Over the past two decades, compounded medicine has re-emerged in medical discussions and practices for the first time in nearly seventy years. The need for personalized pharmaceuticals has gained renewed recognition. Treatments such as bioidentical hormone replacement therapies, erectile dysfunction solutions, tailored dosages, allergy accommodations, and options for uninsured ailments are increasingly prompting compounded prescriptions.
While compounding has established itself as an important component of modern medicine, the industry is still evolving. Ongoing questions about regulations and compliance persist, and new treatments continue to impact sectors of standardized pharmaceuticals. Additionally, broader medical trends contribute to the growth of compounding. For responsible physicians, staying informed about these shifts is essential to ensure patient safety and provide the best available treatment options. Below is an overview of three significant trends to watch as we move into 2025.
1. Regulatory Changes and Sterility Compliance
One of the most significant issues surrounding the resurgence of compounded pharmaceuticals is the concern regarding their safety and the relatively limited government regulation. In response to these concerns, standards for sterility and quality control have become increasingly stringent, and efforts to enhance these regulations continue to gain momentum. This ongoing commitment to improving safety measures is essential for ensuring that compounded medications meet the necessary quality standards for patient care.
Following the Compounding Quality Act of 2014, which substantially increased FDA regulation, many pharmaceutical boards and regulatory bodies have continued to tighten compounding guidelines. The U.S. Pharmacopeia (USP) just recently amended its General Chapters 795 and 797 to “ensure quality compounded preparations, promote public health, and protect patients and healthcare workers.” Accreditations like the PCAB have also helped to distinguish compliant pharmacists, and have become required for recommendation by bodies like the AMA.
Pharmacies that do not prioritize meeting and exceeding these enhanced standards may encounter significant challenges in the future. Physicians are encouraged to engage with their compounding pharmacies to inquire about the compliance measures and accreditations they have in place. Pharmacies that adhere to these regulations not only prioritize patient health but also provide a reliable resource as mandatory standards continue to evolve.
2. Drug Shortages
Prescription drug shortages have been a longstanding issue in the realm of mass-produced medicine. However, the COVID-19 pandemic highlighted the severity and scope of these shortages, revealing the challenges faced by healthcare providers and patients alike. This situation underscores the importance of reliable access to medications, including compounded options, to ensure that patients receive the treatments they need. The pharmaceutical market is still reeling; HRT patches and gels have been in short supply for more than a year and are likely to remain scarce through 2025. Other, lower-demand drugs of equal significance may never come back.
The reasons behind prescription drug shortages are numerous, but they ultimately stem from the fragility of the supply chain and the narrow profit margins that deter the production of many common medications. If even a single ingredient is delayed or if a medication is not financially viable, it may not reach the market.
These scenarios leave both patients and physicians without the necessary medications, leading them to seek compounded alternatives. As supply chains become increasingly unreliable due to geopolitical tensions, this trend is likely to continue. Physicians are encouraged to monitor drugs that may be at risk of shortage or discontinuation and to have contingency plans in place for when these medications become unavailable.
3. Dermatological Demand
While bioidentical hormone replacement therapies, urological treatments, and weight-loss medications have gained prominence in the resurgence of compounding, dermatology has also seen renewed interest in custom formulations. Given the diverse range of skin types and conditions, over-the-counter dermatological treatments often prove ineffective. Additionally, standard prescription medications can be prohibitively expensive for many patients, as cosmetic treatments are frequently not covered by insurance.
This context has allowed skincare brands like Curology, Musely, and Apostrophe to make significant strides by offering custom compounded treatments at relatively low costs. However, some critics raise concerns about the small concentrations of active ingredients in these compounded formulations, and patients with more serious conditions may still prefer prescriptions from their general physician or dermatologist.
These physicians have a valuable opportunity to prescribe compounded treatments for patients seeking dermatological solutions, whether they are trying these options for the first time or have found over-the-counter treatments ineffective. When appropriate, these pharmacy-produced formulations can be both more effective than standard alternatives and more affordable than mass-produced medications, providing patients with tailored solutions for their skincare needs.
Empowering Personalized Care for the Future With Compounding Medicine
Compounded medicine has regained its significance in the pharmaceutical industry and is becoming increasingly prevalent. It enables pharmacists to offer patients personalized and often cost-effective solutions that may not otherwise be accessible. However, this resurgence also brings new risks and considerations for physicians, who must stay informed to fulfill their responsibilities effectively. By closely monitoring the three trends discussed here, physicians can confidently prescribe compounded medications as they move into the new year.
If you’re looking to partner with a reputable, compliant compounding pharmacy, read on to discover how MediVera Compounding Pharmacy checks all the boxes.
