A Major Update for Peptide Compounding: What Prescribers Need to Know

Regulations surrounding certain compounded peptides have taken an important step forward.

The U.S. Department of Health and Human Services (HHS) has announced an interim enforcement-discretion policy regarding 503A compounding using certain peptide bulk drug substances while the 503A Bulks List continues to be developed through formal rulemaking.

For prescribers, we want to make the actual regulatory language easy to access and explain what this development means for working with Cody Drug.

What Changed?

Under the new policy, HHS states that it does not intend to take enforcement action against a state-licensed pharmacy, federal facility, or licensed physician for compounding certain identified peptide bulk drug substances when all conditions outlined in the policy are satisfied.

The peptides currently included in Appendix A of the policy are:

• BPC-157

• Epitalon

• KPV

• MOTS-c

• Semax

• TB-500

This is an interim enforcement-discretion policy, not FDA approval of these compounded drug products. Compounded medications remain subject to applicable federal and state requirements, including the patient-specific prescription requirements of Section 503A.

What Does This Mean for Cody Drug Prescribers?

Our team has been preparing carefully for this development.

We have completed the applicable testing, meticulously developed each formula, and organized the documentation required to support our compounding processes in accordance with the applicable requirements of the policy.

The HHS policy establishes detailed conditions relating to areas including:

• Active pharmaceutical ingredient identity and characterization

• Certificates of Analysis

• API manufacturer registration and documentation

• Purity, potency and contaminant testing

• Product quality and adverse-event reporting

• Product labeling

• Single-active-ingredient formulations

• Route of administration

• Patient-specific prescriptions and other applicable Section 503A requirements

Our priority is to provide prescribers with transparent access to the regulatory information behind this change while maintaining the quality and documentation standards required for compounded medications.

Pre-Orders Are Now Open

Cody Drug is accepting pre-orders now through November 1, 2026.

Shipping will begin November 2, 2026.

If you are a current Cody Drug provider, our team is available to assist with questions regarding ordering, available formulations, documentation, or the onboarding process.

Read the Regulatory Documents

We encourage every prescriber to review the source material directly.

HHS Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances
https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf

Federal Register Notice: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances
https://www.federalregister.gov/d/2026-22192

The Federal Register notice is scheduled for publication on October 30, 2026.

Moving Forward

This policy represents a meaningful development in the regulatory landscape surrounding certain peptide bulk drug substances used in 503A compounding.

At Cody Drug, we will continue monitoring regulatory developments closely and maintaining the testing, documentation, and quality processes applicable to the products we compound.

For questions about peptide availability, pre-orders, or working with Cody Drug, please contact our team.