Compounding pharmacies producing and distributing educational videos to healthcare providers on the benefits and uses of specific compounded drugs face a regulatory minefield of compliance considerations. Understanding these considerations can help pharmacies remain compliant with federal and state regulations while providing valuable educational content.

1. Compliance with FDA Regulations

Compounding pharmacies must adhere to the Federal Food, Drug, and Cosmetic Act (FDCA) and comply with U.S. Food and Drug Administration (FDA) regulations, particularly under Sections 503A and 503B:

• 503A Pharmacies: May compound drugs based on a valid prescription for an identified individual patient but cannot engage in broad promotional activities that resemble drug marketing.

• 503B Outsourcing Facilities: May produce bulk compounded drugs but are subject to more stringent FDA oversight and can provide more general educational content to prescribers.

Key Considerations:

• Ensure the videos do not promote compounded drugs as FDA-approved medications.

• Emphasize that compounded drugs are prepared for specific patient needs and are not mass-produced.

• Avoid claims of superiority over FDA-approved drugs unless supported by clinical evidence.

2. Federal Trade Commission (FTC) and Truthful Advertising

The FTC enforces truth-in-advertising laws that apply to educational materials:

• Educational content should be accurate, non-misleading, and supported by clinical data.

• Avoid making false claims about safety, efficacy, or necessity unless substantiated.

• Disclaimers should be included clarifying that compounded drugs are not FDA-approved.

3. Anti-Kickback and Stark Law Compliance

Federal laws prohibit financial incentives tied to referrals or prescribing behaviors:

• Anti-Kickback Statute: Prohibits offering anything of value in exchange for referrals.

• Stark Law: Restricts financial relationships between providers and entities providing reimbursable drugs.

Best Practices:

• Do not offer incentives (financial or otherwise) to prescribers for promoting compounded drugs.

• Clearly distinguish educational content from promotional marketing.

4. State Pharmacy Board Regulations

Each state has unique regulations governing compounding pharmacy practices. Before distributing educational content:

• Review state-specific advertising and promotion restrictions.

• Confirm whether the state requires additional disclaimers or licensing for educational materials.

• Ensure compliance with any prohibitions on direct marketing to physicians.

5. HIPAA and Patient Privacy

If videos reference patient cases:

• Obtain written consent before discussing any identifiable patient information.

• Use anonymized case studies when illustrating potential benefits.

• Follow all HIPAA privacy and security guidelines when sharing patient-related information.

6. Medical Education and CME Considerations

Compounding pharmacies may collaborate with Continuing Medical Education (CME) providers:

• Ensure content aligns with CME accreditation standards.

• If offering CME credit, work with accredited organizations that comply with the Accreditation Council for Continuing Medical Education (ACCME) guidelines.

• Maintain independence from prescribing incentives in CME presentations.

7. Documentation and Legal Review

Before distributing educational videos:

• Have materials reviewed by legal counsel to ensure compliance.

• Document the intended educational purpose of the content.

• Maintain records of all distributed materials for regulatory review if necessary.

Educational videos can be a valuable tool for compounding pharmacies to inform healthcare providers about compounded medications. However, it is essential to structure these videos in compliance with FDA, FTC, state pharmacy board, and anti-kickback regulations to avoid legal risks. Pharmacies should seek legal guidance to ensure their materials remain educational rather than promotional.