How to Use Compounded Medications for Children Safely

When your child needs a medicine that isn’t available in a store-bought bottle-maybe they can’t swallow pills, have severe allergies, or need a dose too small for commercial products-compounded medications can feel like a lifeline. But here’s the truth: compounded medications are not FDA-approved. That means no government agency has checked their safety, strength, or purity before they reach your child. And for kids, that gap can be deadly.

Why Compounded Medications Are Used for Children

Compounded medications are made by pharmacists to fit a child’s exact needs. Common reasons include:

• Turning a pill into a liquid so a toddler can take it
• Removing dyes, alcohol, or sugar that trigger allergic reactions
• Flavoring bitter drugs like antibiotics to make them palatable
• Creating tiny doses for premature babies or infants who weigh under 5 pounds
• Preparing injectable drugs without preservatives like benzyl alcohol, which can harm newborns

These aren’t luxury options-they’re often medical necessities. But they’re also high-risk. A 2022 study from the Institute for Safe Medication Practices found that 14% to 31% of pediatric medication errors involve compounded drugs, mostly because of wrong dosing or wrong concentration.

The Hidden Dangers: What Goes Wrong

Most parents assume if a pharmacist makes it, it’s safe. That’s not true. Here’s what can go wrong:

• Wrong concentration: A liquid might be labeled as 5 mg/mL, but actually contains 20 mg/mL. One teaspoon could be four times the dose.
• Contamination: In 2012, a compounding pharmacy’s spinal injections caused a fungal meningitis outbreak that killed 64 people. The same risks exist today.
• Under-potency: One parent reported their 8-year-old ended up in the ER after a compounded levothyroxine was 40% weaker than prescribed. Symptoms mimicked untreated hypothyroidism.
• Wrong ingredients: Some compounding pharmacies use low-grade chemicals or skip purity tests to cut costs.

The FDA has logged over 900 adverse events linked to compounded semaglutide and tirzepatide as of December 2024-including 17 deaths. Children are more likely to suffer gastrointestinal issues, fainting, or acute pancreatitis from these errors.

When You Should Avoid Compounded Medications

Compounded drugs should be a last resort. The FDA says clearly: “Unnecessary use of compounded drugs may expose patients to potentially serious health risks.”

Ask your doctor: “Is there an FDA-approved version that works?” For many pediatric needs, there is.

• For antibiotics: Many liquid forms are already available with child-friendly flavors.
• For pain relief: Liquid acetaminophen and ibuprofen come in precise doses.
• For thyroid meds: FDA-approved levothyroxine liquids exist for infants.
• For IV meds: Premixed, single-dose syringes are safer than hand-mixed IV bags.

The tragic case of Emily Jerry-a 2-year-old who died in 2006 from a compounded chemotherapy error-led to major safety reforms. Yet, the technology that could have saved her-gravimetric analysis, which measures ingredients by weight instead of volume-remains underused. Only 7.7% of U.S. hospitals use it, mostly because of cost and training.

How to Spot a Safe Compounding Pharmacy

Not all compounding pharmacies are equal. Here’s how to vet one:

1. Check accreditation: Look for PCAB (Pharmacy Compounding Accreditation Board) or NABP (National Association of Boards of Pharmacy) accreditation. Only about 1,400 of the 7,200 compounding pharmacies in the U.S. have this.
2. Ask for documentation: Request the pharmacy’s license and proof of state board registration. All compounding pharmacies must be licensed, but not all follow safety rules.
3. Ask about technology: Do they use gravimetric analysis for sterile preparations? Do they test potency and sterility? If they say no, walk away.
4. Look for USP compliance: The pharmacy should follow USP Chapter <797> for sterile compounding. That means clean rooms, trained staff, and strict procedures.

If you’re unsure, call your state pharmacy board. They can tell you if the pharmacy has had complaints or violations.

What Parents Must Do Before Giving the Medication

Even if the pharmacy is accredited, mistakes can still happen. Here’s your safety checklist:

• Confirm the concentration: Ask: “What’s the exact strength? Is it mg/mL or mg/tsp?” Write it down. 68% of pediatric compounding errors come from confusion over units.
• Double-check the dose: Calculate it yourself. If the prescription says 0.5 mL of a 10 mg/mL solution, that’s 5 mg total. Use a syringe, not a spoon.
• Verify with two professionals: Ask your doctor and the pharmacist to confirm the dose together. Don’t rely on one person.
• Check the label: Does it say “For External Use Only”? Is there an expiration date? Is the color or smell different from last time?
• Store it right: Some compounded meds need refrigeration. Others degrade in light. Ask how to store it-and throw it out if it’s past the date.

One parent shared on Reddit that their child had a reaction after taking compounded thyroid medication. The pharmacy had mislabeled the concentration. The child’s symptoms didn’t show up until three days later. By then, the child was in the ER.

What to Do If Something Goes Wrong

If your child has a reaction-vomiting, rash, lethargy, rapid breathing, or unusual drowsiness-stop the medication immediately. Call your doctor. Then call poison control (1-800-222-1222 in the U.S.).

Report the incident to the FDA’s MedWatch program. You can do it online or by phone. These reports help the FDA track dangerous compounding practices.

Also, keep the bottle, the prescription, and any paperwork. If you need to file a complaint or seek legal help, you’ll need proof.

The Bigger Picture: Why This Problem Keeps Growing

The compounded medication market hit $11.3 billion in 2024. Pediatric compounding makes up only 8.2% of that-but it’s the most dangerous segment. Why? Because kids’ bodies are tiny. A 0.1 mL error can be life-threatening.

Pharmacies are under pressure. Drug shortages are common. Some compounding pharmacies are exploiting those shortages to mass-produce drugs that should be made by big manufacturers. The FDA says this is against the rules, but enforcement is slow.

Meanwhile, safety technology like gravimetric analysis is proven. Hospitals that use it see a 75% drop in dosing errors. But it costs $25,000 to $50,000 per station. Many small pharmacies can’t afford it.

Advocates like the Emily Jerry Foundation are pushing for “Emily’s Law”-legislation requiring gravimetric verification for all pediatric compounded sterile drugs. As of April 2025, 28 states have introduced it.

Your Role in Keeping Your Child Safe

You are your child’s last line of defense. No pharmacist, doctor, or regulator can be with you when you give the medicine. That’s why your questions matter.

Ask:

• “Is this the only option?”
• “Can you show me the accreditation?”
• “How do you test the strength?”
• “What happens if I give too much?”

Don’t be afraid to say no. If something feels off, trust your gut. There’s almost always a safer alternative.

Final Thought

Compounded medications aren’t inherently bad. They’ve helped children who had no other options. But they’re not a shortcut. They’re a high-stakes gamble-and your child is the one risking everything.

The safest choice? Use FDA-approved drugs whenever possible. When you must use a compounded medicine, treat it like a surgical procedure: verify every step, question every detail, and never assume it’s safe just because a pharmacist made it.