Compounded Medication Disclosure

1. What Are Compounded Medications?

Compounded medications are prescription drugs prepared by a licensed pharmacist for an individual patient based on a prescription from a licensed healthcare provider. Compounding involves combining, mixing, or altering ingredients to create a medication that is tailored to the patient's specific needs.

Compounded medications have been part of pharmacy practice for over a century. They serve patients who cannot use commercially available, FDA-approved drugs because of allergies to ingredients, the need for a specific dose not commercially available, or because the desired medication is not commercially produced as an FDA-approved drug.

2. The Legal Basis for Compounding

Compounding is permitted under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA):

• Section 503A pharmaciesare traditional compounding pharmacies that prepare medications based on individual patient prescriptions. They are regulated primarily by state boards of pharmacy and must comply with the United States Pharmacopeia (USP) compounding standards (USP <795> for non-sterile and USP <797> for sterile compounding).
• Section 503B outsourcing facilities are larger compounding facilities that can prepare medications in bulk without individual patient prescriptions. They are registered with and regulated directly by the U.S. Food and Drug Administration (FDA) and must comply with current Good Manufacturing Practices (cGMP), the same quality standards that apply to FDA-approved pharmaceutical manufacturers.

Pepvio works only with licensed 503A and 503B pharmacies that are registered, inspected, and operating in compliance with applicable federal and state regulations.

3. Compounded Medications Are Not FDA-Approved

The U.S. Food and Drug Administration does not approve compounded drugs for safety, effectiveness, or manufacturing quality in the same manner as FDA-approved finished pharmaceutical products.

FDA approval is the process by which the FDA reviews extensive clinical trial data submitted by a drug manufacturer, evaluates the drug's safety and effectiveness for specific indications, inspects the manufacturing facility, and approves the drug's label, dosing, packaging, and labeling. This process generally takes years and costs hundreds of millions to billions of dollars per drug.

Compounded medications, by contrast, are prepared by licensed pharmacies based on individual prescriptions or established compounding practices. They have not undergone the FDA approval process. This means:

• The FDA has not reviewed the compounded medication for safety in the way it would review a new pharmaceutical drug application
• The FDA has not reviewed the compounded medication for effectiveness for any specific indication
• The FDA has not approved the labeling, dosing, or packaging of the compounded medication
• The FDA has not inspected the specific compounded product (although the compounding pharmacy itself is regulated and inspected)

This does NOT mean compounded medications are unsafe. Compounded medications have been used in the United States for over a century, and licensed compounding pharmacies operate under strict state and federal regulations. It does mean that compounded medications carry a different evidence and oversight profile than FDA-approved drugs, and patients should be aware of this distinction.

4. Variability in Compounded Medications

Compounded medications may have variability between different batches or different pharmacies, including:

• Differences in concentration or potency within tolerances permitted by USP standards
• Differences in inactive ingredients (excipients), preservatives, or carriers
• Differences in physical appearance, color, or consistency
• Differences in formulation (for example, different routes of administration)
• Differences in stability and shelf life depending on storage conditions

Reputable compounding pharmacies test each batch for purity, potency, and sterility (where applicable) and provide certificates of analysis. Pepvio works only with pharmacies that follow these quality assurance practices.

5. Specific Considerations for Compounded Peptides

Peptide therapy involves medications that are short chains of amino acids. Many therapeutic peptides have not been studied in formal large-scale human clinical trials, and the available evidence varies significantly across different peptides. Some peptides have decades of international clinical use and substantial research; others have primarily animal study evidence and clinical experience without rigorous human trials.

You acknowledge and understand:

• The compounded peptides prescribed through the Services have not been FDA-approved as drugs
• Long-term human safety data for many peptides is limited compared to FDA-approved drugs
• Dosing protocols for peptides are based on a combination of clinical research, clinical experience, and physician judgment, and may vary between providers
• Individual response to peptide therapy varies significantly
• Pepvio makes no representation or warranty that any compounded peptide is equivalent to, interchangeable with, or therapeutically the same as any FDA-approved drug
• You should discuss any questions, concerns, or unexpected side effects with your prescribing Provider promptly

6. The 2026 FDA Reclassification

In late 2023, the FDA placed several peptides on its Category 2 restricted list, effectively prohibiting compounding pharmacies from preparing them. In February 2026, the U.S. Department of Health and Human Services announced that approximately 14 of those peptides would be moved back to Category 1 status, restoring legal access through licensed compounding pharmacies under physician prescription. The peptides Pepvio offers are among those returning to Category 1 status.

Category 1 status means the peptide may be legally compounded for individual patients pursuant to a valid prescription. It does NOT mean the peptide is FDA-approved as a drug. The reclassification restores the legal compounding pathway but does not change the regulatory status of compounded medications generally.

7. Quality Assurance

All compounding pharmacies that fill prescriptions for Pepvio patients are licensed and registered under federal and state law. The pharmacies follow USP standards for compounding and provide certificates of analysis (COAs) for each batch of compounded peptides, including:

• Identity verification (confirming the peptide is what it should be)
• Purity testing
• Potency testing (confirming the dose matches the label)
• Sterility testing (for injectable products)
• Endotoxin testing (for injectable products)
• Visual inspection

8. Reporting Adverse Events

If you experience any adverse reaction, side effect, or unexpected symptom while using a compounded medication prescribed through Pepvio, contact your prescribing Provider immediately. For severe or life-threatening reactions, call 911 or go to your nearest emergency room.

You may also report adverse events to the FDA's MedWatch program at www.fda.gov/safety/medwatch or by calling 1-800-FDA-1088.

9. Acknowledgment

By completing the Pepvio health intake and consenting to receive prescription medication through the Services, you acknowledge that:

• You have read and understand this Compounded Medication Disclosure
• You understand that compounded medications are not FDA-approved
• You understand that compounded medications may have variability between batches
• You have had the opportunity to ask questions about compounded medications
• You voluntarily consent to receive compounded peptide therapy
• You will report any adverse reactions or unexpected symptoms to your prescribing Provider

10. Contact

Questions about compounded medications:

• General support: support@pepvio.com
• Clinical questions (forwarded to your Provider): support@pepvio.com