How to Use Compounded Medications for Children Safely

When a child can’t swallow a pill, or a commercial medicine contains ingredients they’re allergic to, compounded medications can be a lifeline. But they’re not magic. They’re custom-made drugs, mixed by pharmacists to fit a child’s exact needs - whether that’s a sugar-free liquid for a diabetic kid, a dye-free version for a sensitive toddler, or a tiny dose of a powerful drug like morphine for a premature baby. The problem? These medications aren’t tested or approved by the FDA. That means no guarantee they’re safe, strong enough, or even clean. And when it comes to kids, mistakes can be deadly.

Why Compounded Medications Are Used for Children

Kids aren’t small adults. Their bodies process medicine differently. Many commercial drugs come in forms that just don’t work for them. A 5-year-old can’t swallow a 100mg tablet. A newborn in the NICU can’t handle preservatives like benzyl alcohol. Some kids gag at the taste of bitter medicine. That’s where compounding comes in.

Pharmacists can turn a tablet into a flavored liquid, remove allergens, dilute a high-strength adult dose into a safe pediatric amount, or even make an injectable without harmful additives. These aren’t just conveniences - they’re medical necessities for children with rare conditions, allergies, or complex treatment plans.

But here’s the catch: this flexibility comes with risk. Unlike factory-made drugs, compounded ones aren’t checked for purity, strength, or consistency. One batch might be perfect. The next might be too weak, too strong, or contaminated. And in children - especially newborns - even a 10% error in dose can cause serious harm.

The Hidden Dangers: Why Compounding Is Risky for Kids

In 2006, a two-year-old named Emily Jerry died after receiving a compounded chemotherapy drug that was 10 times too strong. The error wasn’t due to a doctor’s mistake. It was a pharmacist’s miscalculation. That tragedy led to the creation of the Emily Jerry Foundation, which has spent years pushing for safer compounding practices - especially for kids.

Today, the risks haven’t gone away. The Institute for Safe Medication Practices found that between 14% and 31% of pediatric medication errors involve compounded drugs. Most of these are dosing mistakes. Why? Because compounded medications often come in unusual concentrations. A liquid might be labeled as “5 mg/mL” - but if the pharmacist meant “5 mg/5 mL” and didn’t clarify, a parent might give five times the dose.

Another big issue: contamination. In 2012, a fungal outbreak from tainted compounded spinal injections killed 64 people and sickened nearly 800. While that wasn’t pediatric-specific, it exposed how easily contamination can happen in compounding labs without strict controls.

And now, newer drugs like semaglutide and tirzepatide - originally meant for adults with diabetes or obesity - are being compounded for children. The FDA has logged over 900 adverse events tied to these compounded versions, including 17 deaths. Kids are getting sick from nausea, vomiting, pancreatitis, and dangerously low blood sugar because the doses weren’t properly calculated or tested.

How to Know If a Compounded Pharmacy Is Safe

Not all compounding pharmacies are the same. Some follow strict standards. Others cut corners. You need to know which is which.

First, check accreditation. Look for the Pharmacy Compounding Accreditation Board (PCAB) or NABP seal. These organizations audit pharmacies for cleanliness, training, and quality control. Only about 1,400 of the 7,200+ compounding pharmacies in the U.S. have PCAB accreditation. That means most don’t meet the highest safety standards.

Ask the pharmacy: “Do you use gravimetric analysis?” That’s a fancy term for using a precision scale to measure ingredients by weight, not volume. It’s the gold standard for accuracy. Yet only 7.7% of U.S. hospitals use it for pediatric compounding, mostly because it’s expensive and requires extra training. But if a pharmacy doesn’t use it, they’re relying on syringes and measuring cups - tools that are far more prone to human error.

Also, make sure the pharmacy is licensed by your state’s board of pharmacy. The DEA oversees controlled substances, but state boards handle day-to-day inspections. You can usually verify a pharmacy’s license online through your state’s pharmacy board website.

What Parents Must Do Before Giving the Medicine

You’re the last line of defense. No pharmacist or doctor can be with your child 24/7. You have to ask the right questions.

1. Ask for the exact concentration. Don’t accept “it’s the same as the pill.” Ask: “How many milligrams are in each milliliter?” Write it down. If the label says “10 mg/mL,” make sure your syringe is calibrated to that number. A common error is mixing up “mg/mL” with “mg/tsp” - and a teaspoon holds 5 mL. That’s a fivefold overdose risk.

2. Double-check the dose with both the doctor and the pharmacist. If the doctor prescribed 0.2 mL and the pharmacist says it’s 5 mg/mL, do the math: 0.2 mL × 5 mg/mL = 1 mg. Is that what the doctor intended? Call the doctor’s office to confirm. Don’t assume they know what the pharmacy wrote.

3. Check the expiration date and storage instructions. Some compounded liquids last only 14 days in the fridge. Others need to be frozen. If it’s been sitting on the counter for a week, it might be unsafe. Throw it out if you’re unsure.

4. Look at the color and smell. If the liquid looks cloudy, has particles, or smells weird - like vinegar or rotten eggs - don’t give it. That’s a sign of contamination or chemical breakdown.

5. Use the right measuring tool. Never use a kitchen spoon. Use the syringe or dosing cup the pharmacy gave you. If they didn’t give you one, ask for it. A 1 mL syringe is best for small doses. Mark the correct dose with a permanent marker if needed.

What to Watch For After Giving the Medicine

Even with perfect dosing, compounded meds can cause unexpected reactions. Kids may not be able to tell you what’s wrong. Watch for:

• Unusual vomiting or diarrhea
• Extreme drowsiness or irritability
• Rash, hives, or swelling
• Difficulty breathing
• Seizures or loss of consciousness

If any of these happen, stop the medicine and call your doctor or go to the ER. Bring the bottle with you. The pharmacy may need to test the batch.

Keep a log: note the date, time, dose given, and any symptoms. This helps doctors spot patterns. One parent on Reddit shared that her 8-year-old ended up in the ER after taking compounded levothyroxine - the pharmacy had made a batch that was 40% weaker than it should have been. The child’s thyroid levels crashed. Without the log, the doctor might have blamed the disease instead of the medicine.

When to Avoid Compounded Medications Altogether

Sometimes, the safest choice is to wait. Ask your doctor: “Is there an FDA-approved version available?”

For example, there are now FDA-approved liquid versions of many common drugs like levothyroxine, morphine, and antibiotics. They’re more expensive, but they’re tested. They come with clear dosing instructions. And if something goes wrong, there’s a manufacturer to hold accountable.

The FDA says compounded drugs should only be used when no approved alternative exists. Too often, pharmacies are making these drugs because they’re cheaper or more profitable - not because they’re medically necessary. That’s dangerous.

If your child needs a compounded drug because of a rare condition or allergy, that’s one thing. But if you’re using it just because “it’s easier” or “the pharmacy said so,” think again.

The Bigger Picture: Why This Problem Won’t Go Away

The compounded medication market is growing fast - over $11 billion in 2024. But only 8.2% of that is for children. That doesn’t mean it’s safe. It means it’s a high-risk niche with little oversight.

Pharmacies are under pressure to fill prescriptions quickly. Gravimetric machines cost $25,000 to $50,000. Training staff takes weeks. Many small pharmacies, especially in rural areas, can’t afford it. So they keep using old methods - and kids pay the price.

Twenty-eight states are now considering laws that would require gravimetric verification for pediatric compounded drugs - inspired by Emily Jerry’s story. But until those laws pass, and until more pharmacies invest in safety, the risk remains.

Until then, your vigilance is the most powerful tool you have.