Regulatory Landscape: What Prescribers Need to Know About Compounded Peptides

Introduction

The regulatory framework governing compounded peptides is complex and evolving. For prescribers, understanding these regulations is essential for compliant practice and patient safety.

FDA Framework for Compounding

503A Pharmacies (Traditional Compounding)

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, traditional compounding pharmacies may prepare patient-specific medications when:

• A licensed prescriber writes a prescription for an individual patient
• The compound is not essentially copies of commercially available products
• The pharmacy does not compound in anticipation of receiving prescriptions

Key requirements:

• Patient-specific prescriptions required
• Limited distribution (generally within state)
• State board of pharmacy oversight

503B Outsourcing Facilities

Section 503B facilities operate differently:

• May compound without patient-specific prescriptions
• Must register with FDA
• Subject to FDA cGMP requirements
• Can distribute interstate
• Must comply with additional quality standards

Peptide-Specific Considerations

The FDA Bulk Drug Substances List

The FDA maintains lists of bulk drug substances that may be used in compounding:

• Category 1: Substances that may be used
• Category 2: Substances under evaluation
• Category 3: Substances that may NOT be used

Important: The status of specific peptides on these lists changes. Prescribers should verify current status before prescribing.

Recent FDA Actions

Recent FDA enforcement has focused on:

• Peptides marketed for research use but sold for human use
• Quality concerns at compounding facilities
• Products making unapproved drug claims

State Regulations

Beyond federal requirements, prescribers must navigate state-specific rules:

• Prescribing authority: Some states limit peptide prescribing to certain provider types
• Telemedicine restrictions: Requirements for in-person exams before prescribing
• Compounding pharmacy regulations: State-specific licensing and quality requirements

Best Practices for Compliance

Pharmacy Selection

When selecting compounding pharmacies:

1. Verify licensing: Confirm state and federal registrations
2. Request documentation: Certificates of Analysis, sterility testing, potency verification
3. Evaluate quality systems: USP 797/800 compliance, quality assurance programs
4. Check track record: Inspection history, recalls, enforcement actions

Documentation Requirements

Maintain thorough records including:

• Clinical rationale for peptide selection
• Informed consent discussing compounded nature of medication
• Source pharmacy information
• Lot numbers and beyond-use dates
• Patient response and any adverse events

Informed Consent

Patients should understand:

• The medication is compounded, not FDA-approved
• Potential risks and benefits
• Alternative FDA-approved options when available
• The prescriber's rationale for recommending compounding

Emerging Regulatory Trends

Watch for developments in:

• FDA guidance on peptide compounding
• State-level legislative actions
• Professional society position statements
• Quality standards evolution

Conclusion

Regulatory compliance in peptide prescribing requires ongoing attention to federal and state requirements. Building relationships with reputable compounding pharmacies and maintaining thorough documentation protects both prescribers and patients.

References

1. FDA. Human Drug Compounding. fda.gov/drugs/guidance-compliance-regulatory-information/human-drug-compounding
2. U.S. Pharmacopeia. USP General Chapter 797 Pharmaceutical Compounding—Sterile Preparations.
3. National Association of Boards of Pharmacy. Model State Pharmacy Act and Model Rules.