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Advertising is where many practices first get into trouble with a new service line. The rules are strict, and they apply to every channel: the website, social posts, email, in-office signs, and the handouts patients take home. This article summarizes the main rules for a practice that offers therapies from a pharmacy that compounds. It is general education, not legal advice, and it names no products.
Rule 1: Do not say or imply FDA approval
Drugs a pharmacy compounds are not FDA-approved. Do not describe such a drug as approved, generic, equivalent to an approved drug, or better than one. Watch indirect wording too. "FDA registered pharmacy" beside a product can suggest the product itself is approved.
Rule 2: Every claim needs support
Federal law treats advertising or promotion as misbranding when it is false or misleading in any particular (21 U.S.C. 352(bb)). The FTC expects a health-related claim to rest on competent and reliable scientific evidence. Virginia's Board of Medicine prohibits false, misleading, or deceptive advertising by its licensees and requires documentation supporting advertising claims to be kept and available for the board's review for at least two years (18VAC85-20-30).
Keep a substantiation file. For each claim: the exact wording, where it ran, the dates, the evidence behind it, and who approved it.
Rule 3: Do not present anything as available before it is
If a therapy has no documented, lawful pathway today, it does not appear in ads, on a menu, or in patient materials. "Coming soon" tied to a pending federal policy counts.
Rule 4: Patient stories and before-and-after images are claims
A patient's story and an image are treated as claims. The FTC treats a story about a key result as a claim that the result is typical (16 CFR 255.2). If the practice cannot support that, the ad must clearly disclose the results patients can generally expect, and that disclosure needs evidence too. A patient's story is not scientific evidence, and it cannot say anything the practice could not say itself. Many practices do not use these for this service line.
Rule 5: No pricing gimmicks tied to a prescription
Avoid discount codes, a free first month, a bundled discount, and a referral reward. Depending on the arrangement, those offers can raise state-law questions and fraud and abuse questions. Have counsel review any offer before it runs.
Rule 6: Check each platform's own policies
Search and social platforms have their own rules for health and pharmacy advertising. Google's healthcare and medicines policy, for example, restricts prescription-drug ads and pharmacy ads and requires certification for some advertisers. Check each platform's current policy before a campaign is built.
Rule 7: The practice owns its advertising
If a vendor gives you a template, you are still responsible for what runs under your name. Editing a template does not make a new claim safe. Send every change through the claims review step.
A simple review workflow
- Draft the ad or handout.
- Check it against the rules above and the practice's list of words it will not use.
- The medical director reviews any clinical wording.
- File the final version and its evidence in the substantiation file.
- Review it again when the evidence, the rules, or the offer changes.
How SiriusRx helps
The SiriusRx Peptide Program includes sample language the practice still has to review, a substantiation file for every line in that sample, a list of words to avoid, and training for the people who write ads. The practice remains responsible for its own advertising.
General education, not legal advice.
Sources
- 21 U.S.C. 352(bb), FD&C Act section 502(bb), on false or misleading advertising or promotion: https://www.law.cornell.edu/uscode/text/21/352.
- FDA, Compounding and the FDA: Questions and Answers: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers.
- FTC, Health Products Compliance Guidance (December 2022): https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance.
- 16 CFR 255.2, consumer endorsements: https://www.ecfr.gov/current/title-16/chapter-I/subchapter-B/part-255/section-255.2.
- 18VAC85-20-30, Advertising ethics (Virginia Board of Medicine): https://law.lis.virginia.gov/admincode/title18/agency85/chapter20/section30/.
- Google Ads Help, Healthcare and medicines policy: https://support.google.com/adspolicy/answer/176031.
For practices
This is education for licensed practices. It is not legal, medical, or pharmacy advice, and it does not tell a practice what to prescribe. Contact us with questions about the program.