Compounded drugs fill real gaps in care. But the moment you promote them, you step into a thicket of FDA and FTC rules designed for safety and truthfulness. This article explains when you can legally advertise compounded drugs, what “off-label” promotion really means, and the missteps that can trigger warning letters, injunctions, or even multi‑million‑dollar False Claims Act cases.
What counts as a compounded drug—and why that matters for ads
Compounded drugs are custom medications made for an individual patient or, in limited cases, for office use. They are not FDA‑approved. That single fact drives most of the advertising rules. If you imply that a compounded drug is approved, proven safe and effective, or equivalent to an approved drug, you risk “misbranding.” Misbranding is illegal because it can mislead clinicians and patients about the product’s status and evidence.
- 503A pharmacies compound for patient‑specific prescriptions. They generally cannot make office stock. They must avoid making “essentially a copy” of a commercially available drug.
- 503B outsourcing facilities may compound for office use and must meet FDA current good manufacturing practice. They also must avoid “essentially a copy.” Their labels and ads must make clear the drug is compounded and not approved.
Why this matters for your advertising: every claim you make will be judged against these boundaries. If your ad suggests you can supply large batches without prescriptions (for 503A) or that your product is interchangeable with a brand drug, the FDA can infer you are operating outside your category’s limits.
Can you advertise compounded drugs at all?
Yes, but carefully.
Years ago, a law tried to ban advertising about specific compounded drugs. The Supreme Court struck that ban down as a free‑speech violation. Since then, the FDA has not enforced a blanket ban on compounding ads. However, the agency (and the FTC) can still act when an ad is false, misleading, or promotes illegal activity, like compounding copies of available drugs or selling 503A products as office stock.
The safe path is straightforward: make accurate, balanced, non‑promotional statements about your compounding services and the availability of specific preparations, and avoid claims that imply FDA approval, proven effectiveness, or equivalence to approved drugs.
What “off‑label” promotion means—and how it applies here
For FDA‑approved drugs, the label lists approved uses. Promoting uses outside that label is “off‑label promotion.” Manufacturers can be cited for misbranding when they do this because the labeling no longer gives “adequate directions for use.” Off‑label promotion has fueled many multi‑million‑dollar settlements, especially when it drives government reimbursement claims.
Compounded drugs are different: they have no approved label. So the term “off‑label” technically doesn’t apply. But the legal risk is similar, and the reason is the same: if you claim your compounded product treats, cures, or prevents a disease, you are making a safety and efficacy claim without FDA approval. That is misleading unless you have the kind of evidence and labeling the FDA requires for approved drugs. The FDA and FTC can both act on that.
Bottom line: you can describe what you compound. You cannot claim clinical benefits you have not proven to the FDA.
High‑risk claims that trigger enforcement
- “FDA‑approved” or “FDA‑cleared.” Compounded drugs are not approved. Even saying “FDA registered” in a way that implies approval is risky. Registration only means the facility is listed with FDA, not that products are vetted.
- “Safe and effective.” These are FDA conclusions for approved drugs. Using them suggests approval and evidence you do not have.
- “Generic” or “therapeutically equivalent to [Brand].” FDA’s equivalence ratings apply to approved generics, not compounded products. Such claims can mislead pharmacists and payors.
- Claims of superiority. “Works faster than [Brand],” “fewer side effects,” or “more consistent potency” require head‑to‑head data meeting FDA standards. Without that, they are almost certainly misleading.
- Disease treatment claims for trendy compounds. Examples the FDA has flagged include peptides and semaglutide salt forms for weight loss, ketamine for psychiatric conditions, and “bioidentical hormone” claims like “prevents Alzheimer’s” or “reduces cardiovascular risk.” These statements imply proven outcomes.
- 503A office stock or bulk‑only promotions. If you are a 503A pharmacy, advertising office‑use sales or routine use of bulk substances not allowed for 503A signals noncompliance.
- “Copies” of available drugs. Promoting a compound that is essentially a copy of a marketed product (same active, route, dosage form, strength) is a red flag for both 503A and 503B unless a narrow exception applies (e.g., documented clinical difference for a specific patient or a shortage context consistent with FDA policy).
What counts as “advertising” (more than you think)
FDA looks beyond obvious ads. “Labeling” includes brochures, sales sheets, or web pages distributed with a product. “Advertising” covers your website, email campaigns, social media posts, trade show materials, sales rep decks, webinars, and search ads. Why this matters: a claim you bury on a blog post can trigger the same enforcement as a glossy brochure.
Practical rules for lower‑risk advertising
- Be factual about services. It is safer to say “We compound sterile ophthalmic injections in these strengths” than to say “Our injections lower macular edema faster than [Brand].” The first is a factual capability; the second is an unproven clinical claim.
- Use required identifiers. Prominently state “This is a compounded drug.” 503B products must include required statements such as “Not for resale” and, when applicable, “For office use only.” This avoids misleading status cues.
