Approved for a specific use
FDA approval applies to a defined indication and patient population. It does not automatically apply to every promoted use.
Understand the evidence, regulatory status, and medical considerations before deciding whether a peptide or related therapy may be appropriate for you.
A consultation does not guarantee a prescription. Eligible Florida patients may be seen by telemedicine.

Peptides are short chains of amino acids that act as signaling molecules in the body. As medications, they are laboratory-manufactured to mimic or influence natural signaling processes and target specific physiological functions.
Different peptides act on different systems. Some influence the pituitary pathways involved in growth hormone release. Others have been studied for roles in tissue repair, metabolic function, or central nervous system pathways involved in sexual desire. New peptides are continually researched, and the evidence base for any given one ranges from large controlled human trials to preliminary animal work.
That range is the reason this page separates them by regulatory status rather than presenting them as a uniform menu.
Peptide-based treatments vary considerably in FDA approval status, available clinical evidence, and permitted uses. Some peptide medications are FDA-approved for specific conditions. Others remain investigational. Others may be prepared by a compounding pharmacy when legally and medically appropriate. These are meaningfully different situations:
FDA approval applies to a defined indication and patient population. It does not automatically apply to every promoted use.
A licensed pharmacy may prepare a medication when legally and medically appropriate. The compounded preparation is not an FDA-approved finished drug product.
Safety and effectiveness may not be established through adequate human clinical trials. Some substances may not be legally available for prescribing.
The FDA is constantly evaluating and reevaluating peptides. Before taking any medication, it's important to have a consultation with your physician, speak with your pharmacist, and check the current FDA regulatory status of all medications. All health consultations are handled on a case-by-case basis, and Dr. Mackey will determine patient eligibility.
An important note on how medication reaches patients: NovaGenix does not dispense medication. Dr. Mackey prescribes when treatment is medically appropriate, and a licensed pharmacy dispenses. Regulatory status changes can affect what a pharmacy is permitted to prepare, and pharmacies are typically the first to know when those changes take effect.

Patients also ask about TB-500 and the Wolverine Stack (BPC-157 and TB-500). These guides explain the evidence and limitations. Current availability and suitability must be confirmed with the physician and dispensing pharmacy.
Select a therapy for a concise clinical overview. Availability and candidacy depend on medical evaluation and current pharmacy and regulatory rules.
A growth hormone–releasing hormone analog that stimulates the pituitary pathway responsible for endogenous growth-hormone release.
View Sermorelin overview →A growth-hormone secretagogue discussed in the context of limited evidence, regulatory status, and individualized risk assessment.
View Ipamorelin overview →FDA-approved to reduce excess visceral abdominal fat in adults with HIV-associated lipodystrophy; other uses require separate medical and regulatory consideration.
View Tesamorelin overview →An investigational peptide with claims that extend well beyond the available human clinical evidence.
View BPC-157 overview →Acts on central nervous system pathways associated with sexual desire. Approval is limited to a specific indication and population.
View PT-141 overview →A coenzyme involved in cellular energy metabolism. NAD+ is discussed here as a related wellness therapy, not as a peptide.
View NAD+ overview →Sermorelin is a growth hormone–releasing hormone analog that stimulates the pituitary gland to release the body's own growth hormone, rather than supplying growth hormone directly.
Sermorelin was previously FDA-approved under the brand name Geref for the treatment of short stature associated with growth hormone deficiency in pediatric patients. It was discontinued by the manufacturer in 2008 for commercial reasons rather than for safety or efficacy concerns. Use in adults for other purposes is off-label and requires individual medical evaluation. An increase in a growth-hormone marker alone does not demonstrate better sleep, recovery or another meaningful clinical outcome. Current compounded preparations are not FDA-approved finished products.
Ipamorelin is a selective growth hormone secretagogue that has been studied for its effect on growth hormone release with relatively little stimulation of cortisol or other stress hormones.
Ipamorelin is not FDA-approved for any indication. Its status under the FDA's compounding framework has changed more than once: it was placed in Category 2 of the interim 503A bulk drug substances list in September 2023, removed from that category in September 2024 after the nomination was withdrawn, and referred for further review. The FDA has identified specific concerns, including the potential for immunogenicity related to aggregation or peptide-related impurities, the presence of unnatural amino acids that complicate characterization, and a report of serious adverse events when ipamorelin was administered intravenously in a different clinical context.
