Executive Summary
- What’s new: In early February 2026, FDA announced it is taking issue with the use of the phrase “same active ingredient” in advertising for compounded drugs, saying it may confuse consumers.
- Why it matters: TFDA’s new enforcement approach creates uncertainty for how companies engaged in the development, marketing and sale of compounded and generic drugs communicate with patients, health-care professionals and customers.
- What to do next: We will continue to watch FDA’s evolving enforcement posture with interest. It is unclear if the agency intends to take action or if this is more a threat of potential enforcement to encourage compliance.
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In early February 2026, the U.S. Food and Drug Administration (FDA) announced that it was taking issue with the use of the phrase “same active ingredient” in advertising for compounded drugs. FDA explained that it is concerned that claiming a compounded drug has the “same active ingredient” as an FDA-approved product is confusing to consumers. However, FDA’s position, as currently articulated, appears to be inconsistent with the federal Food, Drug, and Cosmetic Act (FDCA), FDA’s prior communications about active pharmaceutical ingredients used in compounding, and longstanding agency practice. Indeed, it is unclear how compounders or other manufacturers — such as those that make generic drugs — can avoid referencing the concept of “same active ingredient” in discussing their products, as that is the relevant statutory standard.
FDA has a long regulatory history around establishing “active ingredient” sameness, which predates the issue becoming relevant for compounding. Specifically, in the context of generic drug development, the agency has long required that a generic drug’s active ingredient be identical to that of the reference listed drug (RLD). This requirement is codified in 21 CFR 314.3(b) and 314.92(a)(1), and explained at length in the agency’s draft guidance on “Sameness Evaluations in an ANDA — Active Ingredients.” In its guidance, FDA details the scientific and regulatory standards for determining whether an active ingredient is the “same” as that in the RLD, based on the definition of active ingredient in 314.3(b).1 As the guidance explains, FDA intentionally takes a flexible approach in determining active ingredient sameness and an active ingredient does not have to be obtained from the brand manufacturer to be the “same” as that in an RLD. According to the guidance, there are adequate scientific methods available to support establishing the identity of active ingredients, and a less flexible approach may be too rigid to support generic drug development.
The 1992 preamble to the final rule implementing the Hatch-Waxman amendments provides additional insight into why FDA took this flexible approach.2 As explained in that preamble, an active ingredient is the same if it meets the same standards of identity, which in most cases are described in the United States Pharmacopoeia (USP). If there is no USP standard, then FDA may prescribe additional standards to establish the identity of the molecule. FDA’s framework for establishing active ingredient sameness provides that it is established using well-understood scientific methods, as limiting “sameness” to ingredients obtained from brand manufacturers would stifle generic competition.
By the time the Drug Quality and Security Act was passed in 2013, FDA had 20 years of experience developing the scientific and regulatory basis for establishing sameness of active pharmaceutical ingredients. This is likely why Sections 503A and 503B of the FDCA take a very similar approach to that in the 1992 final rule implementing Hatch-Waxman. According to the FDCA, drugs must be compounded using an active ingredient that complies with a USP monograph or, if a monograph doesn’t exist, is a “component” of a drug approved by FDA. In other words, the process for identifying the active pharmaceutical ingredient that may be used in a compounded drug echoes that for generics. Evaluating active ingredient sameness in both of these pathways — generic drugs and compounded drugs — on the basis of establishing similarity to FDA-approved products increases patient access to generic and compounded formulations that contain the same active ingredient as FDA-approved innovator products. It also ensures that there is a scientific basis for the identity and safety profile of the active ingredients used, which flows from FDA’s scientific understanding of the active ingredients in drugs it has already approved.
What’s more, FDA’s guidance documents and public statements have, for years, used the phrase “same active ingredient” or “same API” (active pharmaceutical ingredient) to describe the relationship between compounded drugs and their FDA-approved counterparts, particularly when discussing the legal requirements for compounding under Section 503A. For example, page 6 of FDA’s guidance on “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” states that “[w]hen a compounded drug product offers the same API as a commercially available drug product, in the same, similar, or easily substitutable dosage strength and for use through the same route of administration, we generally intend to consider such a drug product essentially a copy, unless a prescriber determines that there is a change, made for an identified individual patient, that will produce a significant difference for that patient.”
