Research · 10 min read
Who Regulates the Advertising of a Compounded GLP-1
A compounded drug is exempt from the approval requirement but not from the rules against misleading promotion. Two agencies split the work, and the split explains why a telehealth ad and a brand-name ad look nothing alike.
Key takeaways
- A qualifying compounded drug is exempt from good manufacturing practice, adequate directions for use, and new drug approval — not from the misbranding provisions on labeling or prescription drug advertising.
- The statutory bar on a compounder advertising a particular compounded drug was struck by Congress, and the repealed text survives only in the section's editorial notes.
- The Food and Drug Administration takes primary responsibility for labeling claims and the Federal Trade Commission for advertising claims, under an agreement the Commission describes in its own guidance.
- The prescription drug advertising rules bind the manufacturer, packer or distributor of the drug promoted, which is why a telehealth service's page looks different from a brand-name advertisement.
- The Administration publishes a telehealth warning-sign list whose first item is a company claiming a compounded drug is the same as an approved drug, and records having warned telehealth companies over marketing unapproved drugs.
The short answer
Two federal bodies are involved, and they cover different surfaces.
The Food and Drug Administration has primary responsibility for claims that appear in labeling. The Federal Trade Commission has primary responsibility for claims in all forms of advertising. Both agencies describe that division as coming from a longstanding agreement between them.
The Administration also has a specific prescription drug advertising regime, and its reach is narrower than people assume: it binds the manufacturer, packer or distributor of the drug being promoted.
A telehealth company selling a compounded medication as part of a service is advertising a service. That places most of what it says under the Commission's general truth-in-advertising authority rather than under the brand-name drug advertising rules.
What a compounding exemption actually exempts
Start with what the statute switches off, because it is a short and specific list.
Take a drug compounded for an identified individual patient on a valid prescription, meeting the section's conditions. Three provisions of the Federal Food, Drug, and Cosmetic Act then do not apply: the current good manufacturing practice provision, the requirement of adequate directions for use, and the new drug approval section.
Read the list again for what is missing. The misbranding provision covering false or misleading labeling is not on it. Neither is the prescription drug advertising provision.
The outsourcing facility route has its own list, and it is different. There the exemptions are from adequate directions for use, new drug approval, and the drug supply chain security requirements — with the good manufacturing practice provision notably absent.
So compounding removes the approval requirement. It does not remove the requirement that what is said about the drug be true.
The advertising ban that used to exist and does not now
This is the piece most readers have never been told, and it changes how the current market reads.
When the pharmacy compounding section was written, it contained a subsection on advertising and promotion. A drug could be compounded under the section only if the pharmacy, pharmacist or physician did not advertise or promote the compounding of any particular drug, class of drug or type of drug. They were allowed to advertise the compounding service itself.
That subsection was struck out by Congress, and the later subsections were renumbered to close the gap. The repealed text is still printed in the section's editorial notes, which is how anyone can read what it used to say.
The consequence is straightforward. There is no longer a provision in that section barring a compounder from advertising a particular compounded drug by name.
Whether any individual state restricts such advertising is a separate question, decided by state pharmacy and professional rules, and it is not answered here.
What replaced the specific ban is the general law. An advertisement can be lawful to run and still be unlawful because of what it says.
Which agency covers which surface
The Commission's health advertising guidance describes the division of labor in its own words, and it is the clearest published statement of it.
The two agencies share jurisdiction over the marketing of drugs and other health-related products, and coordinate under a memorandum of understanding that governs the basic division of responsibilities.
The Administration has primary responsibility for claims in labeling, including the package, product inserts, and other promotional materials available at point of sale. The Commission has primary responsibility for claims in all forms of advertising.
The guidance then adds a caveat that keeps the line from being a wall. The agreement does not limit the Commission's jurisdiction or prevent it from acting against deceptive labeling claims, or from obtaining orders that address all forms of marketing.
The definitions cooperate with this. The statutory term false advertisement is defined as an advertisement other than labeling that is misleading in a material respect. Labeling is carved out of the advertising definition rather than left ambiguous.
The prescription drug advertising rules, and who they bind
The Administration's regime here is real, detailed, and aimed at a particular party.
The misbranding provision on prescription drug advertisements applies where the manufacturer, packer or distributor of the drug issues, or causes to be issued, advertisements and other descriptive printed matter about it.