Tesamorelin is a growth hormone–releasing hormone analog that stimulates the body's own growth hormone production.
Tesamorelin is FDA-approved for one specific indication: helping reduce excess visceral abdominal fat in adults with HIV-associated lipodystrophy. It is marketed as Egrifta. It is not FDA-approved for general weight loss, body composition improvement, anti-aging, or athletic performance. Any use outside the approved indication is off-label and requires individual medical evaluation and informed discussion of what is and is not established.
BPC-157 is an investigational peptide studied primarily in laboratory and animal models, with research interest focused on tissue-repair pathways. Reliable human clinical evidence establishing its safety, effective dosage, or benefit for injury recovery remains limited. In short, the FDA treats BPC-157 as an unapproved investigational substance. An advisory committee recommended a pathway toward limited compounding eligibility, but the agency's staff opposed it on evidentiary grounds, and no final regulatory authorization for compounding or approval has been granted. Status can change with future rulemaking; always check the official FDA website or current Federal Register notices for the most up-to-date information.
Many compounding pharmacies have prepared BPC-157 in both injectable and encapsulated forms. BPC-157 is listed by the World Anti-Doping Agency as a prohibited, non-approved substance in sanctioned competition. This section is educational. It is not an offer of treatment.
PT-141 (bremelanotide) acts on central nervous system pathways involved in sexual desire, rather than on blood flow the way PDE5 inhibitors such as sildenafil and tadalafil do. Some patients are unable to take PDE5 inhibitors because of their current or past medical history, and PT-141 is sometimes discussed as an option in those cases.
Because the population that cannot take PDE5 inhibitors often overlaps with the population in which bremelanotide requires caution, candidacy is determined during medical evaluation rather than assumed.
Approved population. The FDA-approved formulation is indicated specifically for premenopausal women. It is not approved for postmenopausal women or for men. Use in men is off-label, and safety data in that population is limited.
Drug interactions. Bremelanotide slows gastric emptying and can substantially reduce the absorption of orally administered medications. This is clinically significant with oral naltrexone, where reduced drug levels may result in treatment failure. Patients taking naltrexone should discuss this with the prescribing physician.
Monitoring. Blood pressure elevation can occur even in patients without baseline hypertension. Patients should seek medical attention for severe headache, vision changes, or a pounding sensation in the neck or ears.
Bremelanotide is FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women — a persistent lack of sexual desire causing personal distress, not explained by another medical condition, medication, or relationship factor. It is the only FDA-approved medication acting on this pathway for that indication. There is no FDA-approved indication for bremelanotide in men; use in men is off-label. Compounded formulations, including troches, are not FDA-approved products regardless of the approval status of the branded medication.
Nicotinamide adenine dinucleotide (NAD+) is a coenzyme involved in mitochondrial function and cellular energy production. NAD+ levels decline with age and may be further affected by chronic stress, poor sleep, inflammation, and metabolic strain. NAD+ is not a peptide. It is included in this program because of its role in cellular energy metabolism. Areas of research interest include:
Evidence in humans varies by outcome and route of administration. NAD+’s role in cellular metabolism does not establish that injections restore youthful energy, cognition or recovery. FDA has received reports of severe chills, shaking, vomiting and fatigue after injectable NAD+, sometimes requiring medical treatment, and warns against using unsuitable food-grade ingredients in sterile preparations. Discuss product sourcing, risks and expected benefits with the physician and pharmacist.
Read the FDA notice on injectable NAD+ and sterile-compounding ingredients.
Peptide therapy is not appropriate for everyone, and a consultation does not guarantee a prescription.
Where an FDA-approved medication with established evidence addresses the patient's goal, that option is discussed first.
Dr. Mackey reviews contraindications for any medication under consideration during the initial consultation, to determine whether a patient is a good candidate and whether a peptide is clinically appropriate.
Meet with Dr. Mackey in Jupiter or, when eligible, by Florida telehealth.
Appropriate laboratory testing is ordered based on your history, symptoms, and goals.
Your medical history, medications, goals, and results are evaluated together.
If appropriate, treatment is prescribed through a licensed pharmacy with ongoing follow-up.
The initial consultation is available by telehealth for patients throughout the state of Florida. Patients do not need to travel to Jupiter for the initial visit.
