What Peptides Can Compounding Pharmacies Legally Sell in 2025?

A Complete Guide to FDA Regulations, Banned Substances, and Compliance Requirements

The landscape of peptide compounding has changed dramatically. With recent FDA crackdowns, shortage exceptions expiring, and over 150 warning letters issued in 2025 alone, knowing what's legal isn't just important—it's essential for both pharmacies and consumers.

If you're wondering whether your pharmacy can compound semaglutide, tirzepatide, BPC-157, or other popular peptides, this guide breaks down exactly what's allowed, what's banned, and what the penalties are for getting it wrong.

1. Core Legal Restrictions (503A vs 503B)



Not all compounding pharmacies operate under the same rules. The FDA distinguishes between two types of facilities, each with vastly different capabilities:

Bottom line: You cannot legally compound a peptide if it’s:

• FDA-approved and not in shortage
• Not on the FDA Bulks List
• Marketed for general use (not patient-specific)

2. FDA Bulk Drug Substances Lists (What Peptides Are Allowed?)

The FDA maintains three lists that determine which peptides can be used in compounding:

Officially Banned or Restricted Peptides (2025)

Source: FDA Bulks List (updated Sep 2025)

3. Shortage Exception (Temporary Loophole — Now Closed)

• After these dates: No compounding allowed — even with a prescription.
• FDA issued >150 warning letters in 2025 for continued sales.



4. Other Restrictions (Even If on Bulks List)

Even allowed peptides cannot be:

• Sold with dosing guides, before/after photos, or weight loss claims
• Marketed as "same as Ozempic" or "bioidentical"
• Shipped interstate (503A >5% rule)
• Made in non-sterile conditions (USP <797>)

Example: A pharmacy compounding vasopressin for research must:

• Have a patient-specific Rx
• Use FDA-inspected API
• Label: “For Research Use Only – Not for Human Use” (if not prescribed)

5. Enforcement Actions (2025 Examples)

FDA now uses AI to scan websites, Telegram, Discord, and Reddit for violations.

6. What Can Compounding Pharmacies Legally Sell? (2025)

No “research peptide” loophole — selling BPC-157/TB-500 as “Not for human use” is still illegal if marketed online.

7. Workarounds Some Pharmacies Try (Risky & Often Fail)

8. Bottom Line: What You Need to Know

The Bottom Line: For Compounding Pharmacies Compliance Isn't Optional

The peptide compounding industry is under intense FDA scrutiny, and the consequences of non-compliance are severe for compounding pharmacies ranging from warning letters and product recalls to criminal prosecution and loss of pharmacy licenses. With AI-powered monitoring scanning online marketplaces and social media, there's no flying under the radar.

For pharmacies: If you're unsure whether you can compound a specific peptide, the answer is probably no. When in doubt, consult the FDA Bulks List, seek legal counsel, and prioritize patient safety over profit margins.

For consumers: Take note! Your choices for peptides are severely limited by the FDA. The research peptide market is a gray market with caution and due diligence risks can be mitigated to a degree but it will always exist.

The regulations are clear, the enforcement is real, and the stakes are high. Stay informed, demand transparency from your suppliers, and always verify that every peptide with a 3rd party COA.

Your health depends on it.

Sources & Monitoring

Sources: FDA.gov (503A/503B Guidance, Bulks List, Warning Letters), USP <797>, DQSA 2013, Avalere Health, Pharmacy Times

Monitor: FDA Compounding Page — updated weekly

Disclaimer:

This article is for informational and educational purposes only and does not constitute legal, medical, or professional advice. The information provided is based on FDA regulations and guidance documents current as of the publication date, but pharmaceutical compounding laws are subject to frequent changes and updates.

Not Legal Advice: This content should not be relied upon as legal counsel. Compounding pharmacies, healthcare providers, and businesses should consult with qualified legal professionals and regulatory experts before making compliance decisions.

Not Medical Advice: This article does not provide medical recommendations or endorse any specific treatments. Patients should consult with licensed healthcare providers regarding their individual medical needs and treatment options.

No Warranty: While we strive for accuracy, we make no representations or warranties regarding the completeness, accuracy, or timeliness of the information provided. Regulatory guidance can change without notice, and readers are responsible for verifying current regulations with the FDA and relevant state boards.

Use at Your Own Risk: The author and publisher assume no liability for actions taken based on the information in this article. Violation of FDA regulations can result in serious legal consequences including fines, criminal prosecution, and loss of professional licenses.

Always verify current FDA guidance, consult qualified legal and medical professionals, and review the most recent FDA Bulks Lists and shortage declarations before making any decisions related to peptide compounding.