What to check when a compounded injection arrives

Before the first dose of a compounded injection, check the package, the label, how to measure the dose and the dates. A compounded drug is generally one that a pharmacist or physician has mixed or altered for an individual patient. Compounded drugs are not FDA-approved: the FDA does not review their safety, effectiveness, quality or labels before they are sold.^1,2,3

The package

State pharmacy rules differ. California, for example, makes the pharmacist responsible for a sterile compounded drug’s strength and quality until its beyond-use date, the date after which it must not be used. That holds only if it is stored and handled as the label directs. With any compounded injection that arrives warm, frozen or damaged, ask the pharmacy before using it.^4,5

GLP-1 drugs, such as semaglutide and tirzepatide, act on the body’s receptor for glucagon-like peptide-1 (GLP-1). The FDA says injectable ones require refrigeration. It has received complaints that some compounded GLP-1 drugs arrived warm or with inadequate ice packs. It recommends not using any that arrive warm or poorly refrigerated, because that can affect their quality. The FDA-approved semaglutide and tirzepatide labels also say not to use those products if frozen.^6,7,8

Texas requires packaging that keeps sterile compounded drugs properly stored, and bars pharmacies from dispensing a sterile solution with visible particles. Call the pharmacy about a vial that leaks or has particles in the liquid. The Centers for Disease Control and Prevention (CDC) tells health care providers to discard any vial whose sterility is compromised or in doubt.^5,9

The label

Under federal law, a filled prescription’s label must give the dispenser’s name and address (usually the pharmacy’s), the prescriber’s name and the prescription’s serial number. It must also give the date the prescription was written or filled. If the prescription includes the patient’s name, directions or cautions, the label must give them too.¹⁰

California also requires the drug’s name and strength, the quantity and an expiration date. For sterile compounded drugs, it adds the route, instructions for giving them, and the names of the compounding and dispensing facilities if they differ. Texas requires a beyond-use date on sterile compounded drugs and, for patients outside a hospital, a statement that the pharmacy compounded the drug.^4,5

Outsourcing facilities, registered with the FDA to compound sterile drugs, must label each drug “This is a compounded drug.” or something comparable. The label must also give the facility’s name, address and phone number, and the drug’s name, strength, lot number, compounding date and expiration date, among other items.¹¹

In October 2026 the Department of Health and Human Services (HHS), the FDA’s parent department, published a nonbinding draft policy on six peptides. HHS says it does not intend to take enforcement action against state-licensed pharmacies and licensed physicians compounding BPC-157, epitalon, KPV, MOTS-c, semax or TB-500 under its conditions. Those conditions include a label reading “This is a compounded drug product. Not for resale.” and labeling that explains how to report side effects and quality problems.^1,12,13

Check whether the strength is given per milliliter, for the whole container, or both. A 2018 FDA alert described two overdoses from a compounded IV bag and syringe whose labels showed the per-milliliter strength most prominently. That figure was mistaken for the total amount.³

If anything on the label is unclear, contact the pharmacy that compounded the drug or the telehealth service it came through. The FDA gives that advice for compounded GLP-1 drugs.⁶

Warning signs

A label without a pharmacy’s name and address falls short of federal law. A name alone is not proof, though. The FDA knows of fraudulent compounded semaglutide and tirzepatide whose labels named pharmacies that do not exist, or licensed pharmacies that did not make them.^10,6

The FDA’s “telehealth red flags” for consumers include a company that:⁶

Labels reading “for research purposes” or “not for human consumption” are another warning. The FDA has warned companies that sold unapproved drugs falsely labeled this way, containing semaglutide, tirzepatide, retatrutide, survodutide or mazdutide, directly to consumers with dosing instructions. It urges consumers not to buy them, calling them of unknown quality and possibly harmful.⁶

Some ingredient names are warnings too: the FDA says retatrutide and cagrilintide cannot be used in compounding under federal law, and neither is part of any FDA-approved drug. It also knows of no lawful basis for compounding with semaglutide sodium or semaglutide acetate. The FDA considers these salt forms, semaglutide paired with sodium or acetate, different active ingredients from the semaglutide in approved drugs.^6,14

Dosing errors

In July 2024 the FDA reported harms, some needing a hospital stay, that may have come from dosing errors with compounded semaglutide injections. Most reports described patients drawing more than the prescribed dose from a vial holding several doses (a multiple-dose vial), injecting five to 20 times the intended dose.¹⁴

Milligrams measure the amount of drug, and milliliters the amount of liquid. Instructions for compounded semaglutide sometimes give doses in “units” instead, the marks on an insulin syringe. On a U-100 insulin syringe, each unit is one-hundredth of a milliliter, so the amount of drug in a unit depends on the vial’s concentration, which varies between compounders. The FDA says unfamiliarity with drawing medicine into a syringe, and confusion among these measures, may have contributed to the errors.¹⁴