Those advertisements must carry a true statement of the established name, printed prominently and in type at least half as large as any trade or brand name. They must also carry the quantitative formula, and information in brief summary about side effects, contraindications and effectiveness as required by regulation.
Published direct-to-consumer advertisements must also carry the statement encouraging readers to report negative side effects to the agency, in conspicuous text.
There is a further rule for a direct-to-consumer television or radio advertisement that names the drug and its conditions of use. The major statement about side effects and contraindications must be presented in a clear, conspicuous and neutral manner, a standard the regulation then defines in five parts.
The regulation puts teeth behind it. A non-complying advertisement issued by the manufacturer, packer or distributor causes stocks of the drug in that party's possession, and stocks already distributed and still in commerce, to be misbranded.
A boundary the regulation draws for itself
Two details in that regulation are worth knowing, because they explain shapes you have seen.
The first is what counts as an advertisement. The regulation lists advertisements in published journals, magazines, other periodicals and newspapers, and those broadcast through media such as radio, television and telephone communication systems.
The second is what does not. Brochures, booklets, mailing pieces, file cards, price lists, catalogs, letters, films, exhibits, literature and reprints are treated differently. Where they describe a drug, contain information supplied by its manufacturer, packer or distributor, and are disseminated by or on behalf of them, they are determined to be labeling instead.
That is a real fork. The same sentence can sit under a different rulebook depending on the container it arrives in.
There is also an exemption with an edge on it. Reminder advertisements — those that call attention to a drug's name without giving indications or dosage recommendations — are exempt from the brief summary requirement, within tight limits on what they may contain. But reminder advertisements other than certain price-only ones are not permitted for a prescription drug whose labeling carries a boxed warning about a serious hazard.
The jurisdictional carve-out most people miss
There is a sentence in the misbranding provision that sorts the two agencies rather than describing an advertisement.
It concerns advertisements of a prescription drug published after the effective date of the regulations issued under that paragraph. With respect to the matters specified in the paragraph, or covered by those regulations, such advertisements shall not be subject to the false advertising sections of the Commission's statute.
So for the specific matters the Administration's prescription drug advertising rules cover, in advertisements by the parties they bind, the Commission's false advertising sections step back.
That is a narrow carve-out and it is worth reading its limits. It applies to the matters those regulations cover, in advertisements of a prescription drug, and it does not describe everything a company might say.
Meanwhile the Commission's own false advertising section reaches advertisements likely to induce the purchase of food, drugs, devices, services or cosmetics. The word services was added to that section by amendment, which is why a marketed service is inside it and not merely alongside it.
What the Administration itself says about this market
The agency maintains a public statement about unapproved versions of these medications, and parts of it are about marketing specifically.
It states that unapproved versions do not undergo its review for safety, effectiveness and quality before they are marketed. It adds that compounded drugs are not approved, meaning it does not review them for safety, effectiveness or quality beforehand.
It publishes a short list of telehealth warning signs for consumers. The first item is a company making claims such as that the compounded drug is the same as an approved drug.
The rest of the list is operational rather than scientific. It names prices that seem too good to be true, and medicine that looks different from what you previously received or from what was pictured. It names packaging that is broken, damaged or missing instructions. It names no screening and prescription by a licensed doctor before medicine is provided, and no licensed doctor available afterward. It ends with spelling errors on the label, incorrect pharmacy addresses, and a pharmacy name on the label that looks wrong.
The agency also records that it has warned telehealth companies for marketing unapproved drugs, including instances of direct marketing to consumers. That is a statement about promotion, published by the agency, and it is the clearest signal that this surface is being watched.
Who actually reads the ads
There is an office inside the Administration whose job is exactly this, and knowing it exists helps make the system less abstract.
The Office of Prescription Drug Promotion describes its mission as helping to ensure that prescription drug promotion is truthful, balanced and accurately communicated, through surveillance, compliance and education.
Its reviewers are responsible for reviewing prescription drug advertising and promotional labeling to ensure the information in those materials is not false or misleading.
The office lists what that involves. It includes giving written comments on proposed promotional communications, and reviewing complaints about alleged violations. It includes issuing compliance letters on promotional communications that are false or misleading. It also includes comparing the labeling and promotion of closely related products so requirements are applied consistently, and monitoring promotional exhibits at medical meetings.
