Compounding Pharmacy Contamination

Compounding is when a pharmacist or physician mixes or alters ingredients to make a medicine for a specific patient. Compounded drugs are not FDA-approved, so FDA does not review their safety, effectiveness or quality before they are sold1. When they are contaminated or contain too much active ingredient, they can cause serious injury or death2. A compounding pharmacy lawyer looks at who made the drug and what went wrong.

How compounded drugs are made and regulated

Compounding can serve real needs, such as a patient who is allergic to a dye in the approved product. But FDA reports many serious adverse events tied to contaminated or poor-quality compounded drugs, and it keeps finding insanitary conditions during inspections2. The labels may also lack directions needed for safe use2.

Two kinds of compounders under federal law

503A pharmacies

Compound based on a valid prescription for an individual patient3

503B outsourcing facilities

Must follow manufacturing quality rules (CGMP), are inspected by FDA on a risk-based schedule and must report adverse events. They can supply hospitals and clinics without a patient-specific prescription3

The 2012 fungal meningitis outbreak

In 2012, contaminated drugs compounded by a Massachusetts pharmacy led to more than 750 cases of infection and more than 60 deaths in 20 states3. Congress responded with the Drug Quality and Security Act, enacted Nov. 27, 2013, which created the outsourcing facility category3.

Compounded GLP-1 weight-loss drugs

Compounded semaglutide and tirzepatide are widely sold, often through telehealth. FDA has said4:

• It received multiple adverse event reports, some requiring hospitalization, that may be related to dosing errors with compounded semaglutide
• Some errors came from patients measuring doses themselves, and some from providers miscalculating
• It received reports tied to doses above what the approved label allows
• Fraudulent products have carried the names of pharmacies that did not make them
• Multi-dose vials should be discarded 28 days after first use

Injuries involved

• Fungal or bacterial infections from contaminated injections
• Overdose from a drug that was too strong
• Underdosing that left a condition untreated
• Reactions to a wrong or mislabeled ingredient
• Hospitalization after a dosing error

Who may have a compounding claim

• The name of the compounder or outsourcing facility on the label
• Whether it was prescribed for you or supplied to a clinic
• Any recall or FDA warning about that compounder
• Lab results such as cultures
• The timing of symptoms after the dose

Who may be responsible

An investigation may look at the pharmacy or outsourcing facility that made the drug, the clinic or telehealth company that supplied it, and the supplier of the ingredients. A pharmacy dispensing error at a retail pharmacy raises different questions.

Filing deadlines for compounding pharmacy lawsuits

Deadlines depend on your state and on when you learned of the injury and its possible cause. Examples:

• Arizona: generally two years for personal injury and wrongful death5.
• California: two years for injury to or death of a person caused by another's wrongful act or neglect6.
• New York: three years for personal injury7, with a separate rule that runs from discovery for injuries caused by the latent effects of exposure to a substance in the body8.
• Texas: two years for personal injury and wrongful death9.

When the clock starts can depend on when a person knew, or should have known, about the injury and its possible link to the medicine. Rules for children, wrongful death and claims against public hospitals can differ. Ask a compounding pharmacy attorney to check the rules for your state early, before records are lost.

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Records that help a compounding review

Records worth gathering

Product

• The label, vial or box if you still have it
• Order and shipping records
• Instructions you were given

Medical

• ER and hospital records
• Cultures or lab tests
• Prescriber or telehealth notes

Notices

• Recall or warning letters
• Messages with the seller
• Bills and payments

What happens after you contact CBW Law

How a review works

1. Tell us what happened

   Tell us what you received and what happened. You do not need every record first.

2. We trace the product

   We identify who compounded, sold and shipped the medicine, and whether any recall or warning applies.

3. We gather records

   With your permission, we request pharmacy, medical and billing records from the places that treated you.

4. We explain what we see

   We tell you what the records show, what questions remain and what options may be open, including deadlines.

Compounded drugs are not FDA-approved. A claim depends on who made the drug, what was wrong with it and the harm that followed.

Plain English

Medical, Health & Insurance

Terms you may see in a compounding case.

Compounding terms

Compounding

Mixing or altering ingredients to make a tailored medicine1.

Outsourcing facility

A 503B compounder subject to manufacturing quality rules3.

Sterile compounding

Making injectable or eye products that must be free of germs.

Injury terms

Fungal meningitis

A fungal infection of the lining of the brain and spinal cord.

Dosing error

Taking or giving the wrong amount of a drug.

Care and coverage

Culture

A lab test that grows germs to identify an infection.

Out-of-network

Care from providers outside your plan, often costing more.

Questions

Compounding pharmacy lawsuit questions

Short answers to the questions people ask first.

Are compounded drugs FDA-approved?

No. FDA does not review them for safety, effectiveness or quality before they are sold.

Can I sue a compounding pharmacy?

A compounding pharmacy lawyer can review whether the pharmacy or others may be responsible for a contaminated or mis-made drug.

Does compounded semaglutide count?

Injuries from compounded GLP-1 drugs, including dosing errors, can be reviewed.

What is the difference between 503A and 503B?

503A pharmacies compound for individual prescriptions; 503B outsourcing facilities follow manufacturing quality rules and are inspected by FDA.

What if the pharmacy on the label did not make the drug?

FDA has warned about fraudulent products using real pharmacy names. A compounding pharmacy attorney will trace the real source.

Should I keep the vial?

Keep photos and records. Do not use a product you think is contaminated, and ask how to handle it safely.

How long do I have to file a compounding pharmacy lawsuit?

It depends on your state and on when the injury and its cause were discovered.

What injuries are most common?

Infections from contaminated injections and harm from wrong doses are frequent concerns.

What does it cost to contact CBW Law?

Telling us your story costs nothing, and contacting us does not create an attorney-client relationship.

Tell Us Your Story

If a compounded medicine was contaminated, too strong or wrongly made, a compounding pharmacy attorney can review what happened.

Tell us what happened. CBW Law will review your information and explain what we see. Submitting information does not establish an attorney-client relationship or guarantee representation.

Tell Us Your Story →Call (800) 476-2416

This page is general information about compounded medicines. It is not legal or medical advice and does not create an attorney-client relationship. Do not use a product you believe is contaminated, and talk to your doctor about your treatment. A warning or recall does not by itself establish that a product caused any person's injury. Laws and deadlines differ by state, and no outcome can be promised.