Health care providers made mistakes too. In several reports, they converted milligrams to units or milliliters incorrectly, and patients injected five to 10 times more than intended. One patient, struggling to get clear dosing instructions from the prescribing telemedicine provider, searched online and took five times the intended dose.¹⁴

Reported harms included nausea, vomiting, abdominal pain, fainting, headache, migraine, dehydration, inflammation of the pancreas (acute pancreatitis) and gallstones. The approved semaglutide label notes overdoses of other GLP-1 drugs that caused severe nausea, severe vomiting and severe low blood sugar (hypoglycemia). Semaglutide leaves the body slowly, so the FDA notes that an overdose may need a long period of observation and treatment.^14,7

The FDA also has reports of side effects possibly linked to compounded semaglutide or tirzepatide prescribed beyond the doses in FDA-approved labels. It advises patients to ask the prescriber or compounder how to measure and give the intended dose. It encourages health care providers and compounders to supply a syringe sized for the dose.^6,14

Vials, needles and dates

The CDC tells health care providers to date a multiple-dose vial when opened and discard it within 28 days, unless the manufacturer states another date. The FDA generally recommends the same limit, because the risk of contamination rises after that.^9,6

For compounded GLP-1 drugs, the FDA says to discard the vial within 28 days of first use, even if medicine remains or the compounder’s instructions allow longer. In Texas, an opened multiple-dose vial of a compounded drug may be used until its beyond-use date or for 28 days, whichever comes first. Texas rules define a single-dose container as one meant for a single use and labeled as such. The CDC says a single-dose vial is for one injection, and leftovers should not be kept, even for the same patient.^6,5,9

In August 2026 the FDA told national groups of state medical, pharmacy and nursing boards of rising patient complaints about compounded GLP-1 multiple-dose vials. It had also received complaints about vials too large to use within 28 days, and about advice to keep using them longer. It recommended clear discard instructions, such as “Discard vial after the 4th injection” for a weekly drug. It also warned that compounded and FDA-approved products may differ in concentration, so their volumes are not interchangeable.¹⁵

Use a new, sterile needle and syringe for every dose, the FDA advises, because reused ones can contaminate the medicine. The CDC warns that reusing needles or syringes on more than one person can spread hepatitis B and C, bacterial and fungal diseases and possibly HIV. So can reusing them to draw from vials shared between people.^6,16

Getting rid of used needles

Put used needles and syringes in an FDA-cleared sharps container right after use, and keep it out of reach of children and pets, the FDA advises. If none is available, some community guidelines suggest a heavy-duty plastic household container, such as a laundry detergent bottle, the FDA notes. It should be leak-resistant, stay upright, have a tight, puncture-resistant lid and be labeled to warn of hazardous waste.^17,18

Never put loose needles in the trash, never put needles in a recycling bin, and never flush them. When the container is about three-quarters full, follow local rules for getting rid of it, such as drop-off sites or mail-back programs. The local trash service or health department can explain them.^19,17

If something seems wrong

If too much may have been injected, call the prescriber or the Poison Help line (1-800-222-1222), or go to the nearest emergency room, right away. The FDA-approved patient guides for semaglutide and tirzepatide give that advice. Call 911 if someone has collapsed, had a seizure, has trouble breathing or cannot be woken.^20,7,8

For other symptoms, contact the prescriber. The FDA encourages people to report any reaction to a compounded drug to their health care professional and the FDA.²¹

MedWatch is the FDA’s reporting program for serious reactions, quality problems and mistakes in using a product. Patients can report online, on the consumer form (Form FDA 3500B), or by calling 1-888-INFO-FDA (1-888-463-6332) and pressing 2. Federal law requires outsourcing facilities to report side effects to the FDA, but not other pharmacies. So the FDA says side effects of compounded semaglutide and tirzepatide are likely underreported.^22,11,6

The consumer form asks for the product’s name as labeled, the company that made or compounded it, the lot number, the expiration date and the strength. Keep the product in case the FDA asks to examine it, but do not send it. The form says to send a report even if some details are missing.²³

The FDA counts a reaction as serious when it is life-threatening or leads to death, a hospital stay, disability or permanent damage, or a birth defect. It also counts one that may endanger the patient and may need treatment to prevent those outcomes. Product problems, such as suspected contamination, poor packaging, questionable stability or a labeling concern, can be reported even if no one was hurt.^24,25

A checklist

These checks can catch label, shipping and handling problems. They cannot show whether the drug inside is sterile or as strong as its label says.²