The Alliance for Pharmacy Compounding (APC) has issued a policy blueprint advocating for the removal of federal compounding regulations it considers redundant, unauthorized, or ineffective. These policies were detailed in a recently released report.
According to the APC's policy blueprint, outdated federal regulations are significantly hindering access to customized compounded medications across the United States. The organization points out that many rules, including interpretations under Sections 503A and 503B of the Food, Drug, and Cosmetic Act (FD&C Act), no longer align with modern compounding practices or statutory intent. The report emphasizes the need for a more intelligent regulatory approach to protect public health without restricting patient access or burdening small compounding pharmacies.
As said in the APC blueprint, the FDA’s enforcement of a 1997 Memorandum of Understanding (MOU) limits pharmacies in non-signatory states to shipping no more than 5% of their compounded medications across state lines. This limitation arises from a provision in the FD&C Act that the FDA has continued to enforce despite changes in the regulatory landscape following the passage of the Drug Quality and Security Act in 2013. According to APC, this rule jeopardizes patient access in rural and underserved areas where local compounding services may be unavailable, effectively penalizing pharmacies for their state’s policy choices.
In its 2023 Guidance for Industry #256, the FDA has rejected nearly 93% of the 300 nominated substances proposed for use in veterinary compounding, according to APC. The organization argues that these rejections often lack clear scientific rationale and disproportionately restrict veterinarians’ ability to provide appropriate care, especially for species with limited approved treatment options. The guidance imposes additional regulatory hurdles without a Congressional mandate, raising concerns among pharmacists and veterinarians about its impact on animal health.
According to its official website, APC is the national trade association representing over 600 compounding professionals and small businesses across both 503A and 503B settings. The organization advocates for pharmacy compounding's role in addressing individualized patient needs when commercial drug products are insufficient or unavailable. It supports policies that protect access to compounded therapies while promoting rigorous safety and quality standards.