- Never imply approval. Avoid approval language, FDA seals, or NDC‑like formatting that suggests listing or therapeutic equivalence. Explain you are a 503A pharmacy or a 503B outsourcing facility, not an NDA/ANDA holder.
- Describe ingredients, strengths, and dosage forms accurately. Stick to what you actually make. Avoid suggesting custom strengths are inherently safer or more effective.
- State 503A limitations. If you are 503A, make clear that products are dispensed pursuant to a patient‑specific prescription. This avoids implying office stock.
- Qualify medical discussions as general information. Provide balanced, referenced background about conditions or ingredients, but stop short of claiming your product will diagnose, treat, cure, or prevent disease.
- Use “availability” framing, not outcome claims. “Available preservative‑free formulation for patients intolerant to preservatives” is about access. “Safer than [Brand] because preservative‑free” is a comparative safety claim.
- Respond, don’t push, on clinical questions. If a clinician asks an unsolicited question about evidence, answer with balanced, truthful information and document the request and your response. Proactive promotional blasts about investigational benefits invite trouble.
Special tripwires for 503A vs. 503B
- 503A pharmacies
- Do not advertise office‑use availability. You generally cannot supply office stock.
- Do not promote products from bulk substances unless the substance is permitted for 503A or the product meets a relevant shortage policy and other requirements.
- When a brand drug is commercially available, avoid promoting a same‑strength, same‑route compound unless a prescriber documents a specific clinical difference for the patient. Advertising “we copy [Brand] cheaper” invites enforcement.
- 503B outsourcing facilities
- Ensure required label statements and lot‑level transparency. Ads should match that transparency.
- Do not advertise products that are essentially copies of available drugs or that use bulk substances not permitted for 503B compounding.
- Be cautious with stock images or language that implies your products have been reviewed like approved injectables; they have not.
FDA, FTC, and state roles—who enforces what
FDA oversees labeling and promotion that renders a drug misbranded or adulterated. FTC polices advertising to consumers for deception. They coordinate. A claim can violate both agencies’ standards at once. State boards can add their own rules for pharmacy advertising. Why this matters: your website has multiple audiences and regulators. Design your claims to satisfy the strictest standard.
What enforcement looks like (and why it gets expensive)
- Warning letters force you to correct ads quickly. They become public and draw plaintiff and payor attention.
- Injunctions and seizures shut down lines and destroy inventory. The cost is downtime, disposal, and remediation.
- Criminal liability can attach if violations are knowing or repeated.
- False Claims Act exposure arises when illegal promotion drives government reimbursement. Penalties include treble damages and per‑claim fines. That’s how “off‑label” cases reach the tens or hundreds of millions.
The “why” is simple: misleading promotion can change prescribing and billing at scale. Regulators act to stop it, and payors seek recovery.
Ad copy you can usually keep—and what to cut
- Usually acceptable:
- “We are a 503B outsourcing facility compounding preservative‑free methylprednisolone in these strengths for office use.”
- “This is a compounded drug. It is not FDA‑approved.”
- “Available dosage forms: capsule, oral solution, topical gel.”
- “Patient‑specific prescriptions only (503A).”
- High risk—remove or rewrite:
- “Our compounded semaglutide provides superior weight loss vs. Ozempic.”
- “FDA registered and approved facility.”
- “Generic equivalent to [Brand X].”
- “Safer than commercial products due to XYZ.”
Seven‑step compliance checklist for your next campaign
- Inventory claims on your website, social channels, brochures, and sales decks. Pull anything implying approval, equivalence, superiority, or disease outcomes.
- Add required statements (“This is a compounded drug,” “Not FDA‑approved,” 503A patient‑specific, 503B office‑use as applicable).
- Map each product to authority (503A vs 503B; bulk substance eligibility; “not essentially a copy” rationale; shortage status where relevant).
- Build balance into scientific content. Present limitations. Avoid selective data, and label opinion as opinion.
- Train staff on what they can say, especially sales and customer support. Provide scripts for unsolicited medical information requests.
- Review visuals for implied claims (e.g., FDA‑like seals, NDC‑style numbers, look‑alike packaging).
- Document decisions and keep backup for factual claims. If regulators ask “why did you say this,” you should have contemporaneous notes.
Quick answers to common questions
- Can I list specific compounded formulations on my website? Yes, if you avoid disease cure/treatment claims and include clear “compounded, not FDA‑approved” statements.
- Can I say physicians use our compound for condition X? Not as a promotional claim. That implies effectiveness. If asked by a clinician, you may provide balanced, non‑misleading information in response to an unsolicited inquiry.
- Can a 503A pharmacy promote office stock? No. That suggests illegal distribution. Stick to patient‑specific services.
- Can I compare price to a brand? Price statements are risky if they imply equivalence. If you make them, make clear the products are not FDA‑rated equivalents and avoid clinical comparisons.
Advertise compounded drugs with humility and precision. State what you make, how you make it available, and what you do to ensure quality. Do not claim what only FDA approval can claim. That discipline keeps you compliant—and out of the headlines.
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com