Compounding pharmacists offer unique solutions tailored to meet specific patient needs and should have the opportunity to share these options appropriately in their communities. While promoting awareness of compounding services is vital, it’s important to thoughtfully approach how you market the services your pharmacy provides. Poorly executed marketing can attract regulatory and legal scrutiny. As such, it’s essential to understand that all marketing content, including publicly available materials, are subject to review by regulators and legal entities.

Patients, caregivers and healthcare practitioners seeking treatment options may not be familiar with the concept of compounding or the variety of ways compounding pharmacies can address specific healthcare concerns. It’s crucial that patients have access to all available treatment options and that prescribers are aware of and refer patients to compounding pharmacies that adhere with state and federal regulatory agencies. When promoting your compounding pharmacy, keep in mind the following key areas when creating or contracting marketing collateral.

1. Adhere to Legal and Regulatory Requirements for Compounding

   Compounding pharmacists, technicians and marketers must be familiar with the requirements of the state boards of pharmacy where they are licensed. While state boards typically require compliance with the United States Pharmacopeia (USP), it’s important to note that some states may have alternative or more stringent standards. The FDA also provides various guidance documents that compounding pharmacies should be aware of — notably their Insanitary Conditions guidance. The most important aspect of these standards is patient safety. Staying up to date on compounding regulations helps minimize risks to patients and helps compounders avoid marketing noncompliant compounded preparations or practices.

2. Avoid Unsubstantiated Claims

   Under Section 503A of the Food, Drug and Cosmetic Act, compounded human drugs are exempt from the new drug approval process. Because compounded preparations don’t undergo the FDA’s approval process for safety and efficacy, compounders should refrain from making statements suggesting that these preparations are “safe” or “effective.” It’s critical to avoid marketing materials that could be interpreted as making unsupported claims.

3. Conduct Thorough Marketing Reviews

   Whether you choose to outsource marketing or develop materials in-house, it’s essential that all marketing content is reviewed and approved by someone with the necessary expertise. If your organization lacks this expertise, consider partnering with a legal or regulatory professional who can oversee the approval process. This precaution helps prevent potential pitfalls, such as inadvertently making unapproved claims or what may be perceived as a claim.

Resources: Best Practices for Marketing

It’s crucial that both patients and healthcare practitioners understand that compounding exists to address specific and the often-unmet needs of patients. Appropriately communicating compounding services through various marketing channels is essential — but it must be done responsibly.

The Alliance for Pharmacy Compounding (APC) has developed a detailed document outlining best practices for marketing by compounders. While these recommendations are not legal advice, they provide useful guidance to help navigate the creation of marketing materials.

Ensure your practice remains in FDA regulatory compliance by reviewing the FDA Insanitary Conditions guidance.

PCCA members with clinical services access may reach out to our Clinical Services team for help with marketing, as well as with other compounding concerns.

PCCA is recognized as the leader of quality products, education and advocacy in the compounding industry. Find out how a PCCA membership can benefit your compounding practice.