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, or they’re allergic to dyes, or they need a tiny dose that no manufacturer makes - compounded medications can feel like a lifeline. But behind that lifeline is a hidden risk. Compounded drugs aren’t tested by the FDA. They’re made one at a time, by hand, in a pharmacy. And for kids, even a small mistake can be life-changing.

Why Compounded Medications Are Used for Children

Most kids don’t need custom-made medicines. But some do. The reasons are specific and often urgent:

• Children who can’t swallow pills need liquids - but no company makes a liquid version of their medicine.
• Some kids are allergic to preservatives, dyes, or alcohol found in commercial drugs. Compounding lets pharmacists remove those ingredients.
• Neonates in the NICU need ultra-small doses of powerful drugs like morphine or fentanyl. A single drop too much can be deadly.
• Diabetic children need sugar-free versions of medicines that normally contain syrup.
• Bitter-tasting drugs can be masked with flavorings like strawberry or bubblegum to help kids take them without a fight.

These aren’t luxury choices. They’re medical necessities. But that doesn’t mean they’re safe by default.

The Hidden Dangers of Compounding

The biggest danger isn’t the medicine itself - it’s the process. Compounding is manual. One pharmacist, one scale, one syringe. No automated checks. No batch testing. No FDA oversight.

Here’s what can go wrong:

• Dosing errors: A child weighing 12 pounds needs 0.2 mL of a drug. The pharmacist misreads the prescription and prepares 2 mL. That’s a tenfold overdose.
• Wrong concentration: A parent is told to give 5 mL of a liquid. But the label says 10 mg/mL - when it should’ve been 1 mg/mL. That’s a 10x overdose again.
• Contamination: In 2012, a compounding pharmacy in Massachusetts shipped contaminated spinal injections. 800 people got sick. 64 died.
• Inconsistent potency: One batch of compounded levothyroxine had 40% less active ingredient than prescribed. A child developed severe hypothyroidism and ended up in the ER.

According to the Institute for Safe Medication Practices, between 14% and 31% of pediatric medication errors involve compounded drugs. Most are dosing mistakes. Most are preventable.

When to Avoid Compounded Medications

Not every “custom” medicine is necessary. The FDA says clearly: Don’t use compounded drugs if an approved version exists.

For example:

• If a child needs an antibiotic, there are FDA-approved liquid versions available. Use those.
• If a child needs insulin, premixed, pre-filled syringes exist. Don’t ask a pharmacy to compound it from powder.
• If a child needs GLP-1 drugs like semaglutide (used for obesity or diabetes), the FDA has documented over 900 adverse events - including 17 deaths - linked to compounded versions as of December 2024. These are not safe for children.

Compounding should be a last resort, not a shortcut. If your doctor suggests a compounded drug, ask: “Is there an FDA-approved version?” If the answer is yes, push for it.

How to Choose a Safe Compounding Pharmacy

Not all pharmacies are created equal. Some are clean, trained, and accredited. Others cut corners.

Here’s how to pick the right one:

1. Look for PCAB or NABP accreditation. The Pharmacy Compounding Accreditation Board (PCAB) and the National Association of Boards of Pharmacy (NABP) are the only two groups that certify compounding pharmacies for quality and safety. Only about 1,400 of the 7,200+ compounding pharmacies in the U.S. have this accreditation.
2. Ask if they use gravimetric analysis. This is a high-tech weighing system that measures ingredients to the milligram. It’s far more accurate than manual measuring. Hospitals that use it cut pediatric dosing errors by 75%. But only 7.7% of U.S. hospitals use it - because it costs $25,000 to $50,000 per station.
3. Check if they do double-checks. For every pediatric dose, two trained staff members should independently verify the recipe, the measurement, and the final product. Ask: “Do you have a second pharmacist check every child’s dose?”
4. Ask about their training. Pharmacists who compound for kids need 40+ hours of special training in pediatric calculations. Ask if their staff is certified.

Don’t be shy. This is your child’s life. If the pharmacy hesitates or can’t answer, find another one.

What Parents Must Do Before Giving the Medicine

Even the best pharmacy can make a mistake. You are the last line of defense.

Before you give your child any compounded medicine:

• Ask for the exact concentration. Always. Write it down. Is it 5 mg/mL? 10 mg/mL? 0.5 mg/mL? If they say “it’s the same as the pill,” ask them to show you the label.
• Verify the dose with your doctor and pharmacist. Don’t assume they’re on the same page. Call the doctor’s office and say: “I have a compounded liquid for my child. The prescription says 0.3 mL twice daily. The bottle says 10 mg/mL. Is that correct?”
• Use the right measuring tool. Never use a kitchen spoon. Use the syringe or dosing cup the pharmacy gives you. If they don’t give you one, ask for it. If they say “just use a teaspoon,” walk out.
• Check the color, smell, and texture. If the liquid looks cloudy, smells off, or has particles in it - don’t use it. Call the pharmacy immediately.
• Store it correctly. Some compounded meds need refrigeration. Others must be used within 14 days. Ask for written storage instructions.

68% of pediatric compounding errors happen because the parent didn’t understand the concentration. That’s not their fault. It’s the system’s failure. But you can stop it.

The Tragedy That Changed Everything

In 2006, two-year-old Emily Jerry died after receiving a compounded chemotherapy dose that was 100 times too strong. The error happened because a pharmacist misread a decimal point. The technology to prevent it - gravimetric analysis - was already available. But the pharmacy didn’t use it.

Her father, Jerry, turned grief into action. He founded the Emily Jerry Foundation and pushed for “Emily’s Law.” As of April 2025, 28 states have introduced legislation requiring gravimetric verification for all pediatric compounded sterile preparations.

Emily’s story isn’t just a warning. It’s a blueprint. If your child needs a compounded drug, ask: “Would you have used gravimetric analysis if this were your child?”

What’s Changing in 2025

The FDA is cracking down. In May 2025, they issued a warning that compounding pharmacies are exploiting drug shortages to mass-produce unapproved drugs - even after the shortages are over. They’ve seen more than 900 adverse events linked to compounded semaglutide and tirzepatide, including 17 deaths.

The National Academy of Medicine called the rise in compounding “a significant threat” to children’s health. The ISMP is developing new pediatric safety metrics for 2025. And more hospitals are finally investing in gravimetric systems.

But change is slow. The cost, training, and paperwork are still barriers. Until every pharmacy uses the same safety standards, you have to be your child’s advocate.

Final Checklist for Safe Use

Before giving your child a compounded medication:

• ✅ Is there an FDA-approved version available? If yes, use it.
• ✅ Is the pharmacy PCAB or NABP accredited?
• ✅ Do they use gravimetric analysis for pediatric doses?
• ✅ Do they do a double-check by two trained staff members?
• ✅ Do you have the exact concentration written down? (e.g., 5 mg/mL)
• ✅ Did you confirm the dose with both the doctor and pharmacist?
• ✅ Did you get the correct measuring device?
• ✅ Did you check the medicine’s appearance and smell?
• ✅ Do you know how to store it and when it expires?

If you can answer yes to all nine, you’ve done everything you can to keep your child safe. If even one is no - stop. Call your doctor. Find a better pharmacy. Don’t guess. Don’t rush. This isn’t just medicine. It’s your child’s health.