Peptide Therapy Disclosures

Peptide and Compounded Medication Disclosures

Important information about how we prescribe peptides and compounded medications, the regulatory framework we operate within, and the informed consent process for compounded therapy.

Last reviewed: June 10, 2026

Our prescribing framework

OnPoint Performance PLLC is a licensed medical practice. All medications and peptides discussed on this website are prescribed by Gretchen Delgado, MSN, APRN, AGACNP-BC, following a clinical evaluation that includes patient intake, comprehensive laboratory work, review of your medical history, and a formal Initial Health Assessment.

No medication is prescribed without an established provider-patient relationship, current laboratory results where clinically indicated, and clinical appropriateness as determined by your provider. All medications are dispensed only through licensed pharmacies, either as FDA-approved commercial drug products from retail or specialty pharmacies, or as individual patient-specific compounded prescriptions from licensed 503A compounding pharmacies.

We do not sell peptides or medications direct-to-consumer. We do not offer "research use only" products. We do not fulfill prescriptions from our own facility. We do not advertise or recommend peptides obtained outside a legitimate clinical pathway.

The medications we prescribe fall into two regulatory categories

The medications available through our practice are not a single regulatory category. Different substances have different FDA approval status, different pharmacy sourcing pathways, and different evidence bases. Understanding which category applies to your specific protocol is part of the informed consent process.

Category One

FDA-approved medications

These are peptides and medications that have received full FDA approval as commercial drug products. They have completed clinical trials for their approved indications and are dispensed by retail or specialty pharmacies as brand-name or generic products. They may be prescribed for their approved indications or, at the clinical discretion of a licensed provider, off-label when supported by clinical evidence and provider judgment.

Category Two

Compounded medications prescribed through licensed 503A pharmacies

These are medications and peptides prepared for individual patients by licensed compounding pharmacies operating under Section 503A of the Federal Food, Drug, and Cosmetic Act. Each prescription is patient-specific and issued only after clinical evaluation. Some compounded medications are FDA-approved active ingredients prepared in customized formulations. Others are peptides and compounds that have not received FDA approval as commercial drug products.

The FDA maintains a formal classification system for substances eligible for 503A compounding. This regulatory landscape is under active review, including proceedings scheduled for 2026 that may affect the availability of certain compounded substances. Our practice stays current with FDA guidance and adjusts our formulary accordingly.

OnPoint Performance prescribes compounded medications that we and our licensed pharmacy partners believe to be clinically appropriate for the specific patient. Where a substance falls under active FDA review or has heightened regulatory considerations, we discuss the current regulatory status with the patient during consultation. Prescriptions are issued only after this discussion and only when the provider has determined that the clinical benefit-to-risk assessment supports the therapy for that individual.

FDA approval status and off-label use

For FDA-approved medications

FDA-approved medications may be prescribed for their approved indications, and, at the clinical discretion of a licensed provider, for uses not specifically approved by the FDA ("off-label"). Off-label prescribing is legal and common in medical practice when supported by clinical evidence and provider judgment. If your protocol involves off-label use of an FDA-approved drug, your provider will discuss this with you as part of the informed consent process.

For compounded medications

Compounded medications and peptides are not FDA-approved as commercial drug products. They are prescribed based on clinical judgment and the available scientific and medical literature. The FDA has not evaluated compounded formulations for safety or efficacy in the specific ways they may be used in a clinical protocol. Statements made on this website about compounded medications are for educational purposes and are not FDA-evaluated claims.

Statements on this website about peptides, compounded medications, and their effects have not been evaluated by the FDA unless a specific FDA approval is explicitly referenced. Substances discussed on this website are not intended to diagnose, treat, cure, or prevent any disease unless they are FDA-approved for that specific use.

Informed consent for compounded medications

Before your provider prescribes any compounded medication, including any compounded peptide, you will receive information about:

The current FDA regulatory status of the specific substance, including whether it is on the FDA's Category 1 or Category 2 bulk drug substances list,
The available scientific literature on the substance's use for your clinical situation,
Known potential risks, side effects, and contraindications,
The compounding pharmacy that will fulfill your prescription and its licensure status,
Reasonable alternatives, including FDA-approved medications and non-pharmacologic options,
The evolving nature of the regulatory landscape and how it may affect ongoing availability.

You will have the opportunity to ask questions before agreeing to any compounded medication protocol. You may decline any recommended protocol at any time. If a compounded medication you have been prescribed becomes unavailable due to regulatory changes, we will discuss alternatives with you before your next refill.

Prescriptions for compounded medications are issued only after this informed consent conversation and only when your provider has determined that the therapy is clinically appropriate for you specifically.

Individual results and risks

Any clinical outcomes, patient experiences, or examples discussed on this website reflect the experiences of specific individuals and are not guarantees of results for any other person. Peptide and compounded medication outcomes vary based on individual biology, medical history, adherence to protocol, and many other factors.

All prescription medications carry potential risks and side effects. Your provider will discuss the specific risks, benefits, and alternatives for any recommended protocol during your consultation. Common considerations may include:

Injection site reactions,
Gastrointestinal effects, particularly with GLP-1 receptor agonists,
Potential interactions with other medications you are taking,
Contraindications based on medical history,
Long-term safety data limitations, particularly for compounded substances that have not undergone the full FDA drug approval process.

Our pharmacy partners

All medications prescribed by OnPoint Performance are dispensed by licensed pharmacies. FDA-approved medications are dispensed by retail or specialty pharmacies. Compounded medications are prepared by licensed 503A compounding pharmacies that meet USP 797 sterility standards and use active pharmaceutical ingredients from FDA-registered manufacturers.

Compounding pharmacy partners

OnPoint Performance works with the following licensed 503A compounding pharmacies for patient-specific compounded prescriptions:

Hallandale Pharmacy — a licensed 503A compounding pharmacy based in Hallandale Beach, Florida. Established compounder operating under Florida Board of Pharmacy oversight.
Optimal Pharmacy — a licensed 503A compounding pharmacy fulfilling patient-specific compounded prescriptions for our practice.

Both pharmacies operate under state pharmacy board licensure and comply with USP 797 sterility standards for compounded sterile preparations. Prescriptions are transmitted electronically from our practice to the pharmacy through secure clinical channels. Patients receive medications directly from the pharmacy.

What we do not do

We do not recommend, endorse, or provide guidance for peptides or medications sourced from research chemical suppliers, gray-market vendors, personal importation, or any other source outside a legitimate pharmacy-based prescription pathway. We do not sell peptides or medications directly. We do not fulfill prescriptions from our own facility. Patients who obtain medications outside our clinical pathway are outside the scope of our care, and we cannot provide oversight, monitoring, or dose adjustment for medications we did not prescribe.

This page is educational, not medical advice

The information on this page is provided for general educational purposes. It does not constitute medical advice, diagnosis, or treatment. Individual medication and protocol recommendations are made only during a formal clinical encounter, based on your specific labs, history, and goals. Specific medications, dosing, and protocols are not discussed on this website.

For more detail on the limits of educational content on this website, see our Medical Disclaimer.

Questions about compounded therapy

Discuss your specific case

If you have questions about the medications and peptides we prescribe, our compounding pharmacy partners, or how compounded therapy fits into your protocol, the appropriate next step is an Initial Health Assessment. Your provider will discuss all clinical questions during your consultation, including regulatory status, risks, and reasonable alternatives.

For general questions about this disclosure page, contact us at info@onpointperformancepllc.com.