It also runs a program for reporting potentially false or misleading prescription drug promotion, and publishes the warning and untitled letters it issues.
Reading a telehealth page with the map in hand
The practical upshot is that most of what you read on a telehealth site is judged by the Commission's standard, not by the brand-name drug advertising rules.
That standard is short: advertising must be truthful and not misleading, and the advertiser must already hold adequate substantiation for every objective claim it conveys, expressly or by implication.
So the absence of a brief summary or a scrolling list of side effects on a compounded medication's sales page does not mean a rule is missing. It usually means a different rule applies.
The claims worth reading closely are the ones about equivalence and about approval, because those are where the Administration's own consumer guidance points and where the two rulebooks overlap.
None of that makes any particular page lawful or unlawful. It tells you which questions the page is actually answerable for.
Sources
- 21 U.S.C. § 353a, "Pharmacy compounding" (subsection (a), and the Editorial Notes recording the 2013 amendment)That sections 351(a)(2)(B), 352(f)(1) and 355 of the Act do not apply to a qualifying compounded drug product, and that the misbranding provisions on false or misleading labeling and on prescription drug advertisements are not among the exemptions. Also the Editorial Notes recording that Pub. L. 113-54 § 106(a)(2) and (3) redesignated subsections (d) through (f) as (c) through (e) and struck out former subsection (c), and printing that struck subsection verbatim: that a drug could be compounded under subsection (a) only if the pharmacy, licensed pharmacist or licensed physician did not advertise or promote the compounding of any particular drug, class of drug or type of drug, while permitting advertising and promotion of the compounding service itself.
- 21 U.S.C. § 353b, "Outsourcing facilities" (subsection (a), the exemption list)That sections 352(f)(1), 355 and 360eee-1 do not apply to a drug compounded by or under the direct supervision of a licensed pharmacist in a facility electing to register as an outsourcing facility, provided the section's conditions are met — a different list from the pharmacy compounding section, and one that does not include the current good manufacturing practice provision.
- 21 U.S.C. § 352, "Misbranded drugs and devices" (paragraph (a), false or misleading label, and paragraph (n), prescription drug advertisements)That paragraph (n) applies where the manufacturer, packer or distributor of a prescription drug includes advertisements and other descriptive printed matter about it; the requirements for the established name printed prominently in type at least half as large as any trade or brand name, the quantitative formula, and brief-summary information on side effects, contraindications and effectiveness; the conspicuous adverse-event reporting statement required in published direct-to-consumer advertisements; the requirement that the major statement in a direct-to-consumer television or radio advertisement naming the drug and its conditions of use be presented in a clear, conspicuous and neutral manner; and the provision that such advertisements shall not, with respect to the matters specified in that paragraph or covered by its regulations, be subject to sections 52 to 57 of title 15.
- 21 CFR § 202.1 — Prescription-drug advertisements (paragraphs (e)(1), (e)(2)(i), (k) and (l))The five-part definition of a clear, conspicuous and neutral major statement for direct-to-consumer television and radio advertisements; the reminder-advertisement exemption, its limits on content, and the provision that reminder advertisements other than certain price-only ones are not permitted for a prescription drug whose labeling contains a boxed warning relating to a serious hazard; that a non-complying advertisement issued by the manufacturer, packer or distributor causes stocks in that party's possession and stocks already distributed and still in commerce to be misbranded; the list of media whose advertisements are subject to the provision; and the determination that brochures, booklets, mailing pieces, price lists, catalogs, letters, films, exhibits, literature and reprints supplied by and disseminated on behalf of the manufacturer, packer or distributor are labeling.
- 15 U.S.C. § 55, "Additional definitions" (subsection (a)(1)), and 15 U.S.C. § 52, "Dissemination of false advertisements"That a false advertisement is defined as an advertisement, other than labeling, which is misleading in a material respect — the definitional carve-out that keeps labeling on the other side of the line. Section 52, read in the same session at its own URL, supplies the point that the Commission's false advertising section reaches advertisements likely to induce the purchase of food, drugs, devices, services or cosmetics, with services added to both of its paragraphs by the 1994 amendment recorded in that section's notes.
