--- title: "Gluten-Free Medications: When a Compounded Version Fits" description: "Gluten-free, lactose-free and dye-free medications for patients who react to fillers: what to document and what to write on the script. 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Compounded medications are not FDA-approved. Gluten-free medications, like lactose-free and dye-free ones, are either commercial products made without that ingredient or compounded versions prepared without it. When every commercial version of a drug carries an ingredient your patient reacts to, you can prescribe the compounded version. JAD Family Pharmacy, a 503A pharmacy in Titusville, FL, prepares it from your prescription.   ## What Makes a Medication Gluten-Free, Lactose-Free or Dye-Free? A tablet or capsule is the active drug plus inactive ingredients: fillers, binders, coatings, colors and preservatives. A medication is gluten-free, lactose-free or dye-free when its inactive ingredients don't contain that substance. Lactose is a common filler, dyes color tablets and capsules, and starch often works as a binder or filler.   ## When Should You Prescribe a Compounded Version? Prescribe a compounded version when your patient has a documented allergy, intolerance or sensitivity to an inactive ingredient and every commercial version of the drug contains it. If one manufacturer's product is made without the ingredient, that product is usually the simpler answer. Federal law limits a 503A pharmacy from preparing what is essentially a copy of a commercial drug. A change made for one identified patient falls outside that limit when you, the prescriber, determine that it produces a significant difference for that patient. FDA guidance says that determination should be documented on the prescription. Our guide on [how to choose a 503A compounding pharmacy](https://jadfamilypharmacy.com/blog/how-to-choose-503a-compounding-pharmacy) covers the other situations where compounding fits. Compounded medications require a prescription and are not FDA-approved. The FDA doesn't verify their safety, effectiveness or quality before they are dispensed, and you decide whether a compounded version is appropriate for your patient.   ## How Do You Check a Medication's Inactive Ingredients? Read the inactive ingredient list in the product labeling, which you can search on DailyMed, the National Library of Medicine's labeling database. Check the exact manufacturer your patient receives, because generics of the same drug can use different inactive ingredients. | Your patient reacts to | Look for on the label | | --- | --- | | Gluten | Wheat starch, or starch, pregelatinized starch or sodium starch glycolate with no plant source named | | Lactose | Lactose monohydrate, anhydrous lactose | | Dyes | FD&C and D&C colors, such as FD&C Blue No. 1, and iron oxides | | Preservatives | Parabens such as methylparaben, sodium benzoate | When the label doesn't name a starch's source, the manufacturer can answer. Our pharmacists can also look at a product with you before you write a compounded script: call 321-225-4900.   ## What to Write on the Prescription ![What to Write on the Prescription: patient, drug and strength, form, quantity and directions, omitted ingredient, reason](https://jadfamilypharmacy.com/hs-fs/hubfs/Imported%20sitepage%20images/1Bc0_zovXPnZ6sC9JEMXRnoG-E6XfuPXB=w1600.png?width=720&height=378&name=1Bc0_zovXPnZ6sC9JEMXRnoG-E6XfuPXB=w1600.png) 1. **Patient.** Full name and date of birth. Every preparation we make is for one named patient. 2. **Drug and strength.** State the strength in the unit that fits the form: per capsule, per milliliter or per gram. 3. **Dosage form.** Capsule, oral liquid, troche, cream or gel. 4. **Quantity and directions.** Give directions the patient can follow, and keep a liquid's shorter beyond-use date in mind when you set the quantity. 5. **Ingredient to leave out.** Name it: "made without lactose" or "made without dyes." 6. **Clinical reason.** State why the change matters for this patient, such as "documented dye allergy." Send the prescription by e-script, by fax at 321-567-4742, or by phone at 321-225-4900.   ## Which Forms Can Be Made Without the Ingredient? JAD's [non-sterile compounding services](https://jadfamilypharmacy.com/compounding) follow USP 795, and you can order these forms without a named ingredient: - **Capsules.** Every inactive ingredient is chosen, which makes this the first form to consider for a patient who reacts to fillers or dyes. - **Oral liquids.** A fit for a patient who can't swallow a capsule, with a shorter beyond-use date than a solid form. - **Troches.** These dissolve in the mouth, so the patient doesn't swallow a tablet or capsule. - **Creams and gels.** Applied to the skin, in a base chosen for the prescription. "Made without" describes what goes into the formula. If your patient has a history of severe reactions, call before you write so a pharmacist can talk through the ingredients and the form with you. Our overview of [non-sterile dosage forms you can prescribe](https://jadfamilypharmacy.com/blog/transdermal-compounding-and-dosage-forms) compares each form in more detail.   ## What Your Patient Can Expect From JAD Family Pharmacy Your patient gets a pharmacist who explains how to take the preparation, and your office gets a direct line to our pharmacists and technicians with no call tree. Delivery is free within Brevard County, and orders shipped outside it may carry a fee. Patients can also pick up at the pharmacy in Titusville. To answer questions in your patient's own terms, share our page on [what compounded medicine means for your patients](https://jadfamilypharmacy.com/compounding/for-patients).   --- ## Frequently Asked Questions ### Are generic medications gluten-free? Some are and some aren't, and the answer can differ by manufacturer. Generics of the same drug can use different inactive ingredients, so check the labeling for the exact product your patient receives. If a starch's source isn't named, ask the manufacturer or a pharmacist. ### Can a compounding pharmacy make any medication lactose-free? Not every medication. It depends on the drug, the form and whether a compounded version can be prepared without lactose. JAD prepares non-sterile forms only, so call a pharmacist at 321-225-4900 to talk through a specific prescription before you write it. ### Does insurance cover a compounded dye-free version? Insurance doesn't cover compounded medicine, and that includes a dye-free version. Let your patient know before you send the prescription so the cost isn't a surprise. Our team can answer questions about a specific prescription at 321-225-4900. ### How long does a compounded prescription take? Most compounded prescriptions are prepared within 1 to 2 business days. We let the patient know when the medication is ready, and we can deliver it free within Brevard County. To check on an order, call 321-225-4900. ### Is a compounded medication FDA-approved? No. Compounded medications are not FDA-approved, and the FDA doesn't verify their safety, effectiveness or quality before they are dispensed. You decide whether a compounded version is appropriate, and the pharmacy prepares it for that one patient from your prescription. ### Can a patient get a compounded medication without a prescription? No. Every compounded medication JAD prepares requires a valid prescription for an individual patient. A patient who suspects a reaction to an inactive ingredient should talk with their prescriber, who can review the product and order a version made without that ingredient.   --- ## About the Author **JAD Family Pharmacy Clinical Team.** The licensed pharmacists at JAD Family Pharmacy, an independent community and compounding pharmacy in Titusville, Florida, that prepares non-sterile compounded medications under USP 795 for patients and prescribers across Brevard County. Licensed by the Florida Board of Pharmacy. *This article is written for licensed prescribers and is for informational purposes only. It does not constitute medical advice.* --- **Send a prescription or talk with a pharmacist.** [Partner with JAD Family Pharmacy](https://jadfamilypharmacy.com/compounding/for-providers) through the provider form, or [call JAD Family Pharmacy](https://jadfamilypharmacy.com/contact) at 321-225-4900. 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