Whether an in-person visit is required is determined on a case-by-case basis by Dr. Mackey. In many cases the medical evaluation can be completed remotely. NovaGenix does not prescribe on the basis of an online form — an actual physician evaluation is required before any treatment decision. Blood work is typically required, though the specific labs needed are determined by the physician and discussed during the consultation. Patients may use any Labcorp location convenient to them; travel to Jupiter for the draw is not necessary. NovaGenix is able to assist with all lab work. Treatment decisions are made following medical evaluation, and ongoing monitoring is part of physician-directed care. Follow-up may include repeat laboratory testing, symptom review, and adjustment of the plan based on response and objective findings.

This section is provided for education. Current availability depends on regulatory status and on what a licensed pharmacy is permitted to prepare at any given time, and that status can change. Anyone considering it should confirm the current position with their physician and pharmacist.
Peptide therapy at NovaGenix Health & Wellness is overseen by our medical director, Dr. Timothy Mackey, a Florida-licensed osteopathic physician with internal medicine training and more than two decades in clinical practice. He completed his undergraduate education at Miami University and earned his Doctor of Osteopathic Medicine degree from the Ohio University Heritage College of Osteopathic Medicine in 2001, followed by internal medicine residency training in St. Petersburg, Florida. Before medical school, he served as a non-commissioned officer in the United States Army. His approach emphasizes careful patient selection, evidence-informed decision making, laboratory monitoring, transparent discussion of benefits and limitations, and individualized treatment plans. At NovaGenix, peptide therapy is not presented as a quick solution, but as one component of a broader strategy for long-term health optimization.
NovaGenix Health & Wellness is located in Jupiter, Florida and serves patients locally in Palm Beach County as well as individuals throughout the state of Florida seeking medically supervised peptide therapy. We also offer hormone therapy, weight loss and regenerative medicine services to our patients.
If you are interested in learning whether peptide therapy may be appropriate for your goals, the first step is a comprehensive consultation to evaluate your health history and determine the safest and most effective path forward. Email us at info@NovaGenix.org or call/text at 561-277-8260 to learn more
Some are and most are not. Approval is specific to a medication and an indication rather than to the category. Tesamorelin is FDA-approved for reducing excess visceral abdominal fat in adults with HIV-associated lipodystrophy. Bremelanotide is FDA-approved for hypoactive sexual desire disorder in premenopausal women. BPC-157 and ipamorelin are not FDA-approved for any indication.
Yes. These are prescription medications that require evaluation by a licensed physician. NovaGenix does not prescribe on the basis of an online form, and a consultation does not guarantee that a prescription will be issued.
Yes. The initial consultation is available by telehealth for patients throughout Florida. Whether an in-person visit is needed is determined case by case by Dr. Mackey, and in many cases the evaluation can be completed remotely.
No. Blood work is typically required, but patients may use any Labcorp location convenient to them. The specific labs needed are determined by the physician and discussed during the consultation.
No. Peptides are short chains of amino acids that act as signaling molecules. Anabolic steroids are synthetic derivatives of testosterone and are controlled substances. They are different classes of medication with different mechanisms and different legal status.
Athletes subject to drug testing should assume the answer is no until they have verified otherwise for their specific substance and sanctioning body. The WADA Prohibited List includes a non-approved substances category that is deliberately broad, so a substance does not need to be named individually to be prohibited. Under strict liability, a prescription does not transfer responsibility and is not the same as a Therapeutic Use Exemption, which must be applied for separately.
No. Under the World Anti-Doping Code, strict liability means an athlete is responsible for what is in their body regardless of intent and regardless of who prescribed it. A Therapeutic Use Exemption is a separate application that must be granted by the relevant anti-doping organization, and having a valid prescription is not the same as having one.
Peptides are reviewed through the FDA's bulk drug substances process, which determines what compounding pharmacies may prepare. Substances move between categories as evidence is submitted, nominations are withdrawn, and advisory committees meet. Because status can change, current availability should be confirmed at the time of consultation.
This depends on the medication, the goal, and the individual. Some effects are measured by laboratory values rather than by how a patient feels, and some outcomes are assessed by imaging rather than by scale weight. Realistic timeframes are discussed during consultation based on the specific therapy under consideration.
NovaGenix is a cash-pay practice. Contact the office at 561-277-8260 for current information about consultation, laboratory, and treatment costs before scheduling.
