 RA drugs, you aren’t eligible to participate in the MDL. The MDL actions are suing the manufacturers of the brand-name products. The compounded drugs aren’t part of that lawsuit because they were not made by those manufacturers.

To participate in the MDL, you must be able to show that you used one of the brand name forms of tirzepatide or semaglutide and suffered a serious adverse reaction not listed on the drugs’ warning label.

Our diabetes drug litigation experience

Our attorneys have represented thousands of patients seriously hurt by dangerous prescription and over-the-counter drugs. We know that as a patient or a family member, you may not be fully aware of the harm your medications or a loved one’s medications can cause. 

If you believe a medicine made you sick or hurt you, our medical attorneys have the resources needed to thoroughly investigate and:

• Identify potentially harmful medicines
• Review whether the medicine hurt you
• Review the medicine manufacturer’s compliance with FDA regulations
• Examine the adequacy of the manufacturer’s warning to you about potential side effects
• Recognize other issues that could affect your potential claim

Learn more about our medical drug experience here.

Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death. Ozempic Wegovy, Rybelsus, Mounjaro, Zepbound, Trulicity, Victoza and Saxenda remain approved by the U.S. Food and Drug Administration.