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Best Practices for Promoting Compounded Preparations

Below, we outline key guidelines to help ensure your promotional efforts remain ethical, compliant and effective.

Guidelines for Promotional Content

  1. Focus on Facts
    We encourage members to share factual information about the technical aspects of compounded preparations and ingredients, supported by published articles, case studies and technical reports. Any use of patient testimonials should be focused on aspects of service, such as customer satisfaction, personalization of care or the professionalism of staff, rather than the effects of the compounded medication itself.
  2. Communicating with Care
    When discussing the effects of compounded preparations, it's essential to avoid claims about treating, curing or mitigating diseases unless backed by substantial evidence and in compliance with FDA guidelines. Similarly, steer clear of suggesting that a preparation is "safe" or "effective" for any condition. In all communications, prominently include the disclaimer: “The FDA does not review any compounded medication for safety or efficacy.”
  3. Avoid Comparing Compounded Preparations to FDA-Approved Commercial Drugs
    Avoid all direct comparisons between compounded medications and FDA-approved drugs in marketing materials. Instead, focus on the unique aspects of compounded medications, such as their ability to be tailored to meet individual patient needs when commercially available options are not suitable.

Our Commitment to Compliance

PCCA is committed to upholding the highest compliance standards with regulatory guidelines, recognizing the complexity of pharmaceutical compounding and marketing. These recommendations are a starting point; we strongly encourage engaging with legal counsel who specialize in FDA regulations and pharmacy law to regularly review your marketing materials. This proactive approach ensures your promotional efforts reflect the latest standards and practices.

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