FEDERAL AND STATE REGULATION OF COMPOUNDING

To advocate that the applicable compendial standards of the United States Pharmacopeia be included in state and federal laws and regulations that govern compounding by any health professional; further,

To advocate for mandatory state registration of compounding facilities (e.g., pharmacies, physician offices, clinics, ambulatory surgery centers) that provide products for specific patient prescriptions or in anticipation of specific patient prescriptions or medication orders; further,

To advocate for mandatory Food and Drug Administration registration and current good manufacturing practices requirements for outsourcing facilities that compound and sell products without patient-specific prescriptions across state lines; further,

To advocate for improved patient safety and care through education of regulatory inspectors, increased frequency and improved effectiveness of compliance inspections, and enhancing interagency communications; further,

To advocate that state and federal agencies develop standardized definitions and nomenclature relating to sterile and nonsterile compounding, including but not limited to definitions of compounding, manufacturing, repackaging, and relabeling.

Rationale

The practice of compounding has evolved along with the profession of pharmacy. With the advancement of pharmaceutical manufacturing, the preparation of individualized medications based on a prescription or medication order has also evolved. In particular, sterile preparation and related best practices (e.g., ASHP guidelines) and standards of practice (relevant USP chapters) have also evolved. However, cases of contamination, adulteration, and misbranding have persisted, culminating in the meningitis tragedy caused by contaminated sterile preparations compounded by the New England Compounding Center (NECC). That contamination resulted in 64 deaths and over 700 patient cases, as reported by the Centers for Disease Control and Prevention.

The NECC case highlighted the need for accountability and clear regulatory jurisdiction between state boards of pharmacy and the federal Food and Drug Administration. Since 1997, there has been discussion and debate over the proper oversight of compounding. The NECC case demonstrated the real and potential national public health threat posed by the lack of oversight of the practice of compounding. This threat is particularly acute when high-risk sterile products are prepared in large quantities and sold across state lines without adherence to either relevant USP chapters or Food and Drug Administration (FDA) current good manufacturing practices (cGMPs). Over the past 16 years, a series of court decisions in various federal circuits has resulted in a patchwork application of Section 503A of the Federal Food Drug and Cosmetic Act. In addition, a new type of supplier of sterile compounded preparations has emerged to fill a critical need for high-risk sterile preparations for hospitals and health systems. Those health systems are often unable to make the capital and/or human resource investments to prepare these high-risk preparations and seek to use outside suppliers to meet their patients’ needs. In 2013, Congress passed H.R. 3204, the Drug Quality and Security Act (DQSA) and President Obama signed it into law (P.L. 113-54) on November 27, 2013. Prior to the passage of the DQSA, these outside suppliers operated as licensed pharmacies and in some cases also registered as drug establishments with the FDA. However, the authority for FDA to inspect and enforce either cGMPs or USP standards was unclear. DQSA is designed to provide that clarity as well as delineate the accountability between the FDA and state boards.

ASHP advocates federal oversight of certain entities that compound and engage in interstate commerce to address the wider public health threat when these preparations can potentially be distributed nationwide. ASHP continues to call for state regulation of compounding by health professionals (including pharmacists, physicians, and nurses) that would require meeting the applicable USP standards. ASHP believes that federally registered compounding facilities should be required to meet applicable cGMPs and that state-registered facilities engaged in “traditional compounding” (i.e., compounding for specific patient prescriptions or in anticipation of specific patient prescriptions or medication orders) be required to meet applicable USP standards. ASHP also advocates for inspection by the relevant regulatory body, training of inspectors, and enhanced communication among federal and state regulatory authorities. Finally, ASHP calls for standard definitions and nomenclature for certain terms that may have different definitions within federal law and regulation and between federal and state law and regulation (FDA, Drug Enforcement Administration [DEA], pharmacy practice act and regulation).