Legalities of Injecting PDGF: Off-Label or Out-of-Bounds?

In medicine, science often moves faster than the rules designed to contain it do, and few debates illustrate this tension as starkly as the current one surrounding platelet-derived growth factor (PDGF) injections in aesthetic medicine. Long utilized in wound healing, tissue regeneration, and orthopedic applications, PDGF is now viewed as the “next frontier” in facial injectables.

Here is the dilemma: While PDGF is undeniably a potent agent, its use as a cosmetic injectable exists in a regulatory gray zone. At recent industry gatherings, including Aesthetic Next 7.0, the Tell-All Tribune, and Genesis: Innovations in Aesthetic Regenerative Medicine, clinicians and thought leaders wrestled with a central question: Is injecting PDGF a forward-looking therapy that the US Food and Drug Administration (FDA) simply has not caught up to yet, and that might reasonably be used off-label? Or is it an unapproved, and therefore legally risky, practice that could expose clinicians to regulatory scrutiny and malpractice gaps?

The answer is complicated, and it raises a broader theme critical to regenerative medicine: Unstudied doesn’t necessarily mean unsafe.

FDA’S ROLE: REGULATING PRODUCTS VS THE PRACTICE OF MEDICINE

The FDA regulates the safety, effectiveness, manufacturing, and marketing of drugs, biologics, and medical devices; however, it does not regulate the practice of medicine by physicians. This distinction is critical.

Under the FDA’s framework, injecting a product is inherently a medical act rather than a cosmetic one. In the case of PDGF, that distinction matters because the moment a provider takes a cosmetic topical and injects it, the use is effectively reclassified as drug or biologic administration. Once a product is “FDA approved” and legally on the market, physicians may use it “off-label” within their state-defined scope of practice, exercising their own clinical judgment in deciding what is best for a patient. An example in aesthetics is the use of biostimulators and fillers.

Importantly, this carveout does not extend to unapproved products (those that have never been cleared or licensed by the FDA for any indication), nor does it permit companies or clinicians to promote off-label uses. In this way, the FDA’s authority is limited to regulating the product itself, while the practice of medicine (or how the practitioner chooses to use the product) remains subject to the discretion of licensed clinicians and state medical boards.

FDA APPROVAL AS THE REGULATORY BASELINE

Three categories define how products may be used in clinical practice: on-label, off-label, and unapproved.

On-label use refers to prescribing a product exactly as described in its FDA-approved labeling, including the indication, dosage, and route of administration.

Off-label use occurs when an FDA-approved product is used in a way not specified on its label; for example, for a different indication, altering the original formulation, or varying the dose. While outside the scope of FDA review, off-label prescribing is both lawful and common across many specialties. In aesthetic medicine, there are very few who use only FDA-approved neurotoxins exclusively on-label; most use neurotoxins off-label daily.

A further nuance is what can be called contra-approval. In some cases, the FDA label does not simply omit an indication but explicitly prohibits a particular use. While a product may be contraindicated for a specific route of administration or condition, because the FDA does not regulate how physicians practice medicine, contraindicated use is not illegal. It can, however, increase malpractice exposure.

Unapproved use, by contrast, involves drugs or biologics that have never received FDA approval for any indication. These products must be prescribed or marketed within controlled research pathways, such as those conducted through an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE). Unlike off-label use, which relies on existing FDA approval, unapproved use lacks any regulatory foundation, exposing providers to legal risk.

PDGF UNDER THE FDA LENS

The FDA has approved certain PDGF drugs for clinical “topical use only” and warns against injection. Attempting to inject a drug approved for topical use only is a textbook example of contra-approval—not off-label use. The FDA has also approved certain sterile injectable or implantable PDGF-based products, but only in narrow contexts (not aesthetic or cosmetic). In contrast, PDGF-based formulations that have not received FDA approval for any indication do not fall within the off-label category; instead, they are considered unapproved products.

RESEARCH AND APPROVAL PATHWAYS: THE ONLY LAWFUL OPTIONS

Currently, the only legitimate routes for introducing unapproved PDGF injectables into clinical use are through the FDA’s research and approval mechanisms. One pathway is the investigational route, which allows PDGF to be studied under an IND application if it is treated as a drug or biologic, or an IDE if a device is involved in its delivery. These mechanisms permit limited clinical use of PDGF in the context of carefully designed trials. Given the popularity of these innovative products, we expect manufacturers are seeking (or will soon seek) FDA approval.