In other words, a drug lawfully compounded pursuant to 503A with the same active ingredient as an FDA-approved drug is appropriate to prescribe for an individual patient when there is a change that will produce a significant difference for that patient. Under 503A, compounding must be done using the same active ingredient as an FDA-approved drug, or else it is not lawful and the resulting drugs are unapproved new drugs. This requirement also makes sense because compounded drug products are often made for patients in vulnerable populations or with specific health needs that necessitate a compounded formulation. For those patients especially, it is critical that they receive a compounded drug with the same active pharmaceutical ingredient as the FDA-approved version to avoid unanticipated side effects or drug-drug interactions.
FDA’s Import Alert 66-80, “Detention Without Physical Examination of Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Bulk Drug Substances,” goes so far as to list the active pharmaceutical ingredients that FDA has deemed appropriate for importation for use in compounding GLP-1 products. The import alert describes these products as being “GLP-1 APIs” and notes the specific ingredient being imported, which would allow compounders to say that the active ingredient in the compounded product is, in fact, the same as the active ingredient in the FDA-approved drug. Presumably, FDA felt confident enough in these molecules to list their identities and deem them as appropriate for compounding.
Despite this clear and longstanding framework, as noted above, FDA has recently taken the position that advertising compounded drugs as containing the “same active ingredient” as an FDA-approved product is false or misleading, even when the statement is factually accurate. The agency has argued in warning letters to compounders, social media posts, news interviews and press releases that such statements may imply equivalence to FDA-approved products, rather than simply informing consumers of the identity of the active ingredient in the compounded drug product.
FDA’s recent assertion that the phrase “same active ingredient” is inherently misleading is surprising given that, as discussed above, the statement is consistent with the law. As compounded drugs must use the same active ingredient as an FDA-approved drug, communicating this fact arguably is essential for transparency. Patients have a right to know the identity of the active ingredient in their medication, and the use of the term “same active ingredient” enables them to make informed decisions about their treatment. FDA suggests that the phrase “same active ingredient” may lead to patient confusion, but this seems especially unlikely when compounded drugs often carry a disclaimer that they are not FDA-approved and have not been evaluated for safety, effectiveness or quality by the FDA.
While clearly aimed at drug compounders, FDA’s confusing and inconsistent new position on the use of “same active ingredient” risks sowing broader uncertainty across the pharmaceutical industry, particularly for companies engaged in the development, marketing and sale of generic drugs. If FDA now treats the phrase “same active ingredient” as potentially misleading, despite its factual and legal basis in that space, it could create a chilling effect on other truthful commercial speech.
For example, the generic drug “skinny labeling” cases currently making their way through the courts turn on whether it is truthful and not misleading for an A-rated generic to call itself a “generic version” of the branded drug without such a truthful statement giving rise to a claim of patent infringement. In these cases, FDA has determined that the generic drug is therapeutically equivalent to the brand, meaning it can be automatically substituted at the pharmacy. Generic manufacturers rely on FDA’s therapeutic equivalence determination in stating that their drugs are A-rated generics. If FDA suddenly took the position that such a statement, which is also clearly supported by the statutory framework, could not be used in advertising because it could cause consumer confusion, it could upend the generic industry. Ultimately, FDA’s new compounding enforcement posture may threaten not only the lawful practice of compounding but also the protection afforded to truthful, nonmisleading speech about drug products.
Notably, FDA has not supported its new position by identifying evidence of consumer confusion, other demonstrated harm, a regulatory gap or another statutory basis for prohibiting truthful statements about active ingredient sameness. Rather, FDA’s enforcement rationale seems to reflect an effort to assert control over a sector that has, in recent years, grown in both visibility and market share, often in response to drug shortages or consumer demand. But given the clear statutory and regulatory requirements of “same active ingredient,” changes in this area can only come from Congress, not through enforcement efforts that lack a legal or factual basis.
The statutory standard is clear, and the agency’s attempt to circumvent it by attacking truthful, nonmisleading speech is unpersuasive and likely to be unsustainable.
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1 That definition is “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.” 21 CFR 314.3(b).
2 57 FR 17959 (April 28, 1992).
This memorandum is provided by Skadden, Arps, Slate, Meagher & Flom LLP and its affiliates for educational and informational purposes only and is not intended and should not be construed as legal advice. This memorandum is considered advertising under applicable state laws.