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossThat unapproved versions do not undergo the agency's review for safety, effectiveness and quality before they are marketed; that compounded drugs are not approved and receive no premarket review for safety, effectiveness or quality; the full telehealth warning-sign list for consumers, beginning with a company making claims such as that the compounded drug is the same as an approved drug; and the agency's record of having warned telehealth companies for marketing unapproved drugs, including instances of direct marketing to consumers.
- The Office of Prescription Drug Promotion (OPDP)The office's stated mission of helping to ensure prescription drug promotion is truthful, balanced and accurately communicated through surveillance, compliance and education; that its reviewers are responsible for reviewing prescription drug advertising and promotional labeling to ensure the information is not false or misleading; and the listed activities, including written comments on proposed promotional communications, review of complaints, compliance letters on false or misleading promotional communications, comparison across closely related products, monitoring of promotional exhibits at medical meetings, a program for reporting potentially false or misleading promotion, and publication of warning and untitled letters.
- Health Products Compliance GuidanceThat the two agencies share jurisdiction over the marketing of drugs and other health-related products and coordinate under a memorandum of understanding governing the basic division of responsibilities; that the Food and Drug Administration has primary responsibility for claims in labeling including the package, product inserts and promotional materials available at point of sale, while the Commission has primary responsibility for claims in all forms of advertising; that the agreement does not limit the Commission's jurisdiction or prevent it from acting on deceptive labeling claims or obtaining orders addressing all forms of marketing; and the two-principle statement that advertising must be truthful and not misleading and that advertisers must have adequate substantiation for all objective claims before dissemination.
Frequently asked questions
Is a compounded drug exempt from advertising rules because it is not approved?
No. The pharmacy compounding section exempts a qualifying compounded drug product from the current good manufacturing practice provision, the requirement of adequate directions for use, and the new drug approval section. The misbranding provisions covering false or misleading labeling and prescription drug advertisements are not among the exemptions.
Was compounders' advertising ever restricted by federal statute?
Yes, and that subsection no longer exists. The pharmacy compounding section once carried a condition on advertising. A drug could be compounded under it only if the pharmacy, pharmacist or physician did not advertise or promote the compounding of any particular drug, class of drug or type of drug. It permitted them to advertise the compounding service itself. Congress struck that subsection and renumbered the ones after it, and the repealed text is printed in the section's editorial notes. Whether an individual state restricts such advertising is a separate question that this article does not answer.
Which agency covers a telehealth company's website?
The Commission's health advertising guidance describes the division. The Food and Drug Administration has primary responsibility for claims that appear in labeling, including the package, product inserts and promotional materials available at point of sale. The Federal Trade Commission has primary responsibility for claims in all forms of advertising. The guidance adds that the agreement between the agencies does not limit the Commission's jurisdiction or prevent it from acting on deceptive labeling claims.
Why do brand-name drug ads carry long side-effect statements when telehealth ads do not?
Because the requirement binds a particular party. The prescription drug advertising provision applies where the manufacturer, packer or distributor of the drug issues or causes to be issued advertisements about it. It requires the established name, the quantitative formula, and a brief summary of side effects, contraindications and effectiveness. For direct-to-consumer television and radio advertisements naming the drug and its conditions of use, the major statement must be presented in a clear, conspicuous and neutral manner.
Is a brochure an advertisement or labeling?
The prescription drug advertising regulation answers this for its own purposes. Advertisements subject to the provision include those in journals, magazines, other periodicals and newspapers, and those broadcast through media such as radio, television and telephone communication systems. A different treatment applies to brochures, booklets, mailing pieces, price lists, catalogs, letters, films, exhibits, literature and reprints. Where they describe a drug, contain information supplied by the manufacturer, packer or distributor, and are disseminated by or on behalf of them, they are determined to be labeling.
What does the Food and Drug Administration tell consumers to watch for?
Its statement on unapproved versions of these drugs lists telehealth warning signs. The first is a company making claims such as that the compounded drug is the same as an approved drug. The others are operational. They cover prices that seem too good to be true, and medicine that looks different from what you previously received or from what was pictured. They cover damaged packaging or missing instructions for use. They cover no screening and prescription by a licensed doctor before medicine is provided, and no licensed doctor available afterward. They end with spelling errors on the label, incorrect pharmacy addresses, and a pharmacy name on the label that appears fraudulent.