PATIENT SAFETY AND MALPRACTICE EXPOSURE

The investigational status of PDGF is more than a regulatory technicality; it carries real consequences for clinical practice. Without FDA approval, the safety profile technically remains uncertain and introduces an element of the unknown. Injecting a non-sterile topical gel into the face presents clear risks of infection or adverse reactions; clinicians argue that even sterile formulations have not yet been studied for long-term outcomes specific to aesthetic medicine. However, PDGF supporters in the aesthetic and cosmetic realm continue to conduct and release studies showing positive, low-risk outcomes.

It is the uncertainty around this topic that results in malpractice insurers’ aversion, with many unwilling or unable to provide definitive guidance on coverage. Policies may exclude claims tied to investigational uses, which can leave providers vulnerable if complications arise. As a result, the responsibility falls on clinicians to approach PDGF with both transparency and prudence. While not a cure-all, robust informed consents can be helpful. They demonstrate disclosure and respect for patient autonomy but do not transform an investigational therapy into an accepted standard of care.

STATE LAW: WIDENING THE GAP

Adding to these clinical and insurance-related challenges is the patchwork of state-level regulation. The responsibility of governing the practice of medicine falls to state legislatures and medical boards, and their approaches to regenerative medicine are increasingly divergent.

Some states have taken a permissive stance. Utah and Nevada, for example, explicitly allow certain non-FDA-approved biologics in defined medical contexts. Florida’s 2025 law goes further, authorizing physicians to perform unapproved stem cell interventions with informed consent, particularly in orthopedics and wound care. These laws reflect a broader openness to physician discretion in emerging regenerative therapies.

Other states, however, are moving in the opposite direction, tightening restrictions and heightening oversight of non-FDA-approved products.

Physicians must navigate these rules with particular care because their licensure is governed by state medical boards that impose varying duties and standards of practice. Physicians generally have broader scope of practice than, for example, nurse practitioners or registered nurses, including greater authority to prescribe off-label uses of drugs or biologics. State rules differ, so conduct permitted in one jurisdiction may be sanctionable in another.

This divergence also underscores a broader professional obligation: While drug and biologic companies disseminate information about their products, the law places responsibility squarely on the clinician to remain informed and exercise independent judgment. Courts and regulators consistently emphasize that practitioners must understand their own scope of practice, stay current with state-specific rules, and apply evolving standards of care, rather than relying solely on industry-supplied information.

WALKING THE TIGHTROPE

Injecting PDGF captures both the promise and the peril of regenerative medicine. It reflects the excitement of cellular rejuvenation but also underscores how quickly innovation can outpace the rules designed to safeguard patients.

At present, PDGF injectables remain firmly in a regulatory gray zone, unapproved at the federal level and subject to a patchwork of state approaches that may provide broader discretion in some jurisdictions while prompting heightened scrutiny in others.

Regenerative medicine more broadly is at the forefront of current conversations in aesthetics. Exosomes, polynucleotides, secretomes, amniotic-derived fluids, and other emerging biologics all represent innovative approaches with tremendous promise, but each falls under a different FDA framework and carries its own legal complexities. For that reason, the analysis provided here should not be read as universally applicable; rather, a separate legal assessment for each category of drug is the most prudent path forward. What unites them all, however, is their role in pushing the boundaries of innovation and reshaping how the aesthetic field approaches rejuvenation.

Rather than relying on regulatory gray zones, the aesthetic and regenerative medicine communities have an opportunity to collaborate with manufacturers in building the clinical evidence for PDGF. Clinician participation in research not only strengthens patient safety but also accelerates the pathway toward legitimate approvals that will expand therapeutic options.

Looking ahead, clarity will depend on regulators adapting to keep pace with scientific advances and on states finding an equilibrium between oversight and innovation.

Madison Dini

• Houston managing partner, Michelman & Robinson, LLP.

      Houston, TX

Sheila Barbarino, MD, FACS

• Cosmetic surgeon and key opinion leader

      Austin, TX, and Redondo Beach, CA