Dr. Mackey reviews symptoms, medical history, current medications, prior treatments, and goals, then determines what laboratory testing is appropriate. Recommendations follow the review of results. A consultation does not guarantee that any medication will be prescribed.
If you compete in a sport with drug testing, assume peptides are prohibited until you have confirmed otherwise for your specific substance and your specific sanctioning body. This section is written to be read before a consultation, not after a positive test.
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Two categories of the WADA Prohibited List do most of the work here, and both are prohibited at all times — in competition and out of it. S0, Non-Approved Substances: this category covers any substance not currently approved by a governmental regulatory health authority for human therapeutic use. It is deliberately broad. BPC-157 falls here, and so do many research peptides that have never been individually named on any list. S2, Peptide Hormones, Growth Factors, Related Substances and Mimetics: this covers growth hormone and the substances that stimulate its release, which includes growth hormone–releasing hormone analogs and growth hormone secretagogues. A substance does not need to appear by name to be prohibited. S0 is a catch-all, which means "it isn't on the list" is not a defense.
This is the single most common misunderstanding, and it is expensive.
Strict liability applies. Under the World Anti-Doping Code, an athlete is responsible for what is in their body regardless of intent, and regardless of who prescribed it. A physician's prescription does not transfer that responsibility.
A Therapeutic Use Exemption is a separate application. A TUE must be applied for and granted by the relevant anti-doping organization, generally before use, and is granted only where specific criteria are met. Having a valid prescription is not the same as having a TUE.
A prohibited substance is unlikely to receive a TUE where an approved alternative exists. The criteria weigh whether a permitted treatment would produce a comparable therapeutic outcome.
The WADA list is the reference standard, but it is not always the operative rulebook. Different bodies maintain their own lists, which may be broader, narrower, or simply different. NCAA athletes are governed by the NCAA banned-drug classes, which include peptide hormones and growth factors, and by their institution's own policies. Professional leagues — NFL, MLB, NBA, NHL, and others — negotiate their own programs through collective bargaining, and each differs. High school athletes are subject to state association rules; in Florida that is the FHSAA, alongside NFHS guidance. Olympic and national governing bodies follow WADA through USADA in the United States. Military service members and many law enforcement agencies operate under separate testing policies that have nothing to do with sport. If you compete under more than one of these, the strictest applicable rule governs.
1. Identify every sanctioning body you compete under, including school, league, and national federation
2. Check the current WADA Prohibited List for your specific substance
3. Check USADA resources, including guidance on dietary supplements — contamination is a documented cause of positive tests, and third-party certification such as NSF Certified for Sport reduces but does not eliminate that risk
4. Ask whether a permitted alternative achieves the same clinical goal
5. Confirm status again before each competitive season, since lists are revised annually
6. Tell your physician you are a tested athlete before treatment is discussed, not after
We've consulted with many athletes about peptides and their use in post-injury recovery. Those conversations routinely begin with eligibility rules rather than with medication, and they sometimes end there.
Explore these existing guides for more detail on evidence, regulatory questions and athlete considerations.
Certain Bulk Drug Substances for Use in Compounding That May Present Significant Safety Risks — U.S. Food and Drug AdministrationBulk Drug Substances Used in Compounding — U.S. Food and Drug Administration
Prohibited List — World Anti-Doping AgencyU.S. Anti-Doping Agency
Learn whether a peptide or related therapy may be medically appropriate for you—and understand the evidence and regulatory status before making a decision.
Patients looking to buy peptides online can get a legitimate physician consultation at our Jupiter, Florida clinic, or by telehealth, and may be prescribed peptide therapies, where permitted by law, dispensed from a licensed U.S. pharmacy when clinically appropriate.
No prescription is written before an individual physician evaluation.

Tesamorelin and sermorelin are both growth-hormone-releasing hormone analogs and are often discussed as if they were interchangeable. Their regulatory status is not remotely the same, and that difference is what should drive a decision.
Ipamorelin works through a different receptor again — the ghrelin receptor rather than the GHRH receptor — and holds no FDA approval for any indication. That comparison is here: sermorelin vs. ipamorelin.
Comparing peptides with testosterone treatment? Read Peptides vs. TRT: which peptides actually affect testosterone?
Learn what you want to know about hormone therapy by scheduling a free